Research on Rights Confirmation Procedure Under Drug Patent Linkage System
The drug patent linkage system,also known as the early resolution mechanism for drug patent disputes,prioritizes the resolution of drug patent disputes between generic drugs and patented drugs in the market approval process,aiming to bridge the gap between generic drug approval and patented drug patents.It includes sub systems such as patent declaration system,patent disclosure system,and simplified application system for generic drugs.In judicial practice,the drug patent linkage system does not operate independently,and the trial of invalidation cases is often mixed in the linkage cases.The procedural connection between the two affects the operation of the drug patent confirmation process.With case analysis and comparative reasearch,this article summarizes two practial problems in the field of drug patent after the establishment of the drug patent linkage system:abuse of invalid procedures and assimilation of four types of declarations.On this basis,the article also explores the root causes of the problems,proposes corresponding solutions,and actively explores new possibilities for judicial and administrative organs in the binary system.
drug patent linkdrug patent administrative proceduresdrug patent right confirmation procedure
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