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With the revision of Chinese Patent Law in 2020, the new law came into force on June 1 this year, and a series of related regulations and judicial interpretations concerning pharmaceutical patents also arrived in due course. In July this year, the China National Intellectual Property Administration (CNIPA) and the Supreme People's Court issued new regulations and judicial interpretations related to pharmaceutical patent disputes one after another. For example, the CNIPA issued the Measures for Administrative Ruling on Early Settlement Mechanism of Pharmaceutical Patent Disputes, and the Supreme People's Court also issued the Provisions on Several Issues Concerning the Application of Law in Civil Cases of Patent Disputes Related to the Application for Registration of Pharmaceutical Products.
As a brand-new legal system, the Early Settlement Mechanism for Pharmaceutical Patent Disputes (also known as the Pharmaceutical Patent Linkage System) has no practical basis in China before; however, the system is related to the balance of interests between generic drugs and originator drugs, and is even closely related to public health, therefore, the introduction of the Measures for Administrative Ruling on Early Settlement Mechanism of Pharmaceutical Patent Disputes and the Provisions on Several Issues Concerning the Application of Law in Civil Cases of Patent Disputes Related to the Application for Registration of Pharmaceutical Products is crucial.