Research On The Drug Patent Linkage System

In the fight against the COVID-19 epidemic,the importance of drug research and development for social development has become more and more obvious.At the same time,the protection of intellectual property rights of drugs also needs to be more cautious and balanced because of the particularity of drugs.On the one hand,medicine is a special commodity with the attributes of public welfare,and it is a necessity to maintain human life and guarantee the dignity of life;on the other hand,medicine is a highly specialized product with long cycles,high investment and high risks in the research and development process.Characteristics,it is necessary to use the patent system to protect drug research and development,to ensure that the original research drug companies obtain high profits to recover costs,and stimulate the motivation of the original research drug companies to innovate and develop.Excessive protection of drug patents will cause the price of original drugs to be abnormally high,and it is difficult for generic drugs to enter the market,which affects the availability of drugs to the public;but it is unfavorable to the protection of drug patents,and will also affect the research and development enthusiasm of original drug companies,which is not conducive to the pharmaceutical industry Innovative development.The drug patent linkage system is constructed on the basis of taking into account the sustainable development of the pharmaceutical industry and the protection of citizens’ lives and health.The system links the registration and approval process of generic drugs with the patents of original research drugs,and links the patents that may be triggered by generic drugs after they are marketed.Disputes are resolved at the approval stage in advance,which is essentially an early resolution mechanism for drug patent disputes,in order to achieve a balance of interests between the original research drug companies and generic drug companies,and to promote the public’s access to drugs.For this reason,my country’s "Patent Law" added Article 76 during the fourth revision to establish a drug patent linkage system.It is still in the early stage of the establishment of the system,and the regulations and related rules of the system need to be refined and improved.This article analyzes my country’s new laws and regulations,clarifies the framework of my country’s drug patent linkage system,and focuses on the problems existing in my country’s drug patent linkage system through an extraterritorial investigation of the drug patent linkage system and research on the theoretical basis and practical significance of the drug patent linkage system: Drug patent registration needs to be optimized,drug patent dispute resolution methods need to be clarified,the specific provisions of opposition period and waiting period need to be discussed,and the linkage mechanism of relevant departments needs to be strengthened.Finally,after comprehensively considering theoretical analysis,empirical data,and foreign experience,suggestions for improving my country’s drug patent linkage system are proposed: perfecting the "List of Listed Drugs in China",establishing a drug patent registration and review mechanism;clarifying the patent challenges of generic drugs,The cause of the litigation procedure was clarified;a dual notification mechanism was set up to determine a waiting period of 24 months;the functions of the Drug Administration,the State Intellectual Property Office,and the court were clarified,and communication and coordination between departments were strengthened.