Research On Anti-Monopoly Regulations Of Reverse Payment Agreement For Drug Patents In China

Since the original drug is approved for marketing,it may bring huge sales profits to the original drug company.Hence the company is likely to take actions to ensure the validity of the pharmaceutical patent,among which reaching a drug patent reverse payment settlement with a generic drug company in a patent infringement dispute is one of the measures.The content of the agreement includes the payment of certain benefits by the original drug enterprise,and the promise of the generic drug enterprise to delay entering the relevant market,but such arrangement seriously affects market competition and harms the public interest.The emergence of the drug patent reverse payment agreement has broken the state of checks and balances between the two,from mutual competition and mutual promotion to conspiracy to share the monopoly profits of the original drug,and it is necessary to control its anti-monopoly regulations.In 2021,the Supreme People’s Court conducted the first anti-monopoly review of pharmaceutical patent reverse payment settlements,which means there will inevitably be a a phenomenon of reverse payment agreement for pharmaceutical patents in China,and specific countermeasures need to be discussed.At present,it is difficult for China’s Anti-monopoly Law and relevant laws and regulations to form an effective regulatory mechanism for reverse payment agreements for pharmaceutical patents.The main difficulties are that the monopoly nature and regulatory principles of such agreements are not clearly defined,the functions of anti monopoly law enforcement agencies are vague,and the anti monopoly private enforcement system is incomplete.In order to solve the above problems,this paper proposes to refer to the relevant systems and precedents in Europe and the United States,clarify the connotation of abuse of intellectual property rights,clarify that reverse payment agreements have a monopolistic nature,comprehensively consider a variety of factors to regulate them under the analysis mode of "prohibition in principle + exemption from exceptions",improve the duties of anti-monopoly law enforcement agencies,and strengthen the anti-monopoly private enforcement system.