China Patent Strategy

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  • Biotech,  China,  Court Cases,  Patent Law,  Patent Linkage,  Pharma,  Regulatory

    China Hands Down First Batch of Patent Linkage “Paragraph IV” Litigation Results

    June 30, 2022

    China has been implementing a plethora of new laws and measures that are particularly favorable to drug companies, such as patent term extension and patent linkage. Details of the new implementation measures for patent linkage (technically “early dispute resolution mechanisms for drug patents”) came into effect on July 4, 2021. At around the same time, China’s public registration system for innovator companies to list patent associated with marketed drugs (China’s version of the US FDA’s “Orange Book”) began accepting registrations. It has been close to one year since these mechanisms were put in place. Now, the first legal decisions from these patent challenges are coming out. China’s Patent Linkage System…

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  • Biotech,  China,  Patent Law,  Patent Linkage,  Pharma,  Proposed Changes,  Regulatory

    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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  • China,  Patent Linkage,  Patent Term Extension,  Updates and Changes

    CHINA: New Patent Examination Guidelines Now Available for Public Comment

    August 4, 2021

    Two months after the new Chinese Patent law came into effect, the CNIPA has released a new set of Patent Examination Guidelines (proposed version) for public comments on Aug 3, 2021. Here are the explanation of the amendments (Chinese only). Here is the full set of proposed amendments (Chinese only). Briefly, the new amendment focuses on the following points: Updated Design Application System, involving requirements for partial designs and GUI applications, obviousness standard for designs, domestic priority, and other procedural requirements; Newly added provisions about the Patent Cooperation Treaty, including incorporation, priority restoration, addition, correction, etc.; Newly added provisions about Patent Term Extension and Patent Term Adjustment’; Newly added provisions…

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    New Policies to Promote Importation of Innovative Drugs

    November 8, 2018

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  • Introducing the New USPTO Cancer Moonshot Expedited Examination Pilot Program
  • FOLLOW UP: Amendments to the China Patent Examination Guidelines in 2022 – Part 1: New rules for designs in view of China signing onto the Hague Agreement
  • BREAKING NEWS: New Pilot Program for Hong Kong Applicants to get Accelerated Patent Examination in the Chinese Patent Office Starting January 1, 2023
  • Chinese Courts Cares More About Patent Quality Now (A Doctrine of Equivalents Story)
  • Amendments to the China Patent Examination Guidelines in 2022 – Part 1: New rules for designs in view of China signing onto the Hague Agreement

Recent Posts

  • Jan 10, 2023 Introducing the New USPTO Cancer Moonshot Expedited Examination Pilot Program
  • Jan 04, 2023 FOLLOW UP: Amendments to the China Patent Examination Guidelines in 2022 – Part 1: New rules for designs in view of China signing onto the Hague Agreement
  • Jan 04, 2023 BREAKING NEWS: New Pilot Program for Hong Kong Applicants to get Accelerated Patent Examination in the Chinese Patent Office Starting January 1, 2023
  • Dec 13, 2022 Chinese Courts Cares More About Patent Quality Now (A Doctrine of Equivalents Story)
  • Dec 02, 2022 Amendments to the China Patent Examination Guidelines in 2022 – Part 1: New rules for designs in view of China signing onto the Hague Agreement
  • Nov 24, 2022 China Proposes New Examination Guidelines for Utility Models
  • Nov 17, 2022 China Announcing More Proposed Amendments to the Examination Guidelines in 2022
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