Pharmaceutica L Reverse Payment In The United States From The Perspective Of Patent Law And Anti-Monopoly Lawanti-Monopoly Law

To people's daily life,drugs are necessities highly related to public health,and the accessibility of which have always been the concern of all stakeholders.The litigation risks result from patent disputes would cost billions in pharmaceuticals industry annually.In traditional infringement cases,disputes may end up with settlement agreements where generic drug manufactures pay certain license fees to patent drug manufactures.However,with the passage of Hatch-Waxman bill,a new settlement,the reverse payment agreement,caught a lot of attention.Because of the right originated from their patents,original drug manufacturers often set high prices for their drugs.In order to improve the accessibility of pharmaceuticals,the Federal Food and Drug Administration(FDA)pursues certain law and the establishment of a reasonable system which could legalize the production and sale of generic drugs,setting clear distinction between replication and infringement so as to encourage the development of generic drug market.The 1984 Hatch-Waxman bill,specifies the application process for generic drug companies.It shortens the approval process and meanwhile makes it possible for generic drug manufactures to challenge the patent drug companies.Once completed,the process would lead the generic drug manufactures to market,and also the generic drug manufacture is allowed to prove the validity of its duplication.What's more,the part IV regulating patent challenges would also invalidate the target patent.When it comes to the 21st century,the cost incurred by research and their market profits keeps growing.So the branded drug manufactures began to seek the loopholes of Hatch-Waxman bill,and this is where reverse payment agreement arises as a countermeasure.With such agreement,patent drug manufacturers pay the first generic drug manufactures millions even tens of millions of dollars in exchange of market exclusivity for 180 days,which means the generic drugs shall not be listed during this period.Therefore,reverse payment protocol is also known as "delayed agreement".Such delay as agreed would definitely influence the drug market.And the academy hasn't concluded whether such agreements violate the antitrust law or not.There is no conclusive statement from the academic circle concerning the review of reverse payment agreements,whether it is applicable to intellectual property law or antitrust law.Also,the attitudes of different courts differ while reviewing such agreement.Reverse payment agreement is the product of Hatch-Waxman bill,so it originated from the United States.And the United States is the country with the largest case regarding reverse payment agreement.This thesis tries to analyze the advantages and disadvantages of different principals used to review the validity of reverse payment agreements through arranging available cases,and to work out a possibility to balance the interests of all parties concerned.This paper at first defines reverse payment agreement,the societal and legal background of such agreement and related judicial practices.And then,it analyzes the validity of reverse payment agreement and the challenge it causes to the legal system.In the end,this paper tries to emphasize the application of the rule of reason and put forward feasible suggestions to future regulation of reverse payment agreement in China.