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, data, Invalidation, Patent, Patent Law, Patent Re-examination Board, Patentability, Pharma, Support Requirements
- 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…
- Biotech, China, China Patent Office, CNIPA, Inventions, national phase entry application, Patent, Patent Re-examination and Invalidation Department, PCT, PRD, Priority
Can I transfer priority rights in China without the consent of other applicants? Insights from the Broad Institute’s CRISPR patent
The high-profile disputes surrounding an important CRISPR patent belonging to The Broad Institute, MIT and Harvard (hereinafter “the proprietors”) has attracted a lot of attention in recent years, particularly regarding the validity of priority rights that were challenged worldwide. In Europe, the patent was famously revoked by the European Patent Office (hereinafter “EPO”) due to an invalid priority claim1, though recent decisions by EPO suggest a dramatic shift in EPO’s approach that may lead to a different outcome2. Today, we will discuss the decision of the Chinese National Intellectual Property Administration (hereinafter “CNIPA”) in determining whether the proprietors’ priority claims in their CRISPR patent in China were valid, given discrepancies…