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Study On Legal Regulation Of Drug Patent In China

Posted on:2023-08-10Degree:MasterType:Thesis
Country:ChinaCandidate:Y LingFull Text:PDF
GTID:2556306785488554Subject:Law
Abstract/Summary:PDF Full Text Request
As a superpower with a population of 1.4 billion,China is also a big country producing and using generic drugs.The problem of generic drugs is related to the drug safety of the people and the healthy and stable development of the pharmaceutical industry.Drug patent reverse payment agreement research is in recent years,the agreement refers to the original research company with drug patent and the same generic drug companies private settlement agreement,by the original drug company pay high fees to generic companies to delay generic drug company in a certain period no longer enter the pharmaceutical market,and because in the agreement is by the owner to the accused infringer,so is called "reverse" payment agreement.It is the epitome of the dispute between intellectual property rights and public interest in the drug field.There is no unified view on whether the reverse payment agreement of drug patent is the patent holder or the anti-monopoly behavior that harms market competition.With the promotion of policies to encourage drug innovation and promote the development of generic drugs in China,domestic pharmaceutical companies are highly likely to become the target of foreign pharmaceutical companies to sign reverse payment agreements.Therefore,it is of far-reaching significance to discuss reverse payment agreements in this case.This paper takes the "settlement agreement" involved in the case of Astra Zeneca v.Osecom recently released by the Supreme Court to introduce the question.By discussing the case analysis and dispute focus of this specific case,the attitude and practice of China on the "reverse payment agreement for drug patent" are sorted out.By comparing the effectiveness identification and regulation methods of the reverse payment agreement between the United States and the European Union,the case focuses on whether the settlement agreement involved in the case of Astra Zeneca v.Othcom is legitimate and how to determine its anti-monopoly nature.The phenomenon of "drug reverse payment agreement" is explained,the problem of reverse payment agreement is analyzed according to China’s national conditions and environment,and the inevitability of drug patent reverse payment agreement in China and its current situation and difficulties in legislative and judicial aspects are pointed out.In view of the shortcomings,this paper puts forward perfect suggestions from three aspects:establishing the legal system of regulating reverse payment agreement,improving the law enforcement system of reverse payment agreement,and improving the "exemption system" of drug patent reverse payment agreement.Regulation reverse payment agreement legal system on the patent law on the reverse payment agreement punitive compensation system,improve the private litigation system in the anti-monopoly law,add the main qualification of public interest litigation,law enforcement to improve the professional level of drug reverse payment agreement case law enforcement team,and the relevant provisions detailed exemption terms,to build our drug patent reverse payment agreement legal regulation system,for the pharmaceutical industry subsequent can better development escort,realize the purpose of maintaining social public interests.
Keywords/Search Tags:Original research drug, Reverse payment agreement, Rules and regulations, Drug patent
PDF Full Text Request
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