In this case, the SPC specified a criterion for assessing the inventiveness of novel crystalline forms of compounds. Although the preparation of the novel crystal form has a certain degree of uncertainty, merely preparing and obtaining a novel crystalline form does not necessarily mean that the said crystalline form meets the requirement of inventiveness under the patent law.

In this case, the SPC established an adjudicative standard for identifying common technical knowledge (CTK) and its evidence in the relevant technical field. The identification of CTK as well as evidence of CTK may determine the technical knowledge and cognitive capability that so-called persons skilled in the art shall possess, and, hence, is of significant influence on inventiveness assessment at issue.

In this case, the SPC established the standard for accepting supplementary experimental data by CNIPA in patent invalidation process.

In this case, the SPC pointed out that in terms of inventiveness assessment, if a person skilled in the art cannot obtain the biological material claimed in the patent by repeating the preparation method in the reference document, then the claimed biological material shall be identified as being not disclosed by such reference document.

In June 2018, the Appeal Court of Ireland refused to grant a preliminary injunction and held that preliminary injunctions may not be granted when damages are an adequate remedy for the plaintiff and when the defendant is likely to suffer the greater irreparable damage if the preliminary injunction is granted.

The United States Court of Appeals affirmed the district court’s decision, holding that AstraZeneca’s labeling change of its antipsychotic medication Seroquel was not entitled to an additional period of market exclusivity.

The Court of Justice of the European Union confirmed its position that a contractual obligation to pay royalties for a licensed intellectual property (IP) right does not depend on the validity of the licensed IP right. Such contractual obligation in the Court’s view is compatible with competition law provided the licensee has the right to terminate the licensing agreement. The Court interpreted Article 101 of Treaty on the Functioning of the European Union (TFEU), which is comparable to Article 40.1 and 2 of the TRIPS Agreement.

This case dealt with the interpretation of the Canadian Food and Drug Regulations, subsection C.08.004.1(1) concerning data exclusivity protection. The Federal Court of Canada ruled that the five-year data protection to originator manufacturers is not triggered if the subsequent manufacturer, generally a generic manufacturer, can establish the safety and effectiveness of its product on the basis of bioequivalence or bioavailability studies without the Minister having to consult the confidential data filed by the innovator.

In early 2009, the Commission of the European Communities cleared the proposed acquisition of the generic drug maker Zentiva N.V. by Sanofi-Aventis Europe, subject to conditions. In light of Sanofi-Aventis’ commitment to divest fifteen drugs in Eastern Europe, the Commission concluded that the proposed acquisition would not harm competition in the internal market.

This case concerned a concentration involving two generic producers. The Commission of the European Communities approved the proposed acquisition of Barr Pharmaceuticals, Inc., by Teva Pharmaceutical Industries Limited, subject to conditions. In its decision, the Commission recognized that the third level of the anatomical therapeutic chemical (ATC) classification system, known by the abbreviation ATC3, is not always the most appropriate level for the purposes of market definition. It adopted inter alia a narrower market definition, i.e.