On May 15, 2026, China’s National Medical Products Administration (NMPA) officially announced the final Measures for the Implementation of Drug Trial Data Protection1 (“Measures”), effective May 15, 2026. These Measures provide important details supporting the recently announced Implementing Regulations of the Drug Administration Law (“Regulations” – also effective May 15, 2026), which formally introduced a statutory market exclusivity of up to 7 years for qualifying orphan drugs, up to 2 years for pediatric drugs, and up to 6 years data exclusivity for “new chemical entity drugs and other drugs”. Key Highlights Under the finalized Measures, the NMPA2 grants a maximum regulatory data protection (“RDP”) period of up to 6 years…
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- Biotech, China, China Patent Office, CNIPA, Inventions, national phase entry application, Patent, Patent Re-examination and Invalidation Department, PCT, PRD, Priority
Can I transfer priority rights in China without the consent of other applicants? Insights from the Broad Institute’s CRISPR patent
The high-profile disputes surrounding an important CRISPR patent belonging to The Broad Institute, MIT and Harvard (hereinafter “the proprietors”) has attracted a lot of attention in recent years, particularly regarding the validity of priority rights that were challenged worldwide. In Europe, the patent was famously revoked by the European Patent Office (hereinafter “EPO”) due to an invalid priority claim1, though recent decisions by EPO suggest a dramatic shift in EPO’s approach that may lead to a different outcome2. Today, we will discuss the decision of the Chinese National Intellectual Property Administration (hereinafter “CNIPA”) in determining whether the proprietors’ priority claims in their CRISPR patent in China were valid, given discrepancies…
- 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…
