Analysis of the incentive effect of the patent linkage system on the application of generic drugs in China and suggestions for countermeasures
- VernacularTitle:专利链接制度对我国仿制药申报的激励效果分析及对策建议
- Author:
Jiacheng CAO
1
;
Jiaxun FAN
1
;
Wenzhu WANG
1
Author Information
1. Inspection Center，Jiangsu Medical Products Administration，Nanjing 210019，China
- Publication Type:Journal Article
- Keywords:
patent linkage system;
patent challenges;
generic drug;
drug registration
- From:
China Pharmacy
2023;34(19):2311-2315
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To optimize the system of patent linkage system and provide a reference for encouraging generic drugs to apply for listing. METHODS On the basis of literature research， combined with the author’s work experience， the situation of generic drug application and patent challenge were analyzed comparatively after the implementation of the patent linkage system in China. Based on the patent linkage system， the reasons for the insufficient incentive for the challenge of generic drug patents in China were analyzed； corresponding countermeasures and suggestions were proposed. RESULTS & CONCLUSIONS The patent linkage system in China was implemented in 2021， but due to the implementation of the system being still in its initial stage， the relevant documents for practical guidance are not yet complete， and the supporting incentive mechanism is not yet sound， resulting in a weak willingness of generic pharmaceutical enterprises to initiate patent challenges. It is suggested that China can further improve the patent linkage system by improving the patent information registration platform of generic drugs， developing professional drug patent agencies， and establishing the patent common challenges platform of the first generic drug， in order to incentivize Chinese generic drug enterprises to increase innovation motivation， challenge original research drug patents， and apply for listing， achieving the effect of suppressing drug prices and benefiting the people through full competition.
