China Patent Strategy

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

    A Detailed Dive into China’s New Patent Term Extension Provisions

    December 11, 2020

    This article is a part of a larger article that highlights the newest draft implementation rules of the new Chinese Patent Law. This particular article takes a detailed dive into the patent term extension/adjustment provisions. One of the biggest and most exciting provisions in the newly amended patent law is patent term extension for delay caused by the patent office (PTA) or by the drug regulatory approval process (PTE). In general, the Chinese version seems to be modeled off of existing systems in other jurisdictions around the world (e.g., the US), and as a whole seem reasonable to us. For the sake of easy understanding, we shall use the equivalent…

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  • Dec 04, 2023 Top 10 China IP Board Case 2022 – Validity of RNAi Inventions
  • Nov 27, 2023 Inventive Step for an Enantiomer over a Racemate: “L-ornidazole” Patent Invalidation Case
  • Nov 10, 2023 Announcement: Implementation Regulations (Rules) of the Chinese Patent Law have been Approved
  • Apr 12, 2023 CNIPA further clarifies how it counts “delays” when calculating Patent Term Adjustment (PTA) in the new Draft Examination Guidelines and how it affects international applicants
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