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
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
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.
关键词
首仿药/市场独占期/挑战专利/专利无效宣告/专利链接制度
Key words
first generics/market exclusivity/patent challenge/patent invalidation/pharmaceutical patent link
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