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…
- China, China Patent Office, Court Cases, Courts, Invalidation, Inventions, Patent Law, Top 10 IP Case
- 48 Typical Cases, Biotech, China, China Patent Office, CNIPA, Court Cases, Inventions, Judgement Digests, Patent Law, Pharma
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…
- China, China Patent Office, CNIPA, Examination Guide, Inventions, Patent Law, Patent Term Adjustment, PTA, Updates and Changes
CNIPA further clarifies how it counts “delays” when calculating Patent Term Adjustment (PTA) in the new Draft Examination Guidelines and how it affects international applicants
At the end of October 2022, the China National Intellectual Property Administration (CNIPA) released a new draft amendment of the Patent Examination Guidelines[1] (hereinafter referred to as the “New Draft”) to the new Chinese Patent Law that came into effect in 2021. We highlight two key amendments below. 1. The starting date for calculating PTA (the “date of requesting for substantive examination”) has been amended from the date when the CNIPA issues a “Notice of Entering the Examination Stage” after receiving the substantive examination request to the date on which the substantive examination request is filed AND the examination fee is paid in full in accordance with Rule 113 of…


