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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China’s Newest Examination Guidelines: Post-Filing Supplemental Data for Compounds (Part I)
Post-filing data in China has been a constant issue for many patent practitioners around the world. Examiners seem to require it often, and yet the rules regarding when it is acceptable have seemed much stricter than other jurisdictions worldwide. In fact, we tried to summarize the latest state of the law in an earlier blog post The Latest on Post-Filing Data in China’s Patent Law back in April 2020. A lot has happened around the world this past year (to say the least). In the area of post-filing supplemental data, several different moving parts have contributed to more clarity in China on this issue. First, Phase 1 of the US…
- 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…
