Strategic exploration of the implementation of China’s drug patent linkage system corresponding to international rules
- VernacularTitle:对标国际规则的我国药品专利链接制度实施策略探索
- Author:
Yuan WANG
1
;
Rong SHAO
1
;
Jianzhou YAN
1
Author Information
1. Scientific Research Institute of Drug Administration，China Pharmaceutical University/Key Laboratory for Drug Regulatory Innovation and Evaluation，National Medical Products Administration，Nanjing 211100，China
- Publication Type:Journal Article
- Keywords:
drug patent linkage system;
early resolution mechanism for patent disputes;
patent law;
generic drug
- From:
China Pharmacy
2022;33(21):2566-2571
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To explore the implementation strategy of China ’s drug patent linkage system from the perspective of the system design ，in order to encourage drug innovation and improve the development level of high -quality generic drugs . METHODS The current progress and challenges were summarized from the current situation of the implementation of China ’s drug patent linkage system by sorting out the relevant policy documents of the system . On this basis ，the successful experience and lessons of foreign countries were summarized to provide strategic suggestions for the implementation of China ’s drug patent linkage system in combination with China ’s basic national conditions . RESULTS& CONCLUSIONS With the introduction of the revised Patent Law of the People ’s Republic of China in 2020，China had basically completed the top -level design of the system ，but some rules and regulations had not been improved . There were still some problems ，such as the lack of a “fake infringement ”system in China，the lack of review and correction mechanisms for patent information registration ，poor links between judicial and administrative channels ，the dispute over the length of waiting period ，and the lack of clarity of relevant rules for the exclusivity period system of the first generic drug market . It is recommended that China establish a “fake infringement ”system and a judicial decision procedure for patent invalidation ，adjust the length of the waiting period or the basis for market approval ，further clarify the definition of the first generic drug ，the circumstances of jointly challenging patents and the reasons for the elimination of the market exclusivity period ，and strengthen the functional link procedures of relevant departments and implement the responsibility mechanism.
