New Regulations Promote Drug Patent Linkage System

In July, the State Drug Administration and the CNIPA jointly issued the Measures for the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (for Trial Implementation), and the Supreme People's Court (SPC) promulgated the Provisions on Several Issues Concerning the Application of Law for Hearing Civil Cases of Patent Disputes Related to Drug Applications for Registration. These documents provide specific operational guidelines for the newly established early settlement mechanism for drug patent disputes.

The Measures has 16 articles, covering relevant platform construction and information disclosure system, patent right registration, generic drug patent declaration, judicial and administrative linkage mechanism, drug review and approval classification and the corresponding processes, and possible market exclusivity for first generic drugs.