Genetic resources and associated traditional knowledge in Vietnam's intellectual property system

EffEcTivE PracTical vErificaTion TransParEncy MEchanisM ThE UTilizaTion GEnETic rEsoUrcEs associaTEd TradiTional KnowlEdGE viET naM’ inTEllEcTUal ProPErTy sysTEM UNITED NATIONS CONFERENCE ON TRADE AND DEVELOPMENT UNCTAD/DITC/TED/INF/2020/4 © 2020, United Nations Conference Trade Development work open access complying Creative Commons licence created intergovernmental organizations, http://creativecommons.org/licenses//3.0/igo/. findings, interpretations conclusions expressed authors necessarily reflect views United Nations officials Member States. designation employed presentation material map work imply expression opinion whatsoever part United Nations legal status country, territory, city area authorities, delimitation frontiers boundaries. publication formally edited. iiiGENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE IN VIET NAM’ INTELLECTUAL PROPERTY SYSTEM Contents Acronyms abbreviations ................................................................................................................... iv Acknowledgements ................................................................................................................................ iv 1. INTRODUCTION ................................................................................................... 1 2. INTERNATIONAL RULES ON ACCESS AND BENEFIT SHARING AND DISCLOSURE OF ORIGIN .................................................................................... 2 3. VIET NAM’ LEGAL REGIME FOR ACCESS AND BENEFIT SHARING ........................... 4 4. VIET NAM’ INTELLECTUAL PROPERTY POLICIES AND ITS LIMITATIONS .................... 5 5. RECOMMENDATIONS .......................................................................................... 8 6. IMPLEMENTATION OF THE NEW RULES ............................................................... 10 7. CONCLUSION .................................................................................................... 11 8. ANNEX: LIST OF INTERVIEWEES, UNCTAD MISSION (30–31 MAY, 2019) ................ 13 References ........................................................................................................................................... 14 Notes .................................................................................................................................................... 14 Tables Table 1: Statistics patent applications genetic resource-related invention utility solution (IPC: C12N, A61K35, A61K36, A61K37, A61K38, A61K39, A01H, C07K, A01K) .................................................................................................................... 6 iv TOWARDS AN EFFECTIVE AND PRACTICAL VERIFICATION AND TRANSPARENCY MECHANISM ON THE UTILIZATION OF Acronyms abbreviations ABS Access benefit-sharing ATK traditional knowledge BCA Biodiversity Conservation Agency, Viet Nam CBD Convention Biological Diversity IGC Intergovernmental Committee Intellectual Property Genetic Resources, Traditional Knowledge Folklore ILCs Indigenous local communities IP Viet Nam National Office Intellectual Property Viet Nam ITPGRFA International Treaty Plant Genetic Resources Food Agriculture MAT Mutually agreed terms MARD Ministry Agriculture Rural Development, Viet Nam MOH Ministry Health, Viet Nam MONRE Ministry Natural Resources Environment, Viet Nam MOST Ministry Science Technology, Viet Nam PIC Prior informed consent PVP Plant variety protection TRIPS Agreement Agreement Trade-related Aspects Intellectual Property Rights UNCED United Nations Conference Environment Development UNCTAD United Nations Conference Trade Development UPOV International Convention Protection Varieties Plants WIPO World Intellectual Property Organization Acknowledgements study prepared Nguyen Thi Thanh Ha, Consultant BioTrade Initiative Trade, Environment, Climate Change Sustainable Development Branch UNCTAD. study greatly benefited peer reviews substantive inputs : Kiyoshi Adachi, Legal Officer, Intellectual Property Unit, Division Investment Enterprise (DIAE), David Vivas Eugui, Legal Officer Frederic Perron-Welch, Consultant, Trade, Environment, Climate Change Sustainable Development Branch (TED) UNCTAD. Desktop formatting Rafe Dent UNCTAD. UNCTAD gratefully acknowledges support Swiss State Secretariat Economic Affairs SECO development study Global BioTrade Programme: Linking trade, biodiversity sustainable development. information UNCTAD’ BioTrade Initiative consult website: http://www.unctad.org/biotrade contact : biotrade@unctad.org. 28 October 2020 1GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE IN VIET NAM’ INTELLECTUAL PROPERTY SYSTEM 1. INTRODUCTION study prepared response request technical assistance United Nations Conference Trade Development (UNCTAD) Viet Nam’ Biodiversity Conservation Agency (BCA) guidance proposals implement disclosure origin requirement genetic resources country’ intellectual property laws regulations. study based original research interviews conducted fact-finding mission Hanoi, Viet Nam 30–31 2019 UNCTAD’ local consultant, Ms. Nguyen Thi Thanh Ha, . Kiyoshi Adachi, Legal Officer UNCTAD’ Intellectual Property Unit, Division Investment Enterprise. list individuals interviewed fact-finding mission contained Annex study. UNCTAD grateful support BCA organization fact-finding interviews. study takes board comments BCA National Office Intellectual Property Viet Nam (IP Viet Nam), presented draft form Regional Coordination Workshop BioTrade Access Benefit Sharing Mekong Region 4–5 December 2019, Hanoi, Viet Nam. 2 TOWARDS AN EFFECTIVE AND PRACTICAL VERIFICATION AND TRANSPARENCY MECHANISM ON THE UTILIZATION OF 2. INTERNATIONAL RULES ON ACCESS AND BENEFIT SHARING AND DISCLOSURE OF ORIGIN Convention Biological Diversity (CBD) multilateral environmental treaty opened signature 1992 United Nations Conference Environment Development (UNCED) Rio de Janeiro, Brazil. Viet Nam ratified Convention Biological Diversity 1994 Party early 1995. unique feature treaty , addition objective conserving world’ biodiversity ecosystems, involve plethora animal, plant microbial species, provisions dedicated ensuring parties treaty biological resources sustainable manner, fair equitable sharing benefits arising utilization genetic resources. respect sharing benefits arising genetic resources, numerous clauses CBD attempt address issue misappropriation genetic resources ( ‘biopiracy’). defined term CBD, misappropriation occurs individual firm takes genetic resources country traditional knowledge (ATK), develops technology therefrom obtained permission / sharing benefits derived commercialization product. full extent misappropriation globally , number studies detailed examples misappropriation (, , Mgbeoji, 2006; Robinson, 2010), including intellectual property rights. clauses CBD established basic notions shape national practices considered accessing genetic resources (Article 15, CBD). Genetic resources fall sovereignty States (Article 3, CBD). authority determine conditions access rests national government. national legislation prescribes, lie indigenous local communities (ILCs). national governments require authorization access, genetic resources accessed prior informed consent (PIC) Party providing resources, benefits arising utilization genetic resources commercialization shared fair equitable provider mutually agreed terms (MAT). system commonly access benefit-sharing, ABS. CBD’ provisions ABS considered insufficiently binding, extensive negotiations Parties led 2010 adoption treaty auspices CBD – Nagoya Protocol Access Genetic Resources Fair Equitable Sharing Benefits arising Utilization (Nagoya Protocol). Nagoya Protocol aims establish greater legal certainty ABS, defining PIC MAT operationalized (Articles 5 6), rules relating ATK (Article 7), compliance monitoring (Articles 15, 16 17), international clearing house system – ABS Clearing-House Mechanism - support transparency compliance. , CBD Nagoya Protocol provide guidance countries development national ABS legislation, regulations policies. Nagoya Protocol effect Viet Nam globally 12 October 2014. 9 December 2019, 196 Parties CBD, 123 ratifications Nagoya Protocol (120 Parties 3 accessions entering force December 2019/ January 2020). time, clear stand- ABS laws policies sufficient address problem misappropriation genetic resources ATK (UNCTAD, 2014). noted , misappropriation occurring intellectual property systems exclusive rights granted developed commercial products accessed genetic resources ATK, absent authorization . Article 16(5) CBD recognizes influence patents intellectual property rights, covering varieties plants (PVP), promotion CBD objectives. , requires countries cooperate ensure intellectual property rights supportive , run counter , CBD objectives. , Article 17 Nagoya Protocol Parties measures, , monitor enhance transparency utilization genetic resources, including designating effective checkpoints collect receive, , relevant information utilization genetic resources , inter alia, stage research, development, innovation, pre- 3GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE IN VIET NAM’ INTELLECTUAL PROPERTY SYSTEM commercialization commercialization. misappropriation occurs intellectual property system, States obligation monitor utilization genetic resources jurisdictions, intellectual property offices designated checkpoints implementation Nagoya Protocol (Chiarolla, 2019). Asia region, Bhutan country designated intellectual property office checkpoint.1 Discussions place intergovernmental forums attempt harmonize international intellectual property system ABS system, generally centered desirability mandatory disclosure source/ origin requirement patent law. requirement oblige applicants intellectual property rights disclose source/origin genetic resources / ATK subject matter intellectual property . disclosure interested parties trace origins genetic resource / ATK establish domestic PIC MAT requirements met. Council Agreement Trade-related Aspects Intellectual Property Rights ( TRIPS Council), developing countries tabled proposal amend TRIPS Agreement require disclosure source/origin. Developing countries argued disclosure requirement Article 29 TRIPS Agreement incomplete disclosure source/origin genetic resources / ATK. order remedy , legal obligation establishing mandatory disclosure requirement patent applications contribute preventing misappropriation genetic resources grant erroneous patents, enhance transparency utilization genetic resources / ATK.2 TRIPS Council , , unable agree amendment TRIPS Agreement. Similar discussions negotiations leading Nagoya Protocol World Intellectual Property Organization (WIPO) Intergovernmental Committee Intellectual Property Genetic Resources, Traditional Knowledge Folklore (IGC) equally contentious led legally binding outcome. noted disclosure idea. , , part social contract underlying grant exclusive rights invention, utility model plant variety, technology disclosed experiment build sake innovation technological progress. respect patents, TRIPS, Article 29(1) stipulates : Members require applicant patent disclose invention manner sufficiently clear complete invention carried person skilled art require applicant mode carrying invention inventor filing date , priority claimed, priority date application. standoff making disclosure origin/source mandatory requirement international law generally user countries developed world argue requirement amount adding supplemental condition novelty, inventive step industrial application patentability current text Article 29(1) sufficient assessing patentability criteria; countries origin/source, Viet Nam number countries Southeast Asia substantial biodiversity, requirement codified international level. impasse international requirement disclosure origin resolved future. 4 TOWARDS AN EFFECTIVE AND PRACTICAL VERIFICATION AND TRANSPARENCY MECHANISM ON THE UTILIZATION OF 3. VIET NAM’ LEGAL REGIME FOR ACCESS AND BENEFIT SHARING result, number countries regional organizations (approximately 25 countries 2 regional organizations) waited international consensus disclosure origin introduce laws, regulations policies (Chiarolla, 2019), including Viet Nam. 2008 Law Biological Diversity sets basic requirements PIC access genetic resources benefit sharing related parties based MAT. light accession Nagoya Protocol 2014, Viet Nam promulgated Decree 2017 (59/2017/ ND-CP) setting detail ABS requirements 2008 Biodiversity Law. Notably, Articles 14.3 23.3 Decree provide obligation disclose source geographical origin applying intellectual property rights resulting utilization genetic resources. , relevant part: Article 14. Change intent; transfer genetic resources party; registration intellectual property rights innovative results based genetic resources. 3. Registration intellectual property rights creation resulting utilization genetic resources derivatives state source origin accessed genetic resources, comply Clause 2, Article 22 Decree. Article 23. Sharing -monetary benefits 3. source geographical origin accessed genetic resources stated announcing results scientific research applying intellectual property rights creation resulted genetic resources. articles requirement disclosure ATK, limited genetic resources. , apply forms intellectual property rights resulting utilization genetic resources derivatives, meaning scope obligation patent law. 5GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE IN VIET NAM’ INTELLECTUAL PROPERTY SYSTEM 4. VIET NAM’ INTELLECTUAL PROPERTY POLICIES AND ITS LIMITATIONS Article 14 Decree adopted, Viet Nam requirement disclosure origin genetic resources ATK. Disclosure origin patents governed Viet Nam Article 102(2) Law Intellectual Property 29 November 2005 paragraph 23.11 Circular 01/2007/TT-BKHCN, promulgated Ministry Science Technology (MOST) 14 February 2007. text stipulates mandatory disclosure required applications protection inventions, states : 2. description invention satisfy conditions: ). Fully disclosing nature invention extent invention realized person average knowledge art; ). Briefly explaining accompanied drawings, required clarify nature invention; ). Clarifying novelty, inventive step susceptibility industrial application invention. text mandatory disclosure spelled , reads: 23.11. Additional provisions applicable applications registration inventions genetic resource traditional knowledge general requirements invention registration applications Points 23.1 23.7 Circular, application registration invention genetic resource traditional knowledge documents explaining origin genetic resource / traditional knowledge accessed inventor applicant, invention based genetic resource / traditional knowledge. inventor applicant identify origin genetic resource / traditional knowledge, / declare bear responsibility truthfulness / declaration. decision introduce disclosure origin requirement Circular 01/2007/TT-BKHCN Decree 59/2017/ND-CP – increasing numbers patent utility model applications based type genetic resource, fields health products. data IP Viet Nam, applications exceeded 200 2009, applications originating foreign jurisdictions (Table 1, ). addition, Asian countries, traditional medicine practiced widely Viet Nam, plants animals practice candidates development range health/pharmaceutical products. Circular 01/2007/TT-BKHCN interacts disclosure requirement intellectual property law clear. level, interpreted guide constitute full clear disclosure invention patent application, interpretation consistent text Circular (paragraph 7.2). , practice, interviews staff National Office Intellectual Property 2019, explained , date, invoked paragraph 23.11 Circular require supplemental information. instance request disclosure, explained prospective applicant declare / unaware origin genetic resource traditional knowledge. application accepted formality check level, move substantive patent examination. Compounding problem intellectual property law provide grounds invalidating patents disclosure origin genetic resources ATK . conditions invalidation intellectual property titles set Article 96 intellectual property law, : Article 96. Invalidation Protection Titles 1. Protection Title invalidated cases: ). applicant registration registration assigned ( regard inventions, industrial designs, layout-designs marks); ). subject matter industrial property failed satisfy protection conditions grant date Protection Title. 6 TOWARDS AN EFFECTIVE AND PRACTICAL VERIFICATION AND TRANSPARENCY MECHANISM ON THE UTILIZATION OF Table 1. Statistics patent applications genetic resource-related invention utility solution (IPC: C12N, A61K35, A61K36, A61K37, A61K38, A61K39, A01H, C07K, A01K) Year Genetic resource-related invention Genetic resource-related utility solution Genetic resource-related invention utility solution Invention utility solution   Total Viet Nam Total Viet Nam Total Viet Nam Total  1995 20   0   20 0 748 1996 38   2   40 0 1,092 1997 66   6   64 0 1,333 1998 40   2   42 0 1,139 1999 51   0   51 0 1,202 2000 88 2 3 2 91 4 1,340 2001 83 2 2 2 85 4 1,368 2002 83 3 4 4 87 7 1,314 2003 75 4 5 5 80 9 1,342 2004 115 8 0 0 115 8 1,601 2005 135 5 17 17 152 22 2,201 2006 117 12 5 5 122 17 2,411 2007 168 10 2 2 170 12 3,080 2008 184 3 4 4 188 7 3,484 2009 192 11 8 8 200 19 3,143 2010 197 12 9 8 206 20 3,882 2011 230 12 15 14 245 26 3,995 2012 220 14 17 15 237 29 3,960 2013 256 19 17 17 273 36 4,169 2014 241 14 17 17 258 31 4,447 9/2015 170 14 13 12 183 26 3,389 Source: National Office Intellectual Property, 2019 7GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE IN VIET NAM’ INTELLECTUAL PROPERTY SYSTEM 2. Protection Title partly invalidated part failed satisfy protection conditions. practice, grounds patent invalidation confined applicant apply patent place (.., patent eligibility), challenges based substantive requirements patentability (.., met conditions novelty, inventive step industrial applicability). respect PVP, Viet Nam promulgated amendments intellectual property law 2009 (Law . 36/2009/QH12) implementing Decree 88/2010/ND-CP 16 August 2010 order conform domestic PVP protection laws International Convention Protection Varieties Plants (UPOV), 1991, obliged join condition bilateral trade agreement United States. confirmed interviews Ministry Agriculture Rural Development (MARD) Viet Nam plans accede International Treaty Plant Genetic Resources Food Agriculture (ITPGRFA), establishes multilateral ABS system number important agricultural crops limitations seeking intellectual property rights material received system.3 Viet Nam’ plans change future.4 intellectual property law, amended, Decree 88/2010/ND- CP requirement disclosure source origin, ATK, applications protection plant varieties. analysis shows , patents, requirement Viet Nam disclosure origin source patent applications paper, absence effective enforcement mechanisms renders requirement ineffective. PVP, laws regulations obligation disclose origin source genetic resources, ATK. 8 TOWARDS AN EFFECTIVE AND PRACTICAL VERIFICATION AND TRANSPARENCY MECHANISM ON THE UTILIZATION OF 5. RECOMMENDATIONS IP Viet Nam clear guidance needed enforce requirement disclose origin source envisaged Circular 01/2007/ TT-BKHCN. legislation regulations suggested ( red italics additions strike /blue italics deletions). respect patents, Article 102 intellectual property law amended empower Government MOST provide specifications required disclosure, recommended . effect linking Government Decrees MOST Circulars intellectual property law. Keeping link disclosure origin requirement ambit Article 102 strengthens argument disclosure requirement additional substantive requirement patentability, linked fulfillment patent applicant’ obligations meet requisite formalities patent application examined. Article 102. Requirements Invention Registration Applications 1. Documents identifying invention claimed protection invention registration application include Specification invention Abstract invention. Specification invention consists Description invention Scope protection invention. 2. Description invention fulfill conditions: ). sufficiently disclose nature invention extent invention carried person ordinary knowledge art; ). briefly explain drawings, required clarify nature invention; ). clarify novelty, inventive step susceptibility industrial application invention. 3. Scope protection invention expressed form combination technical features sufficient identify scope rights invention, line Specification invention drawings. 4. Abstract invention disclose essential features nature invention. 5. Ministry Science Technology provide specifications included description invention abstract invention. Paragraph 23.11 Administrative Circular 01/2007/ TT-BKHCN amended clarify scope disclosure requirement, : 23.11. Additional Provisions Applicable Applications Registration Inventions Genetic Resources Traditional Knowledge general requirements invention registration applications Points 23.1 23.7 Circular, application registration invention based genetic resource traditional knowledge Description describe documents explaining origin genetic resource / traditional knowledge accessed inventor applicant, source geographical origin invention based genetic resource / traditional knowledge source geographical origin essential technical feature invention. inventor applicant identify origin genetic resource / traditional knowledge, / declare bear responsibility truthfulness / declaration. amendment aligns disclosure requirement language CBD Nagoya Protocol, covers accessed genetic resources ATK. disclosure triggered , , invention based genetic resource ATK, essential technical feature invention. Finally, amendment Article 96 intellectual property law suggested enable IP Viet Nam invalidate granted titles patents comply disclosure requirement. Article 96. Invalidation Protection Titles 1. Protection Title invalidated cases: ). applicant registration registration assigned ( regard inventions, industrial designs, layout-designs marks); 9GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE IN VIET NAM’ INTELLECTUAL PROPERTY SYSTEM ). subject matter industrial property failed satisfy protection conditions grant date Protection Title. ). Evidence specification invention failed satisfy requirements stipulated Article 102 Law detailing provisions relevant Decrees Circulars. 2. Protection Title partly invalidated part failed satisfy protection conditions. respect plant variety protection, procedures registration PVP rights set Decree 88/2010/ND-CP, designates MARD authority charge managing Viet Nam’ system PVP rights. suggested amend Article 174.1 intellectual property law : Article 174. Protection registration applications 1. protection registration application comprises documents: ). declaration form registration set ; ). Photos technical declarations set form; ). Power attorney, application filed representative; ). Documents evidencing registration registrant transferee registration ; ). Documents evidencing priority , application claim enjoying priority ; ). Vouchers payment fees charges; ). registration plant variety sought developed genetic resources obtained Viet Nam, evidence compliance applicable laws regulations access benefit sharing genetic resources. awareness ABS requirements MARD, making clear obtaining PVPs require disclosure geographical origin source put applicants notice applications scrutinized proper disclosure. case patents, mechanism needed ensure MARD invalidate PVP rights complied Viet Nam’ ABS law. addressed amendment Article 171 intellectual property Law. Article 171. Invalidation Plant Variety Protection Title 1. Plant variety Protection Title invalidated circumstances: ). applicant file application, plant variety assigned holder registration ; ). protected variety meet conditions novelty distinctness time granting plant variety Protection Title; ). protected variety meet conditions uniformity stability plant variety protection certificate granted basis technical test results supplied registrant; ). Evidence plant variety failed satisfy requirements stipulated Article 174 Law detailing provisions relevant Decrees Circulars. addition, policy makers amending penalties violations IP law include cases willfully misleading false declarations disclosure origin, applicants subject measures administrative violations, including fines sanctions, determined competent authorities. 10 TOWARDS AN EFFECTIVE AND PRACTICAL VERIFICATION AND TRANSPARENCY MECHANISM ON THE UTILIZATION OF 6. IMPLEMENTATION OF THE NEW RULES contemplated effect requiring genetic resources ATK data IP Viet Nam databases, enabling searches. , turn, assist Viet Nam discharging obligation ensure compliance CBD/Nagoya Protocol PIC MAT requirements. Optimally, , database local genetic resources long assisting stakeholders preventing misappropriation genetic resources ATK. establishment comprehensive database , , costly time consuming. countries India successfully established database respect traditional medicines, developing countries creating maintaining usable database challenge. , , BCA provide IP Viet Nam list priority genetic resources indigenous Viet Nam potential commercial application, indicating products sectors resource commercial application. list published notification jointly BCA IP Viet Nam, subject procedures. formal examination, application patents reference genetic resources ATK examiner assessment application requires disclosure origin accordance Circular 01/2007/TT-BKHCN. event disclosure origin required (.., genetic resource essential part invention patent claimed , , cited reference), examiner assess sufficient disclosure origin . point time, examiner alert BCA patent application filed priority genetic resource. insufficient disclosure origin, examiner request applicant amend patent application comply Circular. formal examination patent application stayed disclosure . event patent applicant claims / unaware origin source genetic resource, formal examination application stayed time BCA provide opinion genetic resource concerned obtained contravention Viet Nam’ Access Benefit Sharing Decree 59/2017/NB-CP. Finally, BCA lead setting operating Inter-agency Benefit Sharing support system, model hub (BCA), -hubs (IP Viet Nam PVP office) spokes (genetic resources administration authorities MARD Ministry Health (MOH)), aim ensure access propagation intellectual property information related genetic resources/ATK source geographical origin public, beneficiaries genetic resources/ATK. policy regulated legal instruments, task assigned Government agreed related Ministries (.. Ministry Natural Resources Environment (MONRE), MOST, MARD MOH). 11GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE IN VIET NAM’ INTELLECTUAL PROPERTY SYSTEM 7. CONCLUSION requirement disclose origin genetic resources ATK patent PVP application tool number countries defensive measure combat misappropriation. measure necessarily prevent patenting foreign jurisdictions, foreign jurisdictions search patent applications globally ascertain patentability, providing ABS authorities important leads determine compliance domestic ABS laws policies. ensure patents filed Viet Nam demonstrate compliance domestic PIC MAT requirements. Southeast Asia, system place Indonesia Philippines. order effective, , disclosure requirement enforceable, .., consequences -disclosure/- compliance. principal weakness Viet Nam’ existing disclosure requirement date intellectual property legislation regulations consequences absence disclosure. present system, statement applicant unaware origin genetic resource invention suffice move application formality review substantive examination. proposed amendments laws decrees seek address shortcoming. longer run, systemized line communication IP Viet Nam BCA disclosure system , broadly ABS, work effectively. availability searchable databases effort, creation maintenance databases challenging developing countries. measures short run, , BCA identify key indigenous genetic resources commercial potential share IP Viet Nam. actions important building blocks eventually stronger comprehensive ABS system, including designation checkpoint agencies. Key Recommendations 1. Article 102 intellectual property law amended empower Government MOST provide specifications required disclosure: 102(5). Ministry Science Technology provide specifications included description invention abstract invention. 2. Paragraph 23.11 Administrative Circular 01/2007/TT-BKHCN amended clarify scope disclosure requirement: general requirements invention registration applications Points 23.1 23.7 Circular, application registration invention based genetic resource traditional knowledge Description describe documents explaining origin genetic resource / traditional knowledge accessed inventor applicant, source geographical origin invention based genetic resource / traditional knowledge source geographical origin essential technical feature invention. inventor applicant identify origin genetic resource / traditional knowledge, / declare bear responsibility truthfulness / declaration. 3. Article 96 intellectual property law amended enable IP Viet Nam invalidate granted titles patents comply disclosure requirement: 1. Protection Title invalidated cases: … ) Evidence specification invention failed satisfy requirements stipulated Article 102 Law detailing provisions relevant Decrees Circulars. 4. respect plant variety protection, Article 174.1 intellectual property law amended : 1. protection registration application comprises documents: … ) registration plant variety sought developed genetic resources obtained Viet Nam, evidence compliance 12 TOWARDS AN EFFECTIVE AND PRACTICAL VERIFICATION AND TRANSPARENCY MECHANISM ON THE UTILIZATION OF applicable laws regulations access benefit sharing genetic resources. 5. mechanism invalidate PVP rights complied Viet Nam’ ABS law addressed amendment Article 171 intellectual property law: 1. Plant variety Protection Title invalidated circumstances: … ) Evidence plant variety failed satisfy requirements stipulated Article 174 Law detailing provisions relevant Decrees Circulars. 6. Policy makers amending penalties violations IP law include cases willfully misleading false declarations disclosure origin, applicants subject measures administrative violations, including fines sanctions, determined administrative competent authorities. 7. BCA lead setting operating Inter-agency Benefit Sharing support system, model hub (BCA), -hubs (IP Viet Nam PVP office) spokes (genetic resources administration authorities MARD MOH. 13GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE IN VIET NAM’ INTELLECTUAL PROPERTY SYSTEM 8. ANNEX List interviewees, UNCTAD mission (30–31 , 2019) Organization Individual 1 IP Office Leader charge Patent - Deputy Director General Phan Ngan Son 2 - Administrators charge Biological Patent - Staff charge Legal Policy Affairs - Patent Examination Center Deputy Director Nguyen Thanh Tu staff - Legal Policy Affairs Division Staff 3 Plant Variety Protection Office - Leader PVP Office Department Crop Production Director Nguyen Thanh Minh 4 Genetic Resources Management Authorities Ministry Agriculture Rural Development - Department Livestock Production - Department Sea Products - Science Technology Division Invited PVPO 5 Genetic Resources Management Authorities Ministry Health - Traditional Medical Pharmaceutical Administration - Pharmaceutical Material Institute Invited BCA 6 BCA/ Ministry Natural Resources Environment - determined BCA Invited BCA 14 TOWARDS AN EFFECTIVE AND PRACTICAL VERIFICATION AND TRANSPARENCY MECHANISM ON THE UTILIZATION OF References Chiarolla, Claudio. Intellectual Property Global Environmental Law Perspective: Lessons Patent Disclosure Requirements Genetic Resources Traditional Knowledge Transnational Environmental Law 8:3 (2019), pp. 503–521. Mgbeoji, Ikechi. Global Biopiracy: Patents, Plants Indigenous Knowledge. Vancouver, BC: UBC Press, 2006. Robinson, Daniel . “Patent-Related Biopiracy Cases. Confronting Biopiracy: Challenges, Cases International Debates. (pp. 67-76). United Kingdom: Earthscan, 2010. UNCTAD. Convention Biological Diversity Nagoya Protocol: Intellectual Property Implications – Handbook Interface Global Access Benefit Sharing Rules Intellectual Property. York Geneva: United Nations, 2014. Notes 1 Notified CBD Secretariat’ ABS Clearing-House 11 2018 national consultation. 2 Draft Decision Enhance Mutual Supportiveness TRIPS Agreement Convention Biological Diversity, TN///59 19, April 2011, WTO, https://www.wto.org/english/tratop_e/trips_e/ ta_docs_e/4_tncw59_e.pdf. 3 ITPGRFA, Art 12.3(): Recipients claim intellectual property rights limit facilitated access plant genetic resources food agriculture, genetic parts components, form received Multilateral System. 4 Letter 116/ICD-MARD 23 April 2019 requests FAO’ technical support study requirements implications process Viet Nam joining ITPGRFA.