Research On My Country's Generic Drug Patent Linkage System

Generic drugs are rapidly developing in the global pharmaceutical market due to their advantages of high pharmacological activity,good therapeutic effect,and low price.They are of great significance for ensuring the availability of drugs and maintaining public health.Although Chinese generic drug business started late,due to the strong support of the state and government,the generic drug business has developed rapidly on the whole and has a bright future.Under the dual background of the development of global health and the rise of Chinese generic drug industry,China has initially established a patent link system that links the approval of generic drug listing and the expiry of the patent period of the original research drug.However,since the system is imported from abroad,laws and regulations such as the“Patent Law”and the "Drug Supervision and Administration Measures" are not perfect,resulting in the phenomenon of not paying attention to patent rights or abusing patent rights in the medical field.In this context,this study uses conceptual analysis,comparative research methods,public policy analysis and other methods,taking the patent link system as an entry point,summarizing the development status of Chinese generic drugs and advanced experience in the development of generic drugs outside the country,clarifying the contradictory relationship between generic drugs and drug patents,seeking a balance between the patent protection rights of medicines and the right of national public health,to understand the patent link problem in generic drugs more thoroughly and comprehensively,so as to explore and construct the patent link system for generic drugs in China path.The first part of the article gives a general overview of the generic drug patent link system.First,the concepts related to the generic drug patent link system are analyzed,and finally what is the drug patent link system is defined;Then based on the balance of interest theory,law and economics theory,competitive advantage theory,efficiency theory,the theoretical basis of the implementation of the generic drug patent link system was analyzed.The second part is a summary and investigation of the development process and current status of the generic drug patent link system in and outside the domain.On the status quo of the patent linkage system for generic drugs outside the region,it compares and summarizes the enhanced interest balance model in the United States,the accelerated listing approval model in Canada,the public health tilted model in India,and the longest data protection period patent link system in the EU.On the analysis of the current status of the domestic generic drug patent link system,systematically combed the generation and development of Chinese generic drug patent link system,and introduced the legal status of China’s generic drug patent link system.The third part discusses the problems of Chinese generic drug patent link system.On the basis of the content of patent links in China’s existing generic drugs,combined with theoretical basis,through comparison and case evidence,there is a lack of specific laws in China’s generic drug patent link system.It is difficult to coordinate laws and policies.Unreasonable,judicial relief and departmental coordination supporting system need to be improved and other issues are summarized and exemplified.The fourth part is the countermeasures and suggestions to improve the patent link system of Chinese generic drugs.Through the reference to the patent linkage system of generic drugs outside the territory or the patent policy of drugs,combined with the shortcomings of Chinese generic drug patent linkage system in practice,it is proposed from three aspects:multi-institutional research legislation,focusing on the highlighting of patent characteristics,and accelerating the improvement of the derivative system.