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
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…
- Biotech, China, Patent Linkage, Patent Term Extension, Pharma, Proposed Changes, Updates and Changes
China Releases Details on Patent Term Extension, Deferred Examination and More in the Latest Draft Implementation Rules of the New Chinese Patent Law
The China National Intellectual Property Administration (CNIPA) is moving forward at breakneck speeds aiming to get all the necessary pieces in place for the June 1, 2021 date when the new 4th Amendment of the Patent Law will come into effect. Most recently, this means a flurry of drafts coming out from CNIPA, including, but not limited to, draft measures with the National Medical Products Administration (NMPA) relating to patent linkage, draft examination guidelines, and what we’ll discuss today, draft implementation rules of the new patent law. We are encouraged that CNIPA is engaging the public, allowing any member of the public to submit comments within a specific timeframe. We…
