The Supreme People’s Court has just issued draft regulations for comment regarding how new Article 76 will work in conjunction with civil procedure law. The period to submit comments ends December 14, 2020, and the final version will come into force June 1, 2021, together with the new Chinese Patent Law. The Backdrop: New Chinese Patent Law Adds Patent Linkage (Article 76) Linking Drug Approval to a “Clear” Patent Position In October of 2020 China passed the 4th amendment of the patent law which ushered in some sweeping changes in certain areas that are especially exciting for life science companies. One of the most important changes is the introduction of…
- Biotech, China, Patent Linkage, Patent Term Extension, Pharma, Supreme People's Court, Updates and Changes
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Breaking News: China passes Fourth Amendment to the Chinese Patent Law
After 12 years, the Fourth Amendment to the Chinese Patent Law has passed and will be in effect on 1 Jun 2021. After years of multiple draft amendments that moved in various directions, we FINALLY have some clarity on what patent protection is going to look like in China in the coming future. Many of these changes were already in the proposed draft amendments that came out in 2019 and 2020, though there have also been some adjustments. Most notable aspects of this new law include (1) patent term extension due to regulatory or patent office delay (2) patent linkage between new drug approval and patent disputes; (3) litigation reform…
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China Forges Ahead with Draft Measures for New Patent Linkage System
Update! The finalized Implementation Measures are now out. You can read the details here: Breaking: China Released New Implementation Measures for the New Patent Linkage System Last month September 11, 2020, China’s National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly issued a draft set of measures for public opinion about early dispute resolution mechanisms for drug patents, what is referred to as a patent linkage system. Below is a summary highlighting key provisions. Creation of an “Orange Book” List The NMPA will create a public registration platform that will list patent information for all drugs marketed or seeking marketing authority in China (similar to…