How the Supreme People’s Court Established a New Benchmark for Unexpected Technical Effects in a Landmark Diabetic Nephropathy Case Proving inventive step for pharmaceutical compounds, especially a second medical use, remains one of the most challenging aspects of patent prosecution in China. When the prior art discloses a compound’s general therapeutic properties, how can an applicant demonstrate that a specific new use achieves “unexpected technical effects”? The Supreme People’s Court’s (SPC) recent decision in the “Ligustrazine Nitrone Derivative” case offers an answer: If the therapeutic effect of an invention patent application’s technical solution for a certain disease is comparable to that of the world’s first drug approved for treating that disease…
- China, Court Cases, Courts, Inventions, Inventiveness, Patent, Patent Law, Patentability, Pharma, Post-Filing Data, Supreme People's Court
- 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…


