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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Please “Mind the Traps”: Four Common Misconceptions About Hong Kong Patents
For many foreign companies interested in the broader Asian market, Hong Kong is a strategically important jurisdiction. However, because of its unique legal framework, domestic and foreign companies alike are confused by how IP protection works in Hong Kong. Missteps in such understanding can lead to critical, costly “gaps” in IP protection. To safeguard innovations effectively in Hong Kong, be aware of these four common misconceptions: Hong Kong IP protection goes well beyond a simple registration of a Chinese or European/UK patent. There are many strategies and multi-layered approaches for protecting IP in this key jurisdiction. If you would like to have more information on this matter or would like…
- 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…
