Research On The Perfection Of Chinese Drug Patent Linkage System

The drug patent linking system refers to a system that links the approval of drug marketing applications with the patent system to ensure the healthy development of the pharmaceutical industry and thus the right to health.To put it simply,the patent system provides the market with cheap and safe generic drugs by virtue of its generic drug approval system,patent challenge system,and supporting system,and encourages innovation by virtue of its drug patent term extension system and drug trial data protection system.So that new drugs can continuously appear in the market to treat new diseases.The link system enables citizens to obtain cheap medicines and at the same time obtain new medicines to realize the protection of the right to health.my country established a link system in 2002,but the link system is not perfect.Judging from the content of the legislation,first of all,the laws that have been promulgated are incomplete and unavailable;secondly,there is no system to extend the duration of drug patents,and innovation cannot be encouraged.From the perspective of legislative methods,there is no systematic legislation,but the provisions of laws are stipulated in various laws,and a system cannot be formed.More and more countries in the world have established a link system,reflecting the importance that each country attaches to its citizens’ right to health.Foreign countries follow the principle of efficiency and utilization to systematically establish and improve the drug patent link system,w hich is worthy of reference for our country.Based on the existing experience of countries outside the country and combining with China’s basic national conditions,China should improve the drug patent link system from the following six aspects.First,it will improve the approval and supervision procedures for generic drugs,and recommends that the US "prohibition order" be domesticated and Establish a citizen inquiry mechanism;second,improve the patent challenge system,refine the patent declaration wit h reference to the content of the four paragraphs prescribed by the United States,then establish administrative procedures to resolve patent disputes in the patent challenge,and finally improve the patent challenge incentive measures;third,Bridging the patent challenge system with the patent dispute trial mechanism,establishing judicial procedures for filing administrative litigation corresponding to the administrative procedures for resolving patent disputes in patent challenges;fourth,improving the drug test data protection system,recommending transplantation of relevant US regulations and establishing burden of proof Invert the mechanism to improve the drug trial data protection system;Fifth,improve the patent term extension system,it is recomm ended to transplant the relevant provisions of the United States to establish a drug patent term extension system;sixth,improve the supporting system,it is recommended to establish a generic drug use mechanism,citizen participation mechanism,Departme ntal joint mechanism,circumvention of reverse payment mechanism.