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,  Court Cases,  Courts,  Patent Law,  Pharma

    What Kind of Damage Awards Can You Get in China?

    June 16, 2022

    Is it worth filing for a patent in China? What kind of damage awards can you get? Pharma companies care more about injunction than damage awards, since it’s quite unlikely that any damage award can compensate for the large amounts of money that may be lost for patent infringement. Chinese courts often issue injunctions in pharma patent litigations (both by the court and administrative enforcement bureaus), though damage awards are possible too. Although not all court cases are publicly available, there have been some recent published cases with pretty high damage awards, ranging from $750K USD to $25M USD. Keep in mind these are cases litigated under the old patent…

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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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  • First Ever Successful Invalidation Challenge Due to Unauthorized Foreign Filing
  • 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
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Recent Posts

  • Mar 22, 2023 Foreigners Beware: China Proposes Requiring IP Made Using Exported Chinese Genetic Resources to be Co-Owned by Chinese Collaborators
  • Mar 08, 2023 First Ever Successful Invalidation Challenge Due to Unauthorized Foreign Filing
  • 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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