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AT TM THE CONVENTION ON BIOLOGICAL DIVERSITY AND THE NAGOYA PROTOCOL: INTELLECTUAL PROPERTY IMPLICATIONS Handbook Interface Global Access Benefit Sharing Rules Intellectual Property United Nations Conference Trade Development Convention Biological Diversity Nagoya Protocol: Intellectual Property Implications Handbook Interface Global Access Benefit Sharing Rules Intellectual Property Copyright © United Nations, 2014 Convention Biodiversity Nagoya Protocol: Intellectual Property Implications ii Convention Biological Diversity Nagoya Protocol: Intellectual Property Implications, Handbook Interface Global Access Benefit Sharing Rules Intellectual Property 1. Convention Biological Diversity. 2. Intellectual property. 3. Access benefit sharing. 4. Developing countries. Published : United Nations Conference Trade Development (UNCTAD) Palais des Nations 8-14 avenue de la Paix, 1211 Geneva, Switzerland Copyright © United Nations, 2014. queries rights licenses, including subsidiary rights addressed : United Nations Publications 300 East 42nd St York, NY 10017 email: publications@.org website: .org/publications mention specific companies manufacturers’ products imply endorsed recommended United Nations preference similar nature mentioned. Errors omissions excepted, names proprietary products distinguished capital letters. designations employed presentation material imply expression opinion part United Nations legal status country, territory, city area, authorities limitations frontiers boundaries. Material publication freely quoted reprinted, acknowledgement requested, copy publication quotation reprint UNCTAD secretariat. reasonable precautions UNCTAD verify information contained publication. , published material distributed warranty kind, express implied. responsibility interpretation material lies reader. event UNCTAD liable damages arising . publication produced support Government Germany. findings, interpretations, conclusions expressed handbook necessarily reflect views United Nations Member States, donor. UNCTAD/DIAE/PCB/2014/3 Convention Biodiversity Nagoya Protocol: Intellectual Property Implications iii Note publication developed handbook aimed understanding intellectual property implications 1992 Convention Biological Diversity 2010 Nagoya Protocol Access Genetic Resources Fair Equitable Sharing Benefits arising Utilization. textbook, adapted courses formats, including lectures, distance learning blended learning. German Federal Ministry Economic Cooperation Development (BMZ) commissioned United Nations Conference Trade Development (UNCTAD) develop handbook cooperation German International Cooperation (GIZ). UNCTAD mandated undertake research analysis trade development aspects intellectual property, including protection traditional knowledge, genetic resources folklore fair equitable sharing (paragraph 105 Accra Accord (2008) paragraph 65() Doha Mandate (2012)). UNCTAD’ work carried intergovernmental deliberations, research analyses, technical assistance activities, seminars, workshops conferences. term “country” publication refers, , territories areas. designations employed presentation material imply expression opinion whatsoever part United Nations legal status country, territory, city area, authorities, delimitation frontiers boundaries. addition, designations country groups intended solely statistical analytical convenience necessarily express judgment stage development reached country area development process. Reference company, public private centres national programmes activities construed endorsement UNCTAD institution activities. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications iv Acknowledgments drafting team handbook consists lead authors. Chapters 1, 2, 3, 4 7 publication prepared Kiyoshi Adachi, Chief UNCTAD’ Intellectual Property Unit, Investment Capacity-Building Branch Division Investment Enterprise. Chapter 5 publication prepared Hartmut Meyer, Senior Advisor GIZ’ Access Benefit Sharing Capacity Building Initiative. Chapter 6 publication prepared David Vivas Eugui, Legal Officer Trade, Environment, Climate Change Sustainable Development Branch UNCTAD’ Division International Trade Goods Services, Commodities, Xavier Seuba, Professor Law Universitat Pompeu Fabra. UNCTAD gratefully acknowledges extensive comments versions guide Rainer Engels, Ahmed Abdel Latif, Sandy Harnisch, Christoph Spennemann Ermias Biadgleng. UNCTAD expresses peer reviewers comments handbook Ad Hoc Expert Group meeting Development Dimensions Intellectual Property: Biological Diversity Access Benefit Sharing (ABS) held Palais des Nations Geneva, Switzerland, 16-17 April 2013. programme Ad Hoc Expert Group Meeting attached annex publication (Annex IV). Monica Adjivon assistance finalization document. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications Table Contents note.. ...................................................................................................................................................................... iii acknowledgments .................................................................................................................................................. iv table abbreviations ............................................................................................................................................ ix INTRODUCTION ................................................................................................................................................. 1 CHAPTER 1 THE INTERNATIONAL FRAMEWORK FOR ACCESS AND BENEFIT SHARING OF GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE ....................................... 8 . INTRODUCTION ....................................................................................................................................... 8 II. THE GLOBAL FRAMEWORK FOR ACCESS AND BENEFIT SHARING ...................................... 8 . HOW DOES THE GLOBAL ACCESS AND BENEFIT SHARING SYSTEM WORK ............................................ 13 . WHAT DOES THE GLOBAL ACCESS AND BENEFIT SHARING SYSTEM COVER ......................................... 16 1) Temporal Scope Treaties.......................................................................................................... 16 2) Traditional Knowledge (TK) .............................................................................................................. 18 3) Plant Genetic Resources Food Agriculture ........................................................................... 22 4) Viruses Pathogens ............................................................................................................. 25 5) Derivatives ......................................................................................................................................... 27 III. CONCLUSION .......................................................................................................................................... 29 CHAPTER 2 BEYOND THE CBD AND THE NAGOYA PROTOCOL: OTHER INSTRUMENTS THAT AFFECT ABS AND INTELLECTUAL PROPERTY ......................................................................... 30 . INTRODUCTION ..................................................................................................................................... 30 II. INTELLECTUAL PROPERTY TREATIES ......................................................................................... 30 . THE TRIPS AGREEMENT ......................................................................................................................... 30 . THE WIPO TREATIES .............................................................................................................................. 35 . UPOV ..................................................................................................................................................... 37 . FREE TRADE AGREEMENTS ..................................................................................................................... 38 III. THE WHO PANDEMIC INFLUENZA PREPAREDNESS FRAMEWORK .................................... 39 IV. PROTECTING TRADITIONAL KNOWLEDGE ................................................................................. 40 . ILO CONVENTION 169 ............................................................................................................................. 40 . UNIVERSAL DECLARATION OF HUMAN RIGHTS AND ICESCR ................................................................ 42 . UNDRIP ................................................................................................................................................. 43 . UNESCO ................................................................................................................................................ 44 . CONCLUSION .......................................................................................................................................... 45 CHAPTER 3 DISCLOSURE OF ORIGIN/SOURCE AND LEGAL PROVENANCE ............................... 47 . INTRODUCTION ..................................................................................................................................... 47 II. THE RELATIONSHIP BETWEEN DISCLOSURE AND PRIOR ART ............................................ 49 III. SHAPING DISCLOSURE OF ORIGIN REQUIREMENT .............................................................. 52 . ASSUMPTIONS, OBJECTIVES AND LIMITATIONS OF DISCLOSURE OF ORIGIN ............................................ 52 . WHAT OUGHT TO BE DISCLOSED THE CASE OF WHERE PATENT OFFICES AND NATIONAL COMPETENT AUTHORITIES FUNCTION RELATIVELY INDEPENDENTLY .................................................................................. 55 Convention Biodiversity Nagoya Protocol: Intellectual Property Implications vi . WHAT OUGHT TO BE DISCLOSED THE CASE OF WHERE PATENT OFFICES ASSUME GREATER ROLE IN NAGOYA PROTOCOL FUNCTIONS ...................................................................................................................... 62 . ENFORCEMENT AND REMEDIES .................................................................................................................... 65 IV. DISCLOSURE AND OWNERSHIP ........................................................................................................ 68 . TEMPORAL SCOPE OF THE PROTOCOL AND DISCLOSURE .................................................... 70 VI. MEASURES TO HELP PREVENT BIO-PIRACY ABROAD ............................................................. 71 VII. CONCLUSION .......................................................................................................................................... 73 CHAPTER 4 ADDITIONAL MECHANISMS BEYOND DISCLOSURE ................................................... 75 . INTRODUCTION ..................................................................................................................................... 75 II. LIFE FORMS AND THEIR PATENTABILITY ................................................................................... 75 . BIOTECHNOLOGY, GRS AND DERIVATIVES: KEY EXCLUSIONS ............................................................... 75 . PATHOGENS ............................................................................................................................................. 79 III. LIMITATIONS AND EXCEPTIONS TO IP LAWS ............................................................................. 82 . THE RESEARCH AND EXPERIMENTATION EXCEPTION FOR PATENTS AND PBRS ...................................... 82 . THE MEDICAL TREATMENT EXCEPTION .................................................................................................. 86 . THE ‘CLEAN HANDS’ DOCTRINE ............................................................................................................. 89 . UNFAIR COMPETITION, COMPETITION AND UNJUST ENRICHMENT BASED THEORIES .............................. 92 VI. CONCLUSION ............................................................................................................................................. 94 CHAPTER 5 PROTECTION OF TRADITIONAL KNOWLEDGE ........................................................... 96 . INTRODUCTION ..................................................................................................................................... 96 II. DEFINING TK .......................................................................................................................................... 97 III. PROTECTING TK ................................................................................................................................... 98 . THE LIMITS OF MODERN IP LAWS ........................................................................................................... 99 . THE PUBLIC DOMAIN ............................................................................................................................ 103 . SUI GENERIS SYSTEMS .......................................................................................................................... 104 1) Subject Matter Definition ................................................................................................................. 106 2) Holder Rights ............................................................................................................................... 108 3) Scope Rights ................................................................................................................................. 109 4) Acknowledgement Rights ............................................................................................................. 112 5) Publicly TK ...................................................................................................................... 113 6) ABS Elements ................................................................................................................................... 114 7) Elements Positive IPR Protection .............................................................................................. 115 8) Elements Defensive IPR Protection ............................................................................................ 116 9) Pay Systems ....................................................................................................................... 118 . DATABASES ........................................................................................................................................... 118 IV. CONCLUSION ........................................................................................................................................ 119 CHAPTER 6 DISTINCTIVE SIGNS, BIODIVERSITY DERIVED PRODUCTS AND PROTECTION OF TRADITIONAL KNOWLEDGE .................................................................................................................... 121 . INTRODUCTION ................................................................................................................................... 121 . PGIS AND PDOS .................................................................................................................................... 122 . TRADEMARKS, CERTIFICATION TRADEMARKS AND COLLECTIVE TRADEMARKS ................................... 123 . KEY REQUIREMENTS UNDER TRIPS ...................................................................................................... 124 Convention Biodiversity Nagoya Protocol: Intellectual Property Implications vii . LINKS BETWEEN GI WITH AND BIODIVERSITY CONSERVATION ............................................................. 125 . LINKS BETWEEN GIS AND TK ................................................................................................................ 126 . ARE GENETIC RESOURCES PROTECTED BY GI SUBJECT TO ABS RULES ........................................... 128 . CAN DISTINCTIVE SIGNS ADDRESS MISAPPROPRIATION CONCERNS ................................................... 129 . SUMMARY COMPARATIVE TABLE WITH MAIN FEATURES ..................................................................... 131 II. MAIN BENEFITS AND COSTS WHEN MAKING USE OF GIS ..................................................... 133 . BENEFITS ............................................................................................................................................... 133 1) Market differentiation prime price. ..................................................................................... 133 2) Organisation Producers Protection De-localization................................................ 134 3) -Standard Setting Environmental Management .................................................................. 135 4) Enables Revalorization Biodiversity-Derived Products ......................................................... 135 5) Preservation Traditional Methods Production ........................................................................ 136 . COSTS .................................................................................................................................................... 138 1) Distinction costs effects welfare ............................................................................. 138 2) Institutional organizational structures ...................................................................................... 139 3) Costs Establishing Enforcing Standards ............................................................................... 140 4) Higher production costs targeted marketing strategies ............................................................ 141 5) Environmental degradation ............................................................................................................. 142 III. CHECKLIST OF ISSUES FOR SUSTAINABLE USE OF BIODIVERSITY AND TK PROTECTION .................................................................................................................................................. 143 . ENABLING REGULATORY ENVIRONMENT ............................................................................................... 144 . ADMINISTRATIVE CAPACITY ................................................................................................................. 145 . ORGANISATIONAL AND INFRASTRUCTURAL ASPECTS ........................................................................... 146 . TECHNICAL STANDARDS ........................................................................................................................ 147 . QUALITY CONTROLS AND VERIFICATION SYSTEMS ................................................................................ 149 . LABELING AND MARKETING .................................................................................................................. 150 IV. CONCLUSION ........................................................................................................................................ 152 CHAPTER 7 PRIVATE CONTRACT LAW ................................................................................................ 153 . INTRODUCTION ................................................................................................................................... 153 II. MTAS AND OTHER PRIVATE CONTRACTS .................................................................................. 154 III. SUBSTANTIVE PROVISIONS OF MTAS WITH IP IMPLICATIONS .......................................... 156 . PARTIES TO THE AGREEMENT ................................................................................................................ 156 . DESCRIPTION AND TREATMENT OF THE SUBJECT MATTER .................................................................... 157 . THIRD PARTY TRANSFER ....................................................................................................................... 158 . INTELLECTUAL PROPERTY RIGHTS ........................................................................................................ 159 . BENEFIT SHARING ................................................................................................................................. 160 . JURISDICTION AND DISPUTE SETTLEMENT ............................................................................................ 161 . TERM/DURATION OF THE AGREEMENT .................................................................................................. 163 . TERMINATION ........................................................................................................................................ 164 . CONFIDENTIAL INFORMATION ............................................................................................................... 165 IV. CONCLUSION ........................................................................................................................................ 166 REFERENCES .................................................................................................................................................. 167 Convention Biodiversity Nagoya Protocol: Intellectual Property Implications viii ANNEX : REGIONAL AND NATIONAL TK AND ABS-RELATED LEGISLATION .......................... 173 ANNEX II: WHO’ STANDARD MATERIAL TRANSFER AGREEMENTS ......................................... 184 ANNEX III: STANDARD MATERIAL TRANSFER AGREEMENT UNDER THE ITPGRFA ............. 191 ANNEX IV: PROGRAMME .......................................................................................................................... 202 Convention Biodiversity Nagoya Protocol: Intellectual Property Implications ix Table Abbreviations ABS Access benefit sharing ACP countries African, Caribbean Pacific countries AIDS Acquired immune deficiency syndrome ASEAN Association Southeast Asian Nations BRDR Biodiversity-related disclosure requirements CBD Convention Biological Diversity CITES Convention International Trade Endangered Species Wild Fauna Flora COP Conference Parties EIA Environmental Impact Assessment EC European Community EPC European Patent Convention EPO European Patent Office EU European Union FAO Food Agriculture Organization GB Governing body geographical indication GIs Geographical indications HIV Human immunodeficiency virus ICTSD International Centre Trade Sustainable Development IGC Intergovernmental Committee Intellectual Property, Genetic Resources, Traditional Knowledge Folklore ILCs Indigenous local communities), INDECOPI National Institute Defense Competition Protection Intellectual Property Peru IP Intellectual property IPRs Intellectual property rights ITPGRFA International Treaty Plant Genetic Resources Food Agriculture IUCN International Union Conservation Nature LDC Developed Country LMO Living modified organism MAT Mutually agreed terms MTA Material transfer agreement NCAB National Commission Biopiracy Peru NGO -Governmental organizations PBR Plant breeders’ rights PCT Patent Cooperation Treaty PDO Protected denominations origin PGI Protected geographical indications PIC Prior informed consent & Research development SMTA Standard material transfer agreement TCE Traditional cultural expressions TK Traditional knowledge TRIPS Agreement Agreement Trade-related Aspects Intellectual Property Rights UK United Kingdom UNCCD United Nations Convention Combat Desertification UNCED United Nations Conference Environment Development UNCTAD United Nations Conference Trade Development UNDRIP United Nations Declaration Rights Indigenous People Convention Biodiversity Nagoya Protocol: Intellectual Property Implications UNU-IAS United Nations University Institute Advanced Studies UPOV International Union Protection Varieties Plants US United States America WHA World Health Assembly WHO World Health Organization WIPO World Intellectual Property Organization WTO World Trade Organization Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 1 Introduction conservation biological diversity ( biodiversity) 1 ability continue biological resources sustainably pressing issues world faces. Balancing protection ecosystems, involve plethora animal, plant microbial species, sustainable development objectives demands systematic response international, regional, national -national levels myriad actors. effective preservation biodiversity met environmental protection laws . critical problem incoherence – .., situation laws, policies regulations designed protect biodiversity encourage sustainable development established consistent mutually supportive manner laws, policies regulations domains, industrial policy intellectual property (IP), impact biodiversity. order address linkage biodiversity conservation sustainable , Convention Biological Diversity (CBD) introduced objectives fair equitable sharing benefits arising utilization genetic resources providing resources. inclusion access benefit sharing (ABS) objective CBD based premise biodiversity public institutions private entities produce knowledge products brought benefits users, necessarily original owners custodians. ABS aspect entails greatest interface IP rights biodiversity issues. Clear, fair equitable rules ABS critical prevent misappropriation genetic resources traditional knowledge (TK), situation referred ‘biopiracy’. Narrowly defined, misappropriation refers access genetic resources prior informed consent / mutually agreed terms pursuant national access legislation country providing genetic resources applicable international rules access benefit sharing. 2 means genetic resources misappropriated utilizing IP system , , company sources biological resources country consent, utilizes resource & develop invention, attempts patent invention utilizing resource benefits provider, mentioning resource obtained. Civil society organizations cited misappropriation attempted patenting products Swiss company contained rooibos honeybush, box . 1 Article 2 CBD, ‘Biodiversity/Biological Diversity’ consists variability living organisms sources including, inter alia, terrestrial, marine aquatic systems ecological complexes part; includes diversity species (genetic), species ecosystems. Biodiversity term describing variability, ‘ecosystem’ describes dynamic complex plant, animal micro-organism communities -living environment interacting functional unit. 2 view based definition proposed Switzerland WG-ABS 9 18 February 2010 definitions lead COP 10 Nagoya, Japan. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 2 Box 1 Patent Applications Rooibos Products Nestlé, world’ largest food company, [faced] allegations biopiracy applied patents involving plants South Africa negotiated permission South African government. dubbed “rooibos robbery,” Berne Declaration, Swiss advocacy organisation, Natural Justice, South African environmental group, [accused] Nestlé violated South African law Convention Biological Diversity (CBD). issue plants South Africa, rooibos honeybush, commonly herbal teas. Nestec, Nestlé subsidiary, filed international patent applications plants extracts treat hair skin conditions acne, wrinkles, hair loss. application sought patent protection rooibos anti-inflammatory. seeking patent protection large number countries world, including South Africa. Benefit-sharing key issue Natural Justice Berne Declaration, South African Biodiversity Act — country’ implementing legislation CBD - requires companies permit government intend South African genetic resources research patenting. permits obtained benefit-sharing agreement. press release, Natural Justice Berne Declaration South Africa’ department environmental affairs told Nestlé received permits rooibos honeybush. “Based information ,” groups , “ clear patents Nestlé research based contradiction South African law CBD.” food product brands Nescafe, Nespresso, Gerber, Nestle active cosmetic industry. owns quarter ’éal, world’ largest cosmetics firm; companies Laboratoires Innéov, nutritional cosmetics venture. “Nestlé builds business illegally accessed material, precluding South Africa rightful share benefits. illegal behaviour longer supported patent system tolerated governments,” François Meienberg Berne Declaration. Plants sourced South Africa, Nestlé Nestlé … rejected accusations. report South African newspaper Business Day, company spokesman Ravi Pillay Nestlé sourced plants South Africa research . South African suppliers rooibos honeybush extracts material Nestlé research facilities Switzerland France, basic research active ingredients. research, , Nestec filed patents protect research results, showed potential benefits consumers. 3 “Nestec filed patent relating plants , extracts plants. Nestlé commercial patents, plans future,” added. Pillay Nestlé decided patents commercially, comply fully benefit-sharing provisions South African law. , Johanna von Braun Natural Justice Cape Town , South African law, commercial phase bioprospecting begins patent application filed. early 3 Note authors: patent applications failed pre-examination World Intellectual Property Organization (WIPO). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 3 phase, permit - include benefit sharing agreement material transfer agreement - submitted research takes place, . Von Braun companies supplied rooibos honeybush Nestlé secured permits. International law unclear “-situ” resources lacuna international patent law owns genetic resources removed country origin. Convention Biological Diversity specifies genetic resources national sovereignty. clear Nestlé’ responsibilities vis- à-vis genetic resources continent supplied Europe. South African law, , clear: specifies indigenous biological resources historically South Africa. terms South African suppliers plants Nestlé mattered, von Braun explained. “ ’ exporting rooibos tea, don’ permit. research, suppliers needed export permit including bioprospecting application Nestlé.” 2002, parties Convention Biological Diversity negotiating international regime access benefit sharing. create firmer rules genetic resources, including -called “ situ” resources longer country origin. “ Nestlé case highlights urgent protocol prevents misappropriation genetic resources traditional knowledge,” Kabir Bavikatte Natural Justice. “ strong protocol protect developing countries unlawful exploitation companies.” Source: Reproduced permission International Centre Trade Sustainable Development (ICTSD), originally published Bridges Trade Biores, Vol. 10, . 10, 31 2010. misappropriation genetic resources defined legal term, , define misappropriation genetic resources TK broadly. compliance ABS legislation, misappropriation IP system potentially occur firm person user country attempts obtain exclusive rights proprietary names genetic resource related TK exclusion providers, consent. effect allowing marks registered registrants advantage goodwill represented mark attribution compensation providers. cited academic literature attempts coffee bean distributors developed countries obtain global trade rights Ethiopian coffees Sidamo, local communities obtained geographical indication rights coffees grown respective regions. regard, Robinson suggested typology problematic activities, include patent-based biopiracy -patent based biopiracy misappropriation. 4 present, quantify extent misappropriation genetic resources TK underlying contracts transfer genetic resources remain private confidential. ABS regime, discussed , information resources accessed permission based mutually agreed terms registered nationally internationally, address 4 Robinson (2010). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 4 information deficiency. , sources documented examples potential misappropriation, problem remains concern provider countries. 5 contentiousness negotiations Nagoya fall 2010, set treaty laying international rules ABS CBD ( Nagoya Protocol Access Genetic Resources Fair Equitable Sharing Benefits Arising Utilization CBD, Nagoya Protocol) reflection difficulty reaching agreement multilateral level day age. Divisive issues routinely excluded final text search wording minimally acceptable negotiating parties. result satisfactory stakeholders. possibly conclude miracle agreement reached contained definitive rules ABS genetic resources TK, important issues left final text. fair, treaty expected cover aspects topic, gaps additional work needed examine legal regimes configured work synergy, conflict. handbook designed means fill gap understanding treaty text chosen remain silent. Convention Biological Diversity Nagoya Protocol: Intellectual Property Implications addresses global rules ABS genetic resources TK work tandem area mentioned minimally 2010 Nagoya Protocol, .., IP. Specifically, handbook designed show complexity relevant IP policies impact aspects CBD Protocol, provider country perspective. easy simplistic IP stream cash rents derive granted exclusive rights potentially shared benefits. view IP necessarily broader, examining ( ) grant rights, application process generate important information assist implementation ABS rules, rights subject important exceptions limitations policy grounds, traditional IP instruments patents sense protecting intellectual creative endeavors. Chapter 1 starts overview ABS system established CBD Nagoya Protocol, highlighting obligations countries international community put place national ABS legislation administrative machinery ensure countries meet treaty obligations. absence clarity treaties important issues, , sources law fully understand relationship IP ABS. Chapter 2 complementary examination treaties policies govern shape rules IP ABS. emphasis examination IP treaties TRIPS Agreement, minimum measure uniformity signatories’ respective legislation IP. chapters, , language contained CBD/Nagoya Protocol TRIPS Agreement result political negotiations leaves good deal ‘policy space’ ‘flexibility’ countries tailor national legislation support important policy objectives, including read conjunction important international policy statements United Nations Declaration Rights Indigenous Peoples (UNDRIP). 5 Vivas-Eugui (2012), Box 1 - examples. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 5 area potential IP regime support ABS regime disclosure (Chapter 3). Patent applicants disclose material information seek obtain exclusive rights technology. potentially include country origin genetic resources TK contained invention, invention product process. idea transparent subject public scrutiny ABS obligations met ease identification potential cases misappropriation point time applies patent. disclosure date discussed lead Nagoya Protocol negotiations, TRIPS Council World Intellectual Property Organization (WIPO), intergovernmental body date mandated disclosure origin source applying patent international legal obligation, dispute settlement case World Trade Organization (WTO) tests limits disclosure requirement. perspective provider country, weakness disclosure origin/source requirements absence international requirement include national legislation provider country require disclosure, guarantee user countries similarly require disclosure. number ways disclosure origin woven patent law. include, , requiring proof legal provenance simply assuming disclosure origin required generic obligation disclose material information relevant patent application, specific reference origin source genetic resources TK. disclosure requirement similarly woven plant variety protection legislation, country treaty obligation refrain . disclosure origin, chapter 4 examines wide range IP tools potentially harnessed support CBD/Nagoya rules ABS. set measures genetic resources patented, .., excluding discoveries, gene sequences, pathogens naturally occurring biochemical compounds scope patentability. set measures deals protecting activities liability existence patent impede innovation, good policy reasons research experimentation exception ( variant plant variety protection laws) medical treatment exception. final set measures include theories invalidate wrongly granted IP , including judicial doctrine ‘clean hands’ violations public morality order, theories. Chapter 4 clear, , law areas developing. , Zealand’ proposed approach treating patent applications Maori TK presumptively violation public morality tested issue patenting gene sequences considered Supreme Court United States. 6 Chapters 5 6 handbook deal aspects IP law potentially support ABS system designed create rights local indigenous communities provider countries genetic resources daily life, TK. number countries passed legislation rights indigenous local communities (ILCs) TK traditional cultural expressions (TCEs). sui 6 Association Molecular Pathology al. . Myriad Genetics, al. (Case . 12-398, slip op, decided Supreme Court United States 13 June 2013). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 6 generis legislation Western notions IP law patents plant variety protection effective vehicle provide local community proprietary rights. policy goals pursued sui generis regime, laws designed defensive offensive provider country perspective, .., TK/TCE misappropriated, give local indigenous community chance exploit TK/TCE secure benefits event TK/TCE commercialized. scope laws potentially cover practices farming techniques traditional medicine. Chapter 5 highlights laws, , interpreted context international human rights instruments recognize customary rights indigenous peoples. laws , , countries struggling define contours law grant ILCs set enforceable exploitable rights. Chapter 6 examines power distinctive signs secure benefits biodiversity derived products provider countries protect TK. Distinctive signs cover range IP instruments including trademarks, collective trademarks, protected geographical indications (PGIs), protected denominations origin (PDOs) certification marks ( Table 2, Chapter 6). broad objective tools communicate information potential buyer product distinctive sign affixed. extent sign adds product affixed, sign mark secure benefits. case PGIs PDOs, mark certifies quality originality linked specific location. Certification marks consumer procedural quality standards met. trademarks simple indications distinctiveness trademark holder affix product mark registered, collective trademarks, privately owned group proprietors, potentially practices defined geography case PGIs PDOs. Chapter points difficulties managing maintaining distinctive marks. difficulties include determining geographical coverage standards met order sign, maintain quality sign stands enforce signs order prevent misappropriation. rural populations provider developing countries ILCs ill prepared - resourced effectively manage systems govern distinctive signs. final remark signs perspective CBD extent signs promoting consumption resources , conscious mass consumption affect sustainable practices. Finally, Chapter 7 ABS IP laws reflected private contracts cover physical transfer genetic resources. private contracts referred CBD Protocol benefit-sharing agreements, shape material transfer agreements (MTAs), collaborative research agreements, bioprospecting agreements . handbook starts explaining difference MTAs genetic resources contracts physical transfer private object confers complete transfer ownership. extent genetic resources subject sovereign jurisdiction provider country, agreement permits access resource governs provisions transferee genetic resource. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 7 contract negotiations, issues potentially difficult ascertain , inter alia, owners genetic resource local indigenous communities involved, description genetic resource transferred, research permitted resource handle IP applications fruits research, benefits shared, party transfers permitted resource voluntary involuntary termination agreement. Effective negotiation takes practice understanding underlying laws principles. ABS authorities provider developing countries local indigenous groups disadvantage effectively negotiating contract terms lawyers representing biotechnology, cosmetic pharmaceutical firms based developed countries. message carries chapters handbook, , , areas developing areas law policy. , countries experimenting models IP protection ABS. , Switzerland’ disclosure regime differs significantly disclosure Andean countries; countries beginning introduce sui generis regimes geographical indications; judicial interpretation laws patenting gene sequences developed countries rarely consistent. sui generis laws TK TCEs shows country optimum model law works satisfactorily. early talking ‘ practices’. slow pace progress intergovernmental negotiation forums discussing relationship IP ABS reflection interface reached level maturity additional global consensus regulation ‘ripe’. , , learn country’ experience implementing IP ABS legislation, flanking legislation governing ILCs, manner mutually supportive. reason, handbook cites examples existing policies . , TRIPS Agreement CBD/Nagoya Protocol provide ample room policy makers experiment revise national legislation , country’ unique circumstances. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 8 Chapter 1 International Framework Access Benefit Sharing Genetic Resources Traditional Knowledge . Introduction focus handbook legislation international level (treaties) affects national policymaking legislation perspective provider countries. regard, treaties agreements negotiated States, stipulating terms, conditions, rights obligations signatories abide . bilateral, meaning agreement binds States, multilateral, meaning agreement binds States. Multilateral treaties cover region ( European Union (EU)) -region ( Mekong countries); regions (EU-African, Caribbean Pacific (ACP) countries) global scope ( Patent Cooperation Treaty, Agreement Trade-related Aspects Intellectual Property Rights ( TRIPS Agreement)). number formalities needed treaty effective, including, , ratification. cases, treaty provisions implemented national legislation, call establishing laws changing existing fully comply treaty. Finally, established treaties amended elaborated means additional supplementary treaties protocols. chapter examines multilateral treaty framework access benefit sharing (ABS) genetic resources traditional knowledge (TK). II. Global Framework Access Benefit Sharing starting point understanding existing international framework ABS genetic resources TK Convention Biological Diversity (CBD). CBD multilateral treaties opened signature 1992 United Nations Conference Environment Development Rio de Janeiro, Brazil ( Earth Summit UNCED). date, CBD ratified 193 parties, making universal. major user countries, United States America remains -party ( bound provisions), signed treaty 1993. treaty entered force 29 December 1993, objectives, : 1. conservation biological diversity; 2. sustainable components biological diversity7; 3. fair equitable sharing benefits arising utilization genetic resources. Parties CBD nominated national focal points, act designated person representing Party matters related Convention. 7 Sustainable – components biological diversity rate lead long-term decline biological diversity, maintaining potential meet aspirations present future generations (Article 2, CBD). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 9 CBD large number obligations signatories abide , including requirements general conservation measures, situ situ conservation, incentives, range topics. 8 substantive provisions agreed CBD respect fair equitable sharing benefits arising utilization genetic resources 9 Articles 15, 16 19 treaty, reproduced Box 2 . Box 2 CBD Provisions Access Equitable Sharing Benefits Article 15. Access Genetic Resources 1. Recognizing sovereign rights States natural resources, authority determine access genetic resources rests national governments subject national legislation. 2. Contracting Party endeavour create conditions facilitate access genetic resources environmentally sound Contracting Parties impose restrictions run counter objectives Convention. 3. purpose Convention, genetic resources Contracting Party, referred Article Articles 16 19, Contracting Parties countries origin resources Parties acquired genetic resources accordance Convention. 4. Access, granted, mutually agreed terms subject provisions Article. 5. Access genetic resources subject prior informed consent Contracting Party providing resources, determined Party. 6. Contracting Party endeavour develop carry scientific research based genetic resources Contracting Parties full participation , , Contracting Parties. 7. Contracting Party legislative, administrative policy measures, , accordance Articles 16 19 , , financial mechanism established Articles 20 21 aim sharing fair equitable results research development benefits arising commercial utilization genetic 8 Situ – conditions genetic resources exist ecosystems natural habitats, , case domesticated cultivated species, surroundings developed distinctive properties (Article 2, CBD). -situ – conditions genetic resources exist natural habitats, botanic gardens, zoological garden gene banks (Article 2, CBD). 9 CBD international instruments utilize closely related descriptions ‘genetic material’, ‘genetic resources’ ‘biological resources.’ CBD, genetic material means material plant, animal, microbial origin functional units heredity (Article 2, CBD). respect plant genetic material, term defined include material plant origin, including reproductive vegetative propagating material, functional units heredity (Article 2, International Treaty Plant Genetic Resources Food Agriculture). result, genetic material description subject matter reference human . ’Biological resources’ Article 2 CBD defined genetic resources, organisms parts thereof, populations, biotic component ecosystems actual potential humanity. definition, actual potential humans defines subject matter. Biological resources include genetic resources microorganisms. Genetic resources genetic materials actual potential (Article 2, CBD). scientific concept micro-organism refers “member classes: bacteria, fungi, algae, protozoa viruses’ (UNCTAD-ICTSD (2005), . 392). Plant genetic resources refer economic, scientific societal heritable materials contained species (FAO, . 33). legal perspective, , ‘actual potential ’ differentiates genetic resources, microorganisms biological resources simple genetic material. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 10 resources Contracting Party providing resources. sharing mutually agreed terms. Article 16. Access Transfer Technology 1. Contracting Party, recognizing technology includes biotechnology, access transfer technology Contracting Parties essential elements attainment objectives Convention, undertakes subject provisions Article provide / facilitate access transfer Contracting Parties technologies relevant conservation sustainable biological diversity genetic resources significant damage environment. 2. Access transfer technology referred paragraph 1 developing countries / facilitated fair favourable terms, including concessional preferential terms mutually agreed, , , accordance financial mechanism established Articles 20 21. case technology subject patents intellectual property rights, access transfer terms recognize consistent adequate effective protection intellectual property rights. application paragraph consistent paragraphs 3, 4 5 . 3. Contracting Party legislative, administrative policy measures, , aim Contracting Parties, developing countries, provide genetic resources access transfer technology resources, mutually agreed terms, including technology protected patents intellectual property rights, , provisions Articles 20 21 accordance international law consistent paragraphs 4 5 . 4. Contracting Party legislative, administrative policy measures, , aim private sector facilitates access , joint development transfer technology referred paragraph 1 benefit governmental institutions private sector developing countries regard abide obligations included paragraphs 1, 2 3 . 5. Contracting Parties, recognizing patents intellectual property rights influence implementation Convention, cooperate regard subject national legislation international law order ensure rights supportive run counter objectives. Article 19. Handling Biotechnology Distribution Benefits 1. Contracting Party legislative, administrative policy measures, , provide effective participation biotechnological research activities Contracting Parties, developing countries, provide genetic resources research, feasible Contracting Parties. 2. Contracting Party practicable measures promote advance priority access fair equitable basis Contracting Parties, developing countries, results benefits arising biotechnologies based genetic resources Contracting Parties. access mutually agreed terms. 3. Parties modalities protocol setting procedures, including, , advance informed agreement, field safe transfer, handling living modified organism resulting biotechnology adverse effect conservation sustainable biological diversity. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 11 4. Contracting Party , requiring natural legal person jurisdiction providing organisms referred paragraph 3 , provide information safety regulations required Contracting Party handling organisms, information potential adverse impact specific organisms concerned Contracting Party organisms introduced. Source: Convention Biological Diversity (1992). national level, implementation ABS provisions, called Articles 15, 16, 19 CBD, generally slow entry force December 1993. continuing lack "user measures" implement benefit sharing obligations CBD Parties, support user compliance ABS legislation provider countries negotiated MAT conditions highlighted persistent problems. countries ABS legislation, substantial provisions "user measures" practically address access issues. biodiversity-rich countries developed access-oriented policies legislation, lack benefit-sharing policies legislation industrialized countries coming force CBD turned bone contention finally resulted call 2002 World Summit Sustainable Development negotiate "international regime promote safeguard fair equitable sharing benefits arising utilization genetic resources", providing mandate long arduous process led adoption Nagoya Protocol 2010. 10 work provider side . multi-donor ABS Development Capacity Building Initiative, 6 54 African countries developed ABS legislation 2011. 11 protocols adopted CBD date, elaborating obligations signatories specific issues. called Article 19(3), Cartagena Protocol Biosafety Convention Biological Diversity ( Cartagena Protocol) regulates international level safe handling, transport living modified organisms (LMOs) resulting modern biotechnology adverse effects biological diversity, account risks human health. Protocol adopted 29 January 2000 entered force 11 September 2003. protocol adopted CBD Nagoya Protocol Access Genetic Resources Fair Equitable Sharing Benefits arising Utilization Convention Biological Diversity ( Nagoya Protocol). Nagoya Protocol sets rules mechanisms access genetic resources TK, supports fair equitable sharing benefits arising utilization, , basic provisions CBD ABS, forms central body law defines ABS system operates. provisions Nagoya Protocol borrow Bonn Guidelines Access Genetic Resources Fair Equitable Sharing Benefits Arising Utilization, set voluntary -binding guidelines access benefit sharing endorsed CBD Conference Parties (COP) Sixth Session 2002. 12 10 para. 44() Plan Implementation World Summit Sustainable Development, /Conf.199/20 4 September 2002. 11 GIZ (2011). http://www.abs-initiative.info/struct_compedium0.html. 12 Decision VI/24 COP VI (2002). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 12 Nagoya Protocol adopted 10 COP CBD Nagoya, Japan 29 October 2010, opened signature year February 2011, finally receiving 92 signatures, 22 European Union (EU) Member States EU. period signatures ended, Nagoya Protocol ratifications. 13 treaty ratified 50 countries, effect 12 October 2014. countries ratified CBD Nagoya Protocol, domestic ABS legislation shaped relevant provisions CBD Nagoya Protocol, treaty implementation relies large extent national legislation put access benefit sharing provisions effect. decision making bodies CBD Protocols serviced CBD Secretariat, located Montreal, Canada, administratively part United Nations Environment Programme (UNEP). years, CBD Secretariat commissioned number studies relationship IP CBD, including, , compatibility disclosure requirements TRIPS Agreement ( Chapter 3). Article 16 CBD recognizes impact intellectual property (IP) access benefit sharing. Specifically, states “[] Contracting Parties, recognizing patents intellectual property rights influence implementation Convention, cooperate regard subject national legislation international law order ensure rights supportive run counter objectives.” order achieve agreement 2010 governments negotiating treaty text Nagoya, , IP ended largely absent Nagoya Protocol, exception mention means possibly securing equitable benefit sharing ( Annex Nagoya Protocol). importance ABS system, references IP Protocol means derive understanding interface IP ABS CBD Protocol , sources law consulted. Key Points CBD enjoys universal acceptance comprehensive source international law date issues biological diversity. CBD established basic principle States sovereign rights biological resources. Nagoya Protocol, text agreed October 2010, sets system implement rights obligations ABS genetic resources basis CBD Article 8() cover traditional knowledge genetic resources. Nagoya Protocol received 92 signatures awaits 50 ratifications enter force. National implementation ABS legislation, required CBD, slow generally focus access issues benefit sharing. importance, intellectual property largely absent Nagoya Protocol, exception mention means possibly securing equitable benefit 13 3 September 2014, 52 countries ratified acceded Protocol. updated list, readers consult http://www.cbd.int/abs/nagoya-protocol/signatories/default.shtml. COP12 CBD, scheduled October 2014 Korea, meeting Parties Nagoya Protocol. http://www.cbd.int/abs/nagoya-protocol/signatories/default.shtml Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 13 sharing. result, important examine legal instruments order determine shape national IP legislation goals CBD. . Global Access Benefit Sharing System Work Underlying ABS provisions Nagoya Protocol CBD notion, stated Preamble CBD, States sovereign rights biological resources. Access genetic resources users based prior informed consent equitable benefit sharing occur mutually agreed terms ( PIC MAT, ; Nagoya Protocol, Articles 5 6 ( Box 3 ) CBD, Articles 15, 16 19). Box 3 Nagoya Protocol Provisions Access Equitable Sharing Benefits Article 5. Fair Equitable Benefit Sharing 1. accordance Article 15, paragraphs 3 7 Convention, benefits arising utilization genetic resources subsequent applications commercialization shared fair equitable Party providing resources country origin resources Party acquired genetic resources accordance Convention. sharing mutually agreed terms. 2. Party legislative, administrative policy measures, , aim ensuring benefits arising utilization genetic resources held indigenous local communities, accordance domestic legislation established rights indigenous local communities genetic resources, shared fair equitable communities concerned, based mutually agreed terms. 3. implement paragraph 1 , Party legislative, administrative policy measures, . 4. Benefits include monetary -monetary benefits, including limited listed Annex. 5. Party legislative, administrative policy measures, , order benefits arising utilization traditional knowledge genetic resources shared fair equitable indigenous local communities holding knowledge. sharing mutually agreed terms. Article 6. Access Genetic Resources 1. exercise sovereign rights natural resources, subject domestic access benefit-sharing legislation regulatory requirements, access genetic resources utilization subject prior informed consent Party providing resources country origin resources Party acquired genetic resources accordance Convention, determined Party. 2. accordance domestic law, Party measures, , aim ensuring prior informed consent approval involvement indigenous local communities obtained access genetic resources established grant access resources. 3. Pursuant paragraph 1 , Party requiring prior informed consent legislative, administrative policy measures, , : Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 14 () Provide legal certainty, clarity transparency domestic access benefit- sharing legislation regulatory requirements; () Provide fair -arbitrary rules procedures accessing genetic resources; () Provide information apply prior informed consent; () Provide clear transparent written decision competent national authority, cost-effective manner reasonable period time; () Provide issuance time access permit equivalent evidence decision grant prior informed consent establishment mutually agreed terms, notify Access Benefit-sharing Clearing-House ; () applicable, subject domestic legislation, set criteria / processes obtaining prior informed consent approval involvement indigenous local communities access genetic resources; () Establish clear rules procedures requiring establishing mutually agreed terms. terms set writing include, inter alia: () dispute settlement clause; (ii) Terms benefit-sharing, including relation intellectual property rights; (iii) Terms subsequent -party , ; (iv) Terms intent, applicable. Source: Nagoya Protocol (2010). National legislation provide means ensuring seek access genetic resources TK utilization PIC country indigenous peoples local community ( ILC) concerned. Parties Protocol instances PIC required access, include: - genetic resources areas national jurisdiction - case countries origin, - including genetic resources -situ collections. hand, Protocol specifies procedural requirements, complied . include requirement formulate fair -arbitrary rules procedures access, information apply PIC, issuance permits evidence PIC, requirement provide written decision competent national authority reasonable period time . National legislation provide ensure results research development ( &) benefits arising commercial utilization genetic resources shared fair equitable manner, based MAT. 14 Nagoya Protocol establishes compliance system ABS. noted , Parties ensure genetic resources utilized area national jurisdiction 14 Frein Meyer (2012). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 15 accessed based PIC MAT required provider country. national competent authority established implement ABS system, register ABS agreements documentation potentially serve evidence PIC MAT (Nagoya Protocol, Article 13). competent authority grants permit access satisfied PIC MAT requirements national law met. Supportive measures regard utilization genetic resources include nomination effective checkpoints relevant entire product chain (Nagoya Protocol, Article 17(1)()), designed provide information authority permit applications investigate claims ABS regulations . competent authority facilitates transformation national access permit – providing information PIC, MAT, ., internationally recognized certificate compliance publication ABS Clearing House (Nagoya Protocol, Article 17(2)), designed facilitate legitimate movement resources borders. Clearing House established pilot phase. 15 , Parties support fulfilment MAT opportunity legal recourse access justice (Nagoya Protocol, Article 18(2) (3)). Agreed ABS rules PIC MAT thought, inter alia, combat ‘biopiracy’ legal terminology, misappropriation misuse genetic resources TK. mentioned , IP rights, granting exclude intellectual creation, means misappropriation occur. time IP rights means generate income commercialization technology genetic resource TK, benefits potentially shared. Key Points Articles 15, 16 19 CBD Articles 5 6 Nagoya Protocol set basic rights obligations Parties ABS genetic resources. provisions establish requirement access genetic resources based prior informed consent (PIC) mutually agreed terms (MAT). Benefits accruing utilization genetic resources shared fair equitable basis. laying procedural requirements grant PIC, Protocol leaves leeway countries determine substantive conditions PIC required. Competent national authorities established administer system, checks PIC MAT complied , issues access permits applicable requirements met. national competent authority charge ensuring national permits based compliance domestic legislation converted internationally recognized certificate compliance ABS Clearing House. ABS Clearing House pilot phase. 15 http://absch.cbd.int/. http://absch.cbd.int/ Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 16 . Global Access Benefit Sharing System Cover Nagoya Protocol covers utilization genetic resources defined Article 2 CBD, meaning material biological origin functional hereditary material & – .., working genetic biochemical composition material, including development products processes biotechnology. simple sale fruit vegetable borders consumption covered Protocol. hand, transfer sample plants animals research purposes, immediately commercialized, trigger Protocol. biological resources brought borders trade consumption purposes initially, research, provisions Protocol apply. creates difficult situations documents mere purchase commodities necessarily clauses address requirements obtain PIC MAT. study Laird Wynberg published CBD Secretariat: “ CBD Nagoya Protocol, ABS policies intended address research development genetic resources traditional knowledge, biodiscovery, commodity trade raw materials result research development, local trade subsistence . important ensure regulatory frameworks address differences biotrade biodiscovery, acknowledged distinctions clear increasing research development focus commodity- based industries food” 16 sections describe key controversies surrounding scope coverage ABS system established CBD Protocol. Key Points Protocol requirements triggered genetic resources ‘utilized’ & purposes provider country. Contracts documents simple sale seeds, plants vegetables consumption purposes trigger Protocol, research conducted commodities, requirements triggered. practice, sales contracts happen case objective genetic resource . 1) Temporal Scope Treaties Nagoya Protocol negotiations, extensive debate final instrument meant cover genetic resources acquired prior entry force. issues, debate Nagoya place largely North-South lines text Protocol avoids providing clear answer question. extent Protocol dealt question simply suggest Parties establishment global multilateral benefit-sharing mechanism address sharing 16 Laird Wynberg (2012), . 12. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 17 benefits derived utilization genetic resources related TK grant obtain PIC (Nagoya Protocol, Article 10). hand, genetic resources acquired user countries Protocol, CBD. 12 October 2014 Protocol force, genetic resource transfers provider country fact continue pre-Nagoya ( absence Nagoya-compliant ABS legislation). argued exclusion pre-Nagoya/pre-CBD resources condones misappropriation encourages countries delay ratification, view avoiding applicable PIC MAT requirements. 17 problem approach applying Protocol pre-Nagoya/pre-CBD acquisitions acquisitions include resources accessed PIC MAT, subject agreed transfers. Plants part situ collections animals reside zoos examples genetic resources. resources gene banks world. declare Nagoya Protocol requirements apply genetic resources acquired means Protocol applied retroactively, generally frowned matter law. economic consequences significant Protocol invalidate earlier agreements, pre-Nagoya pre-CBD. pointed United Nations University Institute Advanced Studies (UNU-IAS): “Requiring pre-CBD collections produce evidence legal resources, based existence sound legal title obtained country origin, significant impact commercial . wide distribution genetic resources centuries – mainstays global food security – frequently posited reason avoid extending control pre-CBD collections.” 18 matter national law, courts jurisdictions ( government officials administering ABS laws) seek apply laws retroactively genetic resources acquired Protocol compliant domestic ABS regime put place, absent clear intent ABS law . order address problem pre-Nagoya/pre-CBD acquisitions, authors suggested national ABS laws Protocol requirements applicable genetic resources acquired prior law, making timing acquisition irrelevant. 19 ensure benefit sharing occurs respect applications genetic resources acquired prior Nagoya Protocol-compliant ABS law. Protocol prevent Parties including requirement respective laws. 20 17 Nijar (2011a), . 19. 18 Tobin, Burton Fernandez-Ugalde (2008). 19 , , Nijar (2011a), . 20. 20 Benefit sharing Article 5 Nagoya Protocol linked access conditions Article 6, benefit sharing obligation extend GR TK accessed pre-Nagoya, resource accessed PIC. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 18 Key Points Nagoya Protocol stipulates intended cover utilization genetic resources acquired prior Nagoya-compliant ABS legislation. , judges ( government officials) unwilling retroactively apply ABS legislation clear intent law . National ABS legislation stipulate apply applications utilizing genetic resources acquired Nagoya-compliant ABS legislation effect (.., pre-Nagoya/pre-CBD). 2) Traditional Knowledge (TK) genetic resources , CBD Nagoya Protocol address treatment TK genetic resources genetic resources held ILCs. genetic resources held ILCs matter law, PIC MAT requirements apply genetic resources fall jurisdiction national authorities. major difference ILC standing domestic law grant PIC negotiate MAT, national competent authority. , .., TK, governed provisions Nagoya Protocol, discussed historical context. preparations 1992 Earth Summit, efforts number indigenous organisations resulted greater visibility TK biodiversity-related innovations global agenda. February 1992, Charter Indigenous Tribal Peoples Tropical Forests adopted Penang, Malaysia. 21 Article 45 "Intellectual Property" states: " highly technologies** biotechnologies important contributions humanity, including 'developed' countries, demand guaranteed rights collective intellectual property national international law, control development manipulation knowledge." Earth Summit, indigenous organisations adopted Kari-Oca Declaration Indigenous Peoples' Earth Charter. 22 Selected articles Charter specific relevance TK, genetic resources IPR context chapter : "25. Indigenous peoples knowledge, language, culturally education, including bicultural bilingual education. recognizing formal informal ways, participation family community guaranteed. 21 International Alliance Indigenous Tribal Peoples Tropical Forests, ( revised 2002) http://www.international-alliance.org/charter_eng.htm, accessed Jan 2012 (**author' comment: version Charter dealt IP Article 44 spoke "traditional technologies", Posey (1999), pp. 556 ff). 22 Text information : http://dialoguebetweennations./IR/english/KariOcaKimberley/KOCharter.html, accessed Jan 2012 (*** authors' comment: , light developments, crucial sentence deleted paragraph 102 presented mentioned webpage, contained original Charter, Posey (1999), pp. 560 ff). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 19 26. health rights include recognition respect TK held indigenous healers. knowledge, including traditional medicines preventive spiritual healing power, recognized protected exploitation. 96. TK herbs plants protected passed future generations. 97. Traditions separated land, territory, science. 98. TK enabled indigenous peoples survive. 99. usurping traditional medicines knowledge indigenous peoples considered crime peoples. 100. Material culture -Indigenous gain access lands resources, destroying cultures. 102. creators carriers civilizations continue share knowledge, experience, values humanity, require intellectual cultural properties guaranteed mechanism implementation favour peoples studied depth implemented. [ respect include genetic resources, gene banks, biotechnology, knowledge biodiversity programs.]*** 103. list suspect museums institutions misused cultural intellectual properties." 1992 Kari-Oca Declaration reaffirmed Indigenous Peoples Global Conference Rio+20 Mother Earth conference 2012. Rio+20 meeting addition adopted Kari-Oca 2 Declaration states: "[] reject assertion intellectual property rights genetic resources traditional knowledge Indigenous peoples results alienation commodification Sacred essential lives cultures." 23 Agenda 21 24 Chapter 26 "Recognizing & Strengthening Role Indigenous People & Communities" laid informal action plan national governments establish processes empower indigenous people communities strengthen active participation indigenous people communities national formulation policies, laws programmes relating resource management. Agenda 21 touches controversial issues -determination land rights suggests governments : "() ratification application existing international conventions relevant indigenous people communities ( ) provide support adoption General Assembly declaration indigenous rights; () Adopt strengthen policies / legal instruments protect indigenous intellectual cultural property preserve customary administrative systems practices." 23 Text : http://indigenous4motherearthrioplus20.org/kari-oca-2-declaration/, accessed June 2010. 24 Text information : http://www..org/esa/dsd/agenda21/res_agenda21_00.shtml, accessed Jan 2012. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 20 1992 Rio Rio+20 documents treat TK aspects sustainable development environmental protection, dealt policy legal activities national level. Rio Summit , , adopt language formally recognise customary rights indigenous peoples international level. , Principle 22 Rio Declaration Environment Development 25 states: "Indigenous people communities local communities vital role environmental management development knowledge traditional practices. States recognize duly support identity, culture interests enable effective participation achievement sustainable development." documents , , important affirm collective position ILCs maintain control TK practices. legally binding conventions adopted Rio, CBD 26 recognises Preamble: " close traditional dependence indigenous local communities embodying traditional lifestyles biological resources, desirability sharing equitably benefits arising TK, innovations practices relevant conservation biological diversity sustainable components." Article 8() CBD promotes sharing benefits arising utilization traditional knowledge leaves measures achieve objective domestic policies CBD members. states, relevant part, : “Article 8. -situ Conservation Contracting Party , : [...] () Subject national legislation, respect, preserve maintain knowledge, innovations practices indigenous local communities embodying traditional lifestyles relevant conservation sustainable biological diversity promote wider application approval involvement holders knowledge, innovations practices encourage equitable sharing benefits arising utilization knowledge, innovations practices;” article relevance indigenous local communities CBD Article 10(), states: “Article 10. Sustainable Components Biological Diversity Contracting Party , : () Protect encourage customary biological resources accordance traditional cultural practices compatible conservation sustainable requirements;” 25 Text : http://www..org/documents/ga/conf151/aconf15126-1annex1.htm, accessed January 2012. 26 Text information : http://treaties..org/Pages/ViewDetails.aspxsrc=UNTSONLINE&tabid=2&mtdsg_no=XXVII-8&chapter=27&lang=en http://www.cbd.int./convention/text/, accessed Jan 2012 Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 21 suggested “Article 10() requires Contracting Parties protect encourage customary biological resources derived traditional cultural practices compatible requirements biological diversity conservation sustainable components. TK, innovations practices ILCs derive customary biological resources.” 27 , Article 8() Article 10() closely interrelated implemented synergistically. Article 8(), Article 10() drew criticism language explicitly mentions customary rights promotes recognition international level. Articles 15, 16, 19 CBD deal strictly genetic resources deal TK, 7th Conference Parties CBD (COP) 2004 decided mandate Ad Hoc Open-ended Working Group Access Benefit-Sharing, collaboration Ad Hoc Open Ended Inter-Sessional Working Group Article 8() Related Provisions, ensure “ participation indigenous local communities, - Governmental organizations, industry scientific academic institutions, intergovernmental organizations, elaborate negotiate international regime access genetic resources benefit-sharing aim adopting instrument/instruments effectively implement provisions Article 15 Article 8() Convention objectives Convention”. work bodies eventually incorporated Article 7 Nagoya Protocol, stipulates Parties Protocol ensure access TK genetic resources based prior informed consent (PIC) benefit sharing place ( defining traditional knowledge utilization). obligations cover benefits research development (&), , commercialization, condition groups granted determine access genetic resources. , emphasized Protocol governs TK genetic resources, TK. Protocol define kind TK genetic resources, leaving national laws determine TK covered. Chapter 5 handbook examines question TK detail. Key Points preparations Earth Summit, indigenous organisations issue TK biodiversity-related innovations successfully international agenda. February 1992, Charter Indigenous Tribal Peoples Tropical Forests adopted, Earth Summit, indigenous organisations adopted Kari-Oca Declaration Indigenous Peoples' Earth Charter laid basic policy legal issues dominating debate day. Earth Summit documents treat TK aspects sustainable development environmental protection. Rio Summit adopt language formally recognise customary rights indigenous peoples international level, . 27 Glowka al. (1994), . 60. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 22 Article 8() CBD links principle benefit sharing utilisation genetic resources utilisation "TK, innovations practices", subjects measures national legislation. Article 8() served point departure inclusion TK issues 2010 Nagoya Protocol ABS. Article 7 Nagoya Protocol requires countries ensure access TK based PIC benefit sharing place. benefits required cover benefits &, commercialization. Protocol governs TK genetic resources, TK. 3) Plant Genetic Resources Food Agriculture International Treaty Plant Genetic Resources Food Agriculture ( ITPGRFA) entered force 29 June 2004. Treaty overseen Governing Body composed 152 countries ratified October 2014. Governing Body supported secretariat, located Rome, Italy, part UN specialized agency, United Nations Food Agriculture Organization (FAO). secretariat body administers common fund benefit sharing treaty. ITPGRFA establishes, inter alia, multilateral system facilitate access plant genetic resources food agriculture share benefits arising fair equitable manner. ITPGRFA’ multilateral system, parties Treaty agree freely genetic diversity related information stored gene banks , present, 81 forage species 29 genera undefined number crop species 51 genera (covering vast majority plant crops consumed humans important exceptions cocoa, coffee, cotton, soya tomato). Breeders scientists utilize plant genetic resources improve varieties required seek access accordance standardized material transfer agreement (MTA) (Article 12.4, ITPGRFA). access genetic materials system required claim rights "limit facilitated access plant genetic resources food agriculture, genetic parts components, form received" (Article 12.3()), ITPGRFA. plant genetic resources accessed multilateral system commercialized, recipient " pay ... equitable share benefits arising commercialization product, product restriction research breeding, case recipient commercializes encouraged payment" (Article 13.2()(ii), ITPGRFA). pre-fixed percentage benefits commercialization flow common fund support future research, breeding training projects. system operationalized standard MTA ( Annex III). 28 28 MTA, type Access Benefit Sharing (ABS) Agreement, agreement provider receiver genetic resources governing terms access, including, PIC, conditions , benefit sharing. genetic resources, MTA primarily consists transfer specific genetic resources competent authority providing country, entity recipients, research centers, pharmaceutical, biotechnology & based companies, countries, MAT. term ‘MTA’ context agreement transfer tangible research materials entities, , university undertook basic research genetic resource molecule private company develop products commercialisation. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 23 ITPGRFA requires parties implement national legislation measures protect farmers’ rights. relevant provisions farmers’ rights set Box 4 . context ABS TK, important note farmers' rights codified ITPGRFA deal benefit sharing access aspects. ITPGRFA negotiations argued parties farmers’ rights cover free access exchange IP-protected plant material acknowledgement farmers' contribution creation existing diversity plant genetic material modern plant breeding exist. interference IP system accepted countries strong commercial plant breeder interests. ITPGRFA finally equipped provision Article 9.3 national implementation farmers' rights "limit rights farmers save, , exchange sell farm-saved seed/propagating material, subject national law ." international treaty rights, voluntary basis, International Treaty Protection Varieties Plants ( UPOV Convention). Box 4 Article 9. Farmers’ Rights 9.1 Contracting Parties recognize enormous contribution local indigenous communities farmers regions world, centres origin crop diversity, continue conservation development plant genetic resources constitute basis food agriculture production world. 9.2 Contracting Parties agree responsibility realizing Farmers’ Rights, relate plant genetic resources food agriculture, rests national governments. accordance priorities, Contracting Party , , subject national legislation, measures protect promote Farmers’ Rights, including: ) protection traditional knowledge relevant plant genetic resources food agriculture; ) equitably participate sharing benefits arising utilization plant genetic resources food agriculture; ) participate making decisions, national level, matters related conservation sustainable plant genetic resources food agriculture. 9.3 Article interpreted limit rights farmers save, , exchange sell farm-saved seed/propagating material, subject national law . Source: ITPGRFA (2001). Negotiated post-Earth Summit, conscious effort ensure ITPGRFA fully consistent provisions CBD. provision relevance ABS context Article 12.3() "[]ithout prejudice provisions Article, Contracting Parties agree access plant genetic resources food agriculture situ conditions national legislation , absence legislation, accordance standards set Governing Body." definition " situ" ITPGRFA CBD, case cover plant genetic resources natural surroundings farmers' fields "developed distinctive properties" locations. 2010, ad hoc Advisory Technical Committee Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 24 Standard Material Transfer Agreement Multilateral System ITPGRFA started work compiling information views standards. Nagoya Protocol, negotiated ITPGRFA, provision ensures treaty ( Nagoya Protocol/CBD) governs plant genetic resources food agriculture covered ITPGRFA countries ratified . Article 4(4) Protocol, “[] specialized international access benefit-sharing instrument applies consistent , run counter objectives Convention Protocol, Protocol apply Party Parties specialized instrument respect specific genetic resource covered purpose specialized instrument”, , stipulated Article 4(1) Protocol, “ exercise rights obligations damage threat biological diversity.” Key Points ITPGRFA establishes, inter alia, multilateral system facilitate access plant genetic resources food agriculture, regarded major component sharing benefits arising genetic resources fair equitable manner. ITPGRFA’ multilateral system, parties Treaty agree freely genetic diversity related information stored -situ collections , present, 81 forage species 29 genera undefined number crop species 51 genera (covering majority major plant crops important human food security). system operationalized standard material transfer agreement (MTA). access genetic materials system required claim rights limit facilitated access plant genetic resources food agriculture, genetic parts components, form received. plant genetic resources accessed multilateral system commercialized, recipient required pay equitable share benefits arising commercialization product, product restriction research breeding, case recipient commercializes encouraged payment. pre-fixed percentage profits commercialization flow common fund support future research, breeding training projects. system established means benefit sharing ITPGRFA. Nagoya Protocol, negotiated ITPGRFA, provision ensures treaty ( Nagoya Protocol/CBD) governs plant genetic resources food agriculture covered ITPGRFA countries ratified . Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 25 4) Viruses Pathogens pathogen typically defined infectious organism, includes viruses, bacteria fungi, . 29 definitions include biological substances prions. 30 characteristic pathogens diseases. humans, examples viruses include human immunodeficiency virus (HIV), Ebola, smallpox influenza, examples bacteria include Mycobacterium tuberculosis (tuberculosis), Escherichia coli (gastro-intestinal disorders) Salmonella typhi (typhoid). Examples pathogenic fungi include Candida species (yeast infections) Trichophyton species (athlete’ foot). Abnormal prions pathogenic bovine spongiform encephalopathy (.., “mad disease”). Pathogens , , limited affect humans include affecting animals plants . Pathogens important research diseases development treatments diseases, case vaccines monoclonal antibodies. World Health Organization (WHO), IP barrier production vaccines developing countries. cases, modern vaccines embody multiple levels technology licensed multiple partners, implying - vaccine manufacturer developing country ‘work ’ refusal IP holder license specific technology. Additionally, vaccine production technology public domain, developing countries patent owners opted file patent application respect technology. 31 true newer vaccines, , WHO caution Patent Cooperation Treaty (PCT) applications vaccine technology steadily rising time. , April 2011 report -governmental organization (NGO) World Network catalogues number increasingly broad PCT patent applications years medicines, vaccines, microbes, peptides, nucleic acids immunoassays term “H5N1” / “H1N1” claims. 32 interpretations exist respect status pathogens CBD accompanying Nagoya Protocol. interpretation pathogens viruses, innately harmful, linked objective CBD, conservation biological diversity, scope Convention ( NP). 33 view acknowledges pathogens covered scope CBD NP, work WHO virus sharing takes precedence NP. 34 view supports argument pathogens genetic material covered CBD specifically excluded NP . 35 arguments favour view summarized Box 5 . 29 http://www.medterms./script/main/art.asparticlekey=6383. 30 http://en.wikipedia.org/wiki/Pathogen. 31 Friede (2011). Note, , assumed developing country immediately vaccine production technology public domain. 32 Ibid. Hammond (2011). 33 Abbott (2010) Nijar (2011a). 34 Nijar (2011a). 35 Nijar (2011a) argues proposal exclude human pathogens considered failed negotiations leading Conference Parties adopted NP. Biotechnology industry groups countered points, draft texts included excluded pathogens, indicating agreement inclusion pathogens NP. http://patentlybiotech.wordpress./2010/12/07/pathogens---nagoya-protocol---convention--biological- diversity/. http://www.medterms./script/main/art.asparticlekey=6383 http://en.wikipedia.org/wiki/Pathogen http://patentlybiotech.wordpress./2010/12/07/pathogens---nagoya-protocol---convention--biological-diversity/ http://patentlybiotech.wordpress./2010/12/07/pathogens---nagoya-protocol---convention--biological-diversity/ Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 26 Box 5 Main Arguments Pathogens Covered CBD/Nagoya Protocol CBD designed preserve biological diversity , , permit future research development biological resources yield treatments disease.36 CBD NP designed developing countries share benefits exploitation biodiversity resources. Pathogen materials, including virus materials, develop drugs vaccines human animal , potential monetary .37 plain reading definition ‘genetic material’ covered CBD leads conclusion pathogens, bacteria viruses, functional units heredity replicable; CBD, NP international agreement excludes pathogens scope coverage.38 work WHO developing standard material transfer agreements (SMTAs) sharing viruses ( Annex 2) binding treaty guarantees fair access benefit sharing regime pathogens. Source: authors. CBD refer term “pathogen” , defines genetic resources material plant, animal, microbial origin functional units heredity (Article 2, CBD). Paragraph 16 preamble Nagoya Protocol explicit reference document pathogens, stipulates Protocol adopted bearing mind “ International Health Regulations (2005) WHO importance ensuring access human pathogens public health preparedness response purposes” (emphasis added). , Article 8() Protocol obligates Party CBD, formulating access benefit-sharing legislation regulations, “[]ay due regard cases present imminent emergencies threaten damage human, animal plant health, determined nationally internationally.” clause state Parties “ consideration expeditious access genetic resources expeditious fair equitable sharing benefits arising genetic resources, including access affordable treatments , developing countries.” Article 8() Nagoya Protocol limited extent eliminated continue debate status pathogens. Protocol “due regard” means, courts interpret clause formulation national ABS legislation, Parties obliged grant user access pathogens emergency cases. , Protocol provide guidance constitutes “emergency”, assumed, instance, declaration pandemic WHO potentially provide trigger. National declarations emergency health authorities potentially suffice trigger. means, , Ebola outbreak declared developed country Member potentially grounds country demand access virus sample African country 36 Abbott (2010), . 13. 37 Ibid. 38 Nijar (2011a), . 3. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 27 Uganda. provider countries, clause Article designed provide assurance benefit sharing developing countries event pathogen shared user country emergency situations. Notably, Nagoya Protocol Party consideration expeditious fair equitable sharing benefits arising sharing pathogen, leaving Party negotiate response. Key Points longstanding debate delegates CBD Nagoya Protocol cover pathogens. Article 8() Nagoya Protocol, , arguably requires Member States consideration expeditious access pathogens emergency situations expeditious benefit-sharing arising genetic resources. happen national health authority WHO declares outbreak, instance. 5) Derivatives Prior conclusion Protocol, intensive debate final text cover access derivatives genetic resources. debate derivatives covered benefit sharing provisions Nagoya Protocol controversial CBD Parties decided sharing benefits arising derivates covered contractual MAT clauses adopted Bonn Guidelines. 39 ‘Derivative’ defined term Nagoya Protocol. Article 2() Protocol, ‘derivative’ means naturally occurring biochemical compound resulting genetic expression metabolism biological genetic resources. term ‘derivative’ defined clarify defined term, .., ‘biotechnology’. Biotechnology defined Article 2() Protocol “ technological application biological systems, living organisms, derivatives thereof, modify products processes specific ” (emphasis added). term ‘biotechnology’ , turn, definition, .., ‘utilization genetic resources’, means conduct research development (&) genetic / biochemical composition genetic resources, including application biotechnology defined CBD (Article 2() Protocol, emphasis added). Interestingly, clarifying definition, term ‘derivative’ substantive provisions Nagoya Protocol. 40 debate Nagoya Protocol cover derivatives exists partly interpretations CBD definition genetic material, .., materials functional units heredity. Negotiators disagreed means 39 Bonn Guidelines Access Genetic Resources Fair Equitable Sharing Benefits Arising Utilization (2002). 40 Interestingly, derivatives defined functional units heredity, result activity functional units, biological material functional units, genetic resource CBD. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 28 material functional units heredity biological compounds functional units. interpretation holds true, developed developing countries differed positions Protocol obligations extend -genetic compounds, .., derivatives, proteins medicinal active substances. debate issue heated, solution negotiators interpret rewrite fundamental CBD definitions clarify types utilization genetic resources trigger provisions Protocol. respect benefit sharing obligations, Article 5(1) Protocol states “benefits arising utilization genetic resources subsequent applications commercialization shared fair equitable Party providing resources country origin resources Party acquired genetic resources accordance Convention. sharing mutually agreed terms.” , text Nagoya Protocol clear benefit sharing obligations Protocol extend genetic resources subsequent applications commercialization. text formulation potentially covers wide range items, , based definitions utilization genetic resources, derivatives specifically biotechnology, include utilization items naturally occurring manufactured . Nijar broad interpretation supported negotiation history Nagoya Protocol, sense development products based genetic resources reap commercial benefits resources. 41 benefit sharing, status products based genetic resources remains subject interpretation. reasonable, , PIC required users seek access undertake & view developing products based genetic resources ( Article 6 Nagoya Protocol requires PIC prerequisite access genetic resources utilization, definition encompasses biotechnology &, .., technological application biological systems, living organisms, derivatives thereof (Article 2(), Nagoya Protocol)). PIC required Protocol access derivative provider country, resource . National ABS laws provide, , access derivatives conditioned PIC, required genetic resources. Key Points Nagoya Protocol stipulates utilization genetic resources subsequent applications commercialization subject benefit sharing obligations. Protocol leaves open interpretation substances types information generated genetic resources application biotechnology subject benefit sharing obligations. Nagoya Protocol clear derivatives genetic resources subject PIC requirements access, Protocol prevents countries adopting ABS legislation introduces requirement. 41 Nijar (2011a), . 13. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 29 III. Conclusion global ABS system genetic resources TK set CBD Nagoya Protocol. multilateral treaties require access genetic resources based PIC MAT. Parties ensure genetic resources TK utilized area national jurisdiction accessed based PIC MAT required provider country. treaty requirements embedded national law. CBD universal, Protocol received 50 ratifications required force. debate covered Protocol terms genetic resources. debates respect genetic resources TK accessed prior CBD Protocol, status pathogens derivatives, scope TK covered treaties. plant genetic resources excluded scope Protocol covered ITPGRFA. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 30 Chapter 2 CBD Nagoya Protocol: Instruments Affect ABS Intellectual Property . Introduction Chapter 1 overview access benefit sharing (ABS) system established Convention Biological Diversity (CBD) Nagoya Protocol. background understand ABS supposed operate national international levels. chapter dedicated overview international instruments intellectual property (IP) instruments interpret questions ABS IP issues, chapters follow address discrete topics interface. intent chapter detail issue, understand sources international law relevance ABS IP CBD Nagoya Protocol. II. Intellectual Property Treaties Intellectual property ( IP) refers sets exclusive rights granted applicants reward incentive intellectual endeavour. include patents, copyrights, trademarks/trade names, utility models, plant variety protection laws, geographical indications, sui generis traditional knowledge laws, . ABS, IP generally system governed national laws. IP treaties countries signed commitments dictate contours exclusive rights granted remain public domain. key IP treaties affect ABS , discussion state play relevant intergovernmental discussions place hosting institution related issues. . TRIPS Agreement agreements Members World Trade Organization ( WTO) adhere, Agreement Trade-related Aspects Intellectual Property Rights ( TRIPS Agreement) major impact scope intellectual property protection world. TRIPS Agreement establishes minimum standards IP protection, incorporated national legislation WTO Members specifically exempted WTO case Developed Countries ( LDCs). 42 standards established variety IP instruments including patents, copyrights, trademarks, geographical indications ( GIs), industrial designs, plant variety protection, integrated circuit designs undisclosed information. treaty body TRIPS Agreement TRIPS Council, intergovernmental body serviced WTO Secretariat Geneva, Switzerland. 42 waiver exempts LDCs complying substantive provisions TRIPS Agreement 1 July 2021 ( 2016 granting product patent protection pharmaceuticals protection unfair commercial pharmaceutical test data). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 31 perspective potential impact ABS, forms IP important patents, copyrights, trademarks, plant variety protection GIs. incorporating provisions Paris Convention Protection Industrial Property, TRIPS requires patents granted inventions , involve inventive step capable industrial application (Article 27.1). Article 28.1 TRIPS Agreement, patents public authorization grants owner preclude acts making, , offering sale, selling importing protected product process 20 years. WTO Members define respective criteria novelty, inventive step industrial application light policy priorities , offer patent protection 20 years. exceptions recognized TRIPS Agreement WTO Dispute Settlement decisions widely recognized national judicial administrative practices. Petty patents ( utility models) governed TRIPS Agreement. TRIPS Agreement define contours copyright incorporates substantive provisions Berne Convention 1971, including term protection life creator 50 years. Article 9 TRIPS Agreement stipulate, , copyright protection extends expressions ideas, procedures, methods operation mathematical concepts . TRIPS guarantee copyright protection computer programs (Article 10, TRIPS), recognizes rental rights (Article 11, TRIPS) rights performers, producers phonograms broadcasting organizations (Article 14, TRIPS). scope copyrights discussed section World Intellectual Property Organization (WIPO) treaties. Article 15 TRIPS Agreement, “[]ny sign, combination signs, capable distinguishing goods services undertaking undertakings, capable constituting trademark. signs, words including persona names, letters, numerals, figurative elements combinations colours combinations signs, eligible registration trademarks.” term protection trademark potentially indefinite, initial registration term 7 years. Members require trademark order maintain registration (Article 19, TRIPS). Distinctive signs means misappropriation occur, vehicle provider countries prevent misappropriation ( Chapter 6). Plant variety protection governed TRIPS Agreement. functions, TRIPS Council periodically reviews substantive provisions TRIPS Agreement. interface TRIPS Agreement CBD examined TRIPS Council 1999 review Article 27.3(), governments exclude kinds inventions patenting, .. plants, animals “essentially” biological processes ( micro-organisms, -biological microbiological processes eligible patents). time developing countries argued -examine implications allowing -called ‘patenting life’, including examining impact patenting genes, viruses living organisms. TRIPS Agreement, Article 27.3(), mentions plant varieties Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 32 eligible receive form sui generis 43 patent protection, combination . Additional information plant variety protection section International Union Protection Varieties Plants (UPOV) . examination relationship TRIPS CBD higher mandate 2001, WTO Ministerial Conference launched Doha Development decided Declaration TRIPS Council “examine, inter alia, relationship TRIPS Agreement Convention Biological Diversity, protection traditional knowledge folklore, relevant developments raised Members pursuant Article 71.1. undertaking work, TRIPS Council guided objectives principles set Articles 7 8 TRIPS Agreement fully account development dimension”. 44 mandate, issue, GIs ( ), remain set issues negotiated conclude Doha Development . , debate exists WTO Members means issue addressed WTO Trade Negotiations Committee TRIPS Council. result continuing impasse negotiations, Director General WTO launched consultations initiative, attempting resolve outstanding issues CBD/TRIPS relationship GIs 2009. WTO’ work TRIPS CBD generally focused question conflict treaties, amendment TRIPS Agreement ensure treaties implemented ‘mutually supportive’ manner. 45 discussion, specifically, focuses primarily question amendment Article 29 TRIPS Agreement include mandatory disclosure origin requirement patent applications genetic resources / TK. Article 29 TRIPS Agreement requests Member States require patent applicants disclose invention manner sufficiently clear complete invention carried person skilled art. debate framed CBD issue, CBD Nagoya Protocol requires mandatory disclosure origin. extent Nagoya Protocol requires effective checkpoints ensure implementation, , disclosure origin source requirement potentially considered mechanism assist national competent authorities IP offices designated checkpoint. handbook discusses detail substantive issue TRIPS compatibility disclosure requirements Chapter 3. suffices purposes chapter simply governments remain, numerous studies tabled government submissions TRIPS Council 2001 mandate, divided issue North-South lines consequences -compliance disclosure requirement concerned. , April 2011, group developing countries including Brazil, China, Colombia, Ecuador, India, Indonesia, Peru, Thailand, African, Caribbean Pacific Group States ( ACP Group) African Group, tabled draft decision calling amendment TRIPS Agreement Trade Negotiations Committee introducing mandatory disclosure requirement part Agreement’ minimum standards IP. 46 draft Article 29bis proposes : 43 Sui generis Latin term simply means ' kind.' 44 Doha Ministerial Declaration 20 November 2001, WT/MIN(01)/DEC/1, para. 19. 45 WTO document IP///368/Rev.1 8 February 2006, para. 6. 46 WTO document TN///59 19 April 2011. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 33 “1. purposes establishing mutually supportive relationship Agreement Convention Biological Diversity, Members regard objectives, definitions principles Agreement, Convention Biological Diversity, Nagoya Protocol Access Genetic Resources Fair Equitable Sharing Benefits Arising Utilization, provisions prior informed consent access fair equitable benefit sharing. 2. subject matter patent application involves utilization genetic resources / traditional knowledge, Members require applicants disclose: () country providing resources, , country origin resources country acquired genetic resources / traditional knowledge accordance CBD; (ii) source country providing genetic resources / traditional knowledge.” Applicants required “provide copy International Recognized Certificate Compliance” Nagoya Protocol, alternately “relevant information compliance prior informed consent access fair equitable benefit sharing required national legislation country providing genetic resources / traditional knowledge.” action Trade Negotiations Committee Members draft. classified strictly speaking CBD TRIPS compatibility issue ( relevant perspective enabling mutual supportiveness treaties, noted Chapter 6 text), TRIPS Council forum debates occurring amendment TRIPS provisions geographical indications. GIs place names ( countries words place) identify products places characteristics. GIs considered potential tools promote benefit sharing preserve traditional practices genetic resources ( Chapter 6). Article 22 TRIPS Agreement establishes Members provide measure protection GIs order prevent misleading public geographical origin good, prevent unfair competition. higher level protection accorded Article 23 GIs wines spirits, protected public necessarily misled. obligations subject exceptions enumerated Article 24, names commonplace. , debates GIs TRIPS Council focus issues. deals establishment multilateral system notification registration GIs wines spirits, deals extension higher level protection afforded wines spirits Article 23 goods. discussed topics numerous years, WTO Members continue differ widely issues. respect issue, debate focused legal effect multilateral register, countries (including European Union (EU)) arguing TRIPS amended call establishment register establishes “rebuttable presumption” GI protected WTO members — Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 34 country lodged reservation period. 47 called establishing voluntary system GIs notified entered database. Proponents view, includes number developed developing countries, oppose amendment TRIPS Agreement. 48 compromise proposal put Hong Kong SAR, China. convergence views appears imminent, . 49 respect issue, Member governments divided protection granted current regime Articles 22 23 TRIPS Agreement adequate. Director-General WTO summarized current impasse report submitted official TRIPS Council document: “Delegations continued voice divergent views characterized debate, convergence evident specific question extension Article 23 coverage: Members continued argue extension Article 23 protection products; maintained undesirable created unreasonable burdens.” 50 number countries treat issue multilateral register GIs linked negotiations mandatory disclosure requirement. formal decision linking linkage proposed countries, future issues linked uncertain. lack progress reaching consensus issues, remain standard agenda item regular meetings TRIPS Council. Key Points TRIPS Agreement establishes minimum standards protection WTO Members variety IP instruments including patents, copyrights, trademarks, geographical indications, industrial designs, plant variety protection, integrated circuit designs undisclosed information. , considered important reference point international IP rules. TRIPS Agreement designed treaty inherently promotes CBD objectives. provisions treaty impact objectives, including provisions patents, plant variety protection geographical indications. longstanding discussion TRIPS Council disclosure origin requirement ( patent law-related sanctions case -compliance) compatible TRIPS Agreement. debate framed CBD issue, CBD Nagoya Protocol requires mandatory disclosure origin source. Ongoing discussions TRIPS Council include debates surrounding amendment TRIPS Agreement include mandatory disclosure requirement, establishment multilateral register geographical indications 47 WTO document TN///26 14 June 2005. 48 WTO document TN///10/Rev.2 24 July 2008. 49 , WTO, document TN/IP//8, 2003. 50 WTO document TN///61of 21 April 2011. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 35 higher level protection accorded goods, wines spirits. standing items agenda TRIPS Council meetings, major breakthroughs governments reach consensus. . WIPO Treaties Established specialized agency United Nations 1967, World Intellectual Property Organization (WIPO) secretariat services substantive IP treaties venue negotiation IP treaties. include treaties TRIPS Agreement incorporates substantive provisions IP protection, .., Paris Convention Protection Industrial Property Berne Convention Protection Literary Artistic Works. functions, WIPO Secretariat, located Geneva, Switzerland, administrative backbone Patent Cooperation Treaty (PCT), creates mechanism facilitate cross-border patent applications. mentioned , WIPO serves treaty secretariat Berne Convention copyrights. Copyrights significance respect interface ABS IP impact TK treated. Article 2(1) Berne Convention enumerates -exhaustive list items protected copyright: “ production literary, scientific artistic domain, mode form expression, books, pamphlets writings; lectures addresses, sermons works nature; dramatic dramatico- musical works; choreographic works entertainments dumb show’ musical compositions words; cinematographic works assimilated works expressed process analogous cinematography; works drawing, painting, architecture, sculpture, engraving lithography; photographic works assimilated works expressed process analogous photography; works applied art; illustrations, maps, plans, sketches -dimensional works relative geography, topography, architecture science.” Works protected granting exclusive rights work minimum term life creator 50 years. limitations exceptions carved copyright, fair . copyright treaties negotiated WIPO auspices, .., -called WIPO Internet treaties, include WIPO Copyright Treaty WIPO Performances Phonograms Treaty. treaties deal specifically effects digital environment copyright. note WIPO engaged potentially standard setting discussions interface biodiversity IP. October 2000, General Assembly WIPO established Intergovernmental Committee Intellectual Property, Genetic Resources, Traditional Knowledge Folklore ( IGC). WIPO General Assembly mandate IGC conduct negotiations objective reaching agreement text international legal instrument ( instruments) ensure effective protection TK, traditional cultural expressions (TCEs)/folklore genetic resources. negotiations time writing Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 36 produced draft texts respective topics remain heavily bracketed 51 , indicating IGC Members agreement number issues. international work developing suitable legal frameworks TK aims objectives: Recognising cultural spiritual Recognising -determination customary laws practices Respecting basic principles .. free prior informed consent Ensuring protection misappropriation Ensuring sharing benefits generated utilisation Regulating application scientific work industrial processes Responding specific TK holders IGC draft text genetic resources discusses, inter alia, defensive databases, proposed mandatory disclosure requirement intellectual property clauses calling mutually agreed terms access equitable benefit sharing. Major issues negotiations text TK include question constitutes public domain, subject matter protection, beneficiaries protection, exceptions limitations. draft text exists TCEs. Debate continues exist topics covered single treaty separate . date announced diplomatic conference leading treaty instrument(). IGC serviced WIPO Secretariat, number studies topic interface biodiversity, TCEs, TK IP commissioned published WIPO years. Negotiations continue date writing. Key Points substantive provisions basic WIPO treaties Berne Paris Conventions incorporated TRIPS Agreement reference. activity WIPO relevant interface biodiversity IP work Intergovernmental Committee Intellectual Property, Genetic Resources, Traditional Knowledge Folklore (IGC). WIPO General Assembly mandate IGC conduct negotiations objective reaching agreement text international legal instrument ( instruments) ensure effective protection traditional knowledge (TK), traditional cultural expressions (TCEs)/folklore genetic resources. point, clear disclosure requirements form part treaty text emanating IGC. Negotiations IGC continue date writing. WIPO announced date diplomatic conference leading adoption treaty. 51 WIPO document WO/GA/40/7 12 August 2011 Facilitators’ Draft Consolidated Draft Relating Intellectual Property Genetic Resources, 7 February 2013, http://www.ip-watch.org/weblog/wp- content/uploads/2013/02/IGC-consolidated-document-Rev-2-Feb-2013.pdf. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 37 . UPOV noted , Article 27.3() TRIPS Agreement WTO Members option providing patent protection plant varieties setting sui generis system plant breeders’ rights, combination . International Union Protection Varieties Plants (UPOV) multilateral treaty facilitates international protection varieties plants sui generis system plant breeders’ rights plants meet minimum standards. treaty interest users seek commercialize newly developed variety plant. minimum standards contained national legislation differ depending country acceded UPOV treaty amended 1991 earlier version UPOV treaty. plants genetic resources, interface UPOV Nagoya Protocol CBD essentially similar patents, grant plant breeders’ confers exclude variety license, subject number exceptions. , plant breeders’ rights misappropriate genetic resources related TK, serve basis benefit sharing. UPOV Secretariat appears hold view disclosure origin accepted additional requirement protection, conditions plant variety protection UPOV Convention established increased. 52 Objections view raised civil society groups. 53 regard farmers' rights, 1991 text access-related elements farmers' rights limited extent. elements traditionally comprise saving, exchanging selling farm-produced plant material, Article 15(2) optional exception breeder' giving UPOV parties opportunity , " reasonable limits subject safeguarding legitimate interests breeder, restrict breeder’ relation variety order permit farmers propagating purposes, holdings, product harvest obtained planting, holdings, protected variety." farmers’ exception implemented domestically, restricted small-scale farmers coupled specific license fee system. UPOV 1991 essentially abandons practices exchanging selling farm-produced seeds customary law 54 practices involve protected material. UPOV governed Council members, serviced secretariat ( Office) housed WIPO building Geneva, Switzerland. 70 countries , date, member UPOV. country ratified UPOV system place protect plant varieties. , biodiversity rich countries India Thailand opted establish sui generis system plant variety protection UPOV framework, , inter alia, provisions protecting farmers’ 52 Vivas-Eugui Oliva (2010), . 7. 53 , , Dutfield (2011). 54 Customary Law- covers ‘customs accepted legal requirements obligatory rules conduct, practices beliefs vital intrinsical part social economic system treated laws’ (Black’ Law Dictionary, 7th edition, 1999). Traditional communities maintain customary laws governing community environmental resources. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 38 rights recognizes development domestic varieties based traditional means exchange seeds. option TRIPS Agreement meet requirements Article 27.3(). Key Points International Union Protection Varieties Plants (UPOV) multilateral treaty facilitates international protection varieties plants sui generis system plant breeders’ rights plants meet minimum standards. interface UPOV Nagoya Protocol CBD essentially similar patents, grant plant breeders’ confers exclude variety license, subject number exceptions ( , , farmers’ save seeds contained national legislation). biodiversity rich countries India Thailand opted establish sui generis system plant variety protection UPOV framework. . Free Trade Agreements Multilateral treaties sources international law address interface biodiversity intellectual property. Free trade agreements (FTAs), concluded bilateral basis, IP provisions affect CBD objectives. abovementioned multilateral treaties, obligations contained FTAs require national legislation adoption legislation. scope handbook examine variants biodiversity-related IP provisions FTAs. suffices purposes chapter note provisions dealing interface heretofore -called ‘TRIPS- ’, .., requiring countries adhere standards stringent called TRIPS Agreement. , Japanese FTAs countries Chile (2007) Indonesia (2007) oblige countries adhere UPOV 1991 standards TRIPS Agreement oblige countries ( noted , stipulates form plant variety protection offered plant varieties patent protection offered). provision raised lot concern rule US FTAs disclosure invention considered sufficiently clear sufficient information carried person skilled art, invention sufficiently supported disclosure conveys applicant possession claimed invention filing date. arguably difficult FTA partners maintain patent-related sanctions -compliance disclosure origin, source, . 55 provisions potentially obligate countries party FTA adhere standards 55 Articles 16.9.9 16.9.10, FTA USA-Peru. Similar provisions FTA USA- Morocco, Articles 15.21.10 15.21.11. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 39 effect offer, -favoured nation principles, TRIPS- IP protection standards countries negotiated multilaterally. International Centre Trade Sustainable Development (ICTSD) finds, , 2010 study “ increasing number North-South FTAs incorporated biodiversity related provisions bilateral trade agreements addition traditional IP provisions, seeking balanced sustainable approach”. 56 study cites, , examples understandings Colombia Peru, , pursuant concluding FTAs United States. understandings attempt preserve policy space TK biodiversity interests stake. 57 Key Points Free trade agreements (FTAs), concluded bilateral basis, IP provisions affect CBD objectives. provisions dealing interface heretofore -called ‘TRIPS-’, .., requiring countries adhere standards stringent called TRIPS Agreement. studies show , biodiversity TK rich developing countries increasingly resisting call narrow policy space IP provisions impact biodiversity TK resources. III. WHO Pandemic Influenza Preparedness Framework World Health Organization (WHO), United Nations specialized agency headquartered Geneva, Switzerland, engaged work, inter alia, vaccines, potentially interfaces ABS provisions Nagoya Protocol/CBD. exists debate pathogens covered NP, handbook takes position excluded work WHO ( section Chapter 3 Pathogens). Member States World Health Assembly adopted 2011 resolution endorsing report Open-Ended Working Group Pandemic Influenza Preparedness sharing influenza viruses access vaccines benefits, resulting ‘Pandemic Influenza Preparedness Framework’, includes annexes standard material transfer agreements (SMTAs) sharing pathogens entities , part WHO network influenza monitoring, , entities network, including private companies. 58 SMTAs essentially contractual obligations signatories. WHO network participants obliged SMTA, SMTA serves guideline text negotiations MTAs network member parties part WHO network. text SMTAs contained Annex II handbook. 56 Vivas-Eugui Oliva (2010), pp. vi-viii. 57 Ibid., pp. 8 9. 58 World Health Assembly Resolution 64.5 24 2011. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 40 ITPGRFA ( Chapter 1), WHO SMTAs confer government treaty obligation. Article 4(3) Protocol, “[]ue regard paid relevant ongoing work practices international instruments relevant international organizations, supportive run counter objectives Convention Protocol”. language serves largely reminder specifically excepted separate treaty, ABS system established Protocol interpreted courts cover influenza viruses. Key Points World Health Assembly endorsed 2011, standard material transfer agreements (SMTAs) sharing pathogens entities , part WHO network influenza monitoring, , network entities entities network. SMTAs contractual obligations signatories. WHO network participants obliged SMTA, SMTA serves guideline text negotiations MTAs network party parties part WHO network. ITPGRFA, SMTAs confer government treaty obligation. IV. Protecting Traditional Knowledge CBD Nagoya Protocol cover traditional knowledge genetic resources. begs question TK protected. human rights instruments starting point recognition customary rights ILCs, including TK. treaties specifically address ABS IP issues , extent rights ILCs grounded important documents interpret technical treaty provisions ABS IP treaties. survey important treaties. chapter examines appropriateness IP tools protecting TK ( Chapter 5). . ILO Convention 169 Headquartered Geneva, Switzerland, International Labour Organisation ( ILO) UN body specifically dealt indigenous matters. Work started 1926 development standards protection indigenous workers. ILO focused integration indigenous workers mainstream society dealing securing customary indigenous rights. approach changed 1989, Convention 169 ( Convention Indigenous Tribal Peoples Independent Countries) adopted. treaty entered force 1991. Convention 169 focuses land rights, labour, social security education. Article 15(1) rights-based approach natural resources complements 1992 Rio documents, issues TK IPRs scope Convention 169 59 : 59 Text : http://www.ilo.org/ilolex/cgi-lex/convde.plC169, accessed January 2012. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 41 " rights peoples concerned natural resources pertaining lands specifically safeguarded. rights include peoples participate , management conservation resources." Convention define indigenous tribal peoples , criteria describing peoples aims protect. Article 1(2) states: "-identification indigenous tribal regarded fundamental criterion determining groups provisions Convention apply." Article 1(1) describes difference tribal indigenous peoples relevance interpretation CBD Nagoya Protocol. treaties speak "indigenous local communities" giving indications actual members groups. Convention 169, distinction : 1) Tribal peoples: social, cultural economic conditions distinguish sections national community status regulated wholly partially customs traditions special laws regulations 2) Indigenous peoples: regarded indigenous account descent populations inhabited country, geographical region country belongs, time conquest colonisation establishment present state boundaries , irrespective legal status, retain social, economic, cultural political institutions main drawback Convention 169 limited membership 22 states, 14 located Latin America. legally binding members, include enforcement compliance mechanism. specific importance Convention indigenous peoples living Member States specifically context TK IPRs underlined judgement Supreme Court Costa Rica. supporting future patentability inventions "essentially derived knowledge traditional biological practices cultural practices public domain" Costa Rica, Supreme Court stated amendment " change affects interests indigenous communities, , result, conformity 169 Convention amendment consulted…" 60 judgement supports call indigenous peoples’ organisations formally included development national ABS IP regulations cover genetic resources TK. Key Points 60 Cabrera Medaglia (2010), . 286. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 42 ILO Convention 169, limited 22 states signed , important helping interpret term ‘indigenous local communities’ context ABS. judgment Costa Rica supported formal inclusion ILC organizations development national ABS IP regulations. . Universal Declaration Human Rights ICESCR Rights TK discussed light provisions Universal Declaration Human Rights 1948 (UDHR) 61 International Covenant Economic, Social Cultural Rights 1966 (ICESCR, entered force 1976) 62 . recitation important universally accepted human rights norms, treaty obligations United Nations Office High Commissioner Human Rights, headquartered Geneva, Switzerland, services treaty body charged implementing ICESCR. Read sequence, articles instruments shed light human status protection TK intellectual property ( Box 6 ). Box 6 Basic Human Rights Instruments Potential Impact ABS IP ICESCR Article 1 Impact 1. peoples -determination. virtue freely determine political status freely pursue economic, social cultural development. 2. peoples , ends, freely dispose natural wealth resources prejudice obligations arising international economic - operation, based principle mutual benefit, international law. case people deprived means subsistence. Establishes - determination, including dispose natural resources, implying protect resources . intellectual property UDHR Article 7 equal law entitled discrimination equal protection law. entitled equal protection discrimination violation Declaration incitement discrimination. equal protection law implies protection intellectual property indigenous peoples UDHR Article 17 (1) property association . (2) arbitrarily deprived property. Providing collective property protection deprived property UDHR Article 27 (1) freely participate cultural Implying protection rights 61 Text information : http://www..org/en/documents/udhr/, accessed January 2012. 62 Text information : http://www2.ohchr.org/english/law/cescr.htm, accessed January 2012 Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 43 life community, enjoy arts share scientific advancement benefits. (2) protection moral material interests resulting scientific, literary artistic production author. advancements innovations based TK Source: based Posey. 63 UDHR ICESCR instruments define basic rights. making specific reference IP, ABS TK , provide interpretive guidance. Key Points provisions UDHR ICESCR helpful interpretive tools cases involve TK genetic resources. . UNDRIP United Nations Declaration Rights Indigenous People (UNDRIP) comprehensive statement addressing rights indigenous peoples. drafted formally debated twenty years prior adopted 29 June 2006 inaugural session UN Human Rights Council. UNDRIP protects indigenous peoples discrimination, recognizes rights internal -determination, culture, land, spirituality religion, health. UNDRIP acknowledges collective nature indigenous peoples' rights basic principle. UNDRIP emphasizes rights indigenous peoples maintain, control, protect develop cultural heritage, TK TCEs, manifestations sciences, technologies cultures, including human genetic resources, seeds, medicines knowledge properties fauna flora. maintain, control, protect develop intellectual property cultural heritage, TK TCEs. UNDRIP date explicit recognition human rights instrument specific set rights items potentially covered ABS regime, including TK TCEs, manifestations sciences, technologies cultures. UNDRIP legally binding provide compliance enforcement mechanisms, provisions add existing body customary international law, valuable reference point articulating rights indigenous peoples. Relevant provisions UNDRIP reproduced . Box 7 United Nations Declaration Rights Indigenous Peoples (UNDRIP) Article 31. 63 Posey (1994), pp. 125-26. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 44 1. Indigenous peoples maintain, control, protect develop cultural heritage, traditional knowledge traditional cultural expressions, manifestations sciences, technologies cultures, including human genetic resources, seeds, medicines, knowledge properties fauna flora, oral traditions, literatures, designs, sports traditional games visual performing arts. maintain, control, protect develop intellectual property cultural heritage, traditional knowledge, traditional cultural expressions. 2. conjunction indigenous peoples, States effective measures recognize protect exercise rights. Source: UNDRIP (2007). Key Points legally binding, UNDRIP affirms positive indigenous people maintain, control, protect develop cultural heritage, TK TCEs, manifestations sciences, technologies cultures, including human genetic resources, seeds, medicines, knowledge properties fauna flora, oral traditions, literatures, designs, sports traditional games visual performing arts. . UNESCO Adopted United Nations Educational, Scientific Cultural Organization (UNESCO) General Conference 2003, Convention Safeguarding Intangible Cultural Heritage ( CSICH) exists means identify preserve intangible cultural heritage future generations, defined Article 2 Convention: “1. “intangible cultural heritage” means practices, representations, expressions, knowledge, skills – instruments, objects, artefacts cultural spaces therewith – communities, groups , cases, individuals recognize part cultural heritage. intangible cultural heritage, transmitted generation generation, constantly recreated communities groups response environment, interaction nature history, sense identity continuity, promoting respect cultural diversity human creativity. purposes Convention, consideration solely intangible cultural heritage compatible existing international human rights instruments, requirements mutual respect communities, groups individuals, sustainable development. 2. “intangible cultural heritage”, defined paragraph 1 , manifested inter alia domains: () oral traditions expressions, including language vehicle intangible cultural heritage; () performing arts; Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 45 () social practices, rituals festive events; () knowledge practices nature universe; () traditional craftsmanship.” breadth coverage includes practices overlap TK genetic resources, item 2(). “Safeguarding” defined measures aimed ensuring viability intangible cultural heritage, including identification, documentation, research, preservation, protection, promotion, enhancement, transmission, formal -formal education, revitalization aspects heritage. Convention obliges parties Convention measures safeguarding (Article 11(), CSICH), stops short granting specific rights country identified intangible cultural heritage. 64 international level, Committee maintains Representative List Intangible Cultural Heritage Humanity List Intangible Cultural Heritage Urgent Safeguarding. Registration List thought means countries mobilize assistance protect intangible cultural asset. Registration UNESCO intangible heritage , , ILCs making case TK genetic resources belongs , . Convention administered UNESCO’ Secretariat, located Paris, France. Key Points UNESCO’ Convention Safeguarding Intangible Cultural Heritage listing countries intangible cultural heritage Representative List Intangible Cultural Heritage Humanity List Intangible Cultural Heritage Urgent Safeguarding. International registration ILCs making case TK genetic resources belongs , . . Conclusion international policy making landscape issues straddle IP biodiversity issues complex. number forums concluded treaties international level impact biodiversity issues, forums continue engaged discussions potentially change landscape interface. matters complex, issue ( , disclosure origin) discussed forum (WTO WIPO/IGC), subject dealt multilateral bilateral levels ( , plant variety protection). Countries bound treaty, (China bound CBD, ITPGRFA). obligations treaty obligations, contractual ( WHO SMTAs pandemic influenza). 64 hand, Convention prevent Party granting specific rights . Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 46 situation country analyzed basis treaties party , defies easy analysis. remainder handbook dedicated -universal CBD, links ABS system established Nagoya Protocol TRIPS Agreement obligations affect CBD objectives. References agreements relevant. Readers mind, , rules emerge forums mentioned . general observation, , issues considered contentious, time agreement. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 47 Chapter 3 Disclosure Origin/Source Legal Provenance . Introduction Developing countries pushing intergovernmental forums mandatory disclose patent applications source / country origin biological resources, traditional knowledge legal acquisition resources, resources / traditional knowledge (TK) contained invention applicant seeking patent rights. Disclosure origin ( variations) key means ensure IP system supports access benefit sharing (ABS) objectives CBD. 65 negotiations Nagoya opened possibility intergovernmental machinery address proposals mandatory disclosure requirement, issue remains contentious day World Trade Organization (WTO) World Intellectual Property Organization (WIPO) Intergovernmental Committee Intellectual Property Genetic Resources, Traditional Knowledge Folklore ( IGC). Ultimately, delegates Nagoya unable resolve requirement included final treaty text, Nagoya Protocol mandatory disclosure obligation, leaving Parties decide wished incorporate requirement national laws. purposes handbook, disclosure origin/source requirement requirement incorporated national patent law, ABS law. 66 pedagogical purposes, , noted, shorthand range biodiversity-related disclosure requirements ( BRDR), including requiring proof legal provenance submitted patent application. perspective patent office, objective disclosure requirement enable examiners assess claimed invention meets patentability criteria novelty, inventive step industrial application, helps clarify standing apply patent. Disclosure origin/source mandatory plant variety protection/plant breeders’ rights (PBR) applications , issue discussed text . , disclosure – integral part patent application process. Disclosure considered part social contract underlying patents: exclude invention limited period time, license, granted return making information claimed invention public. matter international law, Article 29(1) TRIPS Agreement establishes WTO Members minimum standard disclosure contained national patent legislation. “Members require applicant patent disclose invention manner sufficiently clear complete invention carried person skilled art require applicant mode carrying 65 Vivas-Eugui Muller, Chouchena-Rojas (ed.) (2005), .al., . 24. 66 Disclosure origin requirements contained ABS laws. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 48 invention inventor filing date , priority claimed, priority date application.” national patent laws require patent applicants disclose prior art applicant. 67 Prior art discussed detail chapter. Disclosure functions ensure inventions meet criteria novelty, inventive step industrial application granted exclusive rights, exclude patentability meet criteria, technical information public recreate invention improve . 68 perspective ABS law, requiring inventors include public relevant information important inputs obtained provider countries, disclosure act check misappropriation, determining scope benefit sharing due provider countries indigenous groups. disclosure origin/source requirement builds basic obligation specifies applying patent invention, applicants include description invention work , origin / source genetic resources / related TK invention. countries adopted form disclosure origin requirement, absence obligation international law. 69 authors handbook view absence international obligation, countries recognized potential disclosure requirements patent law natural complement ABS legislation, coming force Nagoya Protocol establishing minimum standards ABS worldwide, trend provider user countries introduce disclosure . countries implemented disclosure requirement varies, references texts contained chapter . Countries making choices respect introducing revising existing legislation aware disclosure affects patent system, requirement aid preventing patent system instrument misappropriation ‘biopiracy’. chapter examines choices detail. Key Points Nagoya Protocol requirement countries adopt mandatory disclosure origin legal provenance. Ongoing discussions intergovernmental forums touching possibility mandatory disclosure time. requiring inventors include public relevant information important inputs obtained provider countries, disclosure act check 67 Rule 56 United States Rules Practice Patent Cases (37 CFR §1.56) includes duty disclose information individual material patentability. Japanese practice similar duty. Japan’ Examination Guidelines Patent Utility Model, Japan Examination Standards Office, December 2011. 68 UNCTAD-ICTSD Resource Book, . 448. 69 Henninger’ “Disclosure Requirements Patent Law Related Measures: Overview Existing National Regional Legislation Intellectual Property Biodiversity” GTZ (2010), pp. 311-21. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 49 misappropriation, determining scope benefit sharing due provider countries indigenous groups. Countries free introduce disclosure requirements, date. Disclosure requirements build minimum standard general disclosure patent application stipulated Article 29(1) TRIPS Agreement. II. Relationship Disclosure Prior Art Prior art refers information public date relevant claim patentability. international level, strict definition term, Rule 5.1()(ii) Regulations Patent Cooperation Treaty (PCT) refers art describing contained disclosure: Rule description claimed invention “ background art , applicant, regarded understanding, searching examination invention, , preferably, cite documents reflecting art.” Prior art relevant patentability criteria: , novelty inventive step. section reviews criteria explains relationship disclosure prior art. Novelty criteria patentability. Patent examiners assess, inter alia, claimed invention light applicable standard examining novelty patent law. Generally, burden proof applicant show patent examiner , light prior art, claimed invention represents . , , exclude possibility patent examiners relying sources external patent application determine state art. country flexibility determining applicable standard examining novelty, number variations exist. Abbott, criterion novelty construed claim prior art considered lack novelty, spectrum, novelty construed subject matter implicit inherent prior art considered defeat novelty. 70 Prior disclosures invention public world result rejection novelty technology patent application (worldwide novelty), limited disclosures invention country (domestic novelty 71 ). Depending practice country, prior disclosure invention oral, contained single document derived combination publications. 72 criterion patentability inventive step. Generally, invention considered met inventive step criterion , account prior art, 70 Abbott (2005). 71 noted domestic novelty . OECD countries, Zealand abandoned domestic novelty favor absolute (.., worldwide) novelty 2008. United States, oral prior art destroys novelty occurs United States ( 35 USC § 102(): “ person entitled patent - [] () invention patented printed publication foreign country public sale country, year prior date application patent United States.”). 72 UNCTAD (2011b), . 67. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 50 obvious person skilled art date filing. purpose requirement prevent granting exclusive patent rights trivial inventions. novelty met ‘quantitative’ assessment claimed invention issue relevant prior art, inventive step test requires invention qualitatively exceed ‘typical person skilled art’ produce. , identifying prior art; , assessing extent invention embodied claim obvious person skilled art ( ) knowledge relevant prior art. 73 relationship prior art inventive step summarized : prior art account, greater chance invention treated obvious, increase possibility fail inventive step test. consideration industrial application ( criterion patentability, connection prior art), countries differ extent apply expansive restrictive criterion novelty combine expansive criterion inventive step. criteria function, , assess difference claimed invention prior art, gap exists, examine claimed invention obvious person skilled art, publicly knowledge. 74 regard, considered prior art purposes novelty differs prior art assessing inventive step. prior art narrow case inventive step, limited publicly knowledge average expert skilled art pertinent case. examination patentability criteria starting point chapter , ultimately, disclosure requirement forces patent applicants open honest genetic resources provider countries / related TK contained claimed invention effective disclosure ( lack thereof) affects application substance, opposed pro forma. 2004 WIPO study notes “[]ailure comply formal terms necessarily consequences, fraudulent remedied timely manner. Failure comply substantive terms ( requirement disclose sufficient material sustain patent claims) major consequences fate patent application granted patent.” 75 ongoing debate disclosure requirement patent applications amounts distinct condition patentability novelty, inventive step industrial application ( discussion section Enforcement, ). noted WIPO study , , doubt compatibility disclosure requirement TRIPS Agreement information gleaned disclosure affects assessment patent examiner claimed invention basic patentability criteria. jurisdictions disclosure requirement patent legislation explicitly approach, . European Union’ Recital 27 Directive 98/44/EC Legal Protection Biotechnical Inventions states, : “ invention based biological material plant animal origin material, patent application , , include 73 Ibid., . 68. assessment -obviousness complex involves combination subjective objective factors detailed examine text. interested invited consult document pp. 69-72. 74 South Centre . , . 49. 75 WIPO (2004), . 5. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 51 information geographical origin material, ; prejudice processing patent applications validity rights arising patents.” type text confer obligation disclose origin source applicant, affect substantive examination application. time, disclosure deemed affect validity rights arising patent, difficult patent granted elements potentially material consideration patentability criteria disclosed patent application. , authors handbook view disclosure origin considered introducing substantive element assessing patents, absent amendment Article 29 TRIPS Agreement WIPO treaty mandating disclosure origin/source. Generally, countries’ national patent legislation incorporated mandatory disclosure origin source pre-requisite additional condition submitting patent applications 76 ; reflects conservative approach, noted date WTO dispute settlement ruling issue. examples national laws highlighted sections . Finally, unique issue respect TK prior art. mistake assume TK public domain automatically constitutes ‘prior art’ patent law purposes. Mgbeoji, , cites examples native healers medicinal knowledge largely secret. 77 National TK legislation customary laws, extent exist jurisdiction, confer ownership attribution rights communities. theoretically patent applicant submit application respect invention similar TK. benefit disclosure requirement cases puts onus applicant truthfully divulge submission government application based TK. Key Points Disclosure helps reveal prior art, consideration assessing patentability criteria novelty inventive step. prior art novelty necessarily prior art inventive step. generally disclosure origin/source incorporated national laws condition patent applications, legislation text implies disclosure strictly pro forma. cases, difficult disclosure material patentability criteria consideration. Requiring disclosure condition submitting patent applications conservative approach generally procedural, add separate 76 Ibid., . 314. jurisdictions evidence prior informed consent pre-requisite patentability, Peru. 77 Mgbeoji Subramanian Pisupati (ed.) (2010), Traditional Knowledge Policy Practice: Approaches Development Human -, . 140. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 52 substantive element existing patentability criteria, ongoing debates WTO WIPO mandatory disclosure requirement international law ( Chapter 2). WTO case date challenged validity disclosure requirement national patent legislation. purposes assessing patent applications utilize TK, erroneous assume TK public domain. disclosure requirement forces applicant honest / drawn TK application. III. Shaping Disclosure Origin Requirement . Assumptions, Objectives Limitations Disclosure Origin Countries putting place disclosure requirement patent law revising existing disclosure legislation/regulations clear disclosure requirement place, seek accomplish requirement. policy objectives clear, easier shape requirement. details, text part patent law regulations / guidelines, considered stage. rationale putting place disclosure requirement rests number general assumptions. : 1. provider countries disclosure requirements means preventing misappropriation genetic resources / related TK. Disclosure viewed primarily defensive strategy prevents granting erroneous patents, purposes CBD Nagoya Protocol. 2. handful inventions incorporate genetic resources related TK provider countries subject patent application, commercialized. applications generally filed developed countries larger developing countries. 3. Patent applicants developing country provider countries predominantly foreign. 4. Ensuring benefit sharing: joint ownership patents arrangements share royalties/license fees patents offer means share benefits invention incorporates genetic resources / related TK provider countries. largest monetary benefits arise successful marketing inventions, parties, sharing benefits covered contractual agreement. 5. Transparency monitoring: patent offices developing countries - resourced, frequently capacity undertake comprehensive examination applications, independent research verify claims patent applications. Research centres providers biological resources developing countries, ministries agriculture environment, frequently capacity identify, trace monitor Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 53 commercialization resources supplied absence duty part recipients disclose origin biological resources patent applications. 6. developing countries aiming TRIPS-compliant patent legislation. points important delineate limitations disclosure requirement accomplish. , incorporating requirement patent law cover handful ABS cases. existence disclosure requirement justify designation IP office checkpoint, national focal point competent national authority meaning Article 13 Protocol. 78 , potential tension assumptions . provider country overzealous rejecting patent applications references genetic resources related TK, country foreclosing opportunities share benefits accruing patent, patentability criteria met. assumption points great deal investigation research attempt commercialize product based genetic resources related TK. implications disclosure, .., frame research exception patent law & treated Protocol ( topic covered handbook). true developing countries patent applications overwhelmingly submitted foreigners, domestic actors attempted acts misappropriation filing patent applications. sense carve separate disclosure requirements targeting foreign applicants. , national treatment principle Article 3 TRIPS Agreement obliges Members accord treatment favourable accords nationals regard protection intellectual property. major limitation disclosure requirements established provider country patent law requirement necessarily prevent -called ‘biopirate’ seeking patent protection jurisdictions requirement exist voluntary, consequences lack disclosure patentability claimed invention. individuals simply avoid attempting obtain patent provider jurisdictions. handbook acknowledges limitation, takes view : 1) countries worldwide, including developed countries, increasingly adopting form disclosure origin requirement critical mass countries requirement lead countries mandatory 79 ; 2) patent applications user country jurisdictions find provider country 78 Nagoya Protocol avoids linking competent authority checkpoints. , meaningful implementation Protocol IP relates provisions requires linkage competent authority checkpoints, remains unclear purpose checkpoints collecting information. 79 authors deliberately excluded analysis question mandatory disclosure origin requirement adopted matter international treaty law. critical mass countries requirement contained patent law creates momentum intergovernmental consensus, debate remains controversial time writing. , exists substantial literature issue, written hopes requirement contained Nagoya Protocol. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 54 jurisdictions result applications submitted numerous countries PCT requests dossiers prior art; 3) patent application disclosures generally comprise prior art jurisdictions extent adopted worldwide standard novelty, increasingly accessible due advances information communications technology ( ICT), including databases. , major advantage patent disclosure permits assessment applications utilize accessed genetic resources TK pre-date CBD / Nagoya Protocol, making issue genetic resources TK accessed moot, patent applications concerned. serve check misappropriation subject resources / TK subject PIC MAT requirements accessed. Finally, explicit assumptions , greatest tensions economic incentives created patent system, objective CBD attempts set basic rules conservation sustainable biological resources ABS worldwide. Patent systems establish incentive commercializing rewarding technological innovation regard conservation sustainable ABS. Nagoya Protocol sets basic rules access fair equitable sharing benefits arising utilization genetic resources TK genetic resources. pre-amble Protocol acknowledges potential role ABS contribute conservation sustainable biological diversity, poverty eradication environmental sustainability, research date ABS system encourages commercialization, patenting, potentially lead acceleration resource depletion. Convention International Trade Endangered Species Wild Fauna Flora ( CITES) designed address issue resource depletion extent 80 , ample room future empirical research relationship patents resource depletion, reiterates ABS competent authority ensure access granted manner supportive CBD objectives. CBD, part, takes challenge connecting duty Parties create conditions facilitate access requirement environmentally sound. worldwide accepted instrument analyze environmental implication activities Environmental Impact Assessment ( EIA) Article 14 CBD, implemented standard operating procedure national environmental laws. handbook recognizes patent system set address conservation equitable ABS concerns, acknowledges effect systems set sets rules. section points , , setting disclosure obligation national patent system involves number potentially competing objectives interests. Countries balance objectives shaping contours disclosure obligation. Additionally, chapter GIs shows IP instruments potentially tailored manner supports sustainable . 80 CITES treaty, established 1973, regulates imports, exports -exports plants animals endangered. information, http://www.cites.org. http://www.cites.org/ Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 55 Key Points Countries clear seek disclosure origin requirement introducing legislation, revising existing legislation. number important assumptions limitations considered framing legislation. include : ABS cases industries generally subject patent applications; national treatment TRIPS requires foreigners nationals treated alike, patent applications developing countries tend overwhelmingly filed foreigners; - bio-pirates file patent applications potentially profitable jurisdictions disclosure requirement; relationship commercialization patenting, depletion resources date -researched. Patents ABS systems set sets rules. advantageous, , , patent system permits assessment applications utilize genetic resources TK pre-date CBD Nagoya Protocol. . Disclosed Case Patent Offices National Competent Authorities Function Independently starting point analysis Nagoya Protocol. disclosure implementation Protocol, examine provisions Protocol requirement support. Protocol covers categories resources – genetic resources owned state, genetic resources owned indigenous local communities (ILCs), TK owned ILCs. key obligations Protocol PIC MAT concerned contained Article 5(1) 5(5), state, , : “ accordance Article 15, paragraphs 3 7 Convention, benefits arising utilization genetic resources subsequent applications commercialization shared fair equitable Party providing resources country origin resources Party acquired genetic resources accordance Convention. sharing mutually agreed terms”; “ Party legislative, administrative policy measures, , order benefits arising utilization traditional knowledge genetic resources shared fair equitable indigenous local communities holding knowledge. sharing mutually agreed terms.” implementation provisions falls purview national competent authority, stipulated Article 13 Protocol. authority responsible Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 56 “granting access , applicable, issuing written evidence access requirements met responsible advising applicable procedures requirements obtaining prior informed consent entering mutually agreed terms.” national authority achieves objective stated ensuring access fair equitable sharing benefits review PIC MAT cases genetic resources TK sourced country. authority Protocol national authority wider CBD issues. national competent authority generally separate country’ IP office. IP office , , designated ‘checkpoint’ assist competent authority discharging duties. rationale -called ‘checkpoint’ system Protocol compliance served separation functions. , , patent system designed manner , national competent authority provider country, generates information , flags authority genetic resource sourced provider country TK provider country utilized; , claiming exclusive rights application commercialization genetic resource TK. patent system conceivably generate information national competent authority evidence PIC MAT 81 , , strictly speaking, necessarily material claim concerns invention criteria novelty, inventive step industrial applicability met. handbook return question sense include evidence PIC MAT patent application chapter. minimum, , disclosure origin/source requirement structured manner ensures patent applications, public publication official gazette, relevant references genetic resources sourced provider country indigenous group() case genetic resources owned ILC TK, applicant. enable staff national competent authority monitor patent applications, flag potential cases interest follow-. patent system, , potentially powerful tool simply generate information national competent authorities primary duty ensure compliance PIC MAT. perspective patent law, generating information disclosure requirements, examiners decide proprietary claim invention merits award exclusive rights, innovation worthy award rights. Ideally, exercise patent examiner’ duties assessing applications serve means address misappropriation ‘biopiracy’ examination existence contents certificates compliance benefit sharing agreements conducted national competent authorities. stated earlier, patent system address potential cases inventions utilize genetic resources TK pre-date CBD Nagoya Protocol. order , , system function generate type information patent examiners reach informed fair decision merits patent application. 81 requiring box checked indicating underlying material transfer agreement, license agreement similar agreement, , applicant attach copy thereof. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 57 Patent systems work basis applications filed seek obtain temporary exclude claimed technological innovation exchange disclosure technology build . applicant burden proof showing technology patent sought invention ( product process, combination thereof), requisite criteria novelty, inventive step industrial application met. , applicants legal obligation show, inter alia, invention represents significant innovation existing prior art. time, economic incentive disclose minimally order secure grant exclusive , applicant generally seek preserve competitive edge working technology event patent granted, exaggerate misrepresent claim bid secure exclusive rights. disclosures trusted, applications generally subject pre-grant opposition, post-grant review procedures, provide opportunities interested parties contest patent. Arguably, existing patent system requires disclosure relevant information, including disclosure origin/source, material decision examiner grant patent. 82 commentators suggested disclosure origin source effect patent system , disclosure origin existed primarily check MAT providers negotiated users genetic resources TK. 83 decision include disclosure origin/source normal disclosure requirements ( called ‘enhanced disclosure’ 84 BRDR 85 ) advantage, , removing uncertainty genetic resource TK provider country material patentability claimed invention. Users disclose stipulated cases patent examiner decide / information disclosed material patentability. country source revealed patent application, effect requirement acts ‘red flag’ type local genetic resource TK implicated patent application, sends signal examiner application warrant investigation. , ensures signal national competent authority stakeholders gazette potential case interest, , helps ensure ABS stakeholders provide patent system information invention relevant patentability. Finally, argued Article 29 TRIPS Agreement stipulates minimum standard disclosure, apparently effective preventing patent system agent misappropriation biopiracy. great deal variation exists patent laws respect disclosure origin/source including triggers requirement disclosed. Article 49() Patent Law Switzerland , , “[] inventions based 82 Tobin .al. (2008), . 43. 83 comment Pierre du Plessis 19th Session Intergovernmental Committee Intellectual Property Genetic Resources, Traditional Knowledge Folklore, contained document WIPO/GRTKF/IC/19/7 20 2011, para. 78. 84 UNEP/CBD/COP/10/INF/44. 85 Vivas-Eugui (2012), . 6. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 58 genetic resources traditional knowledge patent application information source: ) genetic resource inventor applicant access, invention based resource; ) traditional knowledge indigenous local communities related genetic resources inventor applicant access, invention based knowledge. source inventor applicant, applicant confirm writing.” United Nations University Institute Advanced Studies (UNU-IAS), European Community (EC) adopted similar position disclosure, responding “industry concerns overly comprehensive disclosure requirements involve unnecessary costs efforts.” 86 Mandatory disclosure source triggered cases invention based genetic resources ( biological resources case EU) TK. requirement triggered easily existing legislation number countries. Section 10 India’ Patent Act stipulates, , “[] complete specification . . . disclose source geographical origin biological material specification, invention” (emphasis added). Section 30(3A) South Africa’ Patent Law ( amended 2005) “[] applicant lodges application patent accompanied complete specification , acceptance application, lodge registrar statement prescribed manner stating invention protection claimed based derived indigenous biological resource, genetic resource traditional knowledge .” Act 41 2000 amending Denmark’ Patent Act “[] invention concerns biological material vegetable animal origin, patent application include information geographical origin material, . applicant geographic origin material, application” (emphasis added). 87 main difference approaches set cases, disclosure origin required claimed invention based resource, set cases, disclosure origin triggered claimed invention ‘based derived ’ genetic resource TK. , set cases result minimizing impact mandatory disclosure requirement, texts expand scope required disclosure. addition triggers disclosure requirement, distinction disclosed. difference disclosure include disclosure source origin , disclosure TK, provision evidence prior informed consent compliance national ABS laws, certificates compliance issued national competent authorities, / evidence benefit sharing arrangement. 86 Tobin .al. (2008), . 42. 87 amendment lack information geographical origin material ignorance hereon affect assessment patent application validity rights resulting granted patent. amendment cover TK. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 59 jurisdictions reference disclosure origin , stipulate disclosure source ( Swiss ) require ( Indian ). , referred , require evidence compliance legal provenance ( Costa Rican, South African Andean Community examples section ). box outlines potential implications distinctions. variety texts countries adopted disclosure requirements, level content disclosure patent offices ABS national competent authorities function independently UNU-IAS study suggests mandatory disclosure origin requirement state obligation IP applicants, unambiguous information , unreasonable capable implementation IP authorities. 88 regard, empirical evidence scarce, 2010 study distributed delegates Nagoya Conference Parties concludes “[] clear evidence countries adopted enhanced disclosure measures patent applicants readily include information origin sources materials concerned patent applications.” 89 suggest countries disclosure easily triggered, applicants seek patents inventions provider country genetic resources TK cope requirement. Box 8 Origin, Source Legal Provenance terms origin, source legal provenance frequently context establishing ABS certification regime, indigenous terminology typically patent law. terms originally discussed context Nagoya negotiations proposals establish system generate, case , certificates origin, source, compliance legal provenance. 90 , Nagoya Protocol, Article 17(2), establishes system publication national ABS permit ABS Clearing House constitute “internationally recognized certificate compliance” serves “ evidence genetic resource covers accessed accordance prior informed consent mutually agreed terms established, required domestic access benefit-sharing legislation regulatory requirements Party providing prior informed consent.” noted, , Protocol mandates certificate system foreseen Article 6(3) Protocol applies genetic resources traditional knowledge genetic resources ILCs defined Article 7. TK , , included certification system national legislation. worth examining transplanting terms describe certification procedures means context patent disclosure requirements. Disclosure origin generally refers obligation disclose patent applications geographical origin, country, genetic material TK. 91 Disclosure source require disclosure patent applications primary sources genetic material, contracting party providing genetic resources, secondary sources, including situ collections. Source defined person entity providing access genetic resources relates relevant subject matter IP 88 Tobin .al. (2008), . 41. 89 UNEP/CBD/COP/10/INF/44, . 63. 90 Tobin .al. (2008), . 7. 91 Muller (2010), . 7 UNCTAD (2006), . 12. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 60 applications. include indigenous groups case related TK enjoy rights genetic resources. 92 Legal provenance requirement applicants provide evidence process innovation subject patent application undertaken compliance national ABS system country providing PIC granting patent . 93 permit issued ABS national authority published international ABS Clearing House assumed provide evidence compliance/legal provenance 94 , noted applicant prove adherence law. 95 Patent application disclosure obligations require disclosure origin / source, addition, require evidence compliance legal provenance. , disclosure obligation require disclosure origin source, provide evidence PIC MAT. Source: compiled UNCTAD, referenced. 2010 study UNU-IAS shows obtain information patent system obtain good leads disclosure origin source patent system ( Box 9 examples). minimum, disclosures trigger national competent authority source materials cited legally obtained sources jurisdiction. Box 9 Examples Disclosure Origin Source Patent Applications: Results Patent Search Context Words “/Origin/Source” “ invention provide excellent agent treating ulcerative colitis. Mode Carrying Invention: Peony root (paeniae radix) active ingredient treatment agent present invention obtained drying root perennial plant peony family (paeonia albiflora var. trichocarpa) <CW>grown <ST>China, Korea, Japan relative plant. Peony root astringent, emollient, antispasmodic, analgesic, drug oversensitive cold, drug dermatosis. , abdominal distension, abdominal pain, body pain, diarrhea, purulent tumor, . Peony root contained Chinese medicine formulations Shao-Yao-Gan-Cao-Tang, Dang-Gui-Shao-Yao-San, Shi- Quan-Da-Bu-Tang (Juzen-taiho-), Xiao-Qing-Long-Tang (Sho-seiryu-), Da-Chai-Hu-...” US6586022B2 “... considered constitute preferred modes practice. , skill art , light present disclosure, specific embodiments disclosed obtain similar result departing scope invention. Crude Extract Vernonia amygdalina 1 Aqueous Extraction 92 Article 2 CBD defines “Country Origin” country possesses genetic resources -situ conditions (CBD, Article 2). Country providing , hand, defined country supplying genetic resources collected -situ sources, including populations wild domesticated species, -situ sources, originated country (CBD, Article 2). question mandatory disclosure requirement treaty law disclosure origin source important point debate international negotiations. 93 élez (2010), . 3. 94 Protocol mechanism Article 17(4) information contained certificate declared confidential, potentially raises transparency issues. 95 regard, Article 17(4) Protocol grant possibility international certificates confidential terms related PIC MAT, leaves open question extent certificates assumed proof compliance, needed establish fact information certificate. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 61 Vernonia amygdalina Leaves 1. Fresh Vernonia amygdalina leaves <CW>collected Benin City, <ST>Nigeria pesticide-free plants ( important note plants investigated Kupchan al. report collected east Africa, specifically Ethiopia represent Vernonia amygdalina -species properties distinct employed instant invention). 2. 18 grams Vernonia amygdalina leaves washed times distilled water. 3. leaves soaked overnight (12-18 hours) 36 mL distilled water....” US6849604B2 “Cosmetic composition extract Limnocitrus littoralis. present invention relates field cosmetics. relates cosmetic compositions comprising extract Limnocitrus littoralis (Miq.) Swingle, denoted Limnocitrus littoralis, extract field cosmetics. Limnocitrus littoralis plant Rutaceae family basionym Parainignya littora/ Miq. <CW>originates south-east <ST>Asia , information, species indexed genus Limnocitrus. habitat essentially located hot dry zones. shrubs form bushes essentially, uniquely, Vietnam, origin description present invention. Traditional religious plant related legends Vietnamese literature.... GB2439793A “ Phlebodium extract plant extract obtained plant Family Polypodiaceae. Polypodiaceae family generally includes fems, native tropical regions world. , Polypodiaceae family <CW>indigenous Latin <ST>America, Honduran rainforests, South America Brazilian rainforests, Mexico, Caribbean islands. Phlebodium extract typically obtained rhizome root system, / leaves. Phlebodium extract mixture flavonoids, alkaloids, / lipids. Family Polypodiaceae, Phlebodium extracts obtained plants Genus Polypodium, Genus Chrysopteris...” US20060246115A1 Source: results search conducted . Oldham UNEP/CBD/COP/10/INF/44 (2010), . 50 (emphasis added disclosure origin source). <CW> refers context word term <ST> refers country region. reproduced permission. section assumed patent offices national competent authorities Protocol function independently, discharging respective mandate. scenario, ensure positive synergies patent ABS systems established national law. section examine case patent offices assume activist role implementation Nagoya Protocol. Key Points Patent offices national competent authority functions, complement retaining independent mandates. patent system designed manner , national competent authority provider country, generates information , flags authority genetic resource sourced provider country TK provider country utilized; , claiming exclusive rights application commercialization genetic resource TK. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 62 Enhanced disclosure ( BRDR) encompass disclosure origin, disclosure source, certificates compliance proof legal provenance. Disclosure origin / source triggered instances, claimed invention based genetic resource TK resource TK input invention. Variations closer creates safe harbour inventions rely resource TK, variations closer effect leaving discretion materiality patent examiner. . Disclosed Case Patent Offices Assume Greater Role Nagoya Protocol Functions negotiations leading Nagoya Protocol, debate emerged patent offices designated -called ‘checkpoint’. 96 Article 17() Protocol, checkpoint exists monitor genetic resources, Party designate checkpoint : 1) Collect receive, , relevant information related PIC, source genetic resources, establishment MAT, / utilization genetic resources, ; 2) Requires users genetic resources provide information paragraph designated checkpoint, establish effective proportionate measures address -compliance; 3) Provide information national authorities prejudice protection confidential information, Party providing PIC ABS Clearing House, ; 4) Encourage users providers genetic resources include provisions mutually agreed terms share information implementation terms, including reporting requirements; 5) Encourage cost-effective communication tools systems. Generally, designated checkpoints responsible undertake functions, considered , characteristics organization. time writing, , part Protocol’ ABS Clearing House international certification system trial stage, country designated patent office checkpoint. number countries , , mandatory disclosure origin / source undertake functions eventually qualify patent office checkpoint Protocol. functions examples examined . role patent office act checkpoint require submission evidence PIC MAT pre-requisite concurrent filing patent application. Section 30(3B) South Africa’ Patent Law ( amended 2005) “[] registrar call applicant furnish proof 96 Medaglia Rukundo (2010), . 10. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 63 prescribed manner title authority indigenous biological resource, genetic resource, traditional knowledge applicant lodges statement acknowledges invention protection claimed based derived indigenous biological resource, genetic resource, traditional knowledge .” Article 26 Andean Community’ Decision 486 Biological Genetic Heritage Traditional Knowledge (2000) requires copy contract access filed competent authority event patent application filed product process obtained developed genetic resources -products originating Community’ Member Countries. 97 national authorities grant certificates origin/compliance, certification required presented patent application. Article 80 Costa Rica’ Biodiversity Law : “ national Seed Office Registers Intellectual Industrial Property obliged consult Technical Office Commission granting protection intellectual industrial property innovations involving components biodiversity. provide certificate origin issued Technical Office Commission prior informed consent. Justified opposition Technical Office prohibit registration patent protection innovation.” examples show, requirement submit evidence PIC MAT contained national ABS legislation, opposed national patent legislation. main argument favour requirement submit evidence fair equitable benefit sharing evidence PIC MAT ( independently certificates legal provenance) applying patents “[]ntellectual property applicants rewarded rights privileges convey commercial benefits, subject matter applications obtained derived genetic resources traditional knowledge acquired violation CBD prior informed consent requirements conditions access genetic resources. Similarly, intellectual property owners retain commercial benefits violation CBD benefit-sharing requirements.” 98 Requiring IP applicants submit evidence basic PIC MAT obligations complied provider country helps achieve objective. major argument requirement submit evidence legal provenance part patent application “[]equiring patent authorities examine ABS agreements order ensure compliance ABS TK laws provider countries, adequacy benefit sharing, existence valid PIC MAT place” large burden provider country IP offices, IP offices located resource- constrained developing countries. 99 , staff IP offices trained examine patent applications, generally trained compliance ABS laws. study suggests certification alleviate burden enable IP offices confirm legal provenance easily recognizable fashion 100 , developing countries date established working system certification IP offices rely. 97 Andean Community Member Countries Bolivia, Colombia, Ecuador Peru. 98 UNCTAD (2006), . 5. 99 Tobin .al. (2008), . 43. 100 Ibid. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 64 , conceivable patent applicants choose establish legal provenance means certificates (.., submit underlying contract, contract pre-dated establishment national competent authority ABS). Andean Community solution helps resolve tensions : incident filing patent application genetic resource TK implicated, copy contract access resource filed national competent authority patent applicant. impose additional burden patent offices collect contracts underlying certificates. obligation appears relevant ABS legislation , , prospective patent applicants aware file underlying access contract national competent authority. text patent law. Alternatively, disclosure requirement require declaration compliance PIC MAT patent applicant. Key Points Jurisdictions require submission legal provenance submission evidence PIC MAT concurrent disclosure patent application. Patent offices simply ensure information disclosed Nagoya Protocol national competent authority discharging ABS functions. possibility exists IP offices discharge responsibilities checkpoint Protocol. jurisdictions South Africa Andean Community adopted legislation bars patent applications considered event legal provenance established. argument barring patent applications legal provenance established applicants rewarded rights privileges convey potential commercial benefits, subject matter applications obtained derived genetic resources traditional knowledge acquired violation CBD prior informed consent requirements conditions access genetic resources. Patent offices provider countries, developing countries, - resourced, trained examining compliance PIC MAT, happy prospect additional mandate additional resources. solution filing patent application genetic resource TK implicated, copy contract access resource filed national competent authority, alternatively, disclosure requirement complied simple ‘declaration’ patent applicant complied applicable ABS laws, exist, duty furnish contracts certificates patent office. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 65 . Enforcement Remedies analysis discusses range possibilities disclosure requirements, ranging IP offices ABS national competent authorities act relative independence, IP offices -called ‘checkpoint’ functions Nagoya Protocol. perspective CBD/Nagoya Protocol, , ultimate aim BRDR ensure basic PIC MAT requirements complied . naïve assume applicants altruistically comply voluntary disclosure requirement, implication sanction -compliance applicable disclosure obligations. , , range variations. “[] countries require disclosure voluntary disclosure requirement, consequences patents lack fulfilment”, leaving sanctions dealt ABS laws. 101 , countries duty disclose patent applications information material patentability, failing disclose information genetic resources TK breach duty truthfully fill application submitted government office. possibility exists United States patent law, clear evidence omitted disclosure prior art material element patentability claim, applicant. 102 countries requiring disclosure origin/source, approaches remedy failure disclose, inadequate/insufficient disclosure. differences broadly divided remedies patent system remedies patent system relationship validity patent. case European Union countries. , Act 41 2000 amending Denmark’ Patent Act states “[]ack information geographical origin material ignorance hereon affect assessment patent application validity rights resulting granted patent.” , , applicants completely relieved obligation disclose. countries, remains question absence disclosure material patentability criteria novelty, inventive step industrial application. cases, important ABS authorities monitor patent applications pre-grant phase (.., application published official gazette) provide comments IP office . national competent authority stakeholders contesting patent application bear mind basic question ABS requirements PIC MAT met, prior art impact respective criteria novelty inventive step ( discussion prior art ). possibility disclosure origin pre-condition examination patentability. country adopted approach , , Switzerland. Switzerland basically stays examination patentability disclosure requirement 101 Henninger (2010), . 300. 102 purpose, United States advocates development database genetic resources TK, alternative disclosure requirement. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 66 fulfilled. absence disclosure cured, patent office empowered reject patent application ( Article 59a(3b) Patent Law Switzerland (2007)). possibility provision legal provenance (.., evidence PIC MAT, proof resources obtained legally) pre-requisite examination granting patent. type requirement appears text biodiversity laws Latin American countries. instance, Complementary Provision Peru’ Law 27811 Law Introducing Protection Regime Collective Knowledge Indigenous Peoples Derived Biological Resources (2002), “[] patent applied respect goods processes produced developed basis collective knowledge, applicant obliged submit copy license contract prior requirement grant rights concerned, collective knowledge concerned public domain. Failure comply obligation refusal invalidation, case , patent concerned.” fourth possibility disclosure obligations enforced administrative fines, criminal sanctions case wilful violations. Criminal sanctions limited wrongful disclosure, include -disclosure breach duty. Article 81a Swiss Patent Law stipulates, , “[]hoever wilfully wrongful declaration referred Article 49a, liable fine 100,000 Swiss Francs. judge order publication ruling.” Section 8b Norway’ Patent Law states relevant part “[]reach duty disclose information subject penalty accordance General Civil Penal Code Section 166.” enforcement mechanisms include termination full partial transfer entitlements apply intellectual property; curable incurable, temporary permanent, full partial unenforceability 103 , revocation case granted patents, narrowing subject matter; return transfer benefits received intellectual property ownership; enforcement existing obligations provide equitable benefit- sharing. 104 ability impose remedies differ depending discretion country’ adjudicatory authorities domestic law. countries assessing proposals enforcement regime, number important points bear mind. , variations combined – case Switzerland, instance, criminal penalty coupled mandatory obligation disclose, prejudice examination patent substantive grounds. , number countries, Latin America, disclosure origin/source legal provenance prerequisite examination grant patent rights, arguable potentially adds condition patent applications standard required TRIPS Agreement, requires disclosure “sufficiently clear complete invention carried person skilled art”. governments openly questioned requirement TRIPS 103 IP rights granted enforced. Sections 407-408 US Copyright Act (1976), instance, registration copyright required condition lodging infringement suit, affect existence copyright . 104 UNCTAD (2006), . 59. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 67 compliant.” 105 amendment TRIPS Agreement universal disclosure origin requirement potentially settle question compatibility requirements, date issue amendment remains limbo TRIPS Council. noted, , WIPO recognizes disclosed information potentially material, requirement submit evidence legal provenance imposed number Latin American countries challenged WTO dispute settlement panel. note case Zealand, practices interesting unique dealing TRIPS compatibility issue. Disclosure substantive patent law criterion, claimed invention Maori TK PIC considered violate public morality Section 17 1953 Patents Act. result “[] disclosure required precondition processing, patent application suffer, substantive elements chance examined.” 106 Article 27(2) TRIPS Agreement, WTO Members exclude patentability inventions protect public order morality respective jurisdictions. , designing enforcement mechanisms, important leave opportunity cure defects patent applications, inadvertent -wilful violations disclosure obligations. 2006 study commissioned UNCTAD notes: “Opportunities rectify failures disclosure required information . . ., absence bad faith showing required inquiries performed. , opportunities redress limited granting intellectual property.” 107 , thought needed action event claimant unaware origin source filing patent application. underlying assumption case origin/source issues brought attention patent examiner application process, research examiner /, comments received incident publication application official gazette. outcome situation potentially depending mandatory requirement submit evidence legal provenance. requirement, applicant simply cure amending patent application disclose ( forfeit application / disclose). requirement application ‘frozen’, question referred national competent authority patent applicant obtaining proof compliance applicable ABS laws. depending patent ABS legislation effect applicant negotiate conclude benefit sharing agreement order continue patent application process. Fourth, poor quality patent mistakenly granted, interested party opportunity contest patent. imperative form post-grant review procedure incorporated national patent legislation. burden proof lie contesting party cases, , assumption moving 105 US statement WTO Document IP///162 29 October 1999. 106 Henninger (2010), . 301. 107 UNCTAD (2006), . 9. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 68 party opportunity raise objection application initially public official gazette. Finally, imposition criminal sanctions requires proof criminal intent, demonstrated evidence wilful fraud/lying patent application. Cases involving criminal sanctions court law. applicable standards adjudication set laws requiring government filings tax returns completed honestly. Wilful violations difficult establish, , applicants claim confronted situation / disclosed , simply unaware source origin resources related TK. hand, applicant obtained resource provider country contract, patent office national competent authority aware contract, difficult applicant argue / aware source origin genetic resource related TK. Key Points means exist enforce compliance disclosure origin rules. range voluntary compliance criminal sanctions, include consequences patent mistakenly granted. enforcement measures mutually exclusive. debate exists evidence legal provenance pre-condition filing patent application TRIPS-compliant. issue adjudicated WTO dispute resolution panel date. countries legal provenance pre-requisite granting patent contributing compliance, noted text, controversial. matter due process, enforcement measures balanced. opportunity cure offered inadvertent -wilful omissions brought attention patent examiner application process. Post-grant opposition procedures incorporated patent law order address situation mistakenly granted patents due absence incorrect disclosure. Criminal sanctions applied case wilful violations; , , difficult establish absence strong, incriminating evidence. IV. Disclosure Ownership providing patent examiner information related assessing patentability criteria, disclosure requirements determine applicant standing file patent application. Typically, patent laws set give inventor / assignees file application patent inventor’ claimed invention. persons jointly invention, patent laws provide possibility joint ownership. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 69 major distinction IP ABS laws , absent clause prohibits patent application considered evidence legal provenance, legal illegal physical possession GR TK generally effect inventor’ ability submit patent application, patent application addressing underlying intellectual endeavour. ABS laws address issue legality physical possession GR TK. result dichotomy, , invention, patent granted intellectual endeavour, based arguably / possibly permission. cases possession underlying GR TK legal, national competent authority ensure form benefit sharing arrangement worked comply ABS legislation order remedy situation. disclosure reveals invention underlying TK, instance, application fail grounds : 1) claimed invention ; 2) applicant apply patent pass ’ technology . case open possibility pursue criminal sanctions, functioning law protect TK accurate information contained TK databases establishing argument. mere existence disclosure origin/source requirement patent law deter situations, , predicted attempts generally applicants show claimed invention builds TK. case, question patent office simply assessing novelty inventive step (.., claimed invention existing TK, , ). evidence legal provenance required national legislation, disclosure reveal inventor agreed share ownership claimed invention. cases, patent examiner request application amended reflect joint ownership, . Proof legal provenance simply means ABS requirements met, necessarily relevant ownership invention. , evidence legal provenance shows inventor share benefits invention, mention joint ownership ( , proportion stream royalties) applicant free proceed application sole inventor. Annex Nagoya Protocol stipulates numerous ways benefits shared, valid ABS arrangement specifically stipulate joint ownership inventions arising resource related TK, fair require party claiming joint ownership prove . difficult case clear applicant joint owner. happen, , underlying resource applicant received party original provider, legal text ownership documentation resource applicant ( clause ownership exist original provider recipient); resource claimed ambit ABS legislation, instance transfer resource pre-dates ABS law CBD. cases, indication ownership treated, patent offices developing countries trained address issues. suggested cases, question referred patent office ABS national competent authority advice. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 70 Independent disclosure, final scenario ownership disputed case persons claim invention. cases, outcome differ jurisdictions --file approach jurisdictions --invent approach patent applications. --file approach, apply conferred person application earliest filing date , priority 108 claimed, earliest validly claimed priority date. --invent approach, apply conferred person conceive diligently reduce practice invention. countries follow --file approach, including United States, changed --invent --file approach 2013 passage 16 September 2011 Leahy-Smith America Invents Act. Key Points Disclosure origin requirements clarifying standing file patent application. ABS agreements stipulate inventions resulting transferred genetic resources TK jointly owned. patent applications reflect relationship, stipulated. absence clear indication joint ownership, , difficult establish application filed jointly. Annex Nagoya Protocol enumerates number ways benefits potentially shared, joint ownership. jurisdictions follow --file rule event persons claim invention. . Temporal Scope Protocol Disclosure Chapter 1, issue pre-CBD pre-Nagoya transfers addressed, resources possession user obtained legally, absence PIC MAT, benefit sharing. mentioned patent law operates independently ABS law, disclosure origin/source act check patent applications inventions utilize genetic resources covered Nagoya- compliant ABS legislation, check patent applications utilization genetic resources , virtue pre-Nagoya/pre-CBD, scope Protocol. , difficult ABS law subjects applications pre-Nagoya/pre-CBD acquisitions function commensurate patent law disclosure requirement necessitates making public origin genetic resource utilized. requirement apply ABS principles applications accessed genetic resources pre-date Protocol CBD ( mentioned Chapter 1), require disclosure origin/source national patent law important measures ensure benefits shared provider countries absence earlier PIC 108 priority permits applicant file subsequent applications jurisdictions based date filing application. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 71 MAT, mind measures act complete barrier misappropriation. guarantee user country legislation similarly require disclosure origin benefit sharing applications involving utilization genetic resources previously acquired Article 29 TRIPS Agreement amended require mandatory disclosure. Key Points ABS legislation provider countries stipulate apply applications utilizing genetic resources acquired Nagoya-compliant ABS legislation effect (.., pre-Nagoya/pre-CBD). mandatory disclosure origin requirement patent law, plant breeder’ law , expose situations genetic resources . IP law operates independent ABS law, intent ensure coordination regimes Protocol. matter patent law extends disclosure origin applications genetic resources transferred pre-Nagoya Protocol pre-CBD, arguably covered treaties. Mandatory disclosure subjecting ABS requirements absolute check misappropriation, subject patent applications, guarantee user country legislation incorporate similar requirements. VI. Measures Prevent Bio-Piracy , chapter dealt disclosure function relation domestic patent applications, provider countries. , large extent, stakeholders provider country direct influence domestic legislation, wield indirect influence policy decisions adopted countries. IP offices pro-active preventing biopiracy misappropriation, . providing information helps jurisdictions determine patentability question prior art ( part disclosure). Box 10 Experience National Commission Biopiracy Peru (NCAB) NCAB created 2004 interagency coordination technical advisory body reports Presidency Republic. Commission Chaired INDECOPI ( National Institute Defence Competition Protection Intellectual Property) composed public agencies (.. environment, health, agriculture tourism authorities), domestic research centres -governmental organizations (NGOs). mission NCAB develop actions identify, prevent, avoid potential cases “biopiracy” objective protecting interest Peruvian State. functions : Creating maintaining registers biological resources originated Peru collective Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 72 knowledge Peruvian indigenous peoples; Identifying, assessing patent applications filed utilised Peruvian genetic resources TK; Initiating legal actions defence Peruvian genetic patrimony TK indigenous people, including IP system; Establishing channels contact dialogue IP offices matters; Undertaking consultations relevant stakeholders; Supporting Peruvian State multilateral negotiations. , NCAB focusing simplification review ABS regulations. NCAB prioritised 35 Peruvian biological resources significant utility potential . prepared dossiers resources studies potential cases “biopiracy” prior art IP relevant offices countries. contributions matter IGC. NCAB contributed decisions reject, abandon withdraw 9 controversial patents utilizing Peruvian GRs TK. list controversial patents rejected, retired abandoned NCAB dossiers. cases, action NCAB, patents granted, feeding list actual cases “biopiracy” potentially “misappropriation”. Resource Patent patent application IP office Status Maca Compositions methods preparation Lepidium (WO 0051548) PCT Rejected Maca Functional Food Product Maca (Publicació ° 2004-000171) Japan Rejected Maca Ameliorant sleep disturbance (JP2007031371) Japan Rejected Maca manufacturing method composition maca extract (Kr20070073663) Korea Rejected Maca Testosterona increasing composition (jp2005306754) Japan Rejected Sacha inchi extract plant belonging genus Plukenetia volubilis cosmetic . (WO/2006/048158 ) PCT Retired Sacha inchi Utilisation ’huile de protéines extraites de graines de Plukenetia volubilis linneo dans des préparations cosmétiques, dermatologiques nutraceutiques. (FR 2880278) France Retired Camu camu Preserves fruit Myrciaria dubia (Publicació ° 09 – 215475) Japan Abandoned Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 73 Pasuchaca Inhibitor glycosidase (P2005-200389ª) Japan Abandoned Sources: compiled David Vivas Eugui (2011). Information NCAB web site, official documents NCAB (2011) interviews governmental officials.109 Reproduced permission. case Peru, IP office chairs commission charged developing dossiers patent offices countries, assist conducting examination patent applications genetic resources related TK. activities Peru’ National Commission biopiracy summarized box . noteworthy Peruvian patent office lead exercise, patent examiners situated compile dossiers IP offices assessment claimed invention patentable, IP offices contacts IP offices . practice identifying resources significant utility creating dossiers systematic helping user countries comply due diligence disclosure requirements. pro-active approach defence India’ database TK, contents shared patent offices developed countries. commentators pointed limitations database, , , inter alia, limit patent examiner’ ability find state prior art. 110 Key Points countries proactively develop strategies assist user countries assessment patent applications domestically-sourced genetic resources TK. Peru shows IP office ideally situated lead coordinated effort local stakeholders develop dossiers identified priority biological resources. practice purposes handbook. VII. Conclusion 109 Vivas Eugui (2010), pp. 50-51. 110 comment Gopalakrishnan 19th Session Intergovernmental Committee Intellectual Property Genetic Resources, Traditional Knowledge Folklore, contained document WIPO/GRTKF/IC/19/7 20 2011, para. 8. Gopalakrishnan, “[]atabases put limitations finding prior art, understood patent system, determining inventive step, science involved TK, side, science involved modern knowledge, side. Typically, modern patent application drafted modern scientific techniques scientific language, involved largely genetic analysis components GR TK. hand, typical TK documents database documented modern science language, language science TK. comparison patent applications TK, tremendous difference . put tremendous limitations patent examiner determine prior art. conclude disclosed disclosed patent application form, attempt merge understand science TK modern scientific principles”. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 74 Disclosure constitutes important pillars social contract underlying patents – .., technology invention sufficiently disclosed inventor / assignees seeks obtain exclusive rights invention limited period time. Depending required disclosed national patent law, disclosure system potentially efforts combat misappropriation ‘biopiracy’, flagging potential cases national competent authority patent applications published official gazette. Variations exist extent disclosure required. TRIPS minimum, disclosure origin/source genetic resources TK utilized invention, countries require disclosure origin / source, require applicants provide evidence compliance ABS laws. Nagoya Protocol disclosure origin/source proof legal providence mandatory. Controversy exists formulations disclosure text add substantive element patentability TRIPS Agreement. Disclosure origin/source patent examiners assess novelty inventive step. information disclosure system generate vast. IP office designated checkpoint Nagoya Protocol, borne mind patent offices set police ABS laws. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 75 Chapter 4 Additional Mechanisms Disclosure . Introduction Chapter 3, handbook examined disclosure requirements national patent legislation potentially act indicator misappropriation national competent authority Nagoya Protocol indigenous local communities related stakeholders, provide patent authorities relevant information informed decision relevant patent criteria met patent application filed national patent office assessed potential grant rights. range mechanisms exist, , potentially exclude consideration subject matter patentability altogether, proceeding question patentability criteria met, grounds defeat revoke patent. mechanisms examined chapter. strategic perspective, patent law mechanisms classified ‘defensive’, meaning designed prevent reduce misappropriation genetic resources traditional knowledge (TK) intellectual property (IP) system , IP secure benefits provider country indigenous local communities (ILCs) accruing research genetic resources related TK. Importantly, mechanisms apply, national treatment principle, equally foreigners nationals country. patent law mechanisms generally grounded rationales developed time, consideration Convention Biological Diversity (CBD) Nagoya Protocol objectives. Chapter 4 discuss mechanisms background users handbook informed decisions shape domestic legislation negotiation strategies. II. Life Forms Patentability . Biotechnology, GRs Derivatives: Key Exclusions National IP laws, appropriately tailored, assist country addressing situation individuals seek patent products based genetic resources met CBD/Nagoya Protocol obligations. line argument seek patents patent law grant protection product question, provider’ jurisdiction. important stakeholders provider countries aware realistic range possibilities granting access genetic resources negotiating benefits (.., extent obtain patent fruits user’ & benefits shared). question derivatives subject matter covered Nagoya Protocol discussed Chapter 1. , terminology Protocol genetic resources derivatives translate easily language IP practitioners. language Protocol drafted largely avoids linkages Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 76 IP system difficult utilize clarifying IP-related ABS issues. , IP law area complex. 111 perspective patent law, countries traditionally excluded patent protection naturally existing substances. permitted TRIPS Agreement WTO Members, Article 27.1 TRIPS requires patent protection inventions meet patentability criteria, discoveries substances existing nature. Article 27.3() TRIPS Agreement plants animals excluded patentability, measure patent protection micro- organisms. Members generally free determine definitions , scope , terms invention, discovery micro-organism, , defined TRIPS Agreement. countries flexibility implementation Article 27 TRIPS Agreement, differ widely extent substance nature changed, , order patentable. number countries, Latin America, exclude patentability mere extraction isolation naturally existing substance. 112 jurisdictions, underlying biological material undergone structural change order patentable. respect micro-organisms, countries Brazil required order patentable, micro-organisms genetically modified. 113 US 114 , Japanese EU practice, , process isolating substance existing nature qualify patent protection; , process patent claim include underlying substance. 115 noted approaches define patentable challenged WTO dispute settlement date. distinction, legal perspective, removing genetic resources patentable subject matter, question claimed product process meets patentability criteria novelty, inventive step industrial applicability. remains public domain subject exclusive , plant variety protection sui generis TK laws. IP law difficult (mis) genetic resources. National patent law exclude patentability mere discoveries, ensure change underlying genetic resources place order proceed question grant patent. render impossible plants animals patents 116 , remove possibility patenting isolation extraction naturally existing substance. 117 approach , definition, remove patentability 111 term ‘derivatives’ means patent law CBD; term art describe products similar originally patented product, identical. case medicines, , describe chemical entity slightly chemical structure. 112 examples Argentina, Brazil Andean Community. UNCTAD (2011b), pp. 48-49. 113 South Centre, . II (2008), pp. 11-12. 114 US Supreme Court case examining question gene sequences patented. discussion Myriad case . 115 Ibid. Diamond . Chakrabarty 447 .. 303 (1980); Enforcement Standards Substance Patents Japan; Article 3.2 European Directive Biotechnological Inventions. 116 Plants animals excluded patentability wholesale Article 27.3() TRIPS Agreement. 117 authors imply extraction isolation laborious process merits type compensation; authors argue patent system intended provide reward activities closer discoveries inventions. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 77 derivatives Nagoya Protocol, definition derivatives naturally occurring biochemical compounds. Commentary suggests micro-organisms treated manner similar plants animals requirement Article 27.3() TRIPS Agreement micro-organisms remain patentable subject matter. general worldwide consensus micro-organisms, include fungi, bacteria viruses (including classified pathogens) nature patented. 118 provider countries adopt bar patentability lines preceding paragraph, prevent individual company bioprospects seeking patent isolates extracts permitted. 119 noted , US, Japanese EU law genetic resources derivatives extracted isolated, change structure, considered patentability circumstances, patentable provider country legislation. , patent laws prevent patentability bona fide invention utilized unchanged genetic resource. cases, disclosure assess, extent, criteria met order grant patent ( discussion disclosure requirements previous chapter). regard, recalled question mandatory disclosure origin/source revision Article 27.3() remains tabled WTO, delegates closer agreement issue proposal 2008. , case scenario, access genetic resources user MAT include sharing benefits, providers potentially benefit bona fide user decides seek commercialization fruits research jurisdiction broad patentability standards. Depending level sophistication & capacities, provider countries find incentivize local firms seek commercialization fruits research allowing patentability isolates extracts micro-organisms. India, , approach. 120 developing countries home rich biodiversity advantage availability patents extracts isolates micro-organisms, , simplicity exclusion ability patent office assess patent applications adequately practical TRIPS-compliant alternative helping prevent misappropriation. final question relates status genes -cellular components. & genetic code plants, animals micro-organisms origin provider country, & practical applications code, subject applicable ABS requirements Nagoya Protocol, treaty applies genetic resources. IP side, extent -cellular component organism, obligation Article 27.3 TRIPS Agreement provide measure protection genes sequences genetic code. 121 jurisdictions, genetic code living generally regarded substance nature (, excludable patentability). , advances genetic research increasingly subject patent 118 UNCTAD-ICTSD (2005), . 392. 119 South Centre . II (2008), pp. 15-16. 120 Somasekhar (2005). 121 UNCTAD-ICTSD (2005), . 393. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 78 applications jurisdictions & place. genetic code living , including humans, animals, plants micro-organisms, mapped isolated, diagnosis therapy. DNA synthesized messenger RNA (cDNA). Jurisdictions fruits genetic research patented argue takes gene naturally-existing environment, patent-protectable. jurisdictions permitting patenting genes, status patentable subject debate. case US, District Court judgment decided invalidate patents isolated gene sequences granted Myriad Genetics, . gene fragments diagnosis hereditary forms breast ovarian cancer. Court Appeals Federal Circuit decision reversed earlier 2010 District Court judgment held isolated gene fragments potentially patentable. 122 majority Court Appeals argued genes products nature, patents continue granted applicants "isolate" nucleic acid sequences natural environment, sequence , identify functions sequences line existing USPTO practice. majority concluded isolation resulted change molecular structure, change underlying genetic code isolated sequence. judge dissented, , argued mere isolation BRCA gene sequences invention, substantive change isolated gene larger gene sequence. 123 US Supreme Court reversed Court Appeals decision, holding mere isolation gene, case BRCA genes, patentable. 124 Supreme Court decision issue patentability genetic code effect practice US . perspective provider countries, keeping gene sequences genetic resources country origin -patent means prevent misappropriation. true genetic resources potentially covered Nagoya Protocol, including hands user countries (.., pre-dating CBD / Nagoya Protocol). time, case plants, animals micro-organisms generally, exists material transfer agreement MAT, benefits shared ( required Protocol), commercialization potentially offer possibility provider country stakeholders gain patenting. Key Points Nagoya Protocol stipulates utilization genetic resources subsequent applications commercialization subject benefit sharing obligations. Protocol leaves open interpretation substances types information generated genetic resources application biotechnology subject benefit sharing obligations. 122 , , Association Molecular Pathology al. . Myriad Genetics, al. (Case 2010-1406, decided 29 July 2011 US Court Appeals Federal Circuit. 123 dissenting judge’ view similar position European Patent Office (EPO) Technical Board Appeal diagnostic methods developed Myriad patentable, underlying isolated gene normal mutated form . 124 Association Molecular Pathology al. . Myriad Genetics, al. (Case . 12-398, slip op, decided Supreme Court United States 13 June 2013). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 79 TRIPS Agreement permits Members exclude patentability substances existing nature, classified discoveries, inventions. Plants, animals micro-organisms natural form excluded patentability. TRIPS Agreement requires level patent protection micro-organisms, viruses, bacteria, fungi, . countries addressed requirement stipulating genetic change occurred order micro-organism patentable. jurisdictions entertain patent application claims mere isolation extraction. genetics examines -cellular units, micro-organisms cellular, falls obligation relating patentability micro-organisms TRIPS Article 27. IP law patentability fruits genetic research evolving. global consensus patentable. Key questions cases include gene naturally-existing environment; isolated gene sequences patentable; extent gene sequences modified applied order patentable. Exclusions patentability dispense patent offices substantively examine application. result excluded item public domain covered form IP, provider country. attractive TRIPS-compliant alternative developing countries capacity assess complex biotechnology patents. . Pathogens Chapter 1 discussed debate pathogens covered Nagoya Protocol, concluded language text Protocol exclude . link pathogens Article 8() Nagoya Protocol IP surfaces user country firms acquired pathogen create vaccines treatments diseases , seek patents resulting medical product process. , Government Indonesia decided 2007 withhold H5N1 virus samples WHO’ Collaborating Centres mechanism offered fairer terms developing countries. Indonesia’ action initiated discovered sample viruses transferred WHO Collaborating Centres vaccine manufacturers knowledge permission material transfer agreements patents granted manufacturers fruits research based samples. 125 Article 8() Nagoya Protocol, stipulates Parties due regard ABS legislation emergency situations including involving public health, potentially provide limited amount relief event user country firm pathogen obtained provider country create vaccine patented firm. , , exclude consideration developing countries grant issuance compulsory government- licenses import produce vaccines 125 Shashikant (ed.) (2010), pp. 24 31. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 80 locally, assuming patent exists vaccine provider country. National patent legislation provide legal underpinning eventuality, . Specifically, compulsory government- licenses order address emergency situations. National ABS legislation include language access pathogens Article 8() consideration expeditious fair equitable sharing benefits arising genetic resources, including access affordable treatments . order clear national ABS legislation jurisdiction pathogens, preventing Member States stipulating , debate CBD Nagoya Protocol cover pathogens, ABS law covers genetic resources, including pathogens. difficult question determine impact work WHO sharing virus pathogens Nagoya Protocol, developing countries work board formulating strategy deal situation demands user countries access pathogens locally, affect options developing countries -emergency situations. 2011 World Health Assembly, Member States adopted resolution endorsing report Open-Ended Working Group Pandemic Influenza Preparedness sharing influenza viruses access vaccines benefits, resulting ‘Pandemic Influenza Preparedness Framework’, includes annexes SMTAs sharing pathogens entities , part WHO network influenza monitoring, , network entities entities network. 126 negotiations Open-Ended Working Group 64 World Health Assembly (WHA) 2011 output Working Group ultimately endorsed 127 , government delegates largely avoided including language draft SMTAs clarify relationship SMTAs Nagoya Protocol. concept ABS prevalent Nagoya Protocol , , present SMTAs, absence language linking SMTAs Protocol. SMTA WHO network (SMTA1), recipients obliged actively seek participation scientists originating laboratories, developing countries, participating entities required refrain seeking intellectual property (IP) protection vaccines treatments underlying materials. 128 Onward transfer SMTA entity WHO network permitted entity agrees bound terms SMTA. SMTA contracts WHO network entities entities WHO network (SMTA2), recipient virus commit benefit sharing options exchange access virus sample, potentially includes royalty-free licenses manufacturers developing countries, creating reserve developing countries antiviral medicine pandemic situations affordable prices donating 10% vaccine production WHO, . 129 conscious decision part 126 World Health Assembly Resolution 64.5 24 2011. 127 Saez (2011). 128 Assuming pathogens covered Nagoya Protocol, requirement refrain patenting stricter standards required Protocol. 129 Ibid. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 81 governments negotiating instruments avoid reference Nagoya Protocol, sense drafters documents consistent Protocol, event relationship work WHO Protocol decided court law. SMTA1 SMTA2 included Annex II handbook. , WHA Resolution 64.5 urges Member States implement Pandemic Influenza Preparedness Framework ( includes endorsement SMTAs stipulates situations SMTAs ), binding treaty obligation, means general contract law enforce compliance Member State ensure adherence terms SMTAs; countries participating entities WHO Collaborating Centre network , , bound SMTA1. legal standpoint, prudent SMTAs contractual ( opposed treaty-based) safeguard seek obtain IP protection vaccines treatments produced underlying genetic materials ( related TK) permission country granting access, recourse violations SMTAs , principle, limited dispute resolution mechanism stipulated agreements. meant Article 3bis(3) Nagoya Protocol requires “[]ue regard paid relevant ongoing work practices international instruments relevant international organizations, supportive run counter objectives Convention Protocol”, negotiations WHO Working Group place Nagoya Protocol negotiations. matter strategy, developing countries deal issues ABS virus pathogens advised : 1) grant access pathogenic resources WHO network avail SMTA1, document grants greatest measure protection unauthorized patenting products processes developed pathogens; 2) review ABS IP laws ensure compulsory license government- license remedies clause Article 8() Protocol, .., emergency outbreak situations. , reason , access granted pathogens WHO Collaboration Centre framework. cases, governments cite clause Article 8(), justification negotiating material transfer agreement user firms benefit sharing emergency situations ( SMTA2 template). order ensure benefit sharing debate pathogens covered CBD NP -emergency cases, national ABS law clear law intended govern issues related access benefit sharing genetic resources national borders, including pathogens. forums, discussions continue Geneva-based Intergovernmental Committee Intellectual Property Genetic Resources, Traditional Knowledge Folklore (IGC), takes place auspices World Intellectual Property Organization (WIPO). Established October 2000, forum’ mandate 130 shape international sui generis regime protection TK traditional cultural expressions, IP regime addresses misappropriation genetic resources. Discussions IGC examining disclosure requirements feasibility databases international 130 Decision 28 38th WIPO General Assembly (2009). mandate Committee extended 2011. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 82 instrument(), avoided issue evolving sui generis regime interface CBD Nagoya Protocol, pathogens treated. stage, unclear IGC discussion shape international regime ABS pathogens, implications IP. Key Points longstanding debate negotiators CBD NP cover pathogens. Article 8() Nagoya Protocol, , arguably requires Member States consideration expeditious access pathogens emergency situations expeditious benefit-sharing arising genetic resources. , developing countries granting access pandemic virus pathogens cooperation WHO Collaboration Centres SMTA1, called WHA Resolution 64.5. Developing countries review ABS IP laws ensure compulsory license government- license remedies clause Article 8() Protocol, emergency situations. provide access pathogens WHO Collaboration Centres, developing countries negotiate user country firm, possibly SMTA2 template. emergency situations, Article 8() Nagoya Protocol cited obtain benefit sharing. -emergency situations, access pathogens conditional benefit sharing national ABS legislation, clear scope domestic law includes ABS related pathogens. III. Limitations Exceptions IP Laws . Research Experimentation Exception Patents PBRs Exceptions patent law acknowledge existence patent, activities protected subject matter place absence permission patent holder. research experimentation exception patent law exception patent holder exclude patented subject matter subject matter research activities. 131 effect exception shield scientists liability conduct research patented subject matter falls exception permission patent holder. countries included research experimentation exception national patent law. Language World Trade Organization (WTO) dispute settlement case 2000 captures rationale exception : “ key public policy purpose underlying patent laws facilitate dissemination advancement technical knowledge allowing patent owner prevent experimental term patent frustrate part purpose requirement nature invention disclosed 131 UNCTAD-ICTSD (2005), pp. 437-38. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 83 public.” 132 WTO Members relied language formulate explicit research exceptions domestic patent law Article 30 TRIPS Agreement. 133 Practices countries vary, , kind research experimentation falls exception. countries extremely broad language permits virtually scientific technological research activities, irrespective fruits research ( , Brazil, Bangui Agreement). countries attempt distinguish commercial -commercial research, excepting ( , Indonesia, Kenya, Lebanon). countries distinction research “” patented product process research “” patented product process ( , continental European countries generally exception research “” patented product process research “” patented product process). uniform practice countries world. , exact scope exception , date, subject WTO dispute settlement suggestive language EC-Canada case cited . noted IP regimes patents research experimentation exception. relevance CBD context, area plant variety protection, plant breeders’ rights (PBRs). PBRs sui generis form IP protection varieties plants meet criteria. 134 Article 15 1991 International Convention Protection Varieties Plants (UPOV), instance, acts experimental purposes mandatory exception PBRs. UPOV permits free protected varieties breeder purpose developing variety. Countries opted sui generis systems PBRs UPOV regime, Thailand, include statutory research exception PBR legislation. 135 Research exceptions built utility model legislation. Arguably, research experimentation exception patent law fully consistent Nagoya Protocol supports provisions. Notably, Article 8() Protocol states “[] development implementation access benefit-sharing legislation regulatory requirements, Party . . . []reate conditions promote encourage research contributes conservation sustainable biological diversity, developing countries, including simplified measures access -commercial research purposes, account address change intent research.” potential conflict exists PBR laws, . PBR laws broad & exception breeder utilize genetic resources developing varieties, (legally) possesses genetic resources. important note, , research experimentation exception national patent law eliminate PIC Nagoya compliant national ABS legislation event seeks access genetic resources research purposes. 132 Canada-Patent Protection Pharmaceutical Products, WT/DS114/, 17 March 2000, para. 7.69. 133 Article 30 TRIPS Agreement “Members provide limited exceptions exclusive rights conferred patent, exceptions unreasonably conflict normal exploitation patent unreasonably prejudice legitimate interests patent owner.” 134 criteria plant variety receive protection PBR legislation generally novelty, distinctiveness, uniformity stability. 135 Section 33 Thailand’ Plant Varieties Protection Act, .. 2522 (1979), amended. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 84 Article 6(1) Protocol, “access genetic resources utilization subject prior informed consent Party providing resources country origin resources Party acquired genetic resources accordance Convention, determined Party.” Utilization genetic resources defined Article 2 Protocol research development genetic / biochemical composition genetic resources, including application biotechnology defined CBD. Article 8() Protocol, PIC requirement distinction commercial -commercial research. interface provisions & national patent law national ABS legislation sets interesting situation. Patent holders unable prevent & activities involving inventions based genetic resources, & falls scope research experimentation exception. Researchers , , completely free conduct research risk legal liability subject PIC provider country seek access genetic resources, subject requirement , Article 8() Nagoya Protocol, simplified measures access research -commercial. situation necessarily reflect incompatibility sets laws. patent holder economic incentive work development technologies potentially render subject invention obsolete. research exception patent law helps preserve ‘freedom operate’ conduct research furtherance advancement technical knowledge. PIC requirement basic check misappropriation. economic dynamic patent holders present case PIC provider countries. fact, provider countries interested genetic resources TK successful commercial products, benefits accruing products shared provider country / indigenous communities. treatment freedom operate sets laws compatible, countries structure research experimentation exception patent law answering question, important number trends & worldwide. , increasing tendency universities seek patent protection research results consequence national university policies. number developing countries passed legislation passing legislation encourages patenting research results universities. countries include India, Jordan, Malaysia South Africa. laws modelled part US Bayh-Dole Act (1980), , inter alia, actively endorsed practice universities seeking patents, effort bridge gap scientific research commercialization. 136 related trend increased blurring lines commercial -commercial research, courts common law countries United Kingdom United States ambiguity limit scope research exception patent law. 137 increasing presence public-private partnerships research 136 Sampat (2009). 137 Adachi Misati (2010). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 85 areas biotechnology led clarity constitutes commercial -commercial research. Courts common law countries generally favourable arguments universities, encouraged patent , shielded obtain permission patent holders research activities. notable US case Madey . Duke University, 2002 held universities, previously relied wide research exception conduct scientific research activities patented subject matter consent patent holder based charters commit -profit objectives, longer rely exception conduct research research furtherance university’ legitimate business interests. 138 US Party CBD Nagoya Protocol present, court cases widely influential, US universities conducting research bound terms decision collaborate international partners scientific research. trends argue favour wide research exception objective preserve wide freedom operate. exception arguably distinguish commercial -commercial research. increasingly difficult delineate basic applied research, shown increasing trend patenting fruits publicly funded university research policies, partially incentive encourage commercial actors pick research view eventual commercialization. noted , researchers bound terms national ABS laws ( implement Nagoya Protocol) requirement PIC accessing genetic resources provider country. limiting freedom operate, , PIC requirement Protocol act means ensure access genetic resources & purposes board sharing benefits provider country event commercialization. Key Points research experimentation exception patent law exception IP rights permits researchers conduct research patented product patented process license. scope research experimentation falls exception varies jurisdiction jurisdiction, . jurisdictions permit wide research exception, limit exception -commercial research. result partly policies encourage patenting fruits university publicly funded research, increasingly difficult distinguish constitutes -commercial commercial research. Research exceptions patent law generally permitted TRIPS Agreement. WTO Dispute Panel decision, frustrate dissemination advancement technical knowledge, purpose disclosure requirement, patent owner prevent experimental term patent. 138 Madey . Duke University, 307 .3d 1351 (Fed.Cir. 2002), cert. denied 539 .. 958, 123 .Ct. 2639, 156 .Ed.2d 656 (2003). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 86 Research exceptions limited patents; plant variety protection utility model legislation build research exceptions exclusive rights conferred. research experimentation exception national patent law eliminate PIC Nagoya compliant national ABS legislation event seeks access genetic resources research purposes. incentive patent holders prevent emergence competing technologies present case PIC provider countries. fact, provider countries interested genetic resources TK successful commercial products, benefits accruing products shared provider country / indigenous communities. . Medical Treatment Exception Article 27.3() TRIPS Agreement permits Members exclude patentability diagnostic, therapeutic surgical methods treatment humans animals. jurisdictions chosen incorporate medical treatment exception patent law, albeit varying reasons. initial justification European Patent Convention (EPC) exclusion methods medical treatment methods treatment subject industrial application. rationale changed 2000, EPC revised: , medical methods excluded patent protection interests public health. 139 Developing countries generally justified inclusion exception patent law claiming local availability treatment methods, moral grounds. 140 jurisdictions, US Australia, opted exception patentability methods medical treatment grounds methods treatment pharmaceuticals. 141 Ventose lists number reasons exception patent rights methods medical treatment justified. 142 interesting argument favour excluding medical treatment ambit patentability patent protection methods medical treatment “diametrically opposed” “ Hippocratic Oath constituent fiduciary duties bind act solely interests patients.” 143 , exclusion guarantees activities physicians treat patients hampered patents. 144 cynical view historical evolution medical treatment exception presented Piper. 145 exclusion methods treatment patent protection distinguished requirement TRIPS provide patentability pharmaceutical products processes produce pharmaceutical products ( noted handbook, pharmaceutical products longer excludable TRIPS Agreement 139 Ventose (2011), . 45. 140 UNCTAD-ICTSD (2005), . 384. 141 Ibid. 142 Ventose (2011), Chapters 2 3. 143 Ibid., . 63. regard, United States, 1996 Medical Procedures Affordability Act, immunity medical practitioners suits relating patents methods medical treatment. 144 Ibid., . vi. 145 Piper Castle (ed.) (2009). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 87 LDCs). distinction drug patentable meets patentability criteria, industrial process manufacture drug patentable process patent, patent law exclusions medical treatments prevent patentability drug treat condition . , vaccine patentable, procedure administer vaccine patentable. 146 term “medical treatment” defined TRIPS Agreement, , increasing grey area pharmaceuticals methods medical treatment. medical technologies defy classification pharmaceutical product therapy, including, , gene therapies genetic diagnostic testing technologies, stem cell technologies. medical treatment exception prevent patenting substances, instance existing medicine treat condition originally intended. 147 countries, Zealand Switzerland, circumvent exception patent substance claim patent protection drug method manufacturing product treating ailment. 148 perspective CBD Nagoya Protocol, areas relevance: issue traditional medicine; issue genetically based medical technologies. respect , absence widely accepted definition methods treatment, reason exception patent rights methods extend methods treatment understood Western medicine. difficult question, , delineating boundaries traditional medicine. Efforts exist developing countries catalogue traditional medicine practices. countries, China India, regulated codified system traditional medicine developing countries, making easier define methods treatment traditional medicine context. note India’ database traditional medicines, extends 200,000 entries. 149 developed partially means countries assess prior art cases disclosure patent application triggered case claimed invention origin Indian traditional knowledge ( Chapter 3), jurisdictions incorporated wide medical treatment exception patent law rely database exclude medical treatments included database patentability. attempts patent traditional medicines involve cosmetic, health pharmaceutical products fall ambit ‘method treatment’. 150 respects applying Western notions medicine health. perspective defensive CBD/Nagoya Protocol strategy, removing patentability methods treatment related traditional medicine potential treatments medical conditions Western medicine incorporate notions , 146 Administration vaccines event arguably fail lack novelty inventive step patentable. 147 countries explicitly provide exception patentability substances, Article 21 Andean Community’ Decision 486 (14 September 2000). 148 http://www.ajpietras./media.html ( accessed 14 December 2011). 149 Randeep, “India moves protect traditional medicines foreign patents - India fights protect ancient treatments Western pharmaceutical companies” Guardian, 22 February 2009 (accessed http://www.guardian..uk/world/2009/feb/22/india-protect-traditional-medicines). 150 Ibid. include attempt patent products based Indian turmeric neem tree. http://www.ajpietras./media.html http://www.guardian..uk/world/2009/feb/22/india-protect-traditional-medicines Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 88 , preventive medicine health. Chinese traditional medicine practice, including acupuncture, , places great emphasis preventive medicine. 151 important mind, , exclusion traditional medicine patentability affect protections granted traditional medicine TK laws. areas discussed handbook, medical treatment exception contained provider country’ patent legislation affect patent applications law. affect patentability foreign jurisdiction. extent medical treatment exception widely accepted jurisdictions developed countries, important medical treatment defined broadly domestic medical treatment exception provider countries, extent patent applications foreign jurisdictions potentially consideration. Countries legislation medical treatment exception extends traditional medicine. area potential interface medical treatment exception patent law CBD/Nagoya Protocol area genetics related therapies. huge advances gene-based therapies years, due part successes mapping human genome. interface occurs patents sought therapies origins genetic resources covered CBD/Nagoya- compliant legislation provider countries. potentially includes treatments derived genetically manipulating plant animal species ( case plant- derived vaccines involving introduction gene plant species produce vaccine medicine), pathogens, topic covered earlier, manipulated genetically order produce vaccines conventionally. perspective ABS stakeholder provider country, attention paid scope claim , medical treatment exception exists domestic patent law. jurisdictions exclude methods treatment patentability, medicines vaccines treatment industrially produced principle potentially patentable, modes medical products administered patients excluded scope patentability. exclusion object overbroad claims cover method administration. patent law, examine applicable ABS laws fully complied . Key Points TRIPS Agreement permits Members exclude patentability diagnostic, therapeutic surgical methods treatment humans animals. EU developing countries exclude methods patentability, US, Australia countries permit patentability medical treatment methods. term “medical treatment” defined TRIPS Agreement increasing grey area medicines methods medical treatment. medical technologies defy classification pharmaceutical product 151 Hillier Jewel (1983), Chapter 2. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 89 therapy, including, , gene therapies genetic diagnostic testing technologies. Countries free define medical treatment domestic laws include traditional medicine. Countries legislation medical treatment exception extends traditional medicine. Databases, set India document traditional knowledge, define contours medical treatment exclusion domestic law, serve reference point user countries exclusion domestic patent legislation. Patents sought therapies origins genetic resources covered CBD/Nagoya-compliant legislation provider countries. potentially includes treatments derived genetically manipulating plant animal species, pathogens. perspective ABS stakeholder provider country, attention paid scope claim , medical treatment exception exists domestic patent law. . ‘Clean Hands’ Doctrine discussed Chapter 3, remains debate mandatory disclosure origin requirement enforced includes condition obliges complied existing ABS legislation provider user countries pre-requisite granting patent meets basic patentability criteria, TRIPS compliant. Proponents idea patent rights granted applicant affirmatively establish compliance ground argument doctrine ‘clean hands’. UK’ IPR Commission’ 2002 report Integrating Intellectual Property Rights Development Policy: “ principle equity dictates person benefit IP based genetic resources knowledge contravention legislation governing access material. cases burden generally lie complainant prove IP holder acted improperly. , precursor action knowledge wrong. assist respect disclosure requirement type discussed .” 152 potential problems policy granting patents meet TRIPS patentability criteria covered Chapter 3, repeated . suffices country err safe side unresolved debate, patent office require disclosure origin proof legal provenance, relevant patent office consideration assessment, , novelty, inventive step industrial application, determine claimed invention covers patentable subject matter. , , prevent sanction violation ABS laws ABS authority country concerned. 152 Commission Intellectual Property Rights (2002), chapter 4. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 90 story respect possibility prevent - patent seekers abided applicable ABS laws, . ‘clean hands’ doctrine states “equity grant relief party, , actor, seeks set judicial machinery motion obtain remedy, party prior conduct violated conscience good faith equitable principle.” 153 ‘Clean hands’ judicial doctrine traces origin US case law common law precedents. 154 theoretically codify ‘clean hands’ concept nullifies patent applicable ABS laws , raises spectre potential TRIPS -compliance (.., add requirement obtain patent). , , ways ‘clean hands’ doctrine applied question TRIPS compatibility. conservative approach consistent TRIPS invoke ‘clean hands’ lawsuit ABS holders aware problematic patent granted. important criteria underline , patent granted, , doctrine basis civil lawsuit administrative proceeding application patent. technology question application stage, channel principle raise issue -compliance ABS pre-grant oppositions, applicant opportunity cure - compliance. absence compliance ABS laws opportunity , patent issued ( question TRIPS consistency), domestic ABS law give ABS holders opportunity file suit court law, pleading range remedies -enforcement patent, requiring share royalties rights holder(), compulsory licenses permit rights holder() work technology question payment applicable royalty, compulsory cross- licenses 155 , damages. remedies, note legal concept -enforcement patent. concept analogous situation copyrights, enforcement remedies distinguished existence copyright . US, , provisions copyright law deny types damages fees unregistered foreign copyright works. argued behalf US, accepted WIPO, US registration provisions compatible national treatment formalities rules Berne Convention US registration requirement affects specific remedies ability obtain redress . number commentators agree, stating Berne Convention, TRIPS Agreement WIPO Treaties, prohibit formalities condition types remedies, licences, exemptions . 156 similar doctrine conceivably applied case 153 Black’ Law Dictionary definition (ed. 1983). 154 ‘clean hands’ doctrine origins US Supreme Court case Morton Salt . . .. Suppiger ., 314 .. 488 (1942). Subsequent decisions shaped doctrine practiced US courts today. 155 term originates European Directive 98/44 Legal Protection Biotechnological Inventions (passed European Parliament 12 1998 adopted Council published 30 July 1998). Article 12(2) Directive stipulates holder patent biotechnological invention exploit infringing prior plant variety , apply compulsory licence -exclusive plant variety protected , subject payment royalty. Member States provide , licence granted, holder variety entitled cross-licence reasonable terms protected invention. similar provision exists plant breeders’ rights (Article 12(1), Directive 98/44). 156 , , William Belanger, “.. Compliance Berne Convention”, 3 Geo. Mason Indep. . Rev. 373, 393 (1995); Final Report Ad Hoc Working Group .. Adherence Berne Convention, reprinted 10 Colum.- Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 91 -compliance underlying ABS laws case patents, tested date WTO dispute resolution panel. , specific cases room argue civil lawsuit revocation patent event -compliance ABS laws, prevent receipt patent applications TK. proposed amendment Zealand’ Patent Law, inventions Maori TK PIC potentially violation public morality. determination violating public morality Commissioner Intellectual Property advice Maori Advisory Committee. 157 determination enables Commissioner refuse application revoke existing patent. 158 order ensure TRIPS compliance, application invoking Maori TK considered case--case basis designed assess patent application consistent Maori values. Public order morality recognized exception patent law Article 27.2 TRIPS Agreement. Similar mechanisms conceivably devised indigenous groups countries. noted Zealand legislation place, , , case clean hands general sort mechanism tested WTO dispute settlement. similar argument lodged opposition filed European Patent Office Alice Community African Center Biosafety interested parties, patents granted Schwabe Pharmaceuticals Germany method producing extracts varieties Pelargonium plant. plants collected wild Eastern Cape region South Africa communities Alice region, extracts traditionally treat variety infections. Schwabe obtained patent extraction method manufacture medicaments treat infections HIV AIDS. preliminary opinion EPO 159 shows opposition filed plead, number arguments, Schwabe patent rejected grounds public order morality patentee established compliance PIC MAT CBD. analysis contained preliminary opinion, , clear EPO treat absence evidence -compliance PIC MAT se violation public order morality. , states preliminary opinion threat environment potentially constitute public order morality rationale exception patentability, text suggests moving establish argument establish “ harm environment contravenes generally accepted codes conduct”. rooted, part, Article 53() European Patent Convention states public order morality ground - patentability prohibited law regulation contracting states, examined case--case basis. , opposition claim upheld patents revoked EPO 26 January 2010 alternate grounds, .., meet inventive step criteria patentability. US legal precedents, patents invalidated rendered unenforceable shown patentee intentionally misrepresented omitted material facts VLA .. & Arts 513 (1986); Melville . Nimmer & David Nimmer, Nimmer Copyright §17.01() (2008). Nimmer & Nimmer, supra note 29, §17.01(). 157 similar committee exists Zealand’ Trademark Act. 158 application Section 17, Patent Act Zealand (1953, amended). 159 European Patent Office document 02 777 223.5 14 July 2009. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 92 patent application process. 160 US court case voided patent based failure disclose facts related source, origin legal provenance , intentional misrepresentation facts distinguish subject matter prior art, earlier court’ finding implied patentees performed experiment fact , upheld Federal Circuit 2003 case Hoffman-La Roche, . . Promega Corp. case concerned enzyme polymerase chain reaction - process generates copies DNA, patent granted. application referred DNA polymerase derived Taq bacterium prior art, asserted subject matter enzyme advance prior art. Promega challenged patent, arguing assertions patent application intentionally materially misleading, District Court agreed. Federal Circuit agreed findings District Court remanded case District level determine remedy invalidate render unenforceable patent. case settled parties . precedent leaves open possibility render unenforceable patents fail disclose material facts, finding intent crucial, inferred facts, including wording patent application. Key Points ‘Clean Hands’ doctrine states “equity grant relief party, , actor, seeks set judicial machinery motion obtain remedy, party prior conduct violated conscience good faith equitable principle.” Clean hands potentially invoked lawsuit ABS holders aware problematic patent granted. important criteria underline , patent granted , doctrine basis judicial proceeding. Domestic ABS law give ABS holders opportunity file suit court law, pleading range remedies -enforcement revocation patent, requiring share royalties rights holder(), compulsory licenses permit rights holder() work technology question payment applicable royalty, compulsory cross- licenses, damages. cases, difficult establish intent mislead. Intent mislead established facts surrounding case. public order morality argument potentially revoke patent, case draft Zealand legislation. . Unfair Competition, Competition Unjust Enrichment Based Theories alternative legal means address situation applicant attempts obtain exclusive patent rights absence compliance applicable ABS laws justify 160 Hoffman-La Roche, . . Promega Corp., 323 .3d 1534 (Fed. Cir. 2003). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 93 refusal application revoke patent utilizing doctrine unfair competition. Black’ Law Dictionary explains unfair competition : “ term applied generally dishonest fraudulent rivalry trade commerce, applied practice endeavoring substitute ’ goods products markets , established reputation extensive sale, means imitating counterfeiting , title, size, shape, distinctive peculiarities article, shape, color, label, wrapper, general appearance package, simulations, imitation carried mislead general public deceive unwary purchaser, amounting absolute counterfeit infringement trade-mark trade-. … statute prohibiting unfair competition defining meaning including ‘unlawful, unfair fraudulent business practice’ ‘unfair competition’ confined practices involving competitive injury extends practices resulting injury consumers.” 161 address situations misleading marks names, doctrine applies patents trade secrets. US practice, unfair competition injunctive relief prevent importation products covered patent US, , prevent importation products processes patented US, necessarily . 162 Courts generally protect trade secrets unfair competition laws prevent theft owner trade secret reasonable effort secret. argued seeking patent rights technology origins TK obtained violation PIC potentially amounts ‘stealing’ prohibited unfair competition theory. potential difficulties argument, . TK fit neatly abovementioned cases. authors unaware instance -compliance ABS laws invalidate patent unfair competition grounds. , TK secret, necessarily considered ‘trade secret’ strict legal sense term. indigenous group allowed, , traditional medicine practices observed outsider, , strict legal sense sufficient deny trade secret protection. , common law jurisdictions, unfair competition doctrine shaped case law, limit scope claim involving passing related deceptive practices. Finally, rights conferred ABS laws defined jurisdictions - clear ABS laws require PIC MAT, courts interpret amounting property favour indigenous groups remains . Finally, unfair competition claims distinguished competition law claims. Unfair competition law addresses unfair commercial practices competition legislation, general body law, exists act check abuse IPRs, envisaged Articles 8 40 TRIPS Agreement. clauses generally act check exercise granted rights context situation owner patent yields market power. Market concentration power difficult establish indigenous context, potentially relevant 161 Black’ Law Dictionary (ed. 1983). 162 Blenko (1990) http://www.tms.org/pubs/journals/jom/matters/matters-9010.html. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 94 cases involving refusals license, difficult situation competition law successfully deployed address situations patent applications complied applicable ABS laws. competition law unfair competition theories, theoretically frame legal argument misappropriated resources, obtaining IP rights, allowed unjust enrichment theory. Unjust enrichment refers general principle stipulates “ person permitted unjustly enrich expense , required restitution property benefits received, retained appropriated, equitable restitution , action involves violation frustration law opposition public policy, indirectly.” 163 theory generally civil actions. provider argument user patented invention utilized genetic resource TK PIC MAT, violation ABS agreement, argue allowing user 100% benefits arising patent amount unjust enrichment. court law, , strategy entail arguments extent original resource TK contributed patented invention. Key Points Unfair competition theories generally exist address deceptive trade practices, competition law theories exist address abuse market power. theories combat instances -compliance ABS laws limited, , difficult establish legal requisites theories. competition law, providers attempt frame arguments based theory unjust enrichment. VI. Conclusion variety tools exist patent law related jurisprudence potentially address problem misappropriation. line defence apply patent law exclude possibility - ‘biopirate’ obtain patent. arguing, , subject application patentable subject matter (.., invention.). line argument, establish criteria patentability met. exceptions patent law exist shield users engaged & activity medical treatment. Patent authorities , , utilize arguments event domestic party sought obtain patent invention utilizes genetic resource TK . case litigated defeat patent held - ‘biopirate’, theories equity deployed support argument patent revoked remedy aggrieved party. theories include ‘clean hands’ unjust 163 Black’ Law Dictionary definition (1983 ed.). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 95 enrichment, . include violation terms material transfer agreement (MTA), subject chapter 7. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 96 Chapter 5 Protection Traditional Knowledge . Introduction Chapter 1 extent Convention Biological Diversity (CBD) Nagoya Protocol laid rules access benefit sharing (ABS) , inter alia, TK genetic resources. Article 7 Protocol requires access traditional knowledge (TK) genetic resources based prior informed consent (PIC) benefit sharing place event TK accessed. benefit sharing linked TK, , means, , contribution pooled fund. Protocol leaves national legislation define TK genetic resources, type modalities benefit sharing place. requires sharing benefits research development (&), necessarily commercialization. TK, mutually agreed terms (MAT) requirement, Articles 5 6 Protocol deal genetic resources . Articles 5 6 apply indigenous/local community (ILC) legally responsible genetic resource accessed geographic area autonomy. protection TK takes place context wider TK genetic resources purposes CBD Nagoya Protocol. ABS context, reaction TK , , medicinal plant- animal-based preparations utilized shamans traditional Chinese medicine. 164 , concerns expressed ILCs protect TK arose conjunction greater recognition ILCs rights based customary law human rights laws. Existing national regimes negotiations international level seek protect TK cover wider scope, including traditional cultural expressions (TCEs) folklore music oral tradition, case ongoing negotiations World Intellectual Property Organization (WIPO) Intergovernmental Committee Intellectual Property, Genetic Resources, Traditional Knowledge Folklore (IGC). TK encompass therapies genetic resources, massage yoga. cases, laws seek regulate TK deals biological genetic resources. chapter examine larger context means protect TK, limitations Western notions IP protecting TK TK protection regimes utilized countries preserve interests maximize opportunities faced questions access TK. Key Point Legal frameworks seek protect TK cover TK genetic resources. 164 WIPO (2002), . 15. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 97 II. Defining TK proceeding question means protect TK, helps review TK means. ABS perspective, CBD Nagoya Protocol defines TK . Ongoing intergovernmental negotiations WIPO’ IGC ( WTO) resolved issue TK defined . Existing definitions TK gleaned national regional laws academic literature, uniform treatment TK laws . respect cases TK defined broadly, Section 2 African Regional Intellectual Property Office (ARIPO) Swakopmund Protocol Protection TK Expressions Folklore 165 defines TK knowledge developed traditional context embodied traditional lifestyle knowledge systems. TK includes -, skills, innovations, practices learning. National laws designed address narrow issue CBD / Nagoya Protocol compliance tend define TK TK genetic resources. Article 4 Pacific Islands Forum (PIF) Traditional Biological Knowledge, Innovations Practices Act 166 focuses traditional biological knowledge, innovations practices. Andean Community (AC) Decision ABS-related legislation covers TK long biological resources defined CBD. Andean Community Decision 391 Common Regime Access Genetic Resources 167 adds -products genetic resources definition. respect influential academic literature, International Institute Environment Development (IIED) project "Protecting Community Rights Genetic Resources" 168 classification based types TK: Sacred Knowledge held .. elders, healers shamans secret. Specialised Knowledge restricted family, clan kin; holder knowledge ensure proper context community holder belongs. Communal Knowledge public consent original developers holders. implication typology sacred knowledge secret, parties prepared recognise individual collective rights address community requesting access specialized knowledge, access communal knowledge free ; parties supposed restrict access knowledge, products developed therewith. 165 Swakopmund Protocol enter force ARIPO Member States deposit instruments ratification instruments accession; signed Protocol . ARIPO 18 members: Botswana, Gambia, Ghana, Kenya, Lesotho, Malawi, Mozambique, Namibia, Sierra Leone, Liberia, Rwanda, Somalia, Sudan, Swaziland, Tanzania, Uganda, Zambia Zimbabwe. 166 Pacific Islands Forum represents 16 independent States Pacific region: Australia, Cook Islands, Federated States Micronesia, Fiji, Kiribati, Nauru, Zealand, Niue, Palau, Papua Guinea, Republic Marshall Islands, Samoa, Solomon Islands, Tonga, Tuvalu, Vanuatu. TK Act adopted diplomatic conference national implementation members. 167 Andean Community Member States: Bolivia, Colombia, Ecuador Peru. Decisions Andean Community binding members. 168 International Institute Environment Development (IIED) (2010). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 98 definitions show TK uniformly defined. disagreement scope qualifier ‘traditional’ talking TK. voices assume TK equates , outdated knowledge essentially obsolete development modern knowledge based application scientific methodologies. kind knowledge justification legal protection. stressed ‘traditional’ reflects societal context type knowledge evolves , setting traditional lifestyle values. 169 strictly legal viewpoint, definition TK serves limited function delineating protected law . TK defined narrowly purposes ABS genetic resources TK legislation, necessarily TK concept confined dealing biological resources ILCs, exclude defining TK differently purposes law. , TK potentially covered laws. Key Points internationally agreed definition TK. National/regional laws literature define TK broadly narrowly. definition TK delineate coverage ‘protection’ meaning law. confines ABS laws, narrow definition TK focus exclusively TK genetic biological resources purposes CBD Nagoya Protocol compliance. prevent country adopting wider definition TK laws, . III. Protecting TK sheer variety subject matter potentially constitute TK TCEs means means easy establish optimal protection mechanisms. mechanisms protect TK TCEs range putting samples weaving costumes museum, video footage ceremonies, writing book stories passed generation generation. involve establishing database traditional medicines, creating laws grant rights ILCs respect biological resources traditionally food medicine. term ‘protection’ meanings. chapter focus meanings term ‘protection’: , defending TK TCEs misappropriation ; , preserving TK TCEs future generations; , giving opportunity ILCs exploit TK TCEs benefit. term ‘positive law’, context, refers ability give legal recognition TK TCEs means providing protection. 169 Dutfield (2006), .1; WIPO (2003), . 9; Barsh (1999), pp. 74-75. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 99 . Limits Modern IP Laws Modern IP instruments, include patents, utility models, industrial designs, copyrights, trademarks , considered means protect TK TCEs. Historically, modern IP tools developed means provide temporary monopoly inventor creator incentive rewarding innovative creative outputs. notion IP system ‘protect’ intellectual creative endeavour metaphor ability prevent acts misappropriation, enable owner subject matter exclusively benefit invention creation fixed term. order system work TK TCEs, , respective criteria protection patents, plant variety protection, copyrights, . met. Table 1 lists options protect TK existing IPR instruments, limitations highlighted experts. protection modern IP instruments confer rights applicant protecting successful applicant misappropriation subject matter making easier commercialize subject matter, major problem lies contrasting features IPR hand, TK grounded customary rights, including: temporal limitation major instruments; unknown collective inventor/authorship; TK fulfil requirements patenting registration plant varieties; lack protection TK manifestations features , TK passed generation generation disciples, potions ceremonies shamans, practitioners traditional medicine. IP instruments , , time bound – 20 years date application case patents, 50 years life author case copyrights. TK TCEs sense embody technology created possibly ages passed , constitute technology purposes patents utility models, seed case plant variety protection. TK spread widely public documented publications, fulfil basic criteria receive patent protection. Geographical indications collective trademarks offer means protecting mark , underlying TK TCE, important tools preventing misappropriation ILCs exploit assets. limitations corrected adaptation IPR, possibility claim collective authorship institution function substitute unknown authors copyright laws. Similarly patents institution represents collective inventors. literature existing national legislation experience show solutions listed limitations developed amending existing IPR solely combination sui generis options ( ), apparent governments free change current create systems. increasing number countries members WTO TRIPS Agreement Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 100 WIPO IPR treaties, concluded free trade agreements IP-related obligations, bound meet international standards limitations setting IP laws. 170 Key Points major differences IPR TK grounded customary rights : temporal limitation major instruments; unknown collective inventor/ authorship; TK fulfil requirements patenting registration plant varieties; lack protection TK manifestations features; issue protection TK brought public domain consent original developers custodians. literature existing national legislation experience show limitations problems protect TK existing IPR overcome amending existing IPR solely. , countries free adapt legislation accommodate criteria existing IPR categories. 170 , WTO 159 members, WIPO 186 members. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 101 Table 1: Options Protect TK Existing IPRs Applicable IP instrument Applicable IPR Conditions Limitations Problems: Industrial property trade secret commercial knowledge confidential time limit protection ) IPR perspective - commercial shown receive protection; protection easily broken group utilizes procedure public ) TK perspective - effective steps secret; specialized communal knowledge necessarily secret patent invention , inventive susceptible industrial application invention based previously undisclosed information protection 20 years date application ) IPR perspective - criteria apply secret TK usual forms TK widely spread cases documented - holder TK inventor - elements introduced TK, inventive step small face technical problems ) TK perspective - TK public application - limited temporal protection - expiration protection term, knowledge invention public domain - difficulties granting protection title larger communities utility model novelty utility required, necessarily inventive step protection vary depending ) IPR perspective - specific limitations ) TK perspective - TK, functional Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 102 jurisdiction; generally 10 years application date shorter features ceremonial element - TK protected - limited temporal protection industrial design exhibit esthetical features protection spans 15 years ) IPR perspective - specific limitations ) TK perspective - TK, functional features ceremonial element - TK protected - limited temporal protection trademarks GIs meet requirements trademarks; sign capable represented graphically, capable distinguishing goods services undertaking potentially perpetual ) IPR perspective - marks - fit existing system classification goods services ) TK perspective - TK protected - difficulties managing GI collective trademark systems Rights plant varieties plant breeders’ rights plant' geno- phenotype , stable, distinct uniform protection spans 15 - 25 years ) IPR perspective - TK connected wild plants land races cultivated plants fulfil requirements se ) TK perspective - TK plant protected - limited temporal protection Copyrights related rights copyright religious text prayer original expressions intellectual creations religious text prayer ) IPR perspective - author determined cases ) TK perspective Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 103 fixed, incorporating material objects shaman performer accorded authorise fixation performance register prerequisite protection protection spans 50 years - protection words prayer small element ceremony acting elements (symbolic values) - TK protected - applies individual authors collectives - limited time frame Source: Based Vivas Eugui Muller (2002); Alvarez úñez (2008); Milius (2009). . Public Domain Underlying problem modern IP systems failing legal protection subject matter, falls -called public domain. Boyle describes public domain property, .., subject matter proprietary rights free . 171 Numerous scholars Boyle Suthersanen point public domain remains important part modern IP system. suggests, instance, relevance variants concept public domain information commons, open access open source, vitally important technological development day age. 172 Developing countries WIPO called robust public domain order facilitate access knowledge technology transfer, topic examined Committee Development Intellectual Property WIPO Development Agenda. greater access expanding public domain desirable development contexts facilitating access knowledge technology transfer, problem event vehicle existing IP tools protect TK TCEs, subject matter falls public domain default rendering difficult, impossible, ILCs extract commercial therefrom. prevent misappropriation difficult party claim subject matter IPR expired obtain IPR subject matter place, benefit sharing derived subject matter difficult. major debate draft text treaty genetic resources, TK TCEs WIPO reveals gap positions developing countries favour limited definition public domain purposes treaty developed countries favour broader public domain. 173 important point remember 171 Boyle (2008) . xiv. 172 Suthersanen (2008), . 2. 173 Saez (2013). IP Watch article reports “[] noted developing country delegate, IGC, developing countries demandeurs legally binding instrument protecting TK, GR traditional cultural expressions. context, developed countries put arguments developing countries present negotiations order retain flexibility policy space. , delegate , developed countries IGC keen reduce subject matter protection, scope, insistent exceptions limitations widely .” Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 104 public domain , , concept IP law, exclude possibility applying ABS requirements TK TCEs national legislation. governments stakeholders concluded defensive protection sufficient serve expectations holders TK TCEs. develop positive protection - existing IPR, expanded IPRs sui generis elements TK TCEs sui generis options granting rights needed. section discusses sui generis laws . Key Points public domain consists protected IPRs, freely accessible utilize. international debate exists extent TK TCEs fall public domain protected IPR. TK TCEs protected IPRs, subject matter ABS requirements national legislation. . Sui Generis Systems Literally translated Latin, term sui generis means ‘ kind class’. 174 realm IP, term systems protecting intangible property, .., granting rights legitimate claim , manner commonly recognized concepts IP protection industrial property (.., patents, industrial designs, trademarks) copyrights. term , , describe respective systems established protect plant breeders’ rights (plant variety protection), integrated circuit designs utility models, framework patents designs. context TK TCEs, basic sui generis system establishes criteria protection, defines rights granted, period time rights granted, defines exceptions rights sets means enforce rights. uniform definition criteria treaty terms sui generis system protect subject matter adhere, countries complete leeway craft legislation manner suits objectives. regard, countries regional groups attempted frame legislation establishes sui generis rights TK TCEs. number laws examined section. hope examining number laws, policy makers understand potential scope impact laws. added countries experimenting making refinements laws based practical experience. purposes analysis, presented legal texts comprise regional national examples: 174 Black’ Law Dictionary (2009). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 105 Andean Community - 2002: Decision 391 Common Regime Access Genetic Resources Pacific Islands Forum - 2008: Traditional Biological Knowledge, Innovations Practices Act African Regional Intellectual Property Organization - 2010: Swakopmund Protocol Protection TK Expressions Folklore 175 Thailand - 1999: Act Protection Promotion Traditional Thai Medicinal Intelligence, .. 2542 Portugal - 2002: Decree-Law . 118/2002 South Africa - 2004: National Environmental Management: Biodiversity Act South Africa - 2008: Regulations Bio-Prospecting, Access Benefit-Sharing Guyana - 2006: Act provide recognition protection collective rights Amerindian Villages Communities, Granting Land Amerindian Villages Communities Promotion Good Governance Amerindian Villages Communities 176 Relevant text national examples contained Annex handbook, readers interested examining relevant text. selected examples cover wide range regional national legislation access genetic resources TK, defensive positive protection TK, ownership rights genetic resources TK - historical perspectives geo-political backgrounds - provide range approaches solutions. handbook focuses interface ABS IP, examples include laws cover TCEs addition TK . chapter lists regulations 177 analyses provisions presented regulations selection exemplary approaches address solve critical issues problems highlighted previous sections chapter. Due specific objective scope regulations, issues interest covered specific text covered extensively. , texts present range options critical areas: Subject matter definition Holder rights Scope rights 175 Swakopmund Protocol enter force ARIPO Member States deposit instruments ratification instruments accession; signed Protocol . ARIPO 18 members: Botswana, Gambia, Ghana, Kenya, Lesotho, Malawi, Mozambique, Namibia, Sierra Leone, Liberia, Rwanda, Somalia, Sudan, Swaziland, Tanzania, Uganda, Zambia Zimbabwe 176 Amerindian Act adopted 2006 implemented years apparent due formal errors entered force. 2010, Parliament adopted Act time administration rules effective entry force. 177 large collection related regulations, contracts . presented http://www.wipo.int/tk/en/legal_texts/. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 106 Acknowledgement rights TK public domain ABS elements Elements positive IPR protection Elements defensive IPR protection noted rights conferred contained stand- IP legislation Pacific Islands Forum (PIF), African Regional Intellectual Property Office (ARIPO) Thai examples, part ABS laws Andean Community (AC), Portuguese South African examples, part human rights legislation case Guyana. 1) Subject Matter Definition effective unambiguous definition subject law - TK rightful holders - desirable, usefulness fulfil holders TK tested real cases access TK benefit sharing. mentioned , present internationally accepted definition TK, countries agreed national regional definitions inform influence international debate WIPO IGC. Section 2 ARIPO Protocol deals protection TK , Article 4 PIF Act focuses traditional biological knowledge, innovations practices. AC Decision ABS-related legislation covers TK long biological resources defined CBD. CBD definition sees genetic resources subset biological resources; mentioned , AC Decision adds -products genetic resources definition. ARIPO Protocol defines TK knowledge developed traditional context embodied traditional lifestyle knowledge systems. TK includes -, skills, innovations, practices learning. PIF Act defines subject categories: traditional biological knowledge, traditional biological innovations traditional biological practice. AC Decision defines TK intangible component biological resources (based CBD definition), consisting -, innovation practices communities totally partially governed customs, traditions special legislation. definitions stress specific roots TK, relevance daily routines community, innovative elements, essential points international debates previous sections. examples illustrate basic approach groups laws dealing regulating ownership access TK genetic resources, benefit sharing: legal texts emerging field IP policy regulations ARIPO Protocol PIF Act deal depth definition TK holders, texts emerging field ABS policy regulations AC Decision cover TK provisions tend leave basic terms undefined. approach holds true Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 107 Nagoya Protocol. task defining TK remains solved national governments ILCs; negotiators referred ongoing WIPO IGC negotiations forum define IPR-related matters. national laws Annex issues interest perspectives: Thai Act covers development traditional medicinal intelligence, Portuguese Decree-Law covers commercial local autochthonous plants agricultural , South African Act Regulations relates traditional customary knowledge biological resources Guyanese Act deals human land rights Amerindian peoples including basic elements TK ABS. Thai Act specifically covers traditional medicinal procedures diagnosis treatment, traditional drugs devices medicinal TK . Act focuses knowledge issues, deals medicinal plants - meaning genetic resources - sources drugs. Thai Act national legislation aiming protection “Thai local intelligence”, protection types TK discussion. 178 Portuguese Decree starts scope applicable local autochthonous plant material covered IPR. Compared AC Decision line ABS-related legislation general, TK intangible component genetic resources commercial industrial utilization local communities provide specific definitions. South African Regulations refer concepts traditional lifestyle intergenerational context knowledge creation IP-related legislation simply defines TK knowledge indigenous communities. Guyanese Act due broader nature define genetic resources TK states native aboriginal peoples descendants subjects Act, leaves communities -identify Amerindian peoples. Act deals genetic resources TK separate paragraphs. Guyanese draft ABS Regulations 2009 attempt define traditional : “[] customary utilisation genetic resources written Amerindian local communities accordance TK, usages, customs practices observed, accepted recognised ”. Guyanese IPR system address genetic resources TK specifically reformed regard. drafting sui generis system announced. 179 Key Points international definition TK genetic resources awaits finalisation context ongoing WIPO ICG negotiations, regional treaties ARIPO Protocol PIF Act provide definitions. general, definitions TK exhibit common elements : relatedness dependency traditional lifestyle relevance daily routines community 178 Kudngaongarm (2011). 179 Environmental Protection Agency Guyana (2007); Environmental Protection Agency Guyana (2009). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 108 innovative elements dynamic nature Biodiversity-related legislation Nagoya Protocol AC Decision provide ABS-related rules TK general refrains defining . 2) Holder Rights context protection TK ABS issues, question (customary) ownership (formal) recognition prime importance. 2007 United Nations Declaration Rights Indigenous Peoples (UNDRIP) acknowledges rights indigenous peoples genetic resources TK including IPRs rights granted national legislation. exercise rights supported protected judicial administrative procedures. , Nagoya Protocol acknowledges rights provide international standards. Parties Nagoya Protocol involve indigenous local communities ABS procedures “ accordance domestic legislation established rights indigenous local communities”. Nagoya Protocol establishes categories holders: state sovereignty genetic resources, ownership rights indigenous local communities genetic resources established domestic legislation rights TK “held indigenous local communities” rights granted. approach originates CBD provisions, AC Decision Article 5 states owners genetic resources. Article 7, member states, national legislation, recognize rights authority traditional communities decide TK. provision imply ownership rights TK lie respective traditional communities. mentioned section , Article 6 PIF Act, IP-related legislation, determines ownership traditional biological knowledge, innovations practices lies specific social groups. Similarly, Section 6 ARIPO Protocol states owners TK traditional communities, extends ownership recognized individuals. national laws Annex offer concepts ownership. Section 17 Thai Act empowers government notify national formula texts, Section 20 individuals register personal formula texts intellectual property. Thai Act foresee traditional communities holders rights refer specific areas country holders live. laws apply “terroir” approach, reminiscent concept geographic indications ( chapter 6). Article 9 Portuguese Decree-Law empowers legal entity - individual corporate, public private - represents interests geographic area local variety register owner. Depending applicable Portuguese laws regulations, provision exclude associations communities owners. South African Regulations links status indigenous community “living rights interests distinct geographical area ... leadership structure” laying details interests Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 109 determine area. explain rights refers . Individuals rightful holders TK. Guyanese Act Article 10 appoints Village Council collective body holds, inter alia, rights genetic resources TK, respective population living -demarcated area approved territory government. , individuals holders TK. examples implement concepts owner TK: AC Decision, PIF Act, South African Regulations Guyanese Act restrict ownership communities; ARIPO Protocol Portuguese Decree-Law foresee ownership communities individuals; Thai Act defines government individuals groups owners. provisions Thai Act follow general policy line Asian governments European countries advocated negotiations Nagoya Protocol. 180 Delegates frequently rejected application concept “indigenous peoples” specific groups country traditional rights suspended colonial times restored current governments. Governments, representative societal groups individuals, rightful owner property rights. policy explain approach owners TK relation geographic area. Thai Act link TK area lifestyle. regard, Thai Act approach current patent copyright legislation linkages irrelevant describe owner IP. Key Points general, presented legal texts determine traditional communities principal owner TK. examples individuals owners TK. countries follow policy acknowledging specific, customary community-based property rights, ownership rights TK government / individuals. 3) Scope Rights context Nagoya Protocol, utilisation & triggers access provisions genetic resources benefit sharing provisions include phase commercialisation. scope rights regard TK remains undefined, requiring solutions negotiated forums WIPO IGC / formulated national legislation. exclusion Nagoya Protocol access genetic resources traded designed ensure trading genetic resources purposes consumption manufacturing hindered ABS rules. order close foreseeable loopholes, Nagoya Protocol obliges members ensure 180 , , Chouvin al. (2004). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 110 domestic legislation, utilisation - traded goods - research purposes covered ABS rules. regional legislations approaches determination scope granted rights, large extent rooted fact concentrate access issues property rights utilisation. AC Decision adopted long Nagoya Protocol reflects approach countries region include types biological material utilisation ABS rules. specific interest implementation TK related provisions Nagoya Protocol PIF Act ARIPO Protocol. PIF Act deal scope issue specifically. regard strict ownership concept assumed scope ownership rights comprise activities TK, innovation practices purpose. provisions Article 3 AC Decision applicable genetic resources member states countries origin, -products TK. , specific activities purposes mentioned implying cases included. Section 4 ARIPO Protocol explicitly mentions owners exclusive authorize exploitation TK. comprises exclude TK PIC. addition, ARIPO Protocol extends rights utilization products processes traditional context. provisions show ARIPO Protocol developed domain intellectual property organisation aims establishing legal certainty transforming TK products processes enter formal market. laws specifically deal issues commercialisation TK, ABS issues. approaches reflected Thai, Portuguese South African texts. Guyanese text remains silent issue scope rights. information Environmental Protection Agency Guyana, specific ABS legislation regulating issues development. 181 practice, Guyana set PIC system Amerindian Act regulating research biodiversity commercial research forbidden: “ Amerindian communities consulted part Biodiversity Research Process. [...] noted academic commercial research permitted. , researchers prohibited entering Amerindian territory requisite permission Ministry Amerindian Affairs Village Captains. aforementioned Process : 1. Applications biodiversity research filming documentary submitted EPA [Environmental Protection Agency]. 2. Applications reviewed National Biodiversity Advisory Committee - MOAA [Ministry Amerindian Affairs] active member committee. 3. required, applicant seeks permission Ministry Amerindian Affairs Village Captain. 181 Author’ personal communication EPA Guyana October 2011. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 111 4. met criteria, Biodiversity Research Permit issued. process completed months.” 182 Section 34 Thai Act grants owners rights research, distribution, improvement development formulas traditional Thai drugs IPR registered text traditional Thai medicine. Article 10 Portuguese Decree-Law entitles owners receive part benefits genetic resource heard authority resource registered PIC. owner genetic resource knowledge provisions limited rights typical ABS matters PIC MAT, Decree-Law ”owner registration” full responsibility care situ conservation plant. South African Act concentrates activities aiming commercialisation biological resources, including organism parts thereof. Regulations adopted years close gap research activities. South African ABS system covers large area activities biological resources - provisions permit system definitions - TK. Section 6 80 2(), Act excludes human genetic material, exotic organisms altered biotechnology indigenous biological resources listed ITPGRFA. Act define exotic species refers genetic resources listed Annex 1 ITPGRFA. exclusions reflect intense debates negotiations Nagoya Protocol. final compromise text Nagoya Protocol abandoned concept multiple exclusions scope Article 3, read conjunction Article 15 CBD, excludes genetic resources accessed area jurisdiction members. Key Points scope rights vary significantly national examples Nagoya Protocol: regional legislations mention phases chain include research, development commercialisation activities TK; scope Nagoya Protocol regard access provisions; Thai Act Portuguese Decree-Law include TK chain; South African Act concentrates commercialisation phase chain, adopted Regulations include & phases ABS rules include TK. South African Act excludes genetic resources TK scope, human genetic resources genetic resources listed ITPGRFA. 182 Ministry Foreign Affairs Guyana (2009). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 112 4) Acknowledgement Rights definition holders rights TK , clear procedure acknowledge rights concrete fields TK specific holders add certainty predictability legislation implementation. mentioned, Nagoya Protocol clarify ownership TK ILCs formalised. regard, task falls regional national legislation. basic challenges, issue technical concerns debate procedures, hurdles costs registration rights. AC Decision provisions registration TK activity left member states, typical feature ABS-related legislation. Article 4 PIF Act prescribes owner -identify competent authority, details left national implementation Act. Section 4 ARIPO Protocol speaks communities recognized hold specific TK, customary practices, laws protocols mentioned suitable instruments. regional treaties give guidance, selection applicable instruments detailed procedures left national implementation. analysis national examples Annex reveals remain largely silent technicalities registration rights. duty set rules procedures indigenous local communities register TK lies responsible institutions identified respective pieces legislation. Section 15 Thai Act stipulates Institute Traditional Thai Medicine acts registrar include details procedures costs typical registration process. institute enacted effective rules protect IPRs individual holders, focuses application traditional medicinal knowledge national health care system. 183 Article 4 Portuguese Decree utilizes comparable approach: registration plant variety National Centre Registration Protected Varieties, details . South African Act Regulations provide procedures claims rights TK announced indigenous communities . Contrary widely recognised approach -identification holders customary rights, Regulations Article 8(1)() foresees applicant bioprospection permit - cover access TK - identifies relevant stakeholders including indigenous communities holding sought TK. Guyanese Act provisions registration genetic resources TK. noted place, full land, resource ownership rights, granted Village Council -identification acknowledgement Ministry Amerindian Affairs. Details registration TK dealt drafting national ABS law. Key Points Registration procedures facilitate acknowledgement rights TK. regional national examples generally adhere commonly accepted principle -identification holders customary rights TK. 183 Kudngaongarm (2011). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 113 South African Regulations determine applicant bioprospection permit identifies holders TK charges registrar verification claims. examples set rules procedures technical processing registration. 5) Publicly TK highly contentious issue concept public domain applied TK related ABS issues. Representatives indigenous peoples WIPO IGC negotiations view public domain concept flawed process ( related legitimacy/legality) leading placement knowledge -called public domain. agree customary ownership rights cease TK publicly - PIC granted. 184 argument based redress provision Article 11 2 UNDRIP : “States provide redress effective mechanisms, include restitution, developed conjunction indigenous peoples, respect cultural, intellectual, religious spiritual property free, prior informed consent violation laws, traditions customs.” case Asian states, governments claim ownership forms TK public domain, traditional ayurvedic medicine - exemplified section - traditional Thai medicine. Thailand long history publishing traditional medicinal knowledge . 185 respective draft provision Nagoya Protocol deal ABS issues related publicly TK championed governments China, India Nepal, firmly rejected EU supporting governments knowledge public domain freely scope IP protection legislation. 186 controversy open ABS negotiations failed night CBD COP-10. finalisation Nagoya Protocol closed-door process excluding vocal Asian countries, provision deleted. regional legislation language TK public domain PIF Act Article 6. Competent Authority entitled claim ownership knowledge, innovations practices owner exist . authority act trustee case rightful owner eventually surfaces. Section 18 Thai Act government power register formulae texts widely IPR expired, policy Asian countries issue. Article 3 Portuguese Decree deals public domain indirectly. classical IPR rights - exclusive ownership rights prohibition unauthorised parties - genetic resources TK industrial production unknown local 184 , , statements WIPO (2010), pp 36-38. 185 Kudngaongarm (2011). 186 Nijar (2011b), pp 28-29. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 114 community event registration. effect provision resources knowledge public domain longer protected Decree-Law. provision applies genetic resources TK brought public domain entry force legislation cases legitimate owners () registered . approach logic typical IPR legislation conditions procedures TK put public domain, fact public domain relevant regard free availability. South African Act Regulations Guyanese Act deal issue publicly TK. Key Points noted earlier, question TK public domain covered IP protection controversial. Representatives indigenous peoples view public domain concept flawed procedure legitimacy/legality leading placement knowledge public domain. agree customary ownership rights cease TK publicly - PIC granted. Provisions protection publicly TK major deviation existing IPRs require sui generis provisions protected. examples - PIF Thai Act - provide protection publicly TK specific circumstances. Portuguese Decree-Law approach existing IPR legislation explicitly excludes genetic resources TK protection industrial production local community registration. 6) ABS Elements Nagoya Protocol applies “tandem approach” 187 , hand, integrates issues TK core provisions access benefit sharing hand, Article 12 stand- provision aiming clarifying understanding TK international level giving guidance national implementation recognition customary laws practices, strong obligations Parties. Sui generis laws treat TK form IP provisions refer PIC MAT. , AC Decision detailed ABS provisions Titles , VI VII , extent, applicable TK genetic resources accessed utilised. national examples Annex , Portuguese Decree-Law Article 7 typical ABS elements PIC owner TK, application registration authority benefit sharing agreements user perform research commercialisation activities. South African Act Regulations exclusively deal ABS issues related genetic resources. provisions PIC, 187 Frein & Meyer (2012). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 115 MAT benefit sharing laid articles apply TK, . Articles 10 11 PIF Act install PIC procedure potential commercial user TK apply Competent Authority. Based PIC registered owner, ABS agreement negotiated supervision Authority. Section 9 ARIPO Protocol determines holders TK entitled benefit sharing based MAT. Section 15 prescribes authorisation access TK imply consent access genetic resource . Section 19 Thai Act states wishes registered formulae texts pay apply licensing authority. Section 46 adds conduct research, transformation commercial purposes export controlled herbs authorised licensing authority. lack typical “ABS language” PIC MAT explained fact Act finalised 1999, years negotiations Nagoya Protocol increased awareness ABS issues started. Article 5 Guyanese Act clarifies access indigenous territory consent Village Council. addition, research activities biological diversity natural resources separate PIC Village Council, permits required applicable law permission Minister Amerindian Affairs. Article 6 requires PIC sought materials derived research, benefit sharing agreement negotiated Village Council. Key Points Based respective provisions CBD, UNDRIP Nagoya Protocol, application principles (free) PIC MAT access TK sharing benefits arising utilisation firmly established. regional IP-related examples Pacific African region apply principles, implemented respective national IP legislation. appears future national sui generis systems protection TK ABS-related elements implementing provisions Nagoya Protocol. 7) Elements Positive IPR Protection section analyses examples elements positive protection TK. regional laws, ARIPO Protocol presents list traditional sui generis IP provisions. AC Decision, ABS law, deal positive protection IPR. Article 8 PIF Act owner traditional biological knowledge, innovations practices exclusive addition applicable IPR, remains silent nature applicable IPR, details left PIF member states. depend large extent future outcome WIPO IGC negotiations reference ARIPO Protocol. Nagoya Protocol helpful context, substantial references IP system deleted final text. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 116 ARIPO Protocol devotes entire Part II protection TK typical elements existing IPR legislation . Section 8 states owners assign licensing agreements parties. Section 12 introduces concept compulsory licenses “ order fulfil national ” TK “ sufficiently exploited rights holder, holder rights TK refuses grant licences subject reasonable commercial terms conditions”. provisions reflect specific situation traditional communities live differentiate traditional commercialisation. Section 11 requires exclusive rights granted Protocol restrict TK traditional context. concept basis Article 12(4) Nagoya Protocol “Parties, implementation Protocol, , , restrict customary exchange genetic resources TK indigenous local communities accordance objectives Convention.” Section 13 ARIPO Protocol deviates usual time frame IP protection. Protection TK granted long traditional context exists. individual owners register TK traditional context, protection expires 25 years. national examples, Thai Act Section 14 establishes IPR traditional formulae texts. Section 16 addition prescribes categories IP: national, general personal formulae texts. noted implementation provisions remains unsatisfactory day. 188 Article 14 Guyanese Act Village Council certify products residents traditional methods result kind geographic indication. Portuguese Decree-Law South African Act Regulations provisions positive protection TK. Key Points Due largely missing provisions positive protection TK examples, general conclusions drawn requisite elements positive IPR protection. years national examples legislation traditional sui generis options positive protection TK genetic resources drafted. ARIPO Protocol adopts mix traditional IP provisions exclusive rights access TK giving licences parties compulsory licences “ order fulfil national ”, sui generis provisions providing unrestricted access protected knowledge traditional context protection period long traditional context exists. 8) Elements Defensive IPR Protection establishment strengthening rules protect TK misappropriation stringent application criteria patentability central elements debates genetic resources, TK IPRs. largely uncontested governments stakeholders defensive rules , discussion consequences -compliance ranging 188 Kudngaongarm (2011). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 117 nullification granted patents. , interesting note regional examples, AC Decisions, biodiversity-related legislation, strong defensive protection elements. IP-related regional texts deal topic. AC Decision Complementary Provisions prohibits granting IPRs genetic resources, -products TK accessed violation provisions Decision. Member states request nullification unlawfully granted IPR. , applications IPRs genetic resources TK disclose legal provenance. provisions reflect strong position Latin-American governments misappropriation genetic resources TK IP system. PIF Act strong elements defensive IPR protection. Article 7 requires Competent Authority maintain register, Act foresee register means check prior art IPR applications. Article 3 prescribes Act prevails inconsistency IP laws. Section 5 ARIPO Protocol foresees maintenance registers specifically require IPR examinations. Section 10 requires user TK traditional context source origin respect cultural values holders. ARIPO Protocol, contrast AC Decision, explicitly prohibit granting IPRs TK, assumed basis Section 10 provisions Protocol ARIPO grant IPRs TK. Section 22 Thai Act prohibits registration IPRs traditional Thai medicine registrar opinion formula text belongs IP categories traditional medicine. Article 3 Portuguese Decree protects TK reproduction commercial long registered sufficient detail registration. South African Act Regulations provide defensive protection measures. Article 14 Guyanese Act entitles Village Council rules recording publishing intellectual property TK belongs village. Act concrete defensive protection measures. inclusion measures raise considerations TRIPS compatibility similar discussion addition disclosure patentability criteria contained Chapter 3. regard, option require disclosure origin/source patent law, sanctioning failure comply ABS law. Key Points Defensive protection TK built IP laws. necessarily preclude subject matter treated sui generis laws covering TK. regional IP-related texts Pacific African region explicit provisions defensive protection TK. AC Decision prohibits granting IPR genetic resources, -products TK accessed violation provisions Decision. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 118 Member states request nullification unlawfully granted IPR. , applications IPR genetic resources TK disclose legal provenance. Thai Act Section 22 prohibits registration IPR traditional Thai medicine registrar opinion formula text belongs IP categories traditional medicine. 9) Pay Systems concept aims accommodating concerns TK holders suggests IP rights protecting TK set form liability regime. --pay- system simple registration procedures, & based TK elaborated benefit sharing agreement. agreement negotiated marketing products . systems form legal certainty effective monitoring - part sui generis systems. approach reported Namibia - regard access genetic resources, TK. Namibian government gave PIC transfer Marula fruits (Sclerocarrya birrea subsp. caffra) foreign institution sole purpose research chemical composition. Oil Marula seeds special interest cosmetic industry. agreement side foresee benefit sharing early stage chain, hand forbids user publish results commercialise products derived research. case research result outcome considerable market potential, PIC fully fledged benefit-sharing agreement negotiated enter phase product development. 189 Key Point pay systems address benefit sharing respect TK. . Databases number countries, including China, Costa Rica, India, Peru Thailand, attempted catalogue existing TK enter relevant information database. defensive perspective, information contained database wishing examine state prior art event patent application builds TK, case -disclosure, appears build . Accurate, --date information easily searchable database helps efforts combat misappropriation IP channels . difficulty lies, , maintaining database ensuring updated domestic TK evolves. Indian database, 1,200 formulations, 189 Presentation Pierre du Plessis, Expert Meeting ”ABS Intellectual Property Rights”, September 2011, Addis Ababa, Ethiopia. file authors. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 119 accessible online patent examiners http://www.tkdl.res./tkdl/langdefault/common/Home.aspGL=Eng. mentioned countries, India tie information located database domestic legal effect, countries databases ‘registers’. cases countries, underlying TK law grants registrant rights obligations discussed earlier chapter. limitations 190 , general agreement international community databases existing TK tool combat misappropriation. current debate WTO revolves countries databases require mandatory disclosure origin/source amendment TRIPS Agreement registration database automatic legal effect, debate databases . Key Points Databases tools ensure misappropriation local TK . effort required establish maintain updated database. act registration database step procedure obtaining rights sui generis TK law. Current intergovernmental debates focus countries agree establishment databases require mandatory disclosure origin/source, legal effect registration TK database. IV. Conclusion ABS system established Nagoya Protocol CBD designed provide measure protection TK genetic resources, process establishing system ‘protect’ TK challenging . , agreement constitutes TK, treaty, TRIPS Agreement matter, defines term. , difficulties ascertaining vehicles ‘protection’. protection preservation future generations, protection misappropriation. Protection creating means secure monetary -monetary benefits application TK foreign markets. deficiencies protecting TK IP tools originated Western world pointed numerous times existing literature, include problems ‘owner’ TK, lack novelty condition obtaining exclusive rights, temporal scope modern IP tools, combined fact TK falls public domain term expires IP categories. Due limitations, scholars propose sui generis laws confer tailored rights obligations TK holders. experience countries systems show, , laws infancy countries experimenting ways means granting recognition set rights TK. 190 footnote 109. http://www.tkdl.res./tkdl/langdefault/common/Home.aspGL=Eng Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 120 countries agree, , order combat misappropriation TK , catalogue existing TK establish database patent examiners access assess prior art. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 121 Chapter 6 Distinctive Signs, Biodiversity Derived Products Protection Traditional Knowledge . Introduction Geographical indications (GI) signs 191 identify goods originating specific locality, region territory, origin confers noted quality, reputation characteristic. 192 global perspective, GI broad collective umbrella denomination distinctive signs linking products source, includes subcategories trademarks (collective certification trademarks) sui generis forms protection. 193 sui generis subcategories, widely protected geographical indications ( PGI) protected denominations origin ( PDO). 194 addition mentioned ‘positive’ forms protection, GI protection pursued doctrine unfair competition passing , administrative schemes protection, 195 considered ‘preventive’ ‘passive’ forms protection. Biological resources widely inputs products covered GI protection. Climatic factors ecosystems natural frameworks influence quality features GI products. manufacture GI products mirror inspired traditional practices methods production linked local livelihoods. aspects create direct linkages intellectual property (IP) category conservation biodiversity properly designed technical standards organizational structure. regard, GIs voluntary schemes valorize introduction sustainable practices TK preservation measures. GIs provide contribution conservation biodiversity sustainable components (objectives 1 2 Convention Biological Diversity (CBD)). 196 relationship GIs CBD objective - fair equitable sharing benefits arising utilisation genetic resources - clear. GI products incorporate biological resources cases processed ultimately consumed. , cases GI protected products include units heredity (.., fresh fruit vegetable). cases, trade product “commodity” allowed, trade imply authorization purposes “utilization” Nagoya Protocol. case genetic resource covered GI utilised research development (&) purposes (.., seeking improve natural features genetic resource), obligations Nagoya Protocol 191 include words phrases, distinctive marks, symbols, icons groups characters traits linking product territory. 192 Article 22, TRIPS Agreement. 193 broad sense, 10,000 reported exist globally. 194 167 countries actively protect GIs form intellectual property fall main groups: 111 nations specific sui generis systems GI laws 56 prefer trademark systems. . Giovannucci al (2009) . 14. 195 UNCTAD-ICTSD (2005), pp. 274-279; . Giovannucci al (2009), pp. 49-53. 196 Article 1 CBD (1992). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 122 apply. CBD Nagoya Protocol provisions develop biodiversity strategies protection traditional knowledge (TK) relevant. contrary, GIs properly designed, constitute suitable instruments contribute biodiversity conservation sustainable . chapter seeks introduce main links biodiversity, TK, access benefit sharing (ABS) GIs. chapter provide reader understanding benefits costs making GIs sustainable development perspective. Finally, produce checklist issues consideration maximizing potential GIs biodiversity conservation sustainable . Key Points GIs protected modalities distinctive signs including trademarks (certification collective), sui generis forms GI protection. GIs, properly designed, significant contribution conservation biological resources sustainable objectives CBD. GIs voluntary scheme valorize introduction sustainable practices TK preservation measures. links GIs access benefit sharing provisions CBD Nagoya Protocol limited, GIs tend biological resources inputs manufacturing process. , GIs cover genetic resources (.. fresh fruits vegetables) ’utilization’ context Nagoya Protocol trigger access benefit sharing (ABS) provisions. . PGIs PDOs Originally Europe, PGI PDO forms protection specifically conceived link territory ‘’ product. conceptual terminological variations countries products, remain widely . 197 important qualitative difference PGI PDO refers intensity, form objectiveness link product geographic area origin. effect, linkage terroir product stronger PDO, good produced, processed prepared identified geographic area. , case PDO product display characteristics qualities fundamentally owed area. contrast, PGIs concerned, mentioned operations performed area, allowing flexibility conditions long product quality, reputation characteristic attributable area. 198 197 wines spirits, term Europe ‘controlled denomination origin’, terms assuring specific level quality referring ‘controlled denomination origin guaranteed’. 198 article 2.1 () () COUNCIL REGULATION (EC) 510/2006 20 March 2006 protection geographical indications designations origin agricultural products foodstuffs (OJ 93, 31.3.2006, . 12) Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 123 Key Point case PDO, good produced, processed prepared identified geographic area, display features owed area. case PGI, products display quality, reputation characteristic attributable identified area, long produced, processed prepared identified geographic area. . Trademarks, Certification Trademarks Collective Trademarks laws protect GI trademarks, principle mere geographic names registered trademarks products. general prohibition, product geographic identified referring source, producer manufacturer, considered geographic meaning (.., achieved ‘secondary meaning’) fulfills product identification function. Additionally, categories trademarks employed identify goods’ geographic origin: certification collective marks. Certification marks consist words, names, symbols, devices identify quality nature product state meets pre-established standards. standards quality characteristics linked place origin product, nexus GIs. contrast forms GI protection, owner owners mark . contrary, role trademark proprietor consists administering regime denied applicants fulfilling established criteria. mark limited product certifies, extend areas production products products specifically requested registration phase. GIs protected means collective marks, signs distinguishing goods services connection specific group, standards set community. Collective marks exclusively members collective, obtain proprietary rights common identifier. owner mark parent body, collective group organization obliged administer mark interest members collective. imply geographic origin, necessarily geographic content. fact, variety factors distinct geographic origin goods services origin collective. Key Points categories trademarks employed identify goods’ geographic origin, certification collective marks. Certification marks product meets pre-established standards, linked place origin. Collective marks distinguish goods services connection specific group, imply geographic origin. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 124 . Key Requirements TRIPS WTO TRIPS Agreement lays common characteristics legal requirements protection GIs. Article 22 TRIPS, Members obliged provide legal means protection – include protection unfair competition statutory administrative methods protection – indications identify goods originating territory Member. ‘Goods’ wide term potentially covering sorts products, services, protection left national consideration. TRIPS Agreement establishes link product origin exist. precisely, good ‘originate’ place identified GI. specific meaning ‘originating’ flexible , instance, partial manufacture good distinct place. hand, features product ‘essentially attributable’ origin, means attributable designated territory. TRIPS states “ quality, reputation characteristic good” “essentially attributable geographic origin”. opens door distinct possibilities. , specific quality essentially attributable geographic origin. , specific reputation attributed geographic origin, opens door link based favorable considerations respect good. , characteristics distinct quality reputation form basis protection GI, permitting consideration issues color aromatic traits good. possibilities confirm product distinguished characteristics physical properties. scope covered GI broader narrower depending reading term ‘territory’. limited physical aspect, notion narrow. contrast, ‘territory’ includes inhabitants, commonly understood, protect products. relevance issues links TK GI, “cultural geography lead association unique superior quality geographic area. relates traditions skills talents possessed residents area.” 199 aforementioned requirements met, interested parties offered legal means protection avoid indication misleads public true origin product. means protection prevent constitutes act unfair competition. 200 adjudicating conflicts, key discussion focused act “mislead public”. specific meanings ‘public’, ‘mislead’ ’deceit’ key determining existence infringement. 201 hand, article bars registry trademarks GI mislead public real origin goods. 199 Giovannucci al (2009), . 16. 200 Article 22(2), TRIPS. 201 interpretation terms, UNCTAD-ICTSD (2005), pp. 292-295. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 125 Key Points Article 22 TRIPS obliges WTO Members provide legal means protection GIs, include protection unfair competition statutory administrative methods protection. good ‘originate’ place identified GI quality, reputation characteristic good essentially attributable geographic origin. . Links GI Biodiversity Conservation GIs tool biodiversity conservation, market values GI, conservation practices incorporated GI’ technical specifications consumers pay price differential origin-based products. successfully established, added product stimulate preservation genetic resources , TK applied ecosystem landscape created. precisely, GIs “ promote biodiversity conservation specific genetic resource indirectly production management practices include landscape ecosystem considerations”. 202 clear rationale, preservation genetic resources TK consequence economic activity interest, necessarily purposed goal GI protection. rise agro-industrial generic products caused difficulties small medium farmers. difficulty compete terms price volume large agro-industrial corporations obliged small farmers collectivities focus efforts market niches environment conservation, organic food landscape preservation. Larson underlines, GI informative labeling “give possibility commercializing products link area differentiated identity; [] avoid competition based volume, prices marketing”. 203 GIs tend land agro-ecological characteristics impart unique organoleptic 204 aspects, 205 proved distinguishing products producers direct ties land resources. benefits conservation arising GI protection , , developed developing countries. Comparative case studies 206 proven positive relevant effects genetic resource conservation easier place developed developing countries. consequence higher level integration environmental requirements ( species races preservation, grass protection landscape considerations) GI schemes developed countries. , case Comté cheese France, 30 65 botanical species areas covered PDO 207 . field variety botanical species direct impact quality milk organoleptic properties cheese. 202 Larson (2007), . . 203 Larson (2007), . 4. 204 Properties perceived sense organs. 205 Giovannucci al (2009), . 37. 206 Larson (2007). 207 Comité Interprofessionel du Gruyere de Comté (2013). Comté AOP Contributions au Development Local. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 126 contrasts -PDOs artificial fields level botanical diversity 10 botanical species 208 . developing countries, potentially GI protectable products informal nature faced problems integrating environmental requirements. developing countries benefit positive spillovers, factors present ensure conservation practices embodied GI design. , mention institutional strengthening, IP protection, management natural, biological genetic resources. 209 main lessons learnt relationship GIs genetic resources : “) direct contributions landscape ecosystem conservation important GI production systems based natural vegetation, perennial crops extensive input livestock management; ii) GIs based intensive agricultural systems, direct environmental benefits result convergence organic production methods; iii) direct conservation genetic resources results GI implementation intrinsic product ; iv) endangered genetic resources recovered successfully marketed GI developed management germplasm carried producers, governing body GI (GB) alliance regional research institutions; ) GI production systems based managed extractive activities promote conservation natural vegetation forested areas consequent benefits ecosystem landscape conservation; vi) existing biological cultural diversity developing transformation countries asset developed GI differentiation”. 210 Key Points GI tool protection genetic distinctiveness market values GI conveniently rewards . GIs proved distinguishing products producers direct ties land resources. small farmers collectivities focus efforts market niches environment conservation, organic food landscape preservation. . Links GIs TK GIs support local cultures, groups traditions fostering rural development. 211 successfully granted promoted, GI “ provide structure affirm protect 208 Ibid. 209 Larson (2007). 210 Ibid. pp. 39 57. 211 Escudero (2011), important “category intellectual property applied protection TK geographical indication”. . Escudero, International Protection Geographical Indications Developing Countries. Trade-Related Agenda, Development Equity (.....) Working Papers 10. South Centre: Geneva. 2001, : http://www.southcentre.org Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 127 unique intellectual socio-cultural property embodied indigenous knowledge traditional artisanal skills valued forms expression community”. 212 Rangnekar claims GIs intersection culture geography. , GI protection merited due link specific origin cultural manifestation, link product culture. 213 GIs aimed fostering protection cultural local agro-ecological characteristics techniques. instance, local farming techniques, food preservation methods processing procedures resulting distinguishable products eligible GI protection. 214 key mechanism strengthen local characteristics techniques GI reward market. successfully established, added product valorization knowledge implied increase return local communities stimulate preservation conditions traditions allowed producing protected product. mentioned Chapter 5, , GIs protect underlying TK . local culture essential shaping uniqueness protected product, uniqueness main market asset product, GIs potentially powerful conservationist stimulus local TK. focus local sphere, , enables development small-scale economies, frequently based sustainable methods exploitation. related fashion, positive link TK genetic resource conservation established, GIs recovering traditional practices linked underutilized genetic resources neglected industrialization. 215 alluded synergies easy achieve. account GIs difficult establish require good planning institutional framework. , quality product adequate, farming communities poor involved institutional regulatory aspects GI, limit usefulness, damage population, environment, economy culture. negative context, practices resulting homogenization products GI protected, frequently standardize quality products enable mass production, lose differentiation act impetus preservation TK. 216 Key Points GIs foster protection cultural local agro-ecological characteristics techniques, key incentive reward market. local culture essential shaping uniqueness product, GIs powerful conservationist stimulus local TK. Good planning, strong institutional framework, quality attributes product, wealth local community decisive factors achieve positive outcome GI protection. 212 Giovannucci al (2009), . xviii. 213 Rangnekar (2004), pp. 20-21. 214 link local context emphasized laws. instance, French law appellations origin law alludes “local, fair constant practices”. 215 Larson (2007), . 40. 216 Ibid. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 128 . Genetic Resources Protected GI subject ABS rules217 principle, GIs trigger access provisions based Nagoya Protocol 218 utilization defined & genetic biochemical composition genetic origin. mentioned , occasions GIs incorporate biological resources processed ultimately consumed consumers. , & genetic resources general included establishment implementation GIs. operations GIs material biological origin due processing refinements substantial amounts functional genetic information longer - oils spirits - material functional genetic information DNA fingerprinting identity control - wines. 219 operational CBD definition genetic resources based physical presence absence genetic information decreased decades detection limits DNA increased manifold CBD operate threshold values. limited operationality reasons negotiators Nagoya Protocol finally chose manner utilization genetic resources trigger ABS rules addition physical nature accessed material. cases, GI product matches genetic resource. , case Jinxiang Da Suan ( local garlic variety Jinxiang district Shandon Province China), registered PGI Europe. 220 , , imply garlic & purposes China. option countries hand avoid confusion trade “special products/commodities” covered GI transfer genetic resources ABS rules, export documentations labels products authorized utilization context CBD Nagoya Protocol. , Decision 391 Andean Community 221 complementary provision number , stipulates health certificates export biological resources “ product genetic resource authorized”. benefit sharing obligations Nagoya Protocol regard genetic resources 222 include “commercialization” resources including derivatives 223 , user countries discuss implementation provisions regard GIs. issue solved additional profits due willingness consumers pay higher price GI-protected products defined benefit sharing Nagoya Protocol. regard, cases producers exclusive sourcing contracts raw materials provide benefit sharing. , , case cosmetic company business producing 217 section based kind comments Harmut Meyer. 218 Articles 6. 1 2 () Nagoya Protocol. 219 UC Davis (1999). 220 GI protected geographical indication EU regulations 2011. Official Journal EU (2011/ 37/11), EC : CN-PGI-0005-0622-16.07.2007. 221 Andean Common Regime Access Genetic Resources. Decision 391 1996. 222 Article 5(1) Nagoya Protocol. 223 Article 2 ( ) Nagoya Protocol. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 129 argan oil 224 , offered local communities exclusive sourcing inputs form benefit sharing.225 reverse picture arises TK elements GIs discussed light Nagoya Protocol. Access TK genetic resources linked, Nagoya Protocol 226 , specific form utilization. based fact Nagoya Protocol define traditional knowledge included definition “utilization”. utilization TK context GIs qualifies access dependent actual provisions national ABS TK legislation discussed case-- case basis. benefit sharing obligations regard TK Article 5(5) Nagoya Protocol lead conclusion utilization knowledge context GIs trigger rules Nagoya Protocol. regard, assessing application TK rules Nagoya Protocol GI, important determine level engagement community GI scheme cases production facilities GI territory owned “locals” “employ locals”, benefits generated shared community. Key Points product covered GI cases genetic resource. & activity undertaken resource accessed, provisions Nagoya Protocol triggered. Rules indicating type activity authorized export documentation labeling assistance avoiding confusion “special products/commodities” direct consumption authorization utilization genetic material Nagoya Protocol. benefit sharing provisions Nagoya Protocol, benefit arising commercialization genetic resource derivatives shared countries origin. determine additional profit obtained GI scheme considered benefit sharing modality Protocol. application TK protection provisions Nagoya Protocol TK embodied GI product depend national legislation case, cases producers employees GI chain ILCs. . Distinctive Signs Address Misappropriation Concerns important concern biodiversity TK rich countries IP system generated incentives access, utilization misappropriation GRs TK authorization compensation countries origin TK holders. incentives attributed large part consequence emergence biotechnology industries expansion scope patentability life forms 224 request protect argan oil PGI EU regulation submitted 2011. EU Commission request. 225 Lybbert (2007). 226 Article 7 Nagoya Protocol. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 130 components. 227 GRs TK significant inputs & processes leading biotechnological inventions. , conditions set national ABS TK regulations fulfilled utilising resources knowledge introducing IP applications. Today, international processes addressing problem ( sections Disclosure Requirements TK Chapter 3). Claims misappropriation (appropriating GRs TK compensating TK, misuse (acting access conditions mutually agreed terms) common early 1980s continue arise. , add situations -patent ‘biopiracy’ ( applies types IP control biological resources TK, including plant breeders’ rights trademarks). 228 Examples controversial cases trademarks applications/ generic plant names, indigenous terms existing regions developing countries include “Rooibos” exporter United States 229 ( herbal tea South Africa), Maori terminology Lego’ bionicle toys 230 , “Barlovento” chocolate bar Nestle ( cocoa-producing region Venezuela). 231 literature GIs distinctive signs potential tools support sustainable biological genetic resources TK preservation 232 , effect address biopiracy misappropriation concerns patent filing granting clear. GIs forms distinctive signs give protection “indication/sign” “reputation” product “knowledge” se. principle, impede filing invention built genetic resources TK. , reputational content (including qualities biological resources ), codification TK practices technical standards/specifications, continuity protection GI provide information relevance novelty prior art analysis patent breeders’ rights examination improve quality patent breeders’ rights subsequently granted ( defensive function). reported case Darjeeling tea, GI registered India, prevention misappropriation motivations request protection. 233 Similar motivations registration PDO Quinoa Real Bolivia consequence granting patent Quinoa late 1990’ ( abandoned due opposition indigenous peoples civil society organizations). 234 reputational “indication/trade ” protected country origin facilitate oppositions registration trademarks countries similar products related services. 2006, Ethiopian Patent Trade Mark Office initiated opposition procedure trademark application introduced United States Starbucks Corporation Shirkina sun-dried Sidamo coffee. opposition succeeded United States Patent Trade Mark Office decision recognized likelihood confusion trademark “Sidamo” reputational Ethiopian Sidamo coffee. consequence successful opposition Starbucks Corporation abandoned trademark application. 235 227 Pastor . Muller (2009), 11. 228 Robinson (2010), . 77. 229 FAO (2009-10), . 155. 230 Morgan (2003). 231 Vivas Eugui (2001a), . 703. 232 Vivas Eugui Muller (2001b) Robinson (2010). 233 Kumar Datta (2010), .132. 234 Larson (2007), . 49. 235 DePass (2010). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 131 case utilization indigenous terms/designs trademark applications, legislation countries includes explicit prohibitions register words offend community consist names indigenous local communities. examples regard Zealand 236 Andean Community. 237 addition, United States developed database Native American Tribal Insignia ( larger concept trademarks) 238 examination process trademarks order avoid potential cases misappropriation. type database expanded include relevant indigenous terms designs worldwide. Key Points GIs address biopiracy misappropriation concerns. existence GI biological resource, reputation, TK contained technical standards defeat patents, breeders' rights claims novelty prior art examinations. Practical examples evidenced pre-existence GIs trademarks key preventing misappropriation trademarks countries. countries introduced exceptions measures linked trademark/design registration indigenous names, words signs order avoid misappropriation. . Summary Comparative Table Main Features mentioned , ‘GI’ wide denomination distinctive signs link goods source. embraces categories trademarks collective certification trademarks, includes sui generis forms protection. common features, foundational principles category differ, differ ownership, enforcement mechanisms, link protected good origin, conditions set GI issues ties quality technical standards. point view producers, vital choose legal institution suits interest, characteristics goods, area production collectivity GI. 236 Zealand, Trade Marks Act 2002 49, section 17. 237 Article 136 ) Decision 486 Andean Community Nations (2002). 238 http://www.uspto.gov/trademarks/law/tribal/index.jsp. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 132 Table 2: Compared Characteristics PGI, PDO, Certification Marks Trademarks PGI PDO Certification marks Collective trademarks Foundational principles Links GIs certification quality indirectly rural development, increase farmer incomes group development Industrial property rights, differentiation marketing tool Industrial property rights, differentiation marketing tool Ownership Collective public Privately owned, generally government agencies producer organizations Privately owned groups proprietors, public private Preexistent linked territory. chronological order, linkage territory invented link territory. register full rights. invented link territory. registering full rights Link geographic origin Strict. case PDO inputs produced territory PGI requirement flexible Certification marks necessarily require distinctiveness geographic terms. certify features material, methods, quality origin. case collective marks, distinctiveness required geographic terms Ties quality Strong: conceived device signaling quality strong: general marketing tool. , built design strong: general marketing tool. Linked reputation producers. Trade sold delocalized sold licensed sold licensed Access accessible producer region origin meets criteria Certification marks free entry producer fulfills specifications certification Collective marks members community Technical standards Publicly obligatorily linked origin. general standards privately elaborated, exceptions exist Private. needed. collective trademarks identify producers. Duration protection unlimited, maintained condition protection remain. jurisdictions, protection limited 10 years (renewable) Limited period time, 10 years (renewable) Limited period time, 10 years (renewable) Enforcement Public, occasional collaboration individuals concerned Private enforcement. Additionally, party believes certifier standards unfairly denying mark file opposition, cancellation proceeding, action court Owners marks action waiting government enforcement Source: Seuba Vivas, partially based . Stéphan al. (2007) pp. 4-7; .Giovannucci (2009), .55. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 133 II. Main Benefits Costs Making GIs Numerous factors account , , decide desirable develop GI , , category diverse options suit characteristics good, terroir collectivity involved. benefits numerous important, place automatically, case-specific. hand, expected benefits depend investments areas institutional framework standards-setting. , benefits parallel effects welfare, potential difficulties access goods produced GI arise impact prices. picture, , positive institutions rightly chosen flexibility exists adjust local conditions. benefits costs impact society collectivities individuals relationship GI. Benefits preservation TK genetic diversity public goods, reach wider involved geographic area. Economic benefits obtained virtue GI protection principle profit reaped marketing product, related factors increases tax collection considered. costs concerned, borne privately, cases public institutions manage issues quality control, legal protection setting administrative judicial bodies surveillance GI. . Benefits GIs forms distinctive signs designed support sustainable genetic resources protect TK. , potential positive effects/externalities generated correct instruments practice. important effects include . 1) Market differentiation prime price. Geographical indications informative labelling mechanisms give possibility commercializing products link area differentiated identity. avoiding competition based volume, prices mass marketing. 239 GIs permit levels price volatility volumes limited quality fixed technical standards practices. legal point view, GI defense free riding existing indication/reputation product originated processed specific geographical area, means preventing misleading labelling. GIs tend target niche local markets population , due cultural consumer preferences qualitative considerations, pay price . 240 -called prime price marginal difference consumer pay acquiring product compared generic commodity. main drivers willingness special quality product reputation, identified certified GI scheme. GI producers ensure prime price, application quality controls 239 Larson (2007), . 4. 240 Paz Pomareda (2009), .14. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 134 reputation carefully preserved. attack reputation decrease destroy prime price margin. market differentiation prime price GIs sense. , Blue Mountain coffee Jamaica prime price USD14.50 compared soft Colombian coffees. 241 France, average price cheeses protected PDO 2007 10.42 Euros/kg average 8.11 Euros/kg cheeses ( equates 27 cent differential). case Nuoc Mam sauce ( fish sauce Vietnam), pushes domestic foreign demand brought price 200 cent introduction GI protection. 242 reasons GI protected products higher prices higher costs due , inter alia, investments quality (equipment, sourcing grading), standard setting, controls, certification monitoring. 243 , GI schemes provide opportunities costs economies scale inputs acquisition, common manufacture stock facilities, joint labelling, legal defense marketing. 2) Organisation Producers Protection De-localization Cooperative agreements fundamental piece GI governance structure functioning. fact GIs work effectively minimum level organisation pushes producers explore options cooperative arrangements. principle, GI offer incentives emergence cooperative arrangements opening niche markets, obtaining prime price, distributing labour chain achieving economies scale. , agreements arisen automatically experience developing countries, dealing small producers. Technical financial support IP offices, ministries agriculture industries, regional authorities, enterprise development agencies research centres present order support building governance structure effectively represents stakeholders chain production reality. Kampong Speu Palm Sugar Producer Association Cambodia formed task force comprising representatives producers government representatives scientific support organizations. 244 task force responsible discussing drafting -laws future producer association. months work, association created 2007. Today, association composed 142 producers proceeding official registration Kampong Speu Palm Sugar GI product. 245 pilot project lead Ministries Commerce Agriculture Cambodia French Cooperation Agency seeking support development technical standards quality control mechanism GI 246 order fully functional. advantage offered GI, assist preventing delocalization production. 247 GI produced area confers specific characteristics 241 Paz Pomareda (2009), . 14. 242 . Giovannucci al (2009), . 34 243 Ibid, .33. 244 FAO (2009-2010), . 100. 245 Ibid. 246 Ministries Commerce Ministry Agriculture, Fisheries Forestry Cambodia (2010). 247 Ngo Bagal Vittori (2011) . 16. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 135 product. result, large corporations prevented “capturing” added origin products related methods appropriation techniques production geographical area. 248 type “capture” easily occur case companies rely trademarks, acquired part company assets production moved places countries production costs . case GIs, production addition attached territory linked local practices /sign, qualities reputation sold transferred. 3) -Standard Setting Environmental Management particularity GI certification trademarks producers design, adopt implement technical standards. standards binding producers GI /sign obtain certification. Technical standards embody main features production process including acquisition raw materials, treatment, transformation quality specifications. Environmental management embodied technical standards, reflected practice objectives producer associations. case Limon Pica Chile, pesticides chemicals fundamental practice producers. inputs part technical standards, -laws producers association preservation natural resources linked production process included objective. 249 association producers Mezcal Papalote de Chilapá, PDO de Mezcal, adopted extensive forestry management programmes wild species intense cultivation. 250 environmental regulations determine natural resources GI producers part technical standards. , part production Cacao de Chuao (PDO) Venezuela territory Henri Pittier National Park. governing national park regulations production cocoa part ancestral practices local communities 251 , time requires sustainable management cocoa trees, surrounding forest, soil, water landscape. surrounding tropical forest shade cacao trees preserves soil degradation. 252 4) Enables Revalorization Biodiversity-Derived Products GIs seek bring market origin-based special products, utilise endemic locally specifically adapted races, varieties species. diverse plant animal resources include utilised food security purposes qualities (.., nutritional, organoleptic, functional aesthetical). utilisation promotion products utilizing diverse plant animal resources assist resisting pressures increased homogenisation standardisation, preventing disappearance deterioration habitat, landscapes, ecosystems genetic diversity. GIs interesting platform marketing products wider biodiversity base allowing preservation specific potentially commercial species. case food products, wider 248 Ibid. 249 Vandecandelaere Mery (2007). 250 Larson (2007) . 44. 251 González Jiménez . (2007), . 31. 252 Ibid,. . 10. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 136 diversity food products contributes food security objectives larger nutrition dietary base. traditional variety revalorised GI protection case Mais Blanco Gigante del Cuzco (white giant corn Cuzco) Peru. Mais Gigante del Cuzco ancient high altitude variety maize important nutritious, tradition religious functions. 253 protection PDO 2005 allowed recognition indigenous agricultural knowledge clear synergies efforts Cuzco region’ tourist restoration services. Germany, protection Swabian Hall pork meat PGI allowed conservation increased numbers highly endangered population pig breed. 254 production meat pig bred PGI subject outdoor management, positive environmental benefits compared intensive pork production. cases, GIs potentially contribute providing economic species facilitating protection reproduction efforts. Guanaco wool Argentina, Chile Peru, protected GI, potential regard. Guanaco wool highly appreciated local international textile markets. Guanaco camelid protected Annex II CITES Convention 255 majority population wild. GI strategy Guanaco wool includes protection management populations part technical standards facilitate involvement locals conservation production efforts, income survival protection species. 5) Preservation Traditional Methods Production GIs, jointly copyrights industrial designs, relevant existing category IP applied protection TK, including production methods traditional cultural expressions (TCEs). 256 IP categories protection distinctive creative aspects signs, expressions designs present traditional practices. , TK holders cases meet requirements protection (.., distinctive, original aesthetic features) 257 . categories IP protection patents breeders’ rights difficult obtain due limitation criteria protection including novelty industrial application case patents, novelty homogeneity case breeders’ rights. 258 regard, GIs capture distinctive aspects emerge terroir traditional methods production processing difficult duplicate regions countries. 259 specifically, GIs provide legal, governance marketing structure needed affirm protect unique intellectual socio-cultural property embodied indigenous knowledge traditional artisanal skills valued forms expression community. Locally unique farming, harvesting, selection preservation practices 253 FAO (2009-2010), . 24. 254 Larson (2007), . 39. 255 Convention International Trade Endangered Species Wild Fauna Flora 1973. 256 Vivas Muller (2001b). 257 Ibid. , IP categories adaptation order facilitate protection registration. WIPO negotiating set instrument() seek protect traditional knowledge cultural expressions. 258 Chapter 3 Handbook defines explains detail potential advantages limitations IP system offers TK protection stakeholders sui generic system suitable indigenous local communities expectations. 259 Ibid. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 137 processing procedures, designs packaging embody key aspects differentiation GI products. Traditional processes give quality (.., handmade) generate consumer interest due qualitative features final output. increasing successful strategy GIs protect promote traditional techniques knowledge case GIs textile products India. 2010, India 53 textiles GIs protected, showing increasing importance GI developing country context. shows GIs traditional farming knowledge, including skills practices manufactured goods textiles. 260 textile GIs incorporate part production process traditional techniques input harvests (.., flower mineral selection), spinning, weaving, colour preparation, dyeing, knitting, processing, printing labelling. Part process include dressing techniques bring additional aesthetic effects societal recognition. Examples famous Indian textile protected GIs include ochampalli ikat (fabric), Chanderi sari (textiles) Mysore silk (fabric). reported cases, GI protection helped producers boost economic returns significantly. 261 .. James, Director Department IP India: “[]etting products GI registry step realising economic potential. major challenge. people engaged production products small households small units, area. Convincing organise associations move application registration continues Herculean task instances. draw standards inspection mechanisms ensure quality. , , teething troubles; system organised care ”. 262 cases, local supply chain actors, including ILCs, play key role utilizing preserving TK systems. Actors supply chain diverse. cases, key aspects process entrusted women, elderly people, shamans families. fact, local community members product element local culture core local activities. 263 role members community adding cocoa Chuao women dry cocoa beans traditional front village church. type flooring church special drying conditions facilitates fermentation process, improving quality aroma. important note TK practices techniques codified. GI scheme assist codification practices sustain continuity. cases practices “secret sacred”, additional forms sui generic TK protection needed ( chapter 5 TK protection). 260 Based data Government India Intellectual Property India (2010). Geographical Indications Journal. 261 James (2009). 262 Ibid. 263 FAO (2009-2010), . 14. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 138 Key Points GIs forms distinctive signs designed support sustainable GRs protect TK, identification promotion biodiversity-derived products. GIs facilitate market differentiation biodiversity-derived products market move commodity market. Due special features GI products, ensure consumer acceptance margin benefit ( called prime price). GIs means promote creation productive organisational structures focusing origin quality. producers move chain create market niches. GIs incorporate sustainable harvest, production management practices. mandatory, practices base differentiation. GIs -regulation leaving producers selection technical standard ensuring quality safeguarding reputation. GIs wider variety inputs including products linked biodiversity food security local context. revalorisation sustainable reproduction biological resources endangered. fact GI implies production locality region creates disincentives delocalization mass production. TK traditional methods transferred production process technical standards GI allowing preservation economic sustainability. GIs facilitate protection promotion cultural goods textiles handicrafts, preservation livelihoods. . Costs 1) Distinction costs effects welfare implementation schemes protection GIs resource effects grouped categories. hand, identify additional resources required implement obligations frameworks protection GIs. investment implement GI scheme. GI protection essentially public policy, investments needed borne public authorities left producers collectivities. hand, impact effects GI protection economy society observed, quantified. category, impact defined effects public goods, prices, consumption, production , ultimately, welfare. 264 group resource effects positive, instance terms employment protection growth, negative, dimension aspects restriction access goods negative environmental externalities. , uncommon literature dealing GIs terminology 264 distinction IP enforcement obligations. Vid. . Seuba al. (2011). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 139 distinguishes direct indirect costs. 265 regard, “[] costs developing GI extends direct costs filing registration; greater indirect costs weigh benefits.” 266 costs effects welfare identified. respect costs, start classifying direct costs incurred perform basic activities laying criteria standards, developing information education programs, establishing system quality control, promoting GI, setting infrastructure management GI. examples effects welfare concerned, mention probable impact prices GI exclusivity, potential decrease innovation improvement products GI protection reduction competition. 2) Institutional organizational structures Setting institutional organizational structures vital task GI scheme. strength, management adequacy institutional organizational framework largely impact probability success GI. Institutional organizational structures essential aspects GI system. determine products eligible GI, established councils authorities charge recognition producers’ membership. authorities responsibility ensure regulations , perform activities aimed marketing product, basically strengthening goodwill. rightly stated , GI successful, existence strong institutional structures bears importance GI reputation quality achievements. 267 instance, Antigua Café, Guatemala, successful existence local association exporters producers (Asociació de Productores de Café de Antigua) planned multi-year effort led register domestically trademark “Genuine Antigua Coffee”, 2008 obtain GI protection. contrast, case Gobi desert camel wool “difficulties participatory organization resulted stakeholders grasping rights obligations GI.” 268 regard, governance structures designed attain fair distribution benefits, reach producers concentrate distributors middlemen. establishing institutional administrative settings, point departure case developed developing countries. developing countries, significant share economic activity informal nature, production atomised, products sold cases consumers. Constructing GI implies creation cooperative governance structures. structures obtain formal GI protection GI scheme functional. cooperation suggests common agreements delimitation territory, treatment raw material, harmonization production processes, standards setting, quality verification controls joint labelling marketing strategies. institutional framework weaker underdeveloped developing countries. Developed countries, contrast, large tradition cooperative institutions, farmers artisans 265 categories coincidental. instance, costs reorganize production considered indirect costs, case considered investment , , direct cost. 266 Giovannucci al. (2009), . 20 267 Larson (2007), . ix. 268 Giovannucci al. (2009), . 2. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 140 cooperatives. cooperatives readily transformed institutional structure charge administering GI. 3) Costs Establishing Enforcing Standards aforementioned institutional organizational frameworks closely related establishment legal administrative structures protection GI. 269 time, activity implies prior endeavor, demarcation formal geographic area GI. area , fact, territorial jurisdiction institutions created, area application legal administrative standards adopted. interests stake envisaged outcomes, demarcation GI physical boundaries contentious resource consuming activity. stakeholders positively negatively affected outcome, decision -grounded, commonly requires investing time money. step final goal define area matches claimed characteristics product. activity require meetings representatives economic sectors involved, naturalists, geographers sociologists. design implementation standards generate level homogeneity GI products ensure fulfillment safety regulations, transfer TK standard generate tension TK knowledge systems. TK systems evolutionary, standards imply codification harmonization relevant practices. regard, local communities involved chain clear codification harmonization applicable production process. , standards periodically changed evolutionary aspect introduced standard review order maintain authenticity process outcome. institutional point view needed investment arises adoption administrative standards derived GI rules. adjust product organoleptic properties claimed, features claimed, standardization key feature GI frameworks. Empowering local communities setting standards achieving sense ownership adopted standards important avoid exclusions legitimate producers. adoption relevant standards, investment needed record fulfillment, instance trough establishment registry inspections. , producers collectivities necessarily incur costs fulfillment adopted standards, obliged pay fees activities certification. regard, institutional design GI “ transaction cost adequate economic scale production process product.” 270 Activities undertaken GI framework guarantee claimed characteristics effective simple . 271 adoption administrative standards design implementation legal strategy protection GI “steps protect reputation inherent GI 269 infra. 270 Larson (2007), . 72. 271 Ibid. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 141 devaluation.” 272 Legal protection avoid misuse GI central success GI. protection consume significant amount money product sold numerous countries protection overseas sought jurisdictions. instance, reported Parma DO spends approximately USD 1 million year prosecuting infringements. 273 conflict registration Rooibos trademark United States. order achieve recognition “genericness” term, cancel trademark registered United States, South African producers stakeholders spent approximately 750,000 Euros date. 274 Legal protection imply litigating, prevention. bigger GIs pay institutions function sentries countries: institutions visit formal informal markets conduct regular inspections products search illicit versions. strong GIs pass costs final market price good, strength undertake global surveillance activities transfer costs products’ price small GI. , small producers necessarily assume standardization certification costs affecting competiveness terms price. 4) Higher production costs targeted marketing strategies investment develop GI costs produce goods distinguished protected origin particularities impact final price. Studies Europe show GI protected products’ production price 300% higher comparison -protected GIs. 275 differences positive factor terms assuring good return GI producers, instances barrier economic accessibility. , selective marketing techniques restrict availability product, impact accessibility arise. mentioned , GI protected products higher costs, including due investments quality, standard setting, controls, certification monitoring. labour hours, machines, expensive equipment basic factors production contribute higher distinctive quality traits. fact, raw materials tend expensive, technical specifications GI oblige consumption specific product, limiting options producer diminishing competition. characteristics numerous GIs imply levels production productivity, automation, industrial agro-industrial techniques excluded standards exclude market goods meet criteria. certification, international standards govern accreditation qualified certification bodies, increasingly private organizations. Certification business inextricably connected product distinctiveness, , , price. costs certification relevant: 80% cases, certification costs range 0.6% 0.8% turnover (excluding organizational costs). 276 272 Josling (2006), . 4. 273 Giovannucci al. (2009), . 22. 274 Larson (2007), . 48. 275 London Economics (2008). 276 Data ECOCERT, French control certification body working developing countries. Cfr. . Ngo Bagal Vittori (2011), . 18 Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 142 costs collective individual level. varying number local producers forced adapt methods, facilities skills GI technical standards specifications. adaptation imply nature impact. instance, local producers wishing benefit GI change raw materials , undertake courses hitherto neglected aspects. investment important, imply change manufacturing process requires important construction machinery land cattle- management. , certification costs closely linked code rules control plan, largely condition direct certification costs. 277 instance, case Pecorino Toscano cheese, code rules adopted prescriptive typologies cheese produced easily fit PDO. 278 quality distinctive characteristics products belonging GI enables charge premium price target high markets. Competition terms price ceases central issue, product allegedly unique. usual focus quantity volume substituted interest quality. , probable mass distribution substituted selective marketing. , characteristics permit higher turnover, product sold high- niches , , markets. GIs potential negatively affecting access “nutritious culturally valuable resources local income populations” 279 . caused rise exports concomitant undersupply domestic market, large-scale conversion agriculture GI area leading neglect production local products food, situation occur prices higher availability GI products inputs consequence increase demand success GI brand. Allowing production unbranded versions product price local consumption, incentivizing sustainable production inputs creating input quotas local populations assistance addressing problems. 5) Environmental degradation Environmental factors land climatic conditions significant impact quality. , GIs necessarily generate positive environmental externalities production process include environmental management practices. cases, GI large-scale operation, negative effects surrounding environment. regard, breed landrace specialization result loss genetic diversity, intensive agriculture, means irrigation fertilization, change original links product territory GI. 280 notorious agave stems produce Tequila. varieties Agave tequiliana Tequila DO. introduction green biotechnology allowed massive reproduction Agave plants, enabling standardization quality control maturation periods. success tequila sales generated level diversity inputs , Agave variety required technical standards production Tequila. case Mezcal 277 Belletti al., (2007). 278 Ibid. 279 Larson (2007), . 58. 280 Ibid, pp. 39 56. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 143 wider Agave varieties production process. , intensive pesticides, agricultural techniques deforestation caused order gain cultivable hectares, Tequila production criticised environmentally. 281 Sustainable practices, based traditional practices, (.., selective harvesting, organic production, soil water management) incorporated technical standard practices clear, explicit extent homogenous. risk environmental management considerations technical standards, reflect power relations supply chain producers introduce additional costs price structure. 282 Key Points Resource effects GI protection grouped categories: investment implement GI scheme, effects protection pose public goods, prices, consumption, production, ultimately, welfare. strength management institutional organizational structures vital success GI scheme. Developing countries generally difficulties ensure adequacy structures, terms funding traditions. number important activities imply significant costs: demarcation geographic area GI, enactment administrative standards derived GI rules, setting legal administrative structures protection GIs, creation registry, conduction inspections engaging legal protection. Economic accessibility goods GI protected difficult. investment develop GI, costs produce goods distinguished protected origin particularities, increase demand selective marketing techniques increase price product. III. Checklist Issues Sustainable Biodiversity TK Protection making GIs distinctive signs, stakeholders consideration key issues GI protection “origin” based business model order ensure potential sustainable biodiversity TK protection maximised. issues include enabling regulatory environment, administrative capacity, organisational aspects, verification quality control mechanisms, marketing labelling strategies. issues considered integrated beginning environmental social criteria. criteria 283 include: conservation ecosystems, wild populations genetic variety extent ; management natural inputs (water, land, biological resources raw materials); 281 Ibid, . 43. 282 Ibid, . 56. 283 minimum environmental social criteria inspired existing principles criteria UNCTAD’ Biotrade Initiative (2007). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 144 involvement relevant stakeholders design creation GI governance structure; introduction sustainable agriculture manufacturing practices, including traditional , technical standards; inclusiveness sharing benefit GI added chain; fulfillment relevant environmental social regulations. section analyze key aspects GI protection “GI” business model purpose introducing entry points ensure environmental social criteria included GI governing policies. Relevant stakeholders process include, inter alia, governmental authorities (IP offices, ministries agriculture, industry environment sanitary authorities), producers associations ILC organizations. . Enabling regulatory environment Clear, transparent enforceable GIs / distinctive signs regulations place order ensure possibility protection sign/ identifies origin-based product. mentioned , countries option choosing sui generis system, collective/certification trademark system . absence modalities protection, laws unfair competition assistance, implies litigation obtain protection (.., passing ). countries signed free trade agreements United States / European Union, parallel protection GI certification/collective trademarks option. defining criteria protection, countries choose accord specific environmental (.., climate, land, biological resources) social factors (.., traditional methods selection, production packaging) fundamental impact quality specificities product question. Countries choose level IP protection . minimum level protection multilateral level Articles 22 23 TRIPS Agreement. general terms, GIs protected false statements source acts unfair competition (Article 22, TRIPS). higher level protection wines spirits, protected misuse imitation ( terms “kind”, “style”, “imitation” “” information written label accurate). Countries choose -layer level protection mandated TRIPS Agreement. , great interest protecting biodiversity-derived products products TK content, provision higher level protection products wines spirits evaluated, great majority products wines spirits. Countries TRIPS Agreement provide exclusive rights authorised users (.., possibility exclude commercial sign). option default modality protection chosen collective certification trademarks. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 145 Countries clarify incorporation GI exceptions limitations light Article 24 TRIPS Agreement 284 . exceptions include : prior 10 years; prior trademark registry; genericness; wine variety names; personal names; lack national protection. exceptions, European Union Switzerland prohibition register GIs enter conflict plant varieties animal breeds names generate confusion true origin product.285 Typical cases confusion provision plant variety animal breed indications originate territory covered GI request. case animal breed registered GI generate confusion true origin product Portuguese PDO Carnalentejana meat286. cases, granting protection plant variety protect product misappropriation, case “Basmati” rice agricultural products.287 important limitation GI protection international level ensure domestic GI protection seeking protection . country protect foreign GIs protected country origin. Regulations include incentives facilitating promoting GI registration including waiving fees associations small artisanal producers, financial support preparation business plans support documentation making GI request, tax exemptions limited period time order absorb initial cost setting GI governance system quality control systems. . Administrative Capacity important trained personnel equipment IP office order examine GI requests. cases trademark registers place, administrative infrastructural costs introduce GI system . IP offices ministries agriculture industry play role facilitating “creation” GI, countries experience limited. authorities actively engage supporting request protection facilitate transfer practices technical standards. GI regulation place, national authorities ensure existence verification systems order avoid fraud origin products, volumes produced fulfilment technical standards. case technical standards include environmental 284 information scope, interpretation specific exceptions, UNCTAD-ICTSD (2005). 285 article 6 .2 EU Regulation 1151/2012 21 November 2012 article 4b) Swiss ordinance 910/12 28 1997 protection appellations origin protected geographical indications food products. 286 EU/China IPR2 Project (2011). & Manual EU Legislation Geographical Indications. 287 Government India Intellectual Property India (2010). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 146 considerations, involvement agriculture environmental authorities required certify soundness/impartiality private control/inspection bodies place undertake verification falls competencies. capacity verify implies availability laboratories quality control facilities. . Organisational Infrastructural Aspects creation producers’ organization delimitation geographical area challenging activities preparation request protection. producers biodiversity-derived products fully organized face difficulties filing application GI protection. cases, products “informal” nature registered sanitary authorities popular markets. Land issues problem, areas property rights indigenous peoples defined. Associations producers models “incorporation” including formation cooperatives professional corporations (created public private law depending country). countries, associations named “regulatory councils”. Important aspects creation association open transparent consultations, inclusiveness ensuring -financing association. cases, participation governmental technical authorities creation producers association generate trust avoid de facto capture association bigger producers. main functions entrusted producers association include: delineation geographical area; standardization; verification quality controls; certification labelling; maintenance list authorised producers statistical data; promotion GI, collective marketing tourism management. case biodiversity-derived products, preservation land ecosystems traditional methods part key functions, included technical standards. Recording review sustainable practices static function managed proactively order attain highest quality performance. -financing activities producers association challenge, small producers’ associations. models financing activities including members’ contributions linked levels sales production, setting label fee. label fee model case Tequila Mexico leading creation successful Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 147 regulatory council 288 , achieved USD 725 million export sales 2007 289 . Tequila regulatory council successful attracting financing related services activities tourism. 2010, Tequila regulatory council obtained USD 3 million support Inter- American Development Bank development Tequila touristic route. 290 shows GI producers’ associations local development engines assist economic diversification. . Technical standards Setting technical standards ( called “technical specifications”) core aspect “GI” business model. Technical standards harmonize production processes ensure emergence qualities product. application technical standards jointly verification labelling schemes assist reducing information asymmetries producers consumers. give confidence consumers maintenance preservation quality traditional methods production. Technical standards tend include elements 291 : Description product: main physical, chemical, microbiological organoleptic characteristics product, focusing features easily monitored. Inputs raw materials: inputs raw materials avoided production process. aspect relevant case biodiversity-derived products. Definition process: method obtaining GI product phases production process (agricultural production, transport, processing, conditioning, seasoning/maturing final packaging), including, needed, explicit prohibition production methods. List specific quality linked geographical origin: Focus objective elements justifying link specific quality resources geographical area (natural human). Environmental social considerations: include sustainable , environmental/social management TK practices. Depending case & activities surrounding genetic resource, observe CBD Nagoya Protocol provisions, incorporated national ABS regulations ( ). Producers set technical standards voluntary manner, standards comprise regulatory act state. , “mandatory” producers association order enjoy GI protection GI signs labels. Today, proliferation international trade forms “voluntary standards” (.., fair trade, organic farming, good agricultural practice, .) producers provide consumers 288 http://www.crt.org.mx/ 289 Data Ministry Economy Mexico (2008). 290 “Empresas Jalicenses diversifican servicios hacia el sector turístico”. La Jornada, 31 2010. 291 Partially adapted FAO (2009-2010). List main contents code practice. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 148 information qualities products produced. 292 context, GI model raising interest developing countries implementation TRIPS Agreement advanced developing countries. provide credibility, technical standards objective, measurable, verifiable public. approved collectively association producers form -regulation. standards seek respect tradition authenticity, static. Standards setting innovation adaptation achieve specific diverse qualities, introduce efficient/healthy production processes respond evolving local . Traditional techniques coexist affect main qualities product. form -regulation, standards reviewed adapted evolving conditions including environmental conditions consumer choice. , standards GI reflect qualities variety products. , production spirits, GIs Caribbean rums, age level maturation generates products qualitative terms consumed manner. White rums cocktail preparation (.., daiquiris) aged rums consumed similar manner Brandy/Jerez enjoyed cigars (.. Habanos, GI Cuba). seeking GIs promoting sustainable biodiversity protect TK, role technical standards essential. Technical standards embody intangible aspects production process apply phases chain harvesting labelling. Environmental social considerations TK practices perfectly incorporated design GI standards. Table 3 illustrates phases GI chain type sustainable TK practices incorporated GI standard. 292 Ngo Bagal andVittori, (2011) .10. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 149 Table 3 Flow Chart Phases GI Chain Relevant Sustainable TK Practices Source: Vivas Seuba (2012) based simple GI chain model recognising biological cultural inputs proposed Larson (2007). , transfer environmental TK practice considerations automatic cost. Introducing environmental social considerations TK practices (.., hand labour) standards implementation binding participants raise production costs. Depending GI question consumer response, level incorporation considerations practices standards higher. GI associations introduced functions producer association standards . , selection relevant environmental social considerations depend quality specificity final product consumer acceptance. higher impact quality consumer acceptance, incentives incorporation final standards. . Quality controls verification systems Setting quality controls verification systems essential GI requirements overlooked setting GI scheme. mentioned , provide base ensuring minimum levels homogeneity maintaining reputational . Quality controls specific GIs apply products. particularity quality controls GI scheme ensure qualities sought safeguarded entire production process. Quality controls include hygiene, safety, traceability environmental considerations. case Miel Corse PDO (honey Corsica), quality controls specific locality date collection, samples analysed compliance health, Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 150 quality sensorial standards, marketing. 293 Verification systems seek ensure technical standards property applied production process. Verification systems provide information total partial outputs difficulties faced production process. modalities verification systems. common include: 294 -verification: consists guarantees producers based auto controls ( individual producers) internal controls (association producers). Participatory guarantee system: based active participation stakeholders, internal external GI chain ( consumers) built foundation trust, social networks knowledge exchange. system attractive GIs association producers hold TK knowledge practices. -party certification system: involves independent external body (private, public joint public-private) direct interest economic relationship supplier buyer assurance relevant requirements . , standards certified products recognized worldwide (independent party certification – ISO/IEC 65 European standard PDOs PGIs EN 45011). system producer certify aspects product (.. organic fair trade standards). . Labeling marketing GI labelling producers differentiate market communicate differences consumers global, national regional markets. regard, labels main means transmit consumers product specificities including origin production methods reduce information asymmetries. Labels include variety information including mandatory regulatory information ( ingredients), relevant information contained technical standards. Labels aesthetical marketing functions making differentiation easier consumers. Signs labels covey messages territory resources, work, knowledge practices people livelihoods linked product. Differentiation demonstrated packaging (.., bottle forms). Governments design specific labels certify product conformity registered GI public authorities . case EU specific labels accompany producers association GI registered protected EU regulations ( Figure 1). Figure 293 Larson (2007) . 32. 294 Partially adapted FAO (2009-2010) . 74. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 151 Collective marketing financing mechanisms producers’ associations operational optimise benefits ensure wider consumer acceptance. Collective marketing producers’ association economies scale wider label outreach. Finally, unified labelling collective marketing helps undertaking joint legal defense GI signs/names country markets. involves continuous effort producers’ associations order maintain GI GI positioned. , successful collective marking branding strategy (including GI organic brands) Café de Colombia. Federació Nacional de Caféteros Colombia, organisation representing million producers, estimates started differentiation strategy additional revenues obtained surpass USD 3.3 billion. 295 Key Points Developing checklist issues maximizing potential GIs dynamic evolving process. -size-fits- solution, checklist board local knowledge national context. GI business model integrate social environmental criteria. criteria include conservation practices, sustainable management, inclusiveness, benefit sharing, fulfillment applicable social environmental regulations. clear, transparent enforceable GI / distinctive signs regulation place order ensure protection sign/ identifies origin-based product. mentioned , modalities GI protection producers including sui generis models, certification marks collective marks. Administrative capacity relevant authorities key order register, protect, verify GIs. creation organizational structure essential aspect success GI business model. creation structures require technical assistance, guidance support initial phase organization, relation farming communities developing countries. Measures promote competition avoid capture bigger producers place order avoid abuses. 295 Ngo Bagal Vittori, (2011) . 17. EU label Protected Geographical Indication EU label Protected Denomination Origin Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 152 design technical standards fundamental ensure quality features final product. Technical standards embody biodiversity conservation sustainable considerations chain. Quality controls verification systems ensure technical standards fulfilled. provide credibility GI scheme generate confidence consumer side. models verification systems considered producers light capacities. Labeling fundamental aspect product differentiation, consumer recognition public acceptance. developed producers convey qualities product, origin links biodiversity TK. Governments introduce institutional certification schemes guarantee public conformity facilitate protection nationally internationally. IV. Conclusion GIs related distinctive signs potential offensive defensive tools provider countries ILCs. signs add underlying product, signifying potential buyer standards met production (organic, traditional, fair trade, .). Buyers pay premium, moves underlying good chain. marks , , protect underlying product se, goodwill . order preserve potential added, communities manage distinctive sign/GI, delineating geographical boundaries product, carefully ensuring collectivities follow prescribed methodology production maintain added sign. easy constraints faced ILCs communities poorer developing countries. remain option, existing framework IP, provide measure protection traditional methods production realms agriculture. defensive side, GIs case attempting misappropriate goodwill provider community marks, case Ethiopian Sidamo coffee. marks developed consideration CBD objectives environmentally sustainable access, benefit sharing genetic resources TK. practices built GI management practices ensure compatibility preservation sustainable practices, , including international certification schemes. moving chain niche markets, hoped underlying products protected economically mass consumption. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 153 Chapter 7 Private Contract Law . Introduction Ultimately, genetic resources traditional knowledge (TK) transferred & purposes provider users private contracts legally binding documents parties. contracts number forms, including bioprospecting agreements, material transfer agreements (MTAs) collaborative research agreements. 296 contracts considered benefit sharing agreements Nagoya Protocol terms sharing benefits arise access removal genetic resource utilization. keepers genetic resources provider countries, national ABS authority indigenous group, negotiate terms contracts carefully order safeguard interests. trends ABS agreements show “natural product discovery largely smaller discovery companies, semi-governmental governmental entities universities world. Elements large pharmaceutical natural products programs spun - profits semi-governmental entities, compound libraries sold cheaply.” 297 International Federation Pharmaceutical Manufacturers Association ( IFPMA) estimates 19 pharmaceutical multinationals previously natural products programs, 7 programs, Japanese. 298 Laird Wynberg point greater genetic resources TK cosmetic industries, ABS principles understood industries botanicals food/beverages. 299 Negotiating contracts knowledge law takes time practice. , developing country negotiators face informational disadvantages entering contract negotiations. major factor limiting ability parties freely agree terms conditions MTA, focus chapter, contracts respect applicable provisions respective IP ABS laws, relevant legislation. reason bulk handbook spent discussing policies regulations. good negotiation overcome inherent handicaps negotiations, knowledge policies, laws foresight enable negotiators fairer MTAs respect international national ABS rules, ensure outcomes adequately preserve support provider interests. chapter written, chapters, provider country perspective, designed deepen understanding issues provider country negotiator bear mind negotiating contracts. chapter concise guide key points developing country providers bear mind negotiating MTA, focusing provisions relationship IP-related ABS issues. IP represents issue 296 salient differences contracts discussed section II Chapter. 297 Laird Wynberg (2012), . 7. 298 Presentation . Andrew Jenner, Director Innovation, Intellectual Property Trade UNCTAD’ Ad Hoc Expert Group Meeting Development Dimensions Intellectual Property: Biological Diversity Access Benefit Sharing, 16 April 2013. file authors. 299 Laird Wynberg (2012), . 7. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 154 potentially cuts number terms conditions contained MTA. references PIC MAT requirements discussed context. Key Points variety contracts ABS procedures including bioprospecting agreements, material transfer agreements (MTAs), joint research agreements, . benefit sharing agreements extent terms potential actual benefit provider. Genetic resources transferred provider user private contracts called Material Transfer Agreement (MTAs). Providers developing countries disadvantage negotiating contracts, negotiate MTAs safeguard interests. II. MTAs Private Contracts digression terminology focus discussion chapter. , MTA distinguished general license. MTA contract underlies physical transfer genetic resource provider user. terms conditions , , plant botanical garden user country monkey specimen primate research center. MTA actual virus sample provider user, case WHO SMTAs Annex II. MTA embody conditions attached physical transfer, including user genetic resource obtained, including, : & user undertake genetic resource; extent replication, alteration breeding genetic resource permitted; benefits shared commercialization fruits & biological resource transferred; limitations party transfer, ; prohibition permission commercialize transferred resource TK, including results &. contract happen event party fails honor terms contract. contrast, license , contract law, broadly speaking legal agreement embodies permission. 300 , driver’ license grants permission drive, fishing license grants licensee permission fish geographical area. licenses basically grant 300 Black’ Law Dictionary, ed. 1999. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 155 privileges government licensee. context IP, license refers permission utilize intangible property owned licensor. 301 contracts set terms conditions license, including licensee utilize intangible property, jurisdiction, long, (.., royalties). Patents, trademarks -, addition forms IP, licensed, , depending terms license, -licensed. Underlying notion MTA license types contracts owner subject matter change. Licensors remain owners intangible property license; CBD clear States sovereign rights biological resources. underlying contracts simply set terms conditions bind underlying subject matter. confusion created term “deed”, describe model MTAs Australia, MTA license contract considered sales contract, calls change ownership owner freely dispose subject matter title passed. regard, MTAs understood variation loan contract, physical object ( genetic resource) leased change ownership. distinguishing feature MTA, compared IP license subject matter involves physical transfer (.., genetic resource). cases, MTA permit & genetic resources transferred. fruits & genetic resource MTA , , give rise intangible property forms subject matter license agreement ( , patents, plant breeders’ rights trade secrets). regard, Organization Economic -operation Development ( OECD) promulgated 2006 guidelines licensing genetic inventions, advice , inter alia, developing countries negotiate licenses. 302 Sample MTA contracts websites Secretariat CBD (http://www.cbd.int/abs/resources/contracts.shtml), model agreements Argentina, Australia Switzerland; WHO’ SMTAs Pandemic Influenza Preparedness Framework (http://whqlibdoc..int/publications/2011/9789241503082_eng.pdf); ITPGRFA SMTA (http://pgrc3.agr.gc.ca/itpgrfa/smta_e.html). regard, NGO Biodiversity International developed guide ITPGRFA SMTA, online. 303 SMTAs transfers genetic resources ITPGRFA context WHO network sharing pandemic virus samples, . WHO ITPGRFA SMTAs included Annexes II III handbook, . final note provisions contained typical MTA form part larger agreements intended joint & activity, permission granted locate biological material area extract research. provisions contained - called ‘bioprospecting’ agreements , definition utilized Association Southeast Asian Nations ( ASEAN), user permitted access territory provider order search wild species genes produce crops medicines, exploration biodiversity commercially valuable genetic biological resources. 304 bioprospecting agreement essence permit remove defined set biological 301 Ibid. 302 http://www.oecd.org/dataoecd/39/38/36198812.pdf. 303 http://www.bioversityinternational.org/training/training_materials/international_treaty/treaty_module.html. 304 draft text ASEAN Framework Agreement Access Biological Genetic Resources (2000). http://www.cbd.int/abs/resources/contracts.shtml http://whqlibdoc..int/publications/2011/9789241503082_eng.pdf http://pgrc3.agr.gc.ca/itpgrfa/smta_e.html http://www.oecd.org/dataoecd/39/38/36198812.pdf http://www.bioversityinternational.org/training/training_materials/international_treaty/treaty_module.html Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 156 resources defined area jurisdiction permit giver. evidence PIC, purposes chapter, terms conditions contracts extracting transferring resource cover subjects delineated chapter. Key Points MTAs envisage transfer ownership physical transfer genetic resource. regard, closer similar licenses loan agreements, sales contracts. Typical provisions contained MTAs joint research agreements bioprospecting agreements, user permitted access territory provider order search wild species genes produce crops medicines, exploration biodiversity commercially valuable genetic biological resources. III. Substantive Provisions MTAs IP Implications . Parties Agreement noted , MTA concluded provider user. contracts, authorized representative empowered enter obligations bind respective provider user institution. Negotiators ensure person negotiating signing contract authority . easy determine user question, research institution, zoo, botanical garden . hand, provider institution difficult determine. genetic resources linked practices local indigenous group, absence national ABS/TK legislation, clear group national government authority enter contract. Nagoya Protocol establishes cases ownership giving rise rights (giving PIC negotiating MAT): , genetic resources State; , genetic resources ILCs; , TK indigenous local communities, national legislation needed ensure rights operationalized enforced. question ability , , provider government institution authorize transfer resource territory ILC lives, user assurance State requisite authority execute MTA. user government institution authorization negotiate behalf ( , power attorney), underlying law grants government institution authority. Ascertaining provider record important IP perspective benefit sharing includes joint ownership IP payment proportion royalties event fruits & genetic resource transferred rise patent IP rights, party benefit accrue sufficiently established MTA. Depending national legislation stipulates, government ABS authority negotiate execute contract, ensure payment representative indigenous group event MTA covers subject matter originates land held group. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 157 Key Points parties MTA firmly established. provider record important IP perspective benefit sharing include joint ownership IP payment proportion royalties event fruits & genetic resource transferred give rise patent IP rights. genetic resources linked practices ILC, absence national ABS/TK legislation, clear group national government authority enter contract. . Description Treatment Subject Matter typical MTA, underlying genetic resource transferred manner identifiable. , resource transferred contained annex specifications. key difference MTA bioprospecting agreement , find access, specification resource transferred difficult. cases, , , geographic area subject bioprospecting, idea party granted access bioprospecting , bioprospector allowed specimens . description genetic resource, contained annex agreement. general issues, conditions genetic resources transferred IP implication. typical restriction subject matter transferred MTA grants user ability conduct & genetic resource question. , clauses restriction limit & - commercial research. model MTA Argentina minimum clauses common MTAs “[]hether temporarily permanently, material Recipient Institution exclusively -commercial research.” Similarly, Swiss model MTA assumes transfer -commercial purposes, purpose , contract negotiated (Article 7). model MTAs, relevant clauses Australian model MTAs, affirm ability user commercialize obtaining IP rights fruits &. ability apply patents plant variety protection restricted MTAs. noted Chapter 4, increasingly difficult distinguish commercial - commercial research. risk courts deem research commercial nature eventual goal commercialization. time, MTA potentially evidence dispute research conducted considered -commercial nature. 305 , existing research exception patent law wide encompassed scientific research, question research commercial -commercial moot. 305 Chapter 3 notes existence research exception patent plant variety law eliminate permission conduct research MTA. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 158 Key Points genetic resource transferred sufficiently contract. bioprospecting agreements, area , kinds resources , bioprospector allowed specimens identified . Research undertaken genetic resource subject matter MTA limited -commercial research contract, broad research exception permit . . Party Transfer onward transfer underlying genetic resource concern provider MTA binds provider user parties contract. means party genetic resource physically transferred user assume / bound provisions related IP, including covenants seek IP protection benefit sharing obligations involve IP restricted user. main point provider countries mind absent clause MTA prevents user transferring physical genetic resource party, users deem interests. legal matter, , users transfer rights genetic resource extent rights / granted provider. due fact MTA contract envisages change ownership genetic resource; recipient freely dispose resource. safe, provider countries generally include text MTA restricts user providing genetic material party absent consent provider. model MTA Argentina states, , “[] sample component genetic heritage, temporarily permanently, released party Recipient Institution prior execution material transfer agreement original provider Institution Recipient Institution. part -product lent transferred researcher institution prior written authorization, require procedure” (minimum clauses common MTAs). Swiss model MTA Article 8 “[]ransfer Genetic Resources purposes academic research collections, training, teaching education, -commercial activities allowed condition User ensures subsequent person institutions ( Party) informed provisions Agreement undertakes pass Genetic Resources obligations recipient”, including, PIC MAT requirements. WHO system sharing pathogens obliges User ensure onward transfer viruses parties based SMTA1 entities WHO network (Article 5.1.4). consent provider onward transfer granted entities part WHO network SMTA2 (Article 4.3), authorization onward transfer agreement concluded. ITPGRFA SMTA obligates recipient ensure onward transfers “ terms conditions Standard Material Transfer Agreement, material transfer agreement” (Article 6.5()). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 159 contractual clause specifies rights obligations parties event genetic resource TK transferred helps assure legal certainty parties concerned. Key Points legal matter, user transfer extent rights / granted MTA. perspective provider, subsequent transfer subject conditions initial transfer subject , include PIC MAT. , provider opening door potential misappropriation. . Intellectual Property Rights MTAs differ IP rights, patents plant breeders’ rights, related subject matter material treated. spectrum, MTA prohibit user obtaining IP rights material, case WHO’ SMTA 1 (Article 6.1). include prohibition user seeking patent protection gene sequences parts pathogens covered SMTA. public health interest securing greatest access pathogen vaccine sought explain restrictive language SMTA. noted, , language prevent patenting vaccine derived pathogenic material, contractual text limits IPRs material . event, provider countries prevent outright possibility obtain IPRs subject matter, assumed material transferred user position conduct & genetic resource provider, find develop commercialize material transferred. blanket prohibition seeking IPRs user products processes utilize material effectively contract precluding provider secure benefits. MTAs leave open possibility user commercialize IPRs products/processes material, derived therefrom. regard, commercialization necessarily application IPRs, cosmetic nutraceutical products brought market IPR protection. question benefit sharing, numerous variations. Argentina’ model CBD MTAs generally stipulate, , Government Argentina exclusively retains IPRs related material derivatives. user find term acceptable, , effectively prevent IPR recoup costs related underlying &. Australian model MTAs CBD, grants user IPRs arising & activity material (Article 5.2.). Swiss model agreement, commercialization sought fruits &, PIC MAT negotiated (Article 14 Option 15.3), user opportunity file application IPR agreed amount time, provider exercises publish research, placing public domain (Option 15.4). Annex Nagoya Protocol contemplates possibility joint ownership relevant IPRs (Annex 1()). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 160 issue ownership, means IPR benefits shared. proportion royalties sales commercialization product (including IPRs) share benefits. model adopted SMTA ITPGRFA, states Article 6.7 “[] case Recipient commercializes Product plant genetic resource food agriculture incorporates Material referred Article 3 Agreement, Product restriction research breeding, Recipient pay fixed percentage Sales commercialized Product mechanism established Governing Body purpose, accordance Appendix 2 Agreement.” Annex Nagoya Protocol stipulates possibility royalty payments respect relevant IPRs (Annex 1()) means benefit sharing. Key Points MTAs prohibit application user IP rights. time, , provider foreclosing possibility benefiting commercially. variety means share benefits IP rights obtained fruits & utilizing genetic resource question. include joint ownership IP rights, percentage sales commercialized product, priority access product developed, . . Benefit Sharing Benefit sharing defined Nagoya Protocol directed provider. noted , IPRs means benefit sharing, direct link obligation Nagoya Protocol requires IPRs serve purpose benefit sharing. , cash flows related IPRs royalties joint ownership IPRs means benefit sharing Nagoya Protocol. fact, Protocol lists number means share benefits product commercialized resources accessed CBD. Annex Protocol divides, -mutually exhaustive lists, benefits monetary -monetary categories. Examples , joint ownership license fees, milestone payments, special fees paid trust funds supporting conservation sustainable biodiversity, research funding access fees. Examples include sharing & results, collaboration, cooperation contribution scientific & ( biotechnology party providing genetic resources), access databases, education training, food livelihood security benefits, forms technology transfer. monetary -monetary sharing benefits subject separate agreement, equally built underlying MTA. , WHO’ SMTA2 requires recipient pathogen donate 10% real time pandemic vaccine production WHO, affordable prices WHO, / donate affordable price unspecified number treatment courses needed antiviral medicine pandemic WHO. SMTA2 leaves open possibility granting - license WHO (Article 4). ITPGRFA SMTA requires payment fixed percentage sale commercialized product trust fund supports & projects plant varieties designed benefit developing countries (Article 6.7). Australian model Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 161 MTA schedule lists benefits, including schedule threshold payments (Schedule 3). model MTAs Argentina designed joint research collaboration agreement (Model 2). perspective provider resource, general negotiation principles mind. restrictive conditions attached access, limited benefits user provide. Argentinian model MTAs, , stipulate IP rights arising & related material derivatives belong Government Argentina. Users argue provider received fair deal event commercialization, reluctant benefits. exception resource transferred commercialized. Monetary benefits , case, illusory. case, author argues developing country providers placing emphasis opportunities technology transfer. 306 high risk nature bioprospecting success rate finding developing genetic resource commercialized 307 , users spread risk joint collaborative &. wide range benefits assessed negotiating MTA, view reaching satisfactory conclusion acceptable provider user. -IP benefits strategically considered IP-related benefits. Key Points Annex Nagoya Protocol divides, -exhaustive lists, benefits monetary -monetary. Examples , joint ownership license fees, milestone payments, special fees paid trust funds supporting conservation sustainable biodiversity, research funding access fees. Examples include sharing & results, collaborative research, training strengthening capacities technology transfer, . perspective provider resource, general negotiation principles mind. restrictive conditions attached access, limited benefits user provide. exception rule resource transferred commercialized, profits generated development. wide range benefits assessed negotiating MTA, view reaching satisfactory conclusion acceptable provider user. hard foresee potential candidate resource, -IP benefits strategically considered IP-related benefits. . Jurisdiction Dispute Settlement Jurisdiction refers set laws govern interpretation contractual terms applied event dispute. respects contract law common 306 Morioka (2009), Chapter 6. 307 Japanese pharmaceutical firm Eisai ., .’ venture commercialize products biological resources Indonesia Indonesia case study UNCTAD (2011a). venture discontinued due inability commercialize products samples bioprospecting. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 162 elements country country, laws differ substantively, judges country interpret contractual terms. scope handbook discuss differences, . context negotiating contract borders, parties assess designation jurisdiction controlling law advantageous interests. Generally, context MTA, choice controlling law provider country user country. question event dispute important location arbiter dispute impact provider’ ability access justice system. arbiter domestic courts, developed countries tend argue developing country courts unreliable unfamiliar IP issues. provider agrees designation foreign court law resolve disputes settled amicably, provider forced defend great expense foreign distant court law, subject civil procedure rules disadvantageous ( rule requires filings submitted language foreign provider). contracts call arbitration event dispute. Arbitration basically private, professional court. Recourse arbitration binding (mandatory) -binding. idea choice arbitration dispute resolution forum generally private quicker court law. mentioned , argument parties developed countries courts developing countries necessarily capacity adjudicate technical cases. Arbitration venues located world. choice arbitration forum determine choice applicable procedural rules. acknowledged courts developing countries sufficient expertise address case IP, PIC / MAT. Article 18() Nagoya Protocol recognizes obliges Party effective measures access justice. 308 hold true developing countries, , case--case consideration required. perspective developing country provider, distance issue potentially addressed choosing arbitration forum close home applying provider country laws law governing underlying MTA. , check ensure arbitration favor party require panel arbiters, nominated user, provider mutual agreement. choices , , address question strategic advantage relevant dispute proceedings subject public scrutiny. Key Points context MTA, choice controlling law generally provider country user country. Indigenous groups rights holders poorer countries difficulty litigate preserve rights foreign jurisdiction. time, users point limitations jurisdictions hearing cases related IP, PIC MAT. 308 proposal put Nagoya Protocol negotiations creation informal dispute resolution mechanism calling ‘ombudsman’, proposal adopted final text. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 163 Arbitration option parties tailor solution respect venue. Part issue litigate distant jurisdictions addressed choosing arbitration forum closer home. Recourse private arbitration case public scrutiny, extent litigation courts public process documents . . Term/Duration Agreement duration agreement establishes length time parties bound contract. Samples genetic material transferred MTA transferred temporarily (loaned) permanently. genetic material transferred temporarily, contract stipulate long material loaned user, determine duration contract. case animal loaned zoo, . Genetic material transferred permanently, case cell samples. cases, sense original sample period time, sample user intends cultivate cell perform & . term contract , , shorter perpetuity permanent transfer implies. cases, providers ensure commitments entered respect material transferred survive duration contract (.., Argentina’ model MTA . 3, paragraph 9). include covenants seek IPRs benefit sharing arises IPRs, . jurisdictions, courts interpret restrictions survive contract reasonable. cases, contract provide resource destroyed MTA terminated default cancellation permit, model Australian MTA (Article 13.4.1.). practical resources virus samples, practical ethical case endangered species. term contract renewed. cases, renewal stipulate PIC MAT continue met. Key Points Resources transferred MTA temporarily permanently. term MTA contract shorter perpetuity permanent transfer implies. cases, providers ensure commitments entered respect material transferred survive duration contract. contract provide resource destroyed contract term. practical resources virus samples, practical ethical case animal plant species. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 164 . Termination Termination refers agreement. good deal thought trigger termination agreement, consequences . Generally, contracts terminated voluntarily mandatorily occurrence event. case voluntary termination, parties agree period time give written notice termination, months. Generally, legal requirement time required give notice termination equal parties private contract, general standard reasonability. Contracts terminated involuntarily. cases contract terminated involuntarily , , spelt MTA, contract deemed courts continue remain force. case providers aware potential insolvency. Insolvency refers situation person ceased pay debts meet contractual obligations ordinary business pay debts fall due, bankrupt national insolvency law country user. 309 Biotechnology firms engaged high risk activity, face potential risk insolvency. user firm defaults insolvent, trustee assign user assets parties provider intended. include genetic resource transferred, reproductions genetic resource, products variants derived genetic resource IPRs user sought obtained . clear case insolvency, stipulate MTA actual genetic resource transferred returned provider. provide clear instruction trustee bankruptcy disposition genetic resource question. spectrum, IPR intangible asset defaulting user. trustee liberty dispose settlement debts, IPR unintended user. defense perspective provider request establishing MTA inexpensive ( cost-free) irrevocable license IPRs obtained user transferred genetic resources, part benefit sharing package. option agree outset IPRs fruits & jointly owned provider user, disposal thereof require agreement parties. difficult question concerns reproductions genetic resource, variants products derived genetic resource represent & progress, stage embodied registered IPR. strictly defensive position, obligate user destroy event termination, case Australian model MTA ( section ). prevent work progress falling unintended hands, disadvantage fruits & potentially lost. contract terminated material breach agreement cured. constitutes material breach defined parties. , , MTA stipulates recipient seek obtain IPRs genetic materials , user sought obtained patent protection material deemed material violation contract. order act treated material violation, parties expressly stipulate MTA. contract stipulate material breach , 309 definition borrows definition contained Uniform Commercial Code United States. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 165 court decide question deviation contractual obligations constitutes breach, breach warrants termination damages. words, guarantee , absence clear written indication, covenant refrain seeking IPRs genetic materials considered breach. Key Points Contracts terminated voluntarily mandatorily occurrence event. cases contract terminated involuntarily , , spelt MTA, contract deemed courts continue remain force. user firm defaults insolvent, trustee assign user assets parties provider intended. include genetic resource transferred, reproductions genetic resource, products variants derived genetic resource IPRs user sought obtained . termination clause give trustee guidance cases. guarantee , absence clear written indication MTA, covenant refrain seeking IPRs genetic materials considered breach. . Confidential Information Firms seek access genetic resources related traditional knowledge purpose eventual commercialization product developed resource seek maintain competitive advantage potential rivals . firms bring & related - bear resource development, generate data experiments seek secret rivals. reason, MTAs include schedule annex information parties contract oblige confidential (, , model Australian MTA). legal point view, prevents designation information confidential private contract, treat entire MTA contract confidential parties agree . TRIPS Agreement, Article 39, ensures WTO Members protect undisclosed information data submitted governments agencies. Nagoya Protocol places limits treated confidential private contract, subject, , limitation national regulatory authorities require submission underlying contract order obtain national ( international) certificate compliance. regulatory authorities concerned obliged case maintain confidentiality information designated underlying contract. Articles 14 17()(iii) Protocol stipulate information submitted ABS Clearing House “ prejudice protection confidential information”. Article 17(4) internationally recognized certificate compliance minimum information confidential: () issuing authority; () date issuance; Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 166 () provider; () unique identifier certificate; () person entity prior informed consent granted; () subject matter genetic resources covered certificate; () confirmation mutually agreed terms established; () confirmation prior informed consent obtained; () commercial / -commercial regard, hoped groups checkpoints monitor implementation ABS rules misappropriation, practice certificate system’ actual limited certifying , view national competent authority, PIC MAT complied . public policy perspective, providers resist demands treat entire MTA contract confidential insist items contained Article 17(4) Protocol remain -confidential order facilitate monitoring. 310 National legislation access environmental information, exists , support position circumstances. Key Points Nagoya Protocol places limits treated confidential private contract. public policy perspective, providers resist demands treat entire MTA contract confidential insist items contained Article 17(4) Protocol remain -confidential. IV. Conclusion IP ABS regulatory functions, ultimately systems rely heavily private law actual implementation. Key terms ABS agreements important means secure rights provider situation access considered. negotiating contracts aware meaning provisions order ensure contract unwillingly permit lead misappropriation unintended consequences. knowledge law important, negotiating skills provider. 310 noted Article 21(6) Cartagena Protocol significantly limits range confidentiality, similar text adopted final text Nagoya Protocol. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 167 References Abbott, (2010). 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Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 173 Annex : Regional national TK ABS-related Legislation Legislation Thailand - 1999 Act protection promotion traditional Thai medicinal intelligence, .. 2542 Portugal - 2002 Decree-Law . 118/2002 South Africa - 2004 National Environmental Management: Biodiversity Act (: NEMB Act) South Africa - 2008 Regulations Bio-Prospecting, Access Benefit-Sharing (: Regulations BPABS) Guyana - 2006 Act provide recognition protection collective rights Amerindian Villages Communities, granting land Amerindian Villages Communities promotion good governance Amerindian Villages Communities Objectives Article 1. Object (1) Decree establishes legal regime registration, conservation, legal safeguarding transfer autochthonous plant material current potential interest agrarian, agroforest landscape activity, including local varieties spontaneously occurring material referred Article 2, knowledge, [...] NEMB Act Chapter 1 Interpretation, Objectives Application Act Objectives Act 2. objectives Act - () framework National Environmental Management Act, provide - () management conservation biological diversity Republic components biological diversity; (ii) indigenous biological resources sustainable manner; (iii) fair equitable sharing stakeholders benefits arising bioprospecting involving indigenous biological resources; NEMB Act CHAPTER 6 Bioprospecting, access benefit-sharing Purpose application Chapter 80. (1) purpose Chapter - () regulate bioprospecting involving indigenous biological resources; () regulate export Republic indigenous biological resources purpose bioprospecting kind research; () provide fair equitable sharing Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 174 stakeholders benefits arising bioprospecting involving indigenous biological resources. Subject Definition "traditional Thai medicinal Intelligence" means basic knowledge capability concerned traditional Thai medicine; "traditional Thai medicine" means medicinal procedures concerned examination. diagnosis, therapy. treatment prevention , promotion rehabilitation health humans animals, obstetrics, traditional Thai massage, includes production traditional Thai drugs invention medical devices, basis knowledge text passed generation generation; Article 2. Scope (1) Decree-Law applies local varieties spontaneously occurring autochthonous material plant species current potential interest agricultural, agroforest landscape activity, genotypical composition, exception varieties protected intellectual property rights grant protection pending. Article 3. TK (1) TK comprises intangible elements commercial industrial utilization local varieties autochthonous material developed -systematic manner local populations, collectively individually, form part cultural spiritual traditions populations. includes, limited , knowledge methods, processes, products designations applications agriculture, food industrial activities general, including traditional crafts, commerce services, informally preservation local varieties spontaneously occurring autochthonous material covered Decree. NEMB Act Chapter 1 Interpretation, Objectives Application Act 1.(1) Act, context - ‘‘stakeholder’’ means - () person, organ state community contemplated section 82(1)(); () indigenous community contemplated section 82(1)(); Regulations BPABS Interpretations purpose regulations Definitions 1. Regulations, word expression meaning assigned Act meaning assigned , context -. "indigenous community" means community people living rights interests distinct geographical area Republic South Africa leadership structure - () traditional indigenous biological resources application permit relates, initiated contribute form part proposed bioprospecting; () knowledge discoveries indigenous biological resources application permit relates proposed bioprospecting; "traditional knowledge" refers customary utilisation knowledge indigenous biological resources indigenous community, accordance written unwritten rules, usages, customs practices traditionally observed, accepted recognised "Amerindian" means citizen Guyana - () belongs native aboriginal peoples Guyana; () descendant person mentioned paragraph (); Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 175 , includes discoveries relevant indigenous biological resources community. Holder Rights Section 17. Minister power notify formulas traditional Thai drugs text traditional Thai medicine benefit, special medical public health national formula traditional Thai drug, national text traditional Thai medicine, case . Section 20. Personal formula traditional Thai drugs personal text traditional Thai medicine section 16(3) registered protection intellectual property rights promoted provisions Act applying registration registrar. Article 9. Applicant Registration (1) application registration plant material covered provisions Article 4(1) filed entity, public private, individual corporate, fulfils conditions: () required paragraph (2) , represents interests geographical area local variety widely spontaneously occurring autochthonous material displays greatest genetic variability; () complies provisions Article 10(3). (2) satisfy conditions mentioned (1)() , applicant recognized competent municipal chamber means document affirming entity’ fitness protect interests referred paragraph (1). Regulations BPABS Interpretations purpose regulations Definitions 1. Regulations, word expression meaning assigned Act meaning assigned , context -. "indigenous community" means community people living rights interests distinct geographical area Republic South Africa leadership structure Village Councils. 10. (1) Village Council established administer Village (2) Village Council body corporate. (3) discharging function Village Council act collectively. Functions Village Councils. 13. (1) functions Village Council - [...] () hold benefit Village rights, titles interests Village lands; [...] () ensure places artefacts located Village lands hold sacred cultural values Village protected cared ; () protect preserve Village' intellectual property TK; [...] Scope Rights Section 34. holder sole ownership production drug sole research, distribution, improvement development formulas traditional Thai drugs intellectual property rights traditional Thai medicine registered text traditional Thai medicine. Article 10. Rights Obligations Owner Registration (1) entity owning registration receive part benefits resulting Articles 7(1) (2). (2) performance acts Article 7(1) case registered plant material authorized owner registration heard. (3) owner registration responsible maintenance situ registered plant material [...] NEMB Act Chapter 1 Interpretation, Objectives Application Act 1.(1) Act, context — ‘‘bioprospecting’’, relation indigenous biological resources, means research , development application , indigenous biological resources commercial industrial exploitation, includes - () systematic search, collection gathering resources making extractions resources purposes research, development application; () utilisation purposes research development information Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 176 traditional indigenous biological resources indigenous communities; () research , application, development modification , traditional , commercial industrial exploitation; NEMB Act CHAPTER 6 Bioprospecting, access benefit-sharing Purpose application Chapter 80. (2) Chapter - ‘‘indigenous biological resources’’ - () excludes - () genetic material human origin; (ii) exotic animals, plants organisms, exotic animals, plants organisms referred paragraph ()(iii); (iii) indigenous biological resources listed terms International Treaty Plant Genetic Resources Food Agriculture. Regulations BPABS Definitions 1. Regulations, word expression meaning assigned Act meaning assigned , context -. " kind research" means research bioprospecting - () includes systematic collection, study investigation indigenous biological resources, conducted auspices bona fide research institute organisation generate scientific knowledge; () excludes incidental surveys searches; Acknowled gement Rights Section 15. Institute Traditional Thai Medicine responsible compiling information traditional Thai medical intelligence concerned formulas traditional Thai drugs text traditional Thai medicine country, registration. Article 4. Registration Plant Material (1) Plant material falls scope Decree, defined Articles 2(1) (2), registered RRGV, DGPC’ National Center Registration Protected Varieties. Regulations BPABS Conditions subject issuing authorities issue permits 8. (1) Minister issue bioprospecting permit integrated export bioprospecting permit, Minister satisfied - () relevant stakeholders identified accordance principles set Grants land. 60. (1) Amerindian Community apply writing Minister grant State lands - () existence twenty- years; () time application immediately preceding years, Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 177 section 82 Act; comprised fifty persons. Publicly TK Section 18. Minister power notify formulas traditional Thai drugs text traditional Thai medicine widely intellectual property protection expired section 33, general formula traditional Thai drugs general text traditional Thai medicine, case . Article 3. TK (4) registration TK requested industrial activities publicly population local community originated afford owners : () object direct indirect reproduction, imitation / unauthorized parties commercial purposes; (ii) assign, transfer license rights TK, including transfer succession; (iii) exclude protection TK covered specific industrial property registrations. ABS Elements Section 19. wishes national traditional Thai drugs registration permission production drugs Drug Law wishes research improvement development drug formulas commercial benefit, research national text traditional Thai Drugs development improvement commercial benefit, application obtain benefits pay fees remuneration making thereof licensing authority. Section 46. person research export controlled herbs sell transform commercial purposes, licence obtained licensing authority. Article 7. Access Allocation Benefits (1) Access germ plasm plant material referred Articles 2(1) (2) purposes study, research, improvement biotechnological applications subject prior authorization CoTeRGAPA, owner registration heard. (4) Access defined paragraphs (1) (2) requires fair allocation benefits resulting , prior agreement owner registration. Act Regulations numerous ABS provisions reproduced place Entry access; 5. (1) person [...] wishes enter Village lands apply obtain permission Village Council. (3) person [...] wishes conduct scientific, anthropological archaeological research research study relates biological diversity, environment natural resources knowledge thereof Village lands apply obtain advance - () permission Village Council; () permits required written law; () permission Minister. Report; scientific research. 6. (1) person wishes material derived research study section - () apply obtain permission Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 178 Village Council, Minister, Minister responsibility culture, Environmental Protection Agency [...]; () good faith negotiate enter benefit sharing agreement Village Council. Positive IPR Elements Section 14. intellectual property rights traditional Thai medicine protected Act intellectual property formula traditional Thai drugs text traditional Thai medicine. Section 16. types traditional Thai medicinal intellectual property rights : (1) national formula traditional Thai drugs national text traditional Thai Medicine; (2) general formula traditional Thai drugs general traditional Thai medicine document; Thai medicine document; (3) personal formula traditional Thai drugs personal text traditional Thai medicine. Powers Village Council rules. 14. (1) Subject provisions Act, Village Council , exercise functions, rules governing - [...] () certification products residents traditional methods; Defensive IPR Elements Section 22. Registration protection intellectual property rights traditional Thai medicine prohibited registrar opinion : (1) drug formula belongs national formula traditional Thai drugs, national text traditional Thai medicine, general formula traditional Thai drug, general text traditional Thai medicine, (2) drug formula personal formula traditional Thai drug developed -medical basis extracts plants, animals Article 3. TK (2) knowledge protected reproduction commercial industrial long conditions protection met: () TK identified, registered Register Plant Genetic Resources (RRGV); () description referred phrased parties reproduce utilize TK obtain results identical obtained owner Powers Village Council rules. 14. (1) Subject provisions Act, Village Council , exercise functions, rules governing - [...] () access research recording publication intellectual property TK belongs Village; Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 179 microorganisms obtained natural extracts transformation considered rough transformation. knowledge. Issues Andean Community 2002 Decision 391 Common Regime Access Genetic Resources Pacific Islands Forum - 2008 Traditional Biological Knowledge, Innovations Practices Act African Regional Intellectual Property Organization - 2010 Swakopmund Protocol Protection TK Expressions Folklore Objectives / Purpose Article 2.- purpose Decision regulate access genetic resources Member Countries -products, order : ) Establish conditions equitable participation benefits access; ) Lay foundations recognition valuation genetic resources -products intangible components, native, Afro-American local communities involved; protect rights owners traditional biological knowledge, innovations, practices Section 1 Purpose Protocol 1.1. purpose Protocol : () protect TK holders infringement rights recognized Protocol; () protect expressions folklore misappropriation, misuse unlawful exploitation traditional context. Subject Definition BIOLOGICAL RESOURCES: individuals, organisms parts , populations biotic component real potential genetic resource -products. INTANGIBLE COMPONENT: -, innovation individual collective practice, real potential , genetic resource, -products biological resource , protected intellectual property regimes. NATIVE, AFRO-AMERICAN OR LOCAL COMMUNITY: human group social, cultural economic conditions distinguish sectors national community, governed totally partially customs traditions special legislation , irrespective legal status, conserves social, economic, cultural political institutions part . 4 Definitions traditional biological knowledge means knowledge embodied tangible form , belonging social group [ means: family, clan, tribe, village similar social organisation] gained lived close contact nature, : () living , spiritual significance, constituent parts, life cycles, behaviour functions, effects interactions living , including humans, physical environment; () physical environment; () obtaining utilising living -living purpose maintaining, facilitating improving human life. traditional biological innovation means product, belonging social group, resulted biological material usefulness enhanced application traditional biological knowledge. Section 2 Definitions “TK” refer knowledge originating local traditional community result intellectual activity insight traditional context, including -, skills, innovations, practices learning, knowledge embodied traditional lifestyle community, contained codified knowledge systems passed generation . term limited specific technical field, include agricultural, environmental medical knowledge, knowledge genetic resources. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 180 traditional biological practice means process, method , belonging social group gained lived close contact nature. Holder Rights Article 5.- Member Countries exercise sovereignty genetic resources -products determine conditions access , pursuant provisions Decision. Article 7.- Member Countries, keeping Decision complementary national legislation, recognize rights authority native, Afro-American local communities decide -, innovations traditional practices genetic resources - products. 6 Ownership (1) purposes Act, ownership social group [ family, clan, tribe, village similar social organisation] item knowledge innovation practice established history traditions customs usages social group. Section 6 Beneficiaries protection TK owners rights holders TK, local traditional communities, recognized individuals communities, create, preserve transmit knowledge traditional intergenerational context accordance provisions section 4. Scope Rights Article 3.- Decision applicable genetic resources Member Countries countries origin, -products, intangible components genetic resources migratory species natural reasons territories Member Countries. Section 4 Protection criteria TK Protection extended TK : () generated, preserved transmitted traditional intergenerational context; (ii) distinctively local traditional community; (iii) integral cultural identity local traditional community recognized holding knowledge form custodianship, guardianship collective cultural ownership responsibility. relationship established formally informally customary practices, laws protocols. Section 7 Rights conferred holders TK 7.1. Protocol confer owners rights referred section 6 exclusive authorize exploitation TK. 7.2. addition, owners prevent exploiting TK prior informed consent. 7.3. purposes Protocol, term “exploitation” reference TK refer acts: Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 181 () TK product: [...] () TK process: [...] Acknowledgement Rights 4 Definitions relation knowledge, innovations practices, includes : () trustee; () custodian; () steward; meaning context determined history traditions customs usages social group claims ownership knowledge, innovation practice. 10 Identity owner prior informed consent (3) social group claiming ownership identify [Competent National Authority] 30 days date application publicised satisfy [Competent National Authority] claim ownership. Section 4 Protection criteria TK Protection extended TK : (iii) integral cultural identity local traditional community recognized holding knowledge form custodianship, guardianship collective cultural ownership responsibility. relationship established formally informally customary practices, laws protocols. Publicly TK 6 Ownership (2) [Competent National Authority] assert ownership item knowledge innovation practice situations: () satisfied immediately verifiable owner knowledge innovation practice. [Competent National Authority] considered owner purposes Act knowledge innovation practice trustee behalf eventual owner. () satisfied, extensive efforts locate owner item knowledge innovation practice, owner . [Competent National Authority] considered owner purposes Act knowledge innovation practice trustee behalf [ enacting country]. covered Section 4 ABS Elements TITLE ON THE ACCESS PROCEDURE TITLE VI ON THE ANCILLARY CONTRACTS TO THE ACCESS CONTRACT 10 Identity owner prior informed consent (1) prospective user wanting item knowledge, innovation practice commercial purpose, activity assist achieving commercial purpose, Section 9 Equitable benefit-sharing 9.1. protection extended TK holders include fair equitable sharing benefits arising commercial industrial knowledge, determined mutual agreement Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 182 TITLE VII ON THE LIMITATIONS TO ACCESS cases apply [Competent National Authority] form prescribed [Competent National Authority]. 11 Access Benefit Sharing Agreement (1) owner prior informed consent proposed , agreement owner user, Access Benefit- Sharing Agreement, negotiated supervision [Competent National Authority] setting terms permitted regard matters, : parties. Section 15 Access TK genetic resources Authorization Protocol access protected TK genetic resources imply authorization access genetic resources derived TK. Positive IPR Elements 8 Economic rights (1) addition rights applicable intellectual property laws owner item knowledge, innovation practice exclusive authorise knowledge, innovation practice: () commercial purpose, () activity assist achieving commercial purpose. PART II: PROTECTION OF TK Defensive IPR Elements Complementary Provisions SECOND.- Member Countries acknowledge rights, including intellectual property rights, genetic resources, -products synthesized products intangible components obtained developed access activity comply provisions Decision. , Member Country affected request nullification bring actions countries conferred rights granted protective title documents. THIRD.- Competent National Offices Intellectual Property require applicant give registration number access contract supply copy prerequisite granting respective , reasonable indications products processes protection requested obtained 7 Database traditional biological knowledge, innovations practices (1) [Competent National Authority] establish maintain database knowledge, innovations practices enter information receives collects pertaining knowledge, innovations practices. (2) owner enter knowledge, innovations practices database. (3) owner access information, access limited owner. [Competent National Authority] access information purpose seeking identity owner pursuant section 10 Act. 3 Application (1) inconsistency intellectual property laws, Act, extent Section 5 Formalities relating protection TK 5.2. interests transparency, evidence preservation TK, relevant national competent authorities Contracting States ARIPO Office maintain registers records knowledge, subject relevant policies, laws procedures, aspirations TK holders concerned. Section 10 Recognition knowledge holders person TK traditional context acknowledge holders, source , , origin, knowledge manner respects cultural values holders. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 183 developed basis genetic resources -products originated Member Countries. Competent National Authority Competent National Offices Intellectual Property set systems exchanging information authorized access contracts intellectual property rights granted. inconsistency, prevail. Annex II: WHO’ Standard Material Transfer Agreements SMTA 1 Standard Material Transfer Agreement WHO GISRS (SMTA 1) furtherance Pandemic Influenza Preparedness Framework sharing influenza viruses access vaccines benefits ( “Framework”), Standard Material Transfer Agreement (“Agreement” “SMTA 1”) developed. Article 1. Parties Agreement 1.1 Parties SMTA 1 limited influenza laboratories designated recognized WHO accepted work agreed WHO terms reference. Agreement: Provider laboratory sending Materials, defined, ( address provider providing institution, designation laboratory (.. NIC/WHO CC/H5RL/ERL/ authorized laboratory), authorized official, contact information authorized official) (hereinafter referred “ Provider”) 311 Recipient laboratory receiving Materials, defined, ( address recipient recipient institution, designation laboratory (.. NIC/WHO CC/H5RL/ERL/ authorized laboratory), authorized official, contact information authorized official) (hereinafter referred “ Recipient”) 312 1.2 Provider Recipient collectively referred “Parties”. Article 2. Subject Matter Agreement PIP biological materials defined Section 4.1 Framework (hereinafter “Materials”) transferred Provider Recipient subject provisions Agreement. Article 3. General Provisions Provider recipient support strengthening laboratory surveillance capacity networks developing countries. Article 4. Rights Obligations Provider 4.1 Provider undertakes respect Materials: 4.1.1. comply respective WHO GISRS terms reference. 4.1.2. ensure Materials handled accordance applicable WHO guidelines national bio-safety standards. 313 4.2. Provider agrees onward transfer Materials, members WHO GISRS, terms conditions SMTA 1. 311 completed signature required pursuant Article 11 . 312 completed signature required pursuant Article 11 . 313 “WHO Guidance Regulations Transport Infectious Substances”. Document WHO/CDS/EPR/2007.2. Geneva, World Health Organization 2007 “WHO Guidelines collection human specimens laboratory diagnosis avian influenza infection”. http://www..int/csr/resources/publications/swineflu/storage_transport/en/index.html. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 185 4.3 Provider consents onward transfer Materials entities WHO GISRS condition prospective recipient concluded SMTA 2. 4.4. Provider inform WHO shipments Materials entities / WHO GISRS recording IVTM. Article 5. Rights Obligations Recipient 5.1 Recipient undertakes respect Materials: 5.1.1 comply respective WHO GISRS terms reference. 5.1.2. ensure Materials handled accordance applicable WHO guidelines national bio-safety standards. 5.1.3. inform WHO shipments Materials entities / WHO GISRS recording IVTM 5.1.4 event transfers WHO GISRS, accordance SMTA 1. 5.2. Recipient actively seek participation scientists fullest extent originating laboratories authorized laboratories, developing countries, scientific projects research clinical specimens / influenza virus countries actively engage preparation manuscripts presentation publication. 5.3. Recipient appropriately acknowledge presentations publications, contributions collaborators, including laboratories/countries providing clinical specimens influenza virus pandemic potential reagents, existing scientific guidelines. Article 6. Intellectual Property Rights 6.1 Provider Recipient seek obtain intellectual property rights (IPRs) Materials. 6.2 Provider Recipient acknowledge IPRs Materials obtained date adoption Framework World Health Assembly affected SMTA 1. 6.3 Provider SMTA 1 technology protected IPRs generation / modification Materials. recipient Materials acknowledges IPRs respected. Article 7. Dispute resolution 7.1. event dispute SMTA 1, Parties concerned seek instance settle dispute negotiation amicable means choice. Failure reach agreement absolve parties dispute responsibility continuing seek resolve . 7.2. event dispute settled means paragraph 1 Article, Parties concerned refer dispute Director-General, seek advice Advisory Group view settling . Director-General recommendations Parties resolution report World Health Assembly matters. 7.3. Parties acknowledge role Director-General Framework, 7.3.4. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 186 Article 8. Warranty Provider warranties safety Materials, accuracy correctness data . , provider warranties quality, viability, purity (genetic mechanical) Materials furnished. Provider Recipient assume full responsibility complying respective national biosecurity biosafety regulations rules import, export release biological materials. Article 9. Duration Agreement contractual agreement remain force December 31, 2021 automatically renewed December 31, 2031 World Health Assembly decides . Article 10. Acceptance Applicability 10.1.1 Recipients Providers WHO GISRS time adoption Framework World Health Assembly: Acceptance laboratories WHO terms reference, contained Framework, constitutes acceptance SMTA 1. 10.1.2 Recipients Providers join WHO GISRS adoption Framework World Health Assembly: Acceptance designation recognition WHO WHO GISRS laboratory constitute acceptance SMTA 1. 10.2. Applicability: SMTA 1 cease applicable suspension revocation designation recognition WHO formal withdrawal laboratory participation WHO GISRS mutual agreement WHO laboratory. suspension, revocation withdrawal relieve laboratory pre-existing obligations SMTA 1. Article 11. Signature Article 10 entitled “Acceptance & Applicability”, party requires Agreement executed signature printed document, evidence acceptance required. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 187 SMTA 2 Standard Material Transfer Agreement WHO GISRS (SMTA 2) Article 1. Parties Agreement WHO Recipient. 314 Article 2. Subject matter Agreement PIP biological materials defined Section 4.1 Framework (hereinafter “Materials”) transferred Recipient subject provisions Agreement. Article 2. bis Definitions () Section 4 Pandemic Influenza Preparedness Framework sharing influenza viruses access vaccines benefits. () terms agreed parties. Article 3. Obligations Provider agreed parties. Article 4. Obligations Recipient 4.1 recipient agrees comply commitments selected , accordance terms set Annex agreement. 4.1.1 recipient comply commitments selected timetable determined WHO consultation Advisory Group established PIP Framework coordination recipient, based optimal pandemic preparedness response considerations. . manufacturers vaccines / antivirals, recipient commit options: A1. Donate 10% 315 real time pandemic vaccine production WHO A2. Reserve 10% 316 real time pandemic vaccine production affordable prices WHO A3. Donate treatment courses needed antiviral medicine pandemic WHO A4. Reserve treatment courses needed antiviral medicine pandemic affordable prices A5. Grant manufacturers developing countries licenses mutually agreed terms fair reasonable including respect 314 Recipients entities receive “PIP Biological Materials” WHO GISRS, influenza vaccine, diagnostic pharmaceutical manufacturers, biotechnology firms, research institutions academic institutions. recipient select options based nature capacities. 315 Recognizing flexibility important negotiating manufacturers, range 5-20%. 316 Recognizing flexibility important negotiating manufacturers, range 5–20%. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 188 affordable royalties, account development levels country products, technology, -, products processes holds IPR production () influenza vaccines, (ii) adjuvants, (iii) antivirals / (iv) diagnostics. A6. Grant royalty free licenses manufacturers developing countries grant WHO royalty-free, -exclusive licenses IPR, sublicensed, production pandemic influenza vaccines, adjuvants, antivirals products diagnostics needed pandemic. WHO sublicense licenses manufacturers developing countries terms conditions accordance sound public health principles. Option 5 6 selected, Recipient regularly provide WHO information granted licenses status implementation licensing agreement. WHO provide information Advisory Group. . Manufacturers products relevant pandemic influenza preparedness response, manufacturing vaccines antivirals, commit options: A5, A6, B1, B2, B3, B4. B1. Donate WHO 317 diagnostic kits needed pandemics B2. Reserve WHO 318 diagnostic kits needed pandemics, affordable prices B3. Support, coordination WHO, strengthening influenza specific laboratory surveillance capacity developing countries B4. Support, coordination WHO, transfer technology, - / processes pandemic influenza preparedness response developing countries . recipient , addition commitments selected , contributing measures listed , : • Donations vaccines • Donations pre-pandemic vaccines 1 2 • Donations antivirals • Donations medical devices • Donations diagnostic kits • Affordable pricing • Transfer technology processes • Granting sublicenses WHO • Laboratory surveillance capacity building. 4.2 Recipient ensure PIP biological materials handled accordance applicable WHO guidelines national bio-safety standards. 4.3 applicable, Recipient appropriately acknowledge presentations publications, contributions WHO laboratories providing materials identified Article 2, existing scientific guidelines. 317 Recognizing flexibility important negotiating manufacturers. 318 Recognizing flexibility important negotiating manufacturers. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 189 4.4 recipient transfer PIP biological materials prospective recipient concluded SMTA World Health Organization. transfer reported World Health Organization. Director-General , exceptional circumstances, PIP biological materials transferred prospective recipient requesting aforementioned recipient enter SMTA, report “Advisory Group” . 4.5 recipient exchange PIP biological materials holder SMTA concluded World Health Organization. Article 5. Dispute Resolution dispute resolved negotiations -binding means parties' choice, disputes subject binding arbitration conditions mutually agreed parties. Article 6. Liability Indemnity agreed parties. Article 7. Privileges immunity relating clauses imply obligation WHO submit national legislation jurisdiction, deemed waiver privileges immunities WHO conformity Convention Privileges Immunities Specialized Agencies approved General Assembly United Nations November 21, 1947 national international law, convention agreement. Article 8. Emblem agreed parties. Article 9. Warranties agreed parties Article 10. Duration Agreement agreed parties. Article 11. Termination agreed parties. Article 12. Force Majeure agreed parties. Article 13. Governing law agreed parties. Article 14. Signature Acceptance WITNESS Whereof, Agreement duly executed parties. SIGNED behalf WHO Signature Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 190 Title SIGNED behalf Recipient Signature Title ********************* Annex agreed parties. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 191 Annex III: Standard Material Transfer Agreement ITPGRFA STANDARD MATERIAL TRANSFER AGREEMENT UNDER THE INTERNATIONAL TREATY ON PLANT GENETIC RESOURCES FOR FOOD AND AGRICULTURE PREAMBLE WHEREAS International Treaty Plant Genetic Resources Food Agriculture (hereinafter referred “ Treaty”) 319 adopted - session FAO Conference 3 November 2001 entered force 29 June 2004; objectives Treaty conservation sustainable Plant Genetic Resources Food Agriculture fair equitable sharing benefits arising , harmony Convention Biological Diversity, sustainable agriculture food security; Contracting Parties Treaty, exercise sovereign rights Plant Genetic Resources Food Agriculture, established Multilateral System facilitate access Plant Genetic Resources Food Agriculture share, fair equitable , benefits arising utilization resources, complementary mutually reinforcing basis; Articles 4, 11, 12.4 12.5 Treaty borne mind; diversity legal systems Contracting Parties respect national procedural rules governing access courts arbitration, obligations arising international regional conventions applicable procedural rules, recognized; Article 12.4 Treaty facilitated access Multilateral System pursuant Standard Material Transfer Agreement, Governing Body Treaty, Resolution 1/2006 16 June 2006, adopted Standard Material Transfer Agreement. 319 Note Treaty Secretariat: suggested Legal Working Group Contact Group Drafting Standard Material Transfer Agreement, defined terms , clarity, put bold . Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 192 ARTICLE 1 — PARTIES TO THE AGREEMENT 1.1 present Material Transfer Agreement (hereinafter referred “ Agreement”) Standard Material Transfer Agreement referred Article 12.4 Treaty. 1.2 Agreement : BETWEEN: ( address provider providing institution, authorized official, contact information authorized official 320 ) (hereinafter referred “ Provider”), AND: ( address recipient recipient institution, authorized official, contact information authorized official 321 ) (hereinafter referred “ Recipient”). 1.3 parties Agreement agree : ARTICLE 2 — DEFINITIONS Agreement expressions set meaning: “ restriction”: Product considered restriction research breeding research breeding legal contractual obligations, technological restrictions, preclude manner Treaty. “Genetic material” means material plant origin, including reproductive vegetative propagating material, functional units heredity. “Governing Body” means Governing Body Treaty. “Multilateral System” means Multilateral System established Article 10.2 Treaty. “Plant Genetic Resources Food Agriculture” means genetic material plant origin actual potential food agriculture. “Plant Genetic Resources Food Agriculture Development” means material derived Material, distinct , ready commercialization developer intends develop transfer person entity development. period development Plant Genetic Resources Food Agriculture Development deemed ceased resources commercialized Product. 320 Insert . applicable shrink-wrap click-wrap Standard Material Transfer Agreements. “shrink-wrap” Standard Material Transfer Agreement copy Standard Material Transfer Agreement included packaging Material, Recipient’ acceptance Material constitutes acceptance terms conditions Standard Material Transfer Agreement. “click-wrap” Standard Material Transfer Agreement agreement concluded internet Recipient accepts terms conditions Standard Material Transfer Agreement clicking icon website electronic version Standard Material Transfer Agreement, . 321 Ibid. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 193 “Product” means Plant Genetic Resources Food Agriculture incorporate 322 Material genetic parts components ready commercialization, excluding commodities products food, feed processing. “Sales” means gross income resulting commercialization Product Products, Recipient, affiliates, contractors, licensees lessees. “ commercialize” means sell Product Products monetary consideration open market, “commercialization” meaning. Commercialization include form transfer Plant Genetic Resources Food Agriculture Development. ARTICLE 3 — SUBJECT MATTER OF THE MATERIAL TRANSFER AGREEMENT Plant Genetic Resources Food Agriculture Annex 1 Agreement (hereinafter referred “Material”) related information referred Article 5b Annex 1 transferred Provider Recipient subject terms conditions set Agreement. ARTICLE 4 — GENERAL PROVISIONS 4.1 Agreement entered framework Multilateral System implemented interpreted accordance objectives provisions Treaty. 4.2 parties recognize subject applicable legal measures procedures, adopted Contracting Parties Treaty, conformity Treaty, conformity Articles 4, 12.2 12.5 Treaty. 3233 4.3 parties Agreement agree ( entity designated Governing Body), 324 acting behalf Governing Body Treaty Multilateral System, party beneficiary Agreement. 4.4 party beneficiary request information required Articles 5e, 6.5c, 8.3 Annex, 2 paragraph 3, Agreement. 4.5 rights granted ( entity designated Governing Body) prevent Provider Recipient exercising rights Agreement. ARTICLE 5 — RIGHTS AND OBLIGATIONS OF THE PROVIDER Provider undertakes Material transferred accordance provisions Treaty: 322 evidenced, , pedigree notation gene insertion. 323 case International Agricultural Research Centres Consultative Group International Agricultural Research (CGIAR) international institutions, Agreement Governing Body CGIAR Centres relevant institutions applicable. 324 Note Treaty Secretariat: Resolution 2/2006, Governing Body “invite[] Food Agriculture Organization United Nations, Party Beneficiary, carry roles responsibilities identified prescribed Standard Material Transfer Agreement, direction Governing Body, accordance procedures established Governing Body session”. acceptance FAO invitation, term, “ entity designated Governing Body”, replaced document term, “ Food Agriculture Organization United Nations”. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 194 ) Access accorded expeditiously, track individual accessions free charge, , fee charged, exceed minimal cost involved; ) passport data , subject applicable law, -confidential descriptive information, Plant Genetic Resources Food Agriculture ; ) Access Plant Genetic Resources Food Agriculture Development, including material developed farmers, discretion developer, period development; ) Access Plant Genetic Resources Food Agriculture protected intellectual property rights consistent relevant international agreements, relevant national laws; ) Provider periodically inform Governing Body Material Transfer Agreements entered , schedule established Governing Body. information Governing Body party beneficiary. 325 ARTICLE 6 — RIGHTS AND OBLIGATIONS OF THE RECIPIENT 6.1 Recipient undertakes Material conserved purposes research, breeding training food agriculture. purposes include chemical, pharmaceutical / -food/feed industrial . 6.2 Recipient claim intellectual property rights limit facilitated access Material Agreement, genetic parts components, form received Multilateral System. 6.3 case Recipient conserves Material supplied, Recipient Material, related information referred Article 5b, Multilateral System Standard Material Transfer Agreement. 6.4 case Recipient transfers Material supplied Agreement person entity (hereinafter referred “ subsequent recipient”), Recipient ) terms conditions Standard Material Transfer Agreement, material transfer agreement; ) notify Governing Body, accordance Article 5e. compliance , Recipient obligations actions subsequent recipient. 6.5 case Recipient transfers Plant Genetic Resource Food Agriculture Development person entity, Recipient : ) terms conditions Standard Material Transfer Agreement, material transfer agreement, Article 5a Standard Material Transfer Agreement apply; 325 Note Secretraiat: Standard Material Transfer Agreement provision information Governing Body, Articles: 5e, 6.4b, 6.5c 6.11h, Annex 2, paragraph 3, Annex 3, paragraph 4, Annex 4. informationshould submitted : Secretary International Treaty Plant Genetic Resources Food Agriculture Food Agriculture Organization United Nations -00100 Rome, Italy Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 195 ) identify, Annex 1 material transfer agreement, Material received Multilateral System, Plant Genetic Resources Food Agriculture Development transferred derived Material; ) notify Governing Body, accordance Article 5e; ) obligations actions subsequent recipient. 6.6 Entering material transfer agreement paragraph 6.5 prejudice parties attach additional conditions, relating product development, including, , payment monetary consideration. 6.7 case Recipient commercializes Product Plant Genetic Resource Food Agriculture incorporates Material referred Article 3 Agreement, Product restriction research breeding, Recipient pay fixed percentage Sales commercialized Product mechanism established Governing Body purpose, accordance Annex 2 Agreement. 6.8 case Recipient commercializes Product Plant Genetic Resource Food Agriculture incorporates Material referred Article 3 Agreement Product restriction research breeding, Recipient encouraged voluntary payments mechanism established Governing Body purpose accordance Annex 2 Agreement. 6.9 Recipient Multilateral System, information system Article 17 Treaty, -confidential information results research development carried Material, encouraged share Multilateral System -monetary benefits expressly identified Article 13.2 Treaty result research development. expiry abandonment protection period intellectual property Product incorporates Material, Recipient encouraged place sample Product collection part Multilateral System, research breeding. 6.10 Recipient obtains intellectual property rights Products developed Material components, obtained Multilateral System, assigns intellectual property rights party, transfer benefit-sharing obligations Agreement party. 6.11 Recipient opt Annex 4, alternative payments Article 6.7, system payments: ) Recipient payments discounted rate period validity option; ) period validity option ten years renewable accordance Annex 3 Agreement; ) payments based Sales Products sales products Plant Genetic Resources Food Agriculture belonging crop, set Annex 1 Treaty, Material referred Annex 1 Agreement belongs; ) payments independent Product restriction; ) rates payment terms conditions applicable option, including discounted rates set Annex 3 Agreement; ) Recipient relieved obligation payments Article 6.7 Agreement previous subsequent Standard Material Transfer Agreements entered respect crop; Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 196 ) period validity option Recipient payments Products incorporate Material received period Article force, Products restriction. payments calculated rate paragraph () ; ) Recipient notify Governing Body opted modality payment. notification alternative modality payment Article 6.7 apply. ARTICLE 7 — APPLICABLE LAW applicable law General Principles Law, including UNIDROIT Principles International Commercial Contracts 2004, objectives relevant provisions Treaty, , interpretation, decisions Governing Body. ARTICLE 8 — DISPUTE SETTLEMENT 8.1 Dispute settlement initiated Provider Recipient ( entity designated Governing Body), acting behalf Governing Body Treaty Multilateral System. 8.2 parties Agreement agree ( entity designated Governing Body), representing Governing Body Multilateral System, , party beneficiary, initiate dispute settlement procedures rights obligations Provider Recipient Agreement. 8.3 party beneficiary request information, including samples , Provider Recipient, obligations context Agreement. information samples requested Provider Recipient, case . 8.4 dispute arising Agreement resolved manner: ) Amicable dispute settlement: parties attempt good faith resolve dispute negotiation. ) Mediation: dispute resolved negotiation, parties choose mediation neutral party mediator, mutually agreed. ) Arbitration: dispute settled negotiation mediation, party submit dispute arbitration Arbitration Rules international body agreed parties dispute. Failing agreement, dispute finally settled Rules Arbitration International Chamber Commerce, arbitrators appointed accordance Rules. party dispute , chooses, appoint arbitrator list experts Governing Body establish purpose; parties, arbitrators appointed , agree appoint sole arbitrator, presiding arbitrator case , list experts. result arbitration binding. ARTICLE 9 — ADDITIONAL ITEMS Warranty 9.1 Provider warranties safety title Material, accuracy correctness passport data Material. warranties quality, viability, purity (genetic mechanical) Material Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 197 furnished. phytosanitary condition Material warranted attached phytosanitary certificate. Recipient assumes full responsibility complying recipient nation’ quarantine biosafety regulations rules import release genetic material. Duration Agreement 9.2 Agreement remain force long Treaty remains force. ARTICLE 10 — SIGNATURE/ACCEPTANCE Provider Recipient choose method acceptance party requires Agreement signed. Option 1 –Signature∗ , (Full Authorized Official), represent warrant authority execute Agreement behalf Provider acknowledge institution’ responsibility obligation abide provisions Agreement, letter principle, order promote conservation sustainable Plant Genetic Resources Food Agriculture. Signature................................................. Date................................................. Provider ………………… , (Full Authorized Official), represent warrant authority execute Agreement behalf Recipient acknowledge institution’ responsibility obligation abide provisions Agreement, letter principle, order promote conservation sustainable Plant Genetic Resources Food Agriculture. Signature................................................. Date................................................ Recipient………………… Option 2 – Shrink-wrap Standard Material Transfer Agreements* Material conditional acceptance terms Agreement. provision Material Provider Recipient’ acceptance Material constitutes acceptance terms Agreement. Option 3 – Click-wrap Standard Material Transfer Agreement 326 □ agree conditions. 326 Provider chooses signature, wording Option 1 Standard Material Transfer Agreement. Similarly Provider chooses shrink-wrap click-wrap, wording Option 2 Option 3, , Standard Material Transfer Agreement. “click-wrap” form chosen, Material accompanied written copy Standard Material Transfer Agreement. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 198 Annex 1 LIST OF MATERIALS PROVIDED Annex list Material Agreement, including information referred Article 5b. information obtained website: (URL). information included Material listed: passport data , subject applicable law, , , -confidential descriptive information. (List) Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 199 Annex 2 RATE AND MODALITIES OF PAYMENT UNDER ARTICLE 6.7 OF THIS AGREEMENT 1. Recipient, affiliates, contractors, licensees, lessees, commercializes Product Products, Recipient pay point- percent (1.1 %) Sales Product Products percent (30%); payment due Product Products : () restriction research breeding accordance Article 2 Agreement; () purchased obtained person entity payment Product Products exempt obligation payment pursuant subparagraph () ; () sold traded commodity. 2. Product Plant Genetic Resource Food Agriculture accessed Multilateral System material transfer agreements based Standard Material Transfer Agreement payment required paragraph 1 . 3. Recipient submit Governing Body, sixty (60) days calendar year December 31st, annual report setting : () Sales Product Products Recipient, affiliates, contractors, licensees lessees, twelve (12) month period December 31st; () amount payment due; () information identification restrictions rise benefit-sharing payment. 4. Payment due payable submission annual report. payments due Governing Body payable United States dollars (US$) 327 account established Governing Body accordance Article 19.3f Treaty 328 : FAO Trust Fund (USD) GINC/INT/031/MUL, IT-PGRFA (Benefit-sharing), HSBC York, 452 Ave., York, NY, USA, 10018, Swift/BIC: MRMDUS33, ABA/Bank Code: 021001088, Account . 000156426 327 Note Treaty Secretariat: Governing Body considered question currency payment. , Standard Material Transfer Agreements United States dollars (US$). 328 Note Treaty Secretariat: Trust Account Article 6.3 Financial Rules, approved Governing Body Session (Appendix IT/GB-1/06/Report). Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 200 Annex 3 TERMS AND CONDITIONS OF THE ALTERNATIVE PAYMENTS SCHEME UNDER ARTICLE 6.11 OF THIS AGREEMENT discounted rate payments Article 6.11 point percent (0.5 %) Sales Products sales products Plant Genetic Resources Food Agriculture belonging crop, set Annex 1 Treaty, Material referred Annex 1 Agreement belong. Payment accordance banking instructions set paragraph 4 Annex 2 Agreement. Recipient transfers Plant Genetic Resources Food Agriculture Development, transfer condition subsequent recipient pay mechanism established Governing Body Article 19.3f Treaty point percent (0.5 %) Sales Product derived Plant Genetic Resources Food Agriculture Development, Product restriction. months expiry period ten years counted date signature Agreement , , months expiry subsequent periods years, Recipient notify Governing Body decision opt application Article periods. case Recipient entered Standard Material Transfer Agreements, ten years period commence date signature Standard Material Transfer Agreement option Article . Recipient entered enters future Standard Material Transfer Agreements relation material belonging crop[], Recipient pay referred mechanism percentage sales determined accordance Article Article Standard Material Transfer Agreement. cumulative payments required. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 201 Annex 4 OPTION FOR CROP-BASED PAYMENTS UNDER THE ALTERNATIVE PAYMENTS SCHEME UNDER ARTICLE 6.11 OF THIS AGREEMENT (full Recipient Recipient’ authorised official) declare opt payment accordance Article 6.11 Agreement. Signature................................................. Date................................................ 8 8 accordance Article 6.11h Standard Material Transfer Agreement, option modality payment operative notification Recipient Governing Body. signed declaration opting modality payment Recipient Governing Body address, method acceptance Agreement (signature, shrink-wrap click-wrap) chosen parties Agreement, Recipient acceptance option accepting Agreement : Secretary, International Treaty Plant Genetic Resources Food Agriculture Food Agriculture Organization United Nations -00100 Rome, Italy signed declaration accompanied : • date Agreement entered ; • address Recipient Provider; • copy Annex 1 Agreement. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 202 Annex IV: Programme United Nations Conference Trade Development Ad Hoc Expert Group Meeting Development Dimensions Intellectual Property: Biological Diversity Access Benefit Sharing (ABS) Programme 16-17 April 2013 Room IX, Palais des Nations Geneva, Switzerland Day 1, Tuesday, 16 April 2013 10:00 Remarks Kiyoshi Adachi Chief, Intellectual Property Unit Division Investment Enterprise, UNCTAD 10:15 Making Investments & Genetic Resources – Role ABS 1) Convention Biological Diversity Nagoya Protocol Beatriz Gomez Associate Programme Officer, Social, Economic Legal Matters Secretariat Convention Biological Diversity, UNEP 2) Vaccine Research WHO Standard Material Transfer Agreements Steven Solomon Principal Legal Officer, WHO Anne Huvos Team Leader PIP Framework Secretariat, Pandemic Epidemic Diseases Department, WHO 11:15 Coffee Break 11:30 3) Perspectives Pharmaceutical, Health Products Cosmetics Industries Andrew Jenner Director, Innovation, Intellectual Property Trade International Federation Pharmaceutical Manufacturers’ Associations Maria Julia Oliva Senior Advisor ABS Union Ethical Biotrade Discussion 12:30 Lunch Break 14:30 Trends Genetic Resources &, IP ABS 1) Open Science Freedom Operate Padmashree Gehl Sampath Chief, Science Technology Section Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 203 Division Technology Logistics, UNCTAD 2) Patenting Fruits University Research Yumiko Hamano Senior Program Officer WIPO University Initiative Program, WIPO 15:30 Coffee Break 3) Misappropriation Prevention Johanna von Braun ( Skype) Natural Justice Discussion 17:00 Close Day 1 Day 2, Wednesday, 17 April 2013 Peer Review: Handbook interface Global ABS Rules IP 09:30 Presentation Handbook Kiyoshi Adachi Chief, Intellectual Property Unit Division Investment Enterprise, UNCTAD David Vivas-Eugui Vivas Consulting Hartmut Meyer Independent Consultant 10:15 Participants’ Tutors’ Perspective Kongchay Phimmakong Deputy Director, Biotechnology Ecology Institute Ministry Science Technology, Lao PDR Viviana Munoz-Tellez Programme Manager, Innovation Access Knowledge South Centre Christoph Spennemann Legal Expert Intellectual Property Unit, UNCTAD 10:45 Coffee Break 11:00 Peer Reviewers’ Comments Free Discussion 329 Suneetha Subramanian Research Fellow United Nations University Institute Advanced Studies Jayashree Watal 329 Written comments Ms. Katrin Antonow, Lawyer GIZ Consultant. Convention Biodiversity Nagoya Protocol: Intellectual Property Implications 204 Counsellor Intellectual Property Division World Trade Organization Maria Julia Oliva Senior Advisor ABS Union Ethical Biotrade Pedro Roffe Senior Associate Innovation, Technology Intellectual Property Programme International Centre Trade Sustainable Development Paul Oldham Research Fellow United Nations University Institute Advanced Studies Massimo Vittori Managing Director oriGIn Discussion 12:40 Concluding Remarks 12:45
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