The issuing of the Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes(for Trial Implementation)marks the initial attempt of constructing the exclusivity system in China.The first chemical generic drug to successfully challenge a patent and be approved for marketing shall be granted a 12-month market exclusivity period.But it is difficult to meet the conditions of a 12-month market exclusivity period for the varieties in the Encouraged Generic Drug Catalogs.We could learn from the design of the exclusivity system in the US by building a dual-track exclusivity system,to exert the incentive function of the system.In addition,it is better to cooperate with the Encouraged Generic Drug Catalogs,the Priority Review and Approval System,the Communication Mechanism,etc.,to boost the research and development of generic drugs,as well as the quality and therapeutic effect of generic drugs.
关键词
市场独占期/鼓励仿制药品目录/首仿药
Key words
Exclusivity system/Encouraged generic drug catalogs/First chemical generic drug
维普
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