我国首仿药市场独占期制度现状与完善——基于美国、韩国经验的探讨

The Status and Improvement of the Market Exclusivity System for the First Generics in China:A Comparative Exploration Based on the Experiences of the United States and South Korea

目前,我国已基本完成首仿药市场独占期制度的顶层设计,制定出制度框架,但部分细则规定尚未完善。在市场独占期获得方面,存在首个挑战专利成功中四类声明范围待明确、无效决定是否应生效存在争议、共享市场独占期可操作性待提高等问题;在市场独占期丧失方面,缺乏市场独占期丧失事由。在推动市场独占期制度实施过程中,建议我国进一步明确首个挑战专利成功应包含4.1类及4.2类声明、不要求无效决定生效、降低共享市场独占期的要求、设定首仿药市场独占期丧失事由,从而推动原研药和仿制药协同发展。

China has completed the top-level design of the market exclusivity system of first generics,formulating an institutional framework.However,some detailed regulations remain imperfected.Challenges in obtaining market exclusivity include undefined scope of the four types of declaration in the success of the first patent challenge,controversy over the effectiveness of invalid decisions,and poor operability of shared market exclusivity.In terms of the loss of market exclusivity,there is a lack of reasons for its loss.To promote the implementation of the market exclusivity system,it is suggested that China further clarify the success of the first patent challenge,including 4.1 and 4.2 declarations,eliminate the requirement for the effectiveness of invalid decisions,reduce the criteria for shared market exclusivity,and establish reasons for the loss of market exclusivity for first generics.This will promote the collaborative development of original and generic drugs.