The Redemption of Drug Patent Linkage System: The Dilemma and Improvement in the Qualification System of Market Exclusivity Period for China’s First Generic Drug

Abstract

The market exclusivity period for China’s first generic drug is an incentive mechanism of the drug patent linkage system, and its activation and effectiveness are crucial to the whole drug patent linkage system. However, Article 76 of the Patent Law of the People’s Republic of China, Article 11 of Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes (for Trial Implementation), and other relevant provisions must be clarified. There is a great deal of ambiguity, which needs to be further addressed to clarify the determination of eligibility for the market exclusivity period for first generic drug. By sorting out the legislative provisions of the first exclusivity period system and analyzing the judicial practice of the relevant cases, the qualification of the first exclusivity period can be found. This article focuses on the determination of the “first”, the determination of the “challenging a patent successfully”, and the determination of the “jointly challenging a patent successfully”. It puts forward suggestions to improve the qualification system of the market exclusivity period and enhance the system’s overall operability in qualification determination.