December 2023 appears to have been an exceptionally busy and fruitful month in the China patent space. Following the State Council’s approval of the long-awaited Patent Law Implementation Regulations (“Regulations”, similar to the CFR in the US) in November, the CNIPA finally made public the full text of the Regulations just before the arrival of the New Year. At the same time, the CNIPA also released the new Patent Examination Guidelines (“Guidelines”, equivalent to the MPEP in the US), along with specific implementation dates and transitional methods. We will, over the coming period, undertake a detailed analysis and commentary on these amendments and their consequential impacts. Today’s article will focus…
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- China, China Patent Office, CNIPA, Court Cases, Courts, Invalidation, Inventions, Patent Law, Pharma, Top 10 IP Case
Do Promotional Marketing Materials Constitute an “Offer for Sale” under Chinese Patent Law? Bayer IP GmbH v. Nanjing Hang Seng Pharmaceutical
Bayer’s blockbuster drug Rivaroxaban has seen its share of patent litigations in China, several of which are big enough to be listed as Top 10 IP cases or 50 Representative IP cases. We summarized an invalidation case back in 2020 where all of Bayer’s claims directed towards the compound were upheld. Recently, another Rivaroxaban case made it onto China’s 50 Representative IP cases in 2022, this time in a final judgement from the Supreme Court of an infringement case against a generic company who was marketing the patented drug before the patent expiration date. At the heart of the case is a dispute over (1) what acts by a generic…
- China, China Patent Office, Court Cases, Courts, Invalidation, Inventions, Patent Law, Top 10 IP Case
First ever Invalidation decision on an RNAi Invention patent in China
Decision on Examination of Request for Invalidation (No. 58530) In one of China’s Top 10 Patent Re-examination / Invalidation cases of 2022, an invalidation decision on a patent claiming Hepatitis B Virus (HBV) RNAi compositions (No. 58530) by the Patent Re-examination Board (the “Board”) sheds light on the standard for post filing data for rejections against sufficiency and inventive step, issues often faced in the biopharmaceutical field, particularly with regards to inventions with sequence listings. This case, between Alnylam Pharmaceuticals Inc. (the “Patentee”) and Zhang Yuan (the “Petitioner”), also marks the first-ever invalidation decision in China for a patent related to RNAi. RNAi has been gaining traction in the pharmaceutical…
