Research On The Legal Issues Of China’s Pharmaceutical Patent Linkage System

The drug patent linkage system is a system in which generic drug applicants notify the original drug owner of the declaration that the patent is invalid or not falling within the scope of patent protection when conducting marketing approval,so as to realize the "link" between generic drug approval and the patent ownership of the original drug,and clarify whether generic drugs are allowed to be marketed and give market incentives through an early dispute resolution mechanism.China’s 2020 Patent Law established a pharmaceutical patent linkage system,marking that the implementation of the characteristic drug patent linkage system in China has become a foregone conclusion.In order to ensure the smooth implementation of the system,each department has formulated corresponding laws and regulations.In 2021,SIPO and NMPA jointly issued the Implementation Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes(Trial)(hereinafter referred to as the Implementation Measures),the State Intellectual Property Office issued the Administrative Ruling Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes(hereinafter referred to as the Administrative Ruling Measures),and the Supreme People’s Court issued the Provisions on Several Issues Concerning the Application of Law in the Trial of Civil Cases Involving Patent Disputes Related to Drugs Applying for Registration(hereinafter referred to as the Provisions on Drug Patent Disputes).The system is currently in the process of being piloted in the first instance.From the perspective of China’s original drug innovation is weak,the homogeneity of generic drugs is serious,the choice to introduce the drug patent linkage system is the best choice to promote the development of the pharmaceutical industry at present,drugs have the particularity closely related to the life and health of citizens,the particularity and the drug patent linkage system to promote innovative drugs to increase research and development,generic drug enterprises to imitate high-quality drugs and improve the accessibility of drugs The function is objectively intrinsically linked,therefore,China in the practice of resolving pharmaceutical patent infringement disputes.The introduction of a pharmaceutical patent linkage system is of substantial significance.Although the drug patent linkage system has institutional superiority,because the system originated in the United States,the social basis for the implementation of the system is the pharmaceutical industry dominated by innovative drugs,and the system construction is relatively mature.China is a country dominated by generic drugs,and due to the initial introduction of the system,the rules are not perfect,and judicial practice is mostly based on the principle of "freedom if the law does not prohibit it".Therefore,this paper argues that although there are no centralized obstacles to system operation in a short period of time,examining and comparing the system operation experience of the United States,South Korea and Canada can optimize China’s system design,theoretically regulate the problems that may occur in system operation,and make the pharmaceutical market prosperous.In terms of structure,this paper is mainly divided into the following four parts:The first part explains the legal structure and function of the drug patent linkage system.Drug patent link is an institutional system with multiple links,so it is necessary to construct and dissect it,clarify the concept of each part and analyze the overall operation mechanism.The legitimacy,development path and multiple functions of the establishment of drug patent links in China are summarized,which lays a theoretical foundation for the subsequent research.The second part reveals the current situation of legislation and operation of China’s pharmaceutical patent linkage system.Firstly,as far as the legislative status of China’s pharmaceutical patent linkage system is concerned,it mainly stipulates the legal basis,overall framework and core mechanism of dispute resolution for the early settlement of pharmaceutical patent disputes.As far as the current operation situation is concerned,there are three main aspects: the shortcomings of the existing provisions,the possibility of abuse of the patent linkage system,and the conflict of the dual-track dispute resolution mechanism.In the third part,the national drug patent linkage systems of the United States,South Korea and Canada are compared to provide reference for China’s pharmaceutical patent linkage system.The construction of the US pharmaceutical patent linkage system is mature and effective,while South Korea’s pharmaceutical patent linkage system has small characteristics,such as the substantive examination of patent registration,and its operation has also shown positive results.Canada’s drug patent linkage system is not sound in construction and fails to operate on the whole,but there are also points for China to learn from the system.The fourth part puts forward suggestions for the effective implementation of China’s pharmaceutical patent linkage system.First of all,we must adhere to the basic principles of improving the drug patent linkage system,including the principle of balance of interests,the principle of procedural convergence and the principle of clear boundaries;Secondly,to optimize the design of the drug patent linkage system,specifically,it is necessary to strictly set the conditions for the initiation of the procedure,clarify the relationship between the administrative ruling and the confirmation of the invalidation and the confirmation action,and the extension and shortening of the additional period.Finally,the regulatory mechanism of the drug patent linkage system is constructed,that is,the establishment of a regulatory mechanism and opposition procedure for improper registration,the scientific design of the damage compensation system during the waiting period,and the strict review of reverse payment settlement agreements.