The SPC reform which is currently undergoing the legislative procedure in the European Union has taken a further decisive step forward, as the European Parliament’s Committee on Legal Affairs (JURI Committee) has approved an amended version of the draft text of the four new EU regulations on SPCs for medicinal and plant protection products as…

From the potpourri of decisions that the Swiss Federal Supreme Court handed down last year, I have selected one in subjective hindsight that I consider to be particularly relevant regarding further cases. The outcome of most decisions of the Swiss Federal Patent Court in 2023 heavily depended on the specific circumstances and the effects of…

Question: I applied for my SPC in reliance on the law as set out in Neurim[1], following Santen[2] can I still obtain my SPC? Answer: No, according to the English High Court[3]. In 2018, i.e. before the Santen decision from the CJEU, Merck applied to the UK IPO for an SPC for its medicinal product…

On December 21, 2023, the China National Intellectual Property Administration (CNIPA) issued the final version of the revised Implementing Rules for the Patent Law and the Guidelines for Patent Examination, which will become effective on January 20, 2024. These Regulations complete legislative efforts on changes to the Chinese patent system introduced by the 4th amendment…

On November 28, 2023, the Tokyo District Court issued a preliminary injunction order against Sawai Pharmaceutical Co., Ltd. (“Sawai”) to suspend the manufacture and sale of Sawai’s pharmaceutical product (“Sawai’s Product”) developed and sold as a generic drug of Bristol-Myers Squibb (“BMS”)’s cancer drug “Sprycel®” (Case No. 2023 (Yo) 30214; AIK represented BMS in this…

Yes and no, it seems. Well, yes and then no, if recent French decisions are anything to go by. In short, Hesitations Blues reign. This attitude is all the more interesting given that the question, which arose more especially in the FINGOLIMOD case, has been raised before several European courts, all of which are opposed…

On December 6, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (ANVISA) passed new regulations accepting an exemption to allow generics and branded generics (also called “similar” drugs) to remove patented uses from their labels – i.e., skinny labeling. The change will come into effect 60 days after the amended text…

I) Introduction The science of biochemicals and the realm of Section 3(d) of Indian Patents Act! Can there be a reconciliation between the two? This question is a hot topic of discussion amongst the Indian biochemical patent community following the recent decision (Novozymes vs The Assistant Controller of Patents and Designs) pronounced by the Madras…

In April 2023, the European Commission (EC) published the pharmaceutical legislation package, including the proposal for a Pharmaceutical Directive[1] , and further proposals for regulations on SPCs[2]. Article 85 of the proposed Directive aims at providing an amended provision for the so-called Bolar exemption, currently codified in Article 10(6) of Directive 2001/83/EC. The initial EC proposal…

On October 24, 2023, the Brazilian government released an Action Plan aiming at fostering the National Intellectual Property (IP) Strategy. The plan was prepared by the Interministry IP Group ( a group created in 2019 to coordinate the federal government activities in the field of intellectual property. Thirteen Ministries form part of GIPI, and the…