The latest draft implementation guidelines for China’s Drug Administration Law (“Guidelines”) are out and open for comment. Previously, the new implementation measures for early dispute resolution mechanisms for drug patents (“Patent Linkage Measures”) came into effect on July 4, 2021. The Guidelines indicate that the final approval of generic chemical drug applications for marketing approval will be stayed pending Paragraph IV litigation results. Technical review for things like safety and efficacy will proceed regardless. Although previously published Patent Linkage Measures indicate that the maximum stay period is 9 months, these Guidelines only say “a certain period.” The regulatory approval process for generic biologics and traditional Chinese medicines will not be…
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China Patent Office (CNIPA) Releases More Details About Patent Term Adjustment (PTA) in the Draft Examination Guidelines
The new 4th Amendment of the Chinese Patent Law came into effect on June 1, 2021. Right before that date, the Chinese Patent Office (“CNIPA”) released some “Interim Measures” to give us a taste of what was to come, though they have yet to released the actual Implementation Rules. Two months later, CNIPA finally released Draft Patent Examination Guidelines in conjunction with the new Patent Law. We have provided a summary of the key points at this link, and for the next several posts, we will explore some of those topics in greater detail. “PTA” in the Patent Law Patent term compensation for patent office delay, which we will refer…
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China’s Newest Examination Guidelines: Novelty and Inventive Step for Compounds (Part II)
This is Part II of a three-part series summarizing the Examination Guidelines that were released by the CNIPA on January 15, 2021, one year to the date of Phase 1 of the US and China Economic and Trade Agreement. That agreement included specific provisions where China “shall permit pharmaceutical patent applicants to rely on supplemental data to satisfy relevant requirements for patentability, including sufficiency of disclosure and inventive step . . .” (Article 1.10). Furthermore, these new Guidelines also introduce a more rigorous approach to inventive step (to avoid Examiner hindsight!) for chemical and biological inventions, including a number of helpful examples. Part I of this series covered examples on…
