National Medical Products Administration and China National Intellectual Property Administration, Implementing Measures for the Mechanism for the Early Resolution of Pharmaceutical Patent Disputes (Trial Implementation)

国家药品监督管理局、国家知识产权局药品专利纠纷早期解决机制实施办法 (试行)

August 06, 2021 | BY

Susan Mok

An early resolution mechanism is in place for pharmaceutical patent disputes

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Promulgated:July 4, 2021

Effective: as of date of promulgation

Main contents: When a chemical generic drug applicant submits an application for pharmaceutical marketing authorization, it shall compare the patent information disclosed on China's marketed pharmaceutical patent information registration platform and make a statement on each pharmaceutical patent related to the brand name drug. Statements are divided into four categories:

(1) category 1 statement: there is no patent information relating to the brand name drug on China's marketed pharmaceutical patent