Pharma
Beijing IP Court Reverses CNIPA Decision and Upholds Ozempic® semaglutide patent in China as VALID based on Novo Nordisk’s Post Filing Data
27 June 2024Recently, 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 […]
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Do Promotional Marketing Materials Constitute an “Offer for Sale” under Chinese Patent Law? Bayer IP GmbH v. Nanjing Hang Seng Pharmaceutical
12 December 2023Bayer'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 […]
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Inventive Step for an Enantiomer over a Racemate: “L-ornidazole” Patent Invalidation Case
27 November 2023Each year, China’s Supreme People’s Court (SPC) issues its annual “Judgment Digests”, which includes a list of “48 typical cases” highlighting representative SPC decisions in the previous year. The Judgment Digests help us understand more about the SPC’s judicial ideology, trial concepts, and adjudication methods in dealing with difficult and sophisticated legal issues as well […]
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Introducing the New USPTO Cancer Moonshot Expedited Examination Pilot Program
10 January 2023Starting from February 1, 2023, the USPTO will begin the new Cancer Moonshot Expedited Examination Pilot Program that advances out-of-turn applications that are directed to oncology or smoking cessation. This new program will replace the Cancer Immunotherapy Pilot Program that has been in place since 2016, and covers more technologies than only cancer immunotherapies. Applications […]
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Compositions Limited by Use: A Cautionary Tale
26 October 2022Section 4.2.3, Part II Chapter 10 of the CNIPA’s Examination Guidelines (“Guidelines”) stipulates that if the specification only discloses one property or use of a composition, the composition claim shall be drafted as a “composition limited by the function or the use”. Furthermore, it specifically states that “most pharmaceutical claims shall be drafted as claims […]
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How the Chinese Patent Office Rejected a Plate-Making Method Based on Food Safety Law
19 October 2022Previously we published an article about CNIPA rejecting a patent application claiming a food that could also be used to treat or prevent diseases based on the food’s alleged non-compliance with Food Safety Law. China’s Food Safety Law includes a provision which states any use of a composition as a food must be strictly separated […]
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China Hands Down First Batch of Patent Linkage “Paragraph IV” Litigation Results
30 June 2022China has been implementing a plethora of new laws and measures that are particularly favorable to drug companies, such as patent term extension and patent linkage. Details of the new implementation measures for patent linkage (technically “early dispute resolution mechanisms for drug patents”) came into effect on July 4, 2021. At around the same time, […]
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What Kind of Damage Awards Can You Get in China?
16 June 2022Is it worth filing for a patent in China? What kind of damage awards can you get? Pharma companies care more about injunction than damage awards, since it’s quite unlikely that any damage award can compensate for the large amounts of money that may be lost for patent infringement. Chinese courts often issue injunctions in […]
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China Releases Draft Implementation Guidelines for the Drug Administration Law
2 June 2022The latest draft implementation guidelines for China’s Drug Administration Law (“Guidelines”) are out and open for comment. Previously, the new implementation measures for early dispute resolution mechanisms for drug patents (“Patent Linkage Measures”) came into effect on July 4, 2021. The Guidelines indicate that the final approval of generic chemical drug applications for marketing approval […]
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CHINA: How Prohibiting "Illegal" Inventions Runs into Food Safety Law
22 October 2021Chinese Patent Law has an interesting provision that specifically prohibits patent protection on “illegal” or “immoral” inventions. What does this mean, exactly? According to Article 5.1 of the Chinese Patent Law, “no patent shall be granted for an invention that contravenes any law or social moral or that is detrimental to public interests.” On its […]
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