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…
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First Ever Successful Invalidation Challenge Due to Unauthorized Foreign Filing
What does an invention “completed” in China mean? China and the US are similar in that both countries highly value national security, and thus have rules regulating the exportation of technology and information from within their borders. This includes new inventions that arise from within their respective borders. As such, both governments require inventors who create IP within their borders to obtain approval by requesting a foreign filing license (or “confidentiality examination request“ in Chinese) before they can file a patent application in a foreign jurisdiction first (i.e., “export” the “technology”). In China, “inventions or utility models, of which the substantive content of the technical solution is completed within the…