Research On The Improvement Of My Country’s Drug Patent Linkage System

China is a populous country with a vast drug market,but for a long time,the degree of originality and innovation ability of China’s pharmaceuticals has not been sufficient to meet the actual needs of the nation’s people.The existing pharmaceutical industry in China is still dominated by copying the patented drugs of big foreign pharmaceutical companies,resulting in the high prices of some patented drugs on the market,which greatly affects the accessibility of drugs and the public’s right to health.In order to comprehensively improve the R&D and innovation capability of China’s pharmaceutical industry,while taking into account the innovation enthusiasm of patented pharmaceutical companies,it is necessary to weigh the interests and design a reasonable system.Drug patent linkage is such a system that can take into account the interests of both sides.After years of laying the groundwork,the Opinions on Deepening the Reform of the Review and Approval System to Encourage Drug and Medical Device Innovation was published in 2017,kicking off the construction of China’s drug patent linkage system.After four amendments,the Patent Law came into force on January 1,2021.Article 76 of the Law stipulates that the drug supervision and administration agency under the State Council,together with the competent patent department under the State Council,shall collaborate to develop early dispute resolution at the stage of approval and application for the marketing authorization of drugs.On July 4 of the same year,the supplemental introducing department issued the Implementation Measures for Early Dispute Resolution Mechanism for Pharmaceutical Patents(for Trial Implementation)(hereinafter referred to as "Implementation Measures").Subsequently,the State Intellectual Property Office and the Supreme People’s Court also issued a series of supporting specific and detailed specifications one after another.The formulation of these laws,regulations and policies marked that China’s drug patent linkage system has taken shape in the general framework.The overall framework of China’s drug patent linkage system is basically consistent with the relevant construction path of the United States,and at the same time,it has also absorbed the excellent improvements made by Korea and Canada in the construction of the relevant system.The specific contents are also applicable to the actual situation and legal environment of China,forming a drug patent linkage system that is in line with the realistic development of China’s pharmaceutical industry,which is conducive to the good development of China’s pharmaceutical industry.However,at the same time,there are also some shortcomings,for example,the patent information registration system is still imperfect,which may lead to false registration and cannot be countered;the approval waiting period is automatically triggered,and the length setting is unreasonable;The unregulated market exclusivity period has loopholes,which may encourage both parties to reach settlements and lead to "anti-monopoly";the system of "proposed infringement" is not set,resulting in a certain degree of nonconnection of laws and regulations,etc.Therefore,in the subsequent improvement of the drug patent linkage system,China should also take into account the current situation of the development of the drug industry and continue to increase the examination of different practices of foreign countries,such as Canada,South Korea,Australia and even India,so as to finally find a perfect path that is in line with its own national conditions.Specifically,we should further improve China’s drug patent information disclosure platform,increase the feedback mechanism for third-party objections and measures to deal with intentional improper registration;extend the waiting period for drug marketing approval to 12-18 months and change the mode of acquisition to acquisition in accordance with the application;increase the regulation of the first generic drug market exclusivity period and increase the mechanism of "loss of rights";and establish a clear regulation of "loss of rights".The system should be harmonized with the legal system by establishing a clear regulation of "proposed infringement".Ultimately,the drug patent linkage system can better encourage innovation of originator drugs,while reducing drug prices and enhancing people’s welfare.