In theory China’s inventorship standard is similar to others around the world. An inventor is anyone who “makes creative contributions to the substantive features” of an invention. But what does this mean, and how does one apply this standard? Up to this point, this issue hasn’t really been litigated much in China (at least according to publicly available records). We finally have an important case (from the top!) that clarifies this issue. We analyse a binding judgment by the Intellectual Property Court of the Supreme People’s Court (SPC) of China1. It clarifies China’s applicable inventorship standards and the potential legal consequences of omitting qualified inventors. For U.S. companies conducting R&D…
- China, Courts, inventors, inventorship, Patent, patent application, Patent Law, Supreme People's Court
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Breaking: China Released Drug Trial Data Protection Implementation Measures
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…
- China, China Patent Office, CNIPA, Invalidation, Inventiveness, Patent, Patent Re-examination and Invalidation Department
A Stratification Too Far? How the CNIPA Draws the Line on Patient Subgroups in a Recent Precision Medicine Invalidation Case
Precision medicine is rapidly transforming the global healthcare landscape, providing more effective therapies and better patient outcomes through targeted solutions. As therapeutics move away from the traditional “one-size-fits-all” model, unique challenges are presented in the patent examination process. The 2024 Top 10 Patent Re-examination and Invalidation case highlighted below provides further insight into how the China National Intellectual Property Administration (CNIPA) interprets claim scope and inventive step during the examination of precision medicine technologies. Background Generic Drug maker Chia Tai Tianqing Pharmaceutical Group filed an invalidation request before the Patent Re-examination Board (the “Board”) against an invention patent titled “Use of Degarelix1 in the Preparation of a Medicament for Treating…




