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…
-
- 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…
- China, China Patent Office, CNIPA, Invalidation, Inventiveness, Patent, Patent Re-examination and Invalidation Department
A Stratification Too Far? How the CNIPA Draws the Line on Patient Subgroups in a Recent Precision Medicine Invalidation Case
Precision medicine is rapidly transforming the global healthcare landscape, providing more effective therapies and better patient outcomes through targeted solutions. As therapeutics move away from the traditional “one-size-fits-all” model, unique challenges are presented in the patent examination process. The 2024 Top 10 Patent Re-examination and Invalidation case highlighted below provides further insight into how the China National Intellectual Property Administration (CNIPA) interprets claim scope and inventive step during the examination of precision medicine technologies. Background Generic Drug maker Chia Tai Tianqing Pharmaceutical Group filed an invalidation request before the Patent Re-examination Board (the “Board”) against an invention patent titled “Use of Degarelix1 in the Preparation of a Medicament for Treating…
