Research On Anti-monopoly Regulation Of Reverse Payment Behavior In The Medical Field

Withthedevelopmentofsocialeconomyandtheimprovementofscientificlevel,thepharmaceuticalindustryhasembarkedonthefasttrackofdevelopment.The pharmaceuticalindustryisa typicalpatent-intensiveindustrywith extremelyhigh dependence on patents.In recentyears,underthe background of economic globalization,variouscountrieshavestrengthenedtheprotectionofintellectualproperty rights.Patentcompaniesrelyonpatentrightstoobtainmonopolybenefitswithina certainperiodoftimetorecoverthehigh R&Dcostsandearnprofits,sotheprotection ofdrugpatentscanpromotenewdrug R&Dandinnovation,whichisconducivetothe healthydevelopmentofthedrugindustry.However,onceadrugpatentownerabuses itsrights,itwilldisrupttheorderofmarketcompetition,causeunreasonablyhighprices ofdrugsandharmtheinterestsofpatients.Theessenceofreversepaymentisthe "anti-competitive" behaviorofpatent companiestorestrictgenericdrugsfrom enteringthemarketinordertoearnmonopoly benefits.The enactmentofthe Hatch-Waxman Acthas greatly promoted the developmentofgenericdrugs,andthecompetitioninthedrugmarketissofiercethat inordertomaintaintheirmarketshareandhugeprofits,patentcompaniespayhuge monetarybenefitstogenericcompaniesinexchangefordelayingthelaunchofgeneric drugs.Thisactisformallyaprivateagreementbetweenthepatentandgenericdrug companies,butinrealityitharmsmarketcompetitionandpublichealthinterests.Drug consumersandregulatoryauthoritiessuedonthegroundsthattheconductledto unreasonablyhighpricesfordrugsandviolatedtheantitrustlaws.Indeterminingthe natureofthereversepaymentpractice,thecourtshaveadoptedthedoctrineof fundamentalviolation,thepatentscopetest,thedoctrineofconstructiveviolation,and thedoctrineofreasonableness.Theprincipleofreasonablenesswasproposedbythe U.S.Federal Spremeu Court,that is,the review should consider the case comprehensivelyandanalyzeitcomprehensively,takingintoaccounttheinterestsof intellectualpropertyrightsandtheinterestsofpublichealth,andthisprinciplehasmore advantagesthanotherreviewprinciples,thusithasbeenwidelyadopted.In recentyears,China hasbeen committed to deepening thereform ofthe pharmaceuticalfield,encouragingthedevelopmentofgenericdrugs,andensuringthe "accessibility" ofdrugstothepublic,whichhasintensifiedthecompetitioninthe pharmaceuticalmarketandincreasedthepossibilityofreversemedicalpayment.The existenceofthe "patentchallenge" system in Chinahasprovidedalegalgroundforthe occurrenceofreversepaymentbehavior.Inthispaper,wewillconductacomprehensive analysisofthereversepaymentbehaviorinthemedicalfield,drawonadvancedforeign experienceonthebasisof China'snationalconditions,andputforwardsuggestionsfor theregulationofreversepaymentbehaviorin China.Theauthorbelievesthat Chinacan adopttheprincipleofreasonablenessasthereviewprincipleandbuildacompletelegal system forregulatingreversepaymentbehavior,withaviewtoeffectivelyguaranteeing thestabledevelopmentofthepharmaceuticalindustryandeffectivelyprotectingpublic health.