Supreme People’s Court Promulgated Judicial Interpretation on Pharmaceutical Patent Linkage Litigation
ISSUING AUTHORITY:
Supreme People's Court
DATE OF ISSUANCE:
July 4, 2021
EFFECTIVE DATE:
July 5, 2021
In follow up to the joint release by the National Medical Products Administration and China National Intellectual Property Administration of Matters Concerning the Implementation of the Implementing Measures for the Early Resolution Mechanism for Drug Patent Disputes (for Trial Implementation) on July 4, 2021, the Supreme People's Court promulgated Provisions of Supreme People's Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases of Patent Disputes Related to Pharmaceutical Registration Applications (the “Judicial Interpretation”) on the same day.
The Judicial Interpretation, which provides clarity and guidance on the Chinese Pharmaceutical Patent Linkage System (the “System”), entered into force on the date of promulgation. The System originated from the Hatch-Waxman Act of the United States, aiming to balance between competing interests of brand name drug companies and generic drug companies. The System sets up a dual mechanism for preventing marketing approval of drugs based on registered patents and provide an exclusivity period for generics that successfully challenge patents.
In October 2020, Article 76 was added to the fourth amendment of the PRC Patent Law, marking the official establishment of the System in China. To cooperate with the implementation of Article 76 of the PRC Patent Law, the Supreme Court issued the Judicial Interpretation. The Judicial Interpretation focuses on the procedural issues that need to be solved after the establishment of the System and provides for the court of jurisdiction, materials for filing the case, defense grounds, confidentiality obligations of the parties, requirements for technical solutions submitted to the court, etc. Therefore, the Judicial Interpretation may not only help to speed up the trial patent infringement cases but also enable the effective implementation of the System.
Reference:
国家药监局、国家知识产权局关于发布《药品专利纠纷早期解决机制实施办法（试行）》的公告
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
最高法民三庭负责人就《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》答记者问
