Research On The System Of Drug Patent-linkage

Medicine is a special commodity that is closely related to people's life and health.Drug research and development has the characteristics of high risk,high investment and long cycle.Therefore,drug research and development must be protected and stimulated by a patent system with marketing monopoly.However,the expensive innovative drugs have led to the decline of public access to medicines,so it is necessary to actively encourage the production of generic drugs.In the context of complex and intertwined interests,it is necessary to clarify the rights and interests of all parties,actively use the theory of balance of interests,and create a system that encourages drug research and development,encourages the production of generic drugs,and safeguards the public interest.The drug patent linkage system has emerged as the times require.The patent linkage system originated in the United States.China has not fully implemented the system at present,and it is only partially reflected in the form.Based on the status quo of China's national conditions,the paper explores how to make reasonable choices about the content of patent linking system,integrates the proposed infringement rules into China's current legal system,rationally arranges the patent challenge system,comprehensively examines the current legal system and legislative trends,properly designs generic drug incentives and original research drug protection strategy,and finally proposes the establishment of the basic structure of China's drug patent link system.The paper has carried out the following five parts research on the drug patent linkage system:The first part of the article describes the patent protection of drugs.Firstly,the basic concept of the patent link system of drugs is defined,and the connotation of patent linkage system is elaborated.Secondly,it outlines the protection of pharmaceutical patents at home and abroad,focusing on the development of pharmaceutical patents in China.Finally,the differences between the patent linkage system and other drug patent systems are compared and analyzed,and their essential characteristics are highlighted.The second part of the article discusses the legitimacy of constructing a patent linkage system for drugs.On the one hand,it discusses the huge economic benefits brought by the patent linking system and judicial resource savings from the economic perspective.On the other hand,it discusses the significance of the patent linkage system to balance the original drug,generic drug and public interest from the perspective of balance of interests.Through the discussion of two perspectives of economics and interest balance,this paper further analyzes the inherent nature of the drug patent link system and provides a theoretical basis for the construction of China's system.The third part introduces the development experience of the extraterritorial patent link system.First,it introduces that the patent linkage system,originated from the United States,which will be introduced separately from the balance of interests and the content of the system.Then,it studies the development path and experience of Korean drug patent linkage system.Finally,it studies how Canada made reasonable absorption and adaptation of American experience.Drawing on the experience and lessons of development outside the domain can provide an empirical reference for the establishment of the drug patent linkage system in China.The fourth part of the article analyzes the practice and deficiency of China's drug patent linkage.First,it analyzes the relevant legal documents such as China's Patent Law,and Drug Registration Management Measures.The study found that China only partially reflects the patent linkage in the form,lacking the essence based on the balance of interests.Therefore,the important role of patent linkage in maintaining the balance of public interest can not come into play.Then it points out that there are shortcomings in the balance of interests,patent claims,incentive measures,dispute settlement mechanism,and scope of examination in the practice of patent linkage in China.Finally,it provides targeted comments and suggestions.The fifth part of the article puts forward the proposal of establishing a drug patent linkage system in China.Firstly,based on the status quo of China's public health and pharmaceutical industry,the overall framework of China's pharmaceutical patent linkage system is presented in the form of a flow chart.Then,from the perspective of administrative and legislative aspects,it is proposed to improve the patent linkage system of China's medicines in a targeted manner.