China's Measures for Implementation of Early Resolution Mechanism for Drug Patent Disputes (Trial Implementation) Take Effect
On 4 July 2021, the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly promulgated the Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes (Trial Implementation) (No. 89 of 2021), which have come into force upon promulgation.
The early resolution mechanism for drug patent disputes is a system that links the marketing approval procedure of a drug and the resolution procedure for related drug patent disputes. This patent linkage system was introduced to China by Article 76 of the revised Patent Law of China effective 1 June 2021.
The Measures, containing 16 articles, are intended to provide the parties concerned with the mechanism for resolving related patent disputes during the drug marketing review and approval stage, to protect the legitimate rights and interests of drug patent holders, and to reduce the risk of patent infringement after the marketing of generic drugs.
The main contents covered by the Measures include the patent linkage procedures, by the judicial and the administrative channels; registration of patent information on the patent listing platform; patent information disclosure; generic drug patent declaration; approval stay period; categorised review and approval of drugs; and market exclusivity period for first generic drugs.
