Managing global pharmaceutical or chemical portfolios requires navigating China’s notoriously rigid standards on the “same subject matter” requirement for priority and claim amendments. A recent invalidation decision (No. 588094) issued by the China National Intellectual Property Administration (CNIPA) concerning a pharmaceutical patent provides clarity on how numerical ranges and later added experimental data are evaluated in priority claims. More specifically, how much literal support is needed for a claim directed towards a “new” numerical sub-range supported by later added working examples? The Core Dispute: Priority Over specific Ratios and “Added” Data The patent at issue protected a pharmaceutical composition comprising Edaravone (3-methyl-1-phenyl-2-pyrazolin-5-one) and natural borneol (for treating cerebrovascular diseases), specifically…
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- China, Court Cases, Courts, Inventions, Inventiveness, Patent, Patent Law, Patentability, Pharma, Post-Filing Data, Supreme People's Court
Is “Comparable” the New “Unexpected”? China’s SPC Relaxes Inventive Step Standard for Breakthrough Therapeutics
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, China Patent Office, CNIPA, Court Cases, Courts, Invalidation, Inventiveness, Patent, Supreme People's Court, Top 10 IP Case
No More Hindsight Bias: China’s Supreme People’s Court Reins in Patent Inventiveness Assessments
For foreign applicants navigating patent litigation or invalidation in China, a common frustration is hindsight bias. Too often, CNIPA or lower courts strip down a patent into isolated technical features, find those features across disparate prior art references, and declare the invention to be “obvious”. To counter such hindsight reasoning, the core criterion has always been whether a person skilled in the art would readily conceive of such technical solution. In practice, that standard has not been applied consistently. Examiners and judges are often tempted to rely on their own intuitive standard, or worse-yet, directly use hindsight reasoning, undermining the consistency and predictability of the inventive-step analysis. A relatively recent…
