China Patent Strategy

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    China Releases Draft Implementation Guidelines for the Drug Administration Law

    June 2, 2022

    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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  • Biotech,  China,  Patent Term Extension,  Pharma,  Proposed Changes,  Updates and Changes

    China Patent Office (CNIPA) Releases More Details About Patent Term Adjustment (PTA) in the Draft Examination Guidelines

    October 19, 2021

    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)

    April 29, 2021

    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…

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  • Jul 04, 2022 SPC Upholds $2M RMB Award in China’s First Patent Case on a Biological Deposit
  • Jun 30, 2022 China Hands Down First Batch of Patent Linkage “Paragraph IV” Litigation Results
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  • Jun 02, 2022 China Releases Draft Implementation Guidelines for the Drug Administration Law
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  • What Kind of Damage Awards Can You Get in China?
  • China Releases Draft Implementation Guidelines for the Drug Administration Law
  • How Smart is a “Skilled Person in the Art”?
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  • China Joins Two WIPO Treaties, the Hague System and the Marrakesh Treaty

Recent Posts

  • Jul 04, 2022 SPC Upholds $2M RMB Award in China’s First Patent Case on a Biological Deposit
  • Jun 30, 2022 China Hands Down First Batch of Patent Linkage “Paragraph IV” Litigation Results
  • Jun 16, 2022 What Kind of Damage Awards Can You Get in China?
  • Jun 02, 2022 China Releases Draft Implementation Guidelines for the Drug Administration Law
  • Apr 11, 2022 How Smart is a “Skilled Person in the Art”?
  • Apr 04, 2022 Patent Eligibility for Software in China
  • Feb 11, 2022 China Joins Two WIPO Treaties, the Hague System and the Marrakesh Treaty
  • Dec 06, 2021 CHINA DIVISIONAL PATENT STRATEGY: Recent Judgment Narrows What Constitutes “Different Inventions” for Divisionals
  • Oct 22, 2021 CHINA: How Prohibiting “Illegal” Inventions Runs into Food Safety Law
  • Oct 19, 2021 China Patent Office (CNIPA) Releases More Details About Patent Term Adjustment (PTA) in the Draft Examination Guidelines
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