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…
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Inventive Step for an Enantiomer over a Racemate: “L-ornidazole” Patent Invalidation Case
Each 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 as new types of IP cases in high tech fields. Despite the fact that SPC judgments are not precedentially binding on lower courts, they are still very persuasive and provide insights into the types of decisions that are considered “model decisions” by the SPC. This case was one of the 48 “typical” cases and deals…
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Announcement: Implementation Regulations (Rules) of the Chinese Patent Law have been Approved
On November 3rd, 2023, the Premier of the State Council, Li Qiang, chaired a regular meeting where the “Implementation Regulations of the Patent Law of the People’s Republic of China (Revised Draft)” was reviewed and approved. This is great news, as we have been waiting quite some time for these Regulations (Rules) to be approved (see our previous article summarizing the draft Implementation Rules). Considering the 4th Amendment of the new Chinese Patent Law was passed in October 2020, we have certainly been waiting a long time for more details about how this law will be implemented. This document is not publicly available yet. However, the announcement provides a summary of…