Research On Pharmaceutical Patent Linkage System

Medicine is closely related to the quality of human life and is the key to preventing diseases.Various diseases appearing in the process of human development have prompted the pharmaceutical industry to continuously develop new drugs.Since the pharmaceutical industry is a high-tech,high-risk,high-input,high-return,knowledge-intensive high-tech industry,the new drug research and development industry is far more dependent on patent protection than other industries.The patent system allows new drug research companies to monopolize in certain markets.During the period,the cost will be recovered,profits will be earned,and the long-term sustainability of drug development will be maintained.However,excessive drug patent protection has kept drug prices high for a long time,beyond the reach of people,impairing the accessibility of drugs and detrimental to public health.As a substitute for patented drugs,generic drugs can reduce drug prices and improve drug access while ensuring drug safety and effectiveness.The listing of generic drugs divides the monopoly market of patented drugs.There is a competitive relationship between the two,how to effectively balance The interests of both are the core of the Pharmaceutical patent linkage system.The Pharmaceutical patent linkage system is a system of systems,including the promotion of generic drug listing systems,the encouragement of drug research systems,and the resolution of patent disputes in the process of registration and approval of generic drugs.The system began in the United States and has had a profound impact on the US pharmaceutical industry.China has introduced some of the provisions of the system so far,but it is not perfect.In order to promote the development of China's pharmaceutical industry and protect public health,China's drug registration in 2017 The Administrative Measures(Revised Draft)clearly stated that a drug patent link system should be established.Subsequently,China has successively issued a series of documents on the Pharmaceutical patent linkage system.This article is divided into five parts:The first part introduces the emergence and development of the Pharmaceutical patent linkage system.Firstly,it defines the specific meaning of the Pharmaceutical patent linkage system,and clarifies that the research object of this paper is the broad Pharmaceutical patent linkage system;then analyzes the system's production and subsequent development and improvement;finally discusses the relationship between patent protection and drug registration management.The relationship led to potential patent disputes in the drug registration management process.The second part examines the theoretical basis of the Pharmaceutical patent linkage system.The essence of the system is to achieve a balance of interests: the balance of interests between the patentee and the generic drug company,and the balance between the pharmaceutical industry and the public interest.This paper takes the theoretical basis of the patent system and the guarantee obligation of the public health right as the starting point,discusses the theoretical basis of the patent link system of drugs,and analyzes the value of the system.The third part analyzes the status quo and deficiencies of China's pharmaceutical patent link system.By studying China's current government regulation legal system and patent law,this paper analyzes the shortcomings of China's Pharmaceutical patent linkage system from three aspects: encouraging the listing of generic drugs,promoting the research and development of patent drugs,and solving the patent disputes in the process of registration and approval of generic drugs.The system of our country paved the way.The fourth part studies the US patent patent linking system.Since the system originated in the United States,the relevant systems in other countries are the same as those in the United States,and the system has achieved great success in American pharmaceutical practice,and has great reference value for improving China's related systems.Therefore,this article explores the US industry in detail.And the status quo of legislation,and analyzed the importance of the Pharmaceutical patent linkage system to the United States.The fifth part puts forward suggestions for perfecting China's Pharmaceutical patent linkage system.Through the research on the US patent link system,this paper proposes to introduce the US system from three aspects: encouraging the listing of generic drugs,promoting the development of patented drugs,and solving the patent disputes in the process of registration and approval of generic drugs.At the same time,combined with China's national conditions,it promotes The listing of generic drugs,encourage generic pharmaceutical companies to challenge patents,the appropriate weakening of patent protection and Carefully introduce the patent extension system for drugs for pharmaceuticals have enabled Chinese pharmaceutical companies to have the opportunity to accumulate funds and gradually improve their innovation capabilities.