Crystalline forms are critical to pharmaceutical patents, offering extended protection for improved stability, bioavailability, or manufacturability. However, securing such patents in China has grown increasingly difficult due to the China National Intellectual Property Administration (CNIPA)’s strict patentability criteria. Unlike the U.S. or Europe, where structural novelty or problem-solving utility may suffice, China demands quantifiable evidence of superiority over prior art forms and rejects patents based on routine screening alone. Recent decisions, like the invalidation of fruquintinib Crystal Form I, highlight common pitfalls: insufficient comparative data, incremental technical effects, and failures to preempt obviousness challenges. With China’s pharmaceutical market surging and secondary patents under heightened scrutiny, companies must strategically align their IP strategies…
- China, China Patent Office, CNIPA, data, Invalidation, Patent, Patent Law, Patent Re-examination Board, Patentability, Pharma, Support Requirements
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Beijing IP Court Reverses CNIPA Decision and Upholds Ozempic® semaglutide patent in China as VALID based on Novo Nordisk’s Post Filing Data
Recently, all eyes have been on China as the fundamental patent covering semaglutide, the active ingredient in Ozempic® and Wegovy®, will expire on March 20, 2026. It goes without saying that generics are ramping up bigtime in China (and also around the world), preparing to manufacture and sell this blockbuster drug to one of the biggest markets in the world. Any shortening of the patent term for this key semaglutide patent in China could cause an immediately shift in the Chinese Ozempic market (not to mention directly impacting Novo Nordisk). Novo Nordisk’s Semaglutide Patent in China On September 5, 2022, the China National Intellectual Property Association (China’s patent administrative office,…
- 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…