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…
