The Regulation Of Antitrust Law On Reverse Payment Of Drug Patents

In recent years,the drug price competition and patent term recovery act of reverse payment has given rise to a large number of drug patents,the original drugs and generic drugs enterprises in patent infringement litigation process patent settlement agreement,agreed the original drug companies to generics firms to make huge pay in some way,in return for a generic enterprise within a certain period of time not to launch a generic.Reverse Payment of Drug Patents is a product of highly developed of Drug research and circulation.It breaks the balance between the original drug industry and the generic drug industry,eliminates and restricts competition to a certain extent,and inhibits the free and fair competition environment of the drug market.Therefore,it must be regulated by the antitrust law.After years of anti-monopoly regulation practice,the United States has made specific responses to drug patent reverse payment in the fields of legislation,law enforcement and justice,introduced and improved relevant laws and regulations,Established a professional law enforcement mechanism,and established anti-monopoly review principles and judgment standards for drug patent reverse payment.Although there is no case of reverse payment of drugs patents in China,as a large generic drug country,with the constant changes in the pharmaceutical industry and legal system,China has gradually developed the conditions for the formation of reverse payment of drugs patents,and reverse payment of drugs patents has emerged in practice.Therefore,it is necessary to deal with it through the construction of anti-monopoly law regulations.This paper is divided into four parts:The first part is the definition of reverse payment of drug patents.Reverse payment of drug patents refers to the patent settlement agreement reached between the original pharmaceutical company and the generic pharmaceutical company in the patent infringement litigation process,which stipulates that the original pharmaceutical company will make a huge payment to the generic pharmaceutical company in a certain way,in exchange for the promise that the generic pharmaceutical company will not launch a generic drug in a certain period of time.Reverse payment of drug patents has the characteristics of reversion,concealment,high value and anti-competition,including money payment,patent authorization and sbsidiary agreement.The second part is the anti-monopoly law regulation on reverse payment of drug patents in the United States.After years of anti-monopoly regulation practice,the United States has made specific responses to reverse payment of drug patents in legislation,law enforcement and judicial fields,issued and improved relevant regulations,established a professional law enforcement mechanism,and established anti-monopoly review principles and judgment standards for reverse payment of drug patents.The third part is the necessity and feasibility of anti-monopoly law regulation on reverse payment of drug patents in China.The necessity includes the realistic possibility of reverse payment of drug patents in China,the limitation of intellectual property law regulation,the feasibility includes the legislative feasibility,the law enforcement feasibility and the rich foreign experience for reference.The fourth part is the construction of anti-monopoly law of reverse payment of drug patents.Put forward the method of building our anti-monopoly law regulation of reverse payment of drug patents,namely to establish drug patents reverse payment of anti-monopoly legislation path,the clear reverse payment of drug patents antitrust review applicable principles and standards,to establish mechanism of antitrust exemption and establish antitrust cooperation mechanism of reverse payment of drug patents.