Introduction “I have a tank, I have a gun—boom! Tank gun?” Each year the CNIPA releases a list of Top Ten Patent Re-examination and Invalidation Cases. These cases are meant to be guiding cases, showcasing exemplary real-world decisions that clarify certain aspects of the law. Over the next several months we will be highlighting many of these cases. Today’s article relates to design patents and the standard of what is “distinctly different”. Particularly, this case asks whether two prior art design elements can be combined to invalidate the novelty of a design if the two prior art features come from different categories of products. The Chinese patent law states: “A…
- China, China Patent Office, CNIPA, Design, Inventiveness, Patent Re-examination and Invalidation Department
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NMPA’s Releases Draft Measures for Data Protection (Data Exclusivity)
In March 2025, China’s National Medical Products Administration (NMPA) released yet another set of draft implementation measures on data protection.1 Key highlights of these new measures include the following: A Bit of History China’s journey toward a comprehensive pharmaceutical data protection framework has been ongoing for over two decades, a roller coaster ride from its initial commitments upon joining the World Trade Organization (WTO) to its most recent draft regulations. WTO Accession (2001) and Early Provisions (2002) When China joined the WTO in 2001, it signed the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). In line with its WTO obligations, China incorporated data exclusivity into its domestic law…
- China, China Patent Office, CNIPA, data, Invalidation, Patent, Patent Law, Patent Re-examination Board, Patentability, Pharma, Support Requirements
How to Protect a Crystal Form (Polymorph) Patent in China
Crystalline forms are critical to pharmaceutical patents, offering extended protection for improved stability, bioavailability, or manufacturability. However, securing such patents in China has grown increasingly difficult due to the China National Intellectual Property Administration (CNIPA)’s strict patentability criteria. Unlike the U.S. or Europe, where structural novelty or problem-solving utility may suffice, China demands quantifiable evidence of superiority over prior art forms and rejects patents based on routine screening alone. Recent decisions, like the invalidation of fruquintinib Crystal Form I, highlight common pitfalls: insufficient comparative data, incremental technical effects, and failures to preempt obviousness challenges. With China’s pharmaceutical market surging and secondary patents under heightened scrutiny, companies must strategically align their IP strategies…


