The Antitrust Law Regulation Of Reverse Payment Agreement In Drug Patents

Drug is a special commodity.On the one hand it is complex and ruinously expensive to research and development in the early stage,in order to stimulate the pharmaceutical companies' enthusiasm for innovation,we need to create a reasonable monopoly rights,that is,patent rights.On the other hand,encouraging generic drugs to enter the market become a proper part of the drug accessibility issue,for the effective and timely supply of drugs has a bearing on the healthy development of the people.In the unavoidable game between the patent drug company and the generic drug company,reverse payment agreements began to appear.It not only inhibits patent drug company's innovation to discovery new drugs,but also hindered the timely entry of cheap generic drugs to the public.As a big country in the production and use of generic drugs,it is imperative for China to maintain orderly competition between patent drugs and generic drugs and regulate reverse payment agreements.However,because of the limitations of the Patent Law,it is impossible to adjust the reverse payment agreement and the legal relationship after the settlement,and it needs to be regulated under the anti-trust legal system.In determining the basic principles and specific standards of regulation,it can be standardized based on the practice of the United States and the European Union,combined with China's legal environment and institutional system.The article is composed of introduction,main body and conclusion,in which the main body is divided into four parts:The first part of the article is about the legal basis of Antitrust Law to regulate reverse payment agreements in drug patents.The first section of this section startswith the definition and type of drug patent reverse payment agreement.First,it introduces the industry background and legal background of the agreement to explore the origin of it;secondly,it expounds the basic definition of the reverse payment agreement and its requirements to clarify the scope of the reverse payment agreement discussed in this paper.Finally,the agreement is divided according to different classification criteria,and the effect of each type of agreement on competition is analyzed.The second section discusses the legal regulation of the reverse payment agreement in drug patents.Because of the limitation of its legal nature and legislative purpose,the Patent Law has weaker regulatory capacity for the reverse payment agreement itself,and it is unable to adjust the legal relations after the execution of reverse payment agreement.The Antitrust Law can regulate,in the absence of the Patent Law,the reverse payment behavior which is alleged to abuse of patent right,on the legal basis of the protection of competition and consumer.The second part of the article is about the development of the Antitrust Law regulations for reverse payment agreements in drug patents between the United States and Europe.The United States is the first country to regulate the drug patent reverse payment agreements with Antitrust Law,but it has undergone a tortuous exploration of the selection of regulatory principles.It has applied the principles of Per Se Illegal,The Scope-of-the-Patent Test,Quick look rule of reason and Rule of Reason.The author introduces these principles by sorting out representative cases of US courts.In the ongoing supervision of the pharmaceutical industry,the EU has drawn two criteria for analyzing whether reverse payment agreements are anti-competitive: whether to restrict the entry of generic drugs into the market and whether there is a reverse value transfer.At the end of this section,the author combines the practices of U.S.and EU with the current scholars' main viewpoints on the selection of basic principles,compares and analyzes the advantages and disadvantages of the four principles.Based on the complicated expression of the patent reverse payment agreement and its double legal interests,it is ultimately determined that Rule of Reason should be applied to the illegality of the reverse payment agreement.The third part of the article analyzes the factors that determine the illegality of drug patent reverse payment agreements,based on the application of Rule of Reason.Determine whether the agreement is illegal by considering both the internal and external dimensions of the behavior and the existence of exemptions.The internalconsiderations based on the agreement itself are to determine whether the agreement has an exclusive effect.The external considerations based on the relevant market are to determine whether the subject of the agreement possesses the power to bring that unjustified anticompetitive harm about in practice.Although the analysis of internal and external factors determines that the reverse payment agreement has an exclusive effect,and the entity has sufficient market power to rule out competition,it does not necessarily violate the Antitrust Law.It should also be analyzed whether there is a reasonable explanation for reverse payment and whether the agreement can bring about the effect of promoting competition,to comprehensively weigh the impact of the agreement on competition,thus to ultimately determine whether the reverse payment agreement violates the Antitrust Law.The fourth part of the article analyzes the current situation and recommendations of China's Antitrust Law on the regulation of drug patent reverse payment agreement.In the legal background and social environment of our country,the reverse payment agreement in the field of medicine can emerge theoretically and has already begun to emerge in reality,but China's Drug Registration Regulations,Patent Law and Antitrust Law cannot regulate it.The Antitrust Guidelines on the Abuse of Intellectual Property(Draft for Comments)does not explicitly include the reverse payment agreements in the scope of regulation,and can only be reviewed with reference to the principled provisions therein.In this regard,the author puts forward a recommendation from the executive aspect.First,the principles and criteria for reviewing reverse payment agreements should be determined.Based on the application of Rule of Reason,the factors listed in the third part should be use to comprehensively identify the illegality of the agreement.Second,it is necessary to strengthen the professional enforcement of reverse payment agreements,establish professional enforcement teams,and conduct follow-up investigations of patent settlements in the pharmaceutical field.