This article originally appeared in IP Watchdog here. In compliance with the Phase One Trade Agreement, China has implemented a patent linkage system in their amended patent law, which became effective June 1, 2021 (Article 76 of the Patent Law of the People’s Republic of China (2020)). The Chinese patent linkage system prevents marketing approval of generic drugs until after the expiration of patents covering the drugs or uses. Specifically, the Center for Drug Evaluation (CDE) of the National Medical Products Administration …
Category: New Law, Rule or Implementing Regulation
China’s National Intellectual Property Administration Releases Patent Linkage Administrative Adjudication Measures
In follow up to the joint National Medical Products Administration (NMPA) and China National Intellectual Property Administration (CNIPA) release of patent linkage implementation measures, CNIPA has released the Administrative Adjudication Measures for Early Resolution Mechanisms for Drug Patent Disputes (药品专利纠纷早期解决机制行政裁决办法) on July 5, 2021. These Measures provide an alternative dispute mechanism to litigation (see the Supreme People’s Court’s (SPC) litigation provisions also issued July 5, 2021). CNIPA’s administrative adjudication may be the preferable route for patentees as the Administrative Adjudication …
China’s Supreme People’s Court Releases Patent Linkage Trial Provisions
In follow up to the joint National Medical Products Administration (NMPA) and China National Intellectual Property Administration (CNIPA) release of patent linkage implementation measures, China’s Supreme People’s Court released Provisions of the Supreme People’s Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases Concerning Patent Disputes Related to Drugs Applied for Registration (最高人民法院关于审理申请注册的药品相关的专利权纠纷民事案件适用法律若干问题的规定) on July 5, 2021. Of note is that while the Implementing Measures specify a 9-month moratorium in marketing authorization for a …
China Releases Patent Linkage Implementation Measures
On July 4, 2021, the National Medical Products Administration (NMPA) in conjunction with the China National Intellectual Property Administration (CNIPA) released the Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial) (药品专利纠纷早期解决机制实施办法（试行)). The Measures set up a registration system, set up a dual mechanism (via Courts or via CNIPA) for preventing marketing approval of drugs based on registered patents, and provide an exclusivity period for generics that successfully challenge patents.