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…
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- 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…
- China, China Patent Office, CNIPA, Key decisions, parameter feature, Patent, patent application, Patent Law
Why Do Examiners Fail to Recognize the Importance of my “Parameter Features”?
The Impact of Parameter Features on Inventiveness ”Parameter features” – numerical or mathematical expressions that define the quantity or physical properties of a subject – frequently appear as technical features within a claim. Often described as numerical ranges or measurements, they frequently play a critical role in addressing technical problems. However, in practice, Examiners and courts often disregard or devalue the inventive contribution of these “parameter features”, leading to considerable confusion among inventors. Recently, the China National Intellectual Property Administration (CNIPA) released the 2023 Compilation of Key Decisions in Patent Reexamination and Invalidation Cases. Among the cases discussed, two decisions (Cases No. 24 and 25) provide valuable insights into how…
