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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- 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…
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What Microsoft’s Recent Patent Invalidation Case in China Teaches Us About User Interface Patents
Each year the CNIPA publishes its Top Ten Patent Re-examination and Invalidation Cases for the previous year. These cases are meant to be guiding cases, showcasing exemplary real-world decisions that clarify certain aspects of the law. Today we’ll be sharing about one of the Top 10 Invalidation Cases in 2024 involving Microsoft (China) Co., Ltd. petitioning to invalidate a patent by Newman Infinite Inc. in the field of human-computer interaction (HCI). Case summary The patent claimed methods and devices for manipulating a touch screen user interface that could help differentiate between various touch targets, preventing undesired interactions with non-target elements. The patentee used a self-defined term “clutch user interface element”,…
