| When the medical technology,medical economy and public health are concerned,how to effectively protect the patent of medical invention can not only stimulate the innovation of medical technology and promote the development of medical industry,but also meet the accessibility of drugs and protect the realization of public health rights and interests,which has become a key topic discussed by the domestic and foreign academic and industrial circles.At present,China's drug registration and approval process does not examine the patent status of the drugs to be listed,which leads to the dual risks of patent infringement and delisting.In the process of drug registration and approval,there is no effective patent dispute resolution mechanism to effectively protect the legitimate rights and interests of drug patentees.The system needs to introduce a mechanism to link the registration and approval of drugs with the protection of patent rights.The drug patent linkage system first came into being in the Hatch Maxman Act of 1984 in the United States,and was optimized and improved in the Medicare Prescription Drug,Improvement,and Modernization Act of 2003.China's current measures for the administration of drug registration only makes basic provisions on the relationship between the review and approval of drugs and the ownership status of patents.Our country has not yet established a substantial drug patent linkage system.China's existing regulations are too simple and broad,lack of practical operability,and the actual operation effect is not good,so it is difficult to meet the actual demand of pharmaceutical industry innovation and development.At present,the macro policy level of our country proposed to explore the construction of drug patent linkage system,which caused extensive discussion in the theoretical and practical circles.In order to ensure the effective deployment and implementation of pharmaceutical innovation policy,it is necessary to design the construction scheme of pharmaceutical patent linkage system on the basis of scientific research.It is of great practical and theoretical significance to conduct a comprehensive and systematic study on the drug patent linkage system.This paper comprehensively combs and analyzes the causes,background,development process,basic contents and functions of the drug patent linkage system,excavates the purpose and value concept contained in the system,analyzes the internal operation mechanism and defects of the system,explores the key and important influencing factors in the establishment and implementation of the system,and finds and solves the drug patent linkage system.Based on the comparative analysis of the legislative practice,actual operation and implementation effect of the United States,Canada,South Korea and other countries that have established drug patent linkage system,the paper summarizes and analyzes the advantages and disadvantages of different legislative models,and absorbs and reasonably draws lessons from these problems Based on the beneficial attempts,explorations and experiences of the state in the field of drug patent protection and drug regulatory system reform,combined with the actual development of China's pharmaceutical industry,pharmaceutical innovation policies and institutional environment,the state has established the legislative model of drug patent linkage,established a scientific,reasonable and sound drug patent linkage system,and improved the system of drug patent protection and drug regulatory system in China.In addition to the introduction and conclusion,this paper has six chapters as following:The first chapter is about the theory of drug patent linkage system.This chapter starts from the connotation of the drug patent linkage system,clarifies the meaning and application scope of the drug patent linkage system,clarifies the judgment criteria for the establishment of the drug patent linkage system,combs the origin and evolution process of the drug patent linkage system,analyzes the internal operation mechanism and defects of the drug patent linkage system,and determines the function and work of the drug patent linkage system.The basic contents of drug patent linkage system are analyzed.The content of this chapter lays a foundation for the discussion of drug patent link system.As far as the drug patent linkage system itself is concerned,it is a "double-edged sword".When it plays a positive role in promoting the research and development of new drugs and determining the legal status of patents in time,it also has a negative effect in impeding the competition of generic drugs and endangering the accessibility of drugs.The second chapter is about the necessity and feasibility of the construction of drug patent linkage system in China.In this chapter,by analyzing the system logic and its reasonable core of drug patent linkage,the legitimacy basis and basic value orientation of the establishment of the system are explored.Combined with the development of China's pharmaceutical industry and the evolution process of pharmaceutical industry policy,the necessity and legitimacy of the establishment of the system in China are explored.The drug patent linkage system provides a way for drug patentees to solve patent disputes before drug listing,which is one of the means to realize the social dispute resolution mechanism.The system follows the constitutional principle of inviolability of private property rights,the legislative purport of interest balance,the basic value goal of legal system,the requirement of optimal resource allocation,the policy position of intellectual property rights and the policy goal of building an innovative country.This system is conducive to strengthening the protection of drug patent rights,encouraging drug innovation,promoting the full competition between generic drugs and innovative drugs,realizing the healthy development of the pharmaceutical industry,and solving the contradiction between citizens' health demand and insufficient drug supply.The drug patent linkage system is an important way to solve the problems of weak protection of drug patents,lack of innovation in the pharmaceutical industry and shortage of high-quality drugs in China.It is also an important system design to implement the innovation and development of the national pharmaceutical industry and deepen the reform of the review and approval system to encourage drug innovation policies and build a healthy China.The third chapter is the comparative study of drug patent linkage system.This chapter mainly reviews the legislation and judicial practice of the countries that establish the drug patent linkage system,and at the same time,it forecasts the future development trend of the drug patent linkage system in combination with the provisions of the regional free trade agreement signed in recent years.The United States is the first country in the world to establish and implement the drug patent link system,which has been followed by Canada,Australia,South Korea and other countries.The countries that implement the drug patent linking system adopt different linking modes based on their own actual situation and policy objectives,and have different implementation effects.The United States promotes the drug patent linkage mechanism in domestic legislation to other countries or regions through bilateral or regional free trade agreements.At this stage,due to the different economic development level and economic structure of each member,the drug patent linkage system has not been able to form a unified standard in the international scope.In the future,it will become a basic criterion in the field of international drug patent protection.The fourth chapter is the supporting legal system of drug patent linkage system.This chapter introduces the system contents of drug test exception,patent term extension and data protection related to drug patent linkage system in detail,analyzes the functions and functions of these three systems,the advantages and disadvantages of the system itself,and the relationship between the three systems and drug patent linkage system.In essence,these systems focus on the contradiction between drug patent protection and innovative drug research and development,and the relationship between the private interests of drug patentees and the public interests of social welfare.The relationship between drug test exception system and drug patent linkage system is mutual cooperation and restriction.The parallel implementation of drug patent linkage system and drug patent term extension system has played a role of mutual cooperation and restriction.Drug test data protection is the basis of drug patent linkage,which is the extension of drug test data protection.The mutual cooperation,restriction and balance of various systems related to drugs can jointly stimulate the development of innovative drugs and accelerate the timely listing of generic drugs.The fifth chapter is the legal regulation of the abuse of drug patent linkage system.This chapter mainly discusses the legislation and judicial practice of the United States and Canada in dealing with the abuse of drug patent linkage system,as well as the experience of the European Union in dealing with related issues.From the microcosmic point of view,this paper analyzes the classic cases in the implementation of drug patent linkage system,reveals the different legal application of courts in similar cases,and sums up the elements for determining the illegality of related acts.In view of the problems in the actual operation of drug patent linkage system,based on the experience of other countries,combined with the development of China's pharmaceutical industry,legal system and judicial system,this paper puts forward countermeasures and suggestions to deal with relevant problems.The abuse of drug patent linkage system is mainly manifested in two typical behaviors: improper registration of drug patent and reverse payment agreement.The problems of patent evergreen and reverse payment agreement in drug field essentially reflect the conflict and balance between incentive protection of drug innovation and free market competition.There is a legitimate basis for the use of anti-monopoly law to regulate the evergreen behavior and reverse payment behavior of drug patents.The antimonopoly law regulation of these behaviors should follow the reasonable rule analysis method to comprehensively measure the positive and negative effects of monopoly behavior on competition,so as to determine whether they fall into the regulation category of anti-monopoly law.The sixth chapter is the systematic construction of the drug patent linkage system in China.In this chapter,based on combing and analyzing the existing drug patent linkage mode,analyzing the current legislative provisions,implementation status and existing problems related to drug patent linkage in China,and learning from the relevant legislation and practice of other countries,combined with the actual development and legal environment of China's pharmaceutical industry,the author puts forward the basic idea and specific implementation scheme of the system in China.There are some outstanding problems in the current legislation related to drug patent link in China,such as lack of basis of superior law,lack of systematicness,standardization and operability.In the practice of drug registration and approval,patent disputes caused by drug registration can not be effectively resolved.Therefore,in order to construct the drug patent linkage system in China,we need to supplement the basis of system creation and design an operable patent link scheme.At the same time,in the specific system design,we need to base on the reality of our country,pay attention to the coordination and connection with the relevant legal system,and establish the corresponding supporting legal mechanism.The reasonable core of the drug patent linkage system lies in the balance of interests.Through a series of delicate and balanced designs,the original research and development enterprises are encouraged to continue to develop new drugs and push them to the market,and the generic pharmaceutical enterprises are encouraged to challenge the patents of the original research and development enterprises,so that the original research and development industry and the generic pharmaceutical industry can maintain good and coordinated development.The effective implementation of the drug patent linkage system and the realization of the value goal of interest balance that it pursues need the restriction,cooperation and support of relevant legal systems to build a relatively complete legal system to promote the coordinated development of the original drugs and generic drugs.In the context of China,we should be aware of the possible anti competitive risks caused by the abuse of drug patent linkage system.Legislators and policy makers should evaluate the advantages and disadvantages of drug patent linkage system scientifically,overcome the inherent defects of the system itself,and eliminate the adverse effects of the system on drug accessibility. |
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