Research On Legal Issues In Constructing Drug Patent Linkage System In China

The drug patent linkage system originated from the Hatch-Waxman Act of 1984 in the United States.Its main function is to resolve drug patent disputes in advance,balance the interests between new drug companies and generic drug companies,protect new drug patent rights,and encourage generic drug companies to actively imitate drug.Based on the experience of the United States,Canada,and Taiwan,this article studies the content,operation mechanism,and improvement process of the drug patent linkage system,and puts forward appropriate suggestions based on China's national conditions.This article uses comparative analysis research methods,literature analysis research methods,etc.to conduct comprehensive research and analysis on the drug patent linkage system.China should reasonably set up the system and content of drug patent linkage system,and build a drug patent linkage system based on "China New Drug Catalogue".The establishment of a drug patent linkage system in China will help improve the availability of drugs in China and the level of protection of intellectual property rights in drugs in China.When constructing a drug patent linkage system in China,we should take "improving drug accessibility" as the main value pursuit,and at the same time,we must focus on protecting new drug patent rights and promoting the coordinated development of new drugs and generic drugs in the competition.In order to better build China's drug patent linkage system,this article proposes the following: from the legislative level,determine the status of the drug patent linkage system;limit the types of drugs and patents registered in the "China New Drug List";ensure that the "China New Drug List" The openness and accuracy of patent information;strictly limit the patent subject matter on which new drug companies file infringement lawsuits;improve the type of patent declarations;realize the functional “connection” between the State Drug Administration and the State Intellectual Property Office,and the substance Examine the status of drug patents;restrict the conditions for obtaining the approval waiting period,reasonably set the length of the waiting period for approval;introduce the monopoly system of the first generic drug market;introduce a system of infringement;regulate the reverse payment agreement.