Research On Drug Patent Linkage System In China

As we all know,medicines are special commodities that are related to life,health and people’s safety.Since the reform and opening up,my country’s pharmaceutical industry has developed rapidly.However,compared with developed countries,the degree of technological innovation and R&D capabilities are relatively weak.The drug patent link system is undoubtedly the core mechanism for realizing the good operation of the pharmaceutical industry in the new era.The drug patent link system links generic drug marketing approval with the original brand drug patent ownership status,and resolves generic drug patent infringement disputes in advance to the marketing approval stage,thus protecting the interests of both the original brand drug and the generic drug.In 2021,my country’s new "Patent Law" and "Implementation Measures for the Early Resolution Mechanism of Drug Patent Disputes(Trial)" established my country’s drug patent linkage system.The establishment of the new system is a pioneering work.This paper deeply explores my country’s characteristic drug patent link system,and analyzes its operation mechanism and value trend in detail;through the comparative study of foreign systems,combined with the current situation of my country’s pharmaceutical development and legislation,it proposes countermeasures for possible problems in practice.Specifically,the first chapter clarifies the relevant theories of the drug patent linkage system,the development context outside the territory and the development process of our country,and analyzes the necessity of establishing a drug patent linkage system in our country.It is clarified that the "link" of the drug patent link system is mainly manifested in three levels;it summarizes that my country’s drug patent link system has experienced the development process of low-level,low-protection,low-link,high-level,high-protection,high-link;The inevitable choice of the development of the times.The second chapter focuses on analyzing the status quo and deficiencies of my country’s drug patent linkage system.In general,its main framework is roughly the same as that of the United States,but it combines my country’s national conditions and legislative environment in detail settings to form a Chinese-style drug patent link system,and points out the innovation of the new patent law and the connection between the confirmation lawsuit and the current law.,the patent information registration system and the inadequacy of the reverse payment agreement.The third chapter analyzes the specific content and implementation effect of the extraterritorial patent linking system,compares the key elements of the extraterritorial patent linking system horizontally,analyzes and summarizes the drawbacks and optimization paths of the system,and inspires the improvement of our country’s system.The United States is the identification promoter of the system,which has achieved the legislative purpose of balancing imitation and innovation;South Korea has rationally internalized its own national conditions and has achieved remarkable results;Canada is a passive transplant,which not only fails to stimulate innovation and R&D capabilities,but also causes damage to the booming generic drug industry.While India and the European Union are the representatives of the insistent opposition.The main drawbacks in the implementation process of various countries are: abuse of patent registration system,abuse of waiting period,and reverse payment.However,countries have also taken corresponding countermeasures,which are worthy of reference for our country.The fourth chapter proposes the optimization path of my country’s drug patent link system,and proposes that my country should set up special fictitious infringement cases to provide legal reasons for patent challenges;strictly limit the time for supplementary registration on the patent registration information platform,add opposition procedures,and expand the scope of opposition.Provide adverse results to ensure the authenticity and integrity of patent registration information;include monopoly profits during the period of delayed generic drug launch of original research drugs into the calculation of damages;set up anti-monopoly filing and review of settlement agreements to reduce the damage of anti-competitive behavior;It is recommended that various administrative agencies set up offices to achieve deep functional links.