Regulation Of Reverse Payment Settlement Under Antitrust Law

Because of the huge cost and high failure rate of developing new drugs,pharmaceutical enterprises need to protect their drug patents in order to encourage the continuous innovation of pharmaceutical enterprises.The particularity of the pharmaceutical industry is reflected in the public health and social public interests.Therefore,increasing the affordable supply of medicines and promoting the development of generic drug enterprises also need balance.At present,Chinaundefineds established policies continue to strengthen the protection of drug patents and encourage the innovation of patented drugs,and at the same time,to encourage the development of generic pharmaceutical enterprises.In this context,the contradiction between patent companies and generic drug companies will be highlighted more acutely.On the one hand,patent pharmaceutical enterprises based on the high investment in research and development,expect to exclude any competitors by the legal rights granted by the patent law,and obtain high R&D returns;On the other hand,generic drug companies are encouraged by state policy because of their low prices and efficient treatment.In terms of national public health,the entry of generic drugs into the market can effectively ease the high cost of national health care;from the perspective of drug consumers,the supply of generic drugs can significantly reduce the spending of drug consumption.It is not surprising that patent companies use reverse payment agreements with generic companies as a means of safeguarding their own interests.Reverse payment protocols first appeared in the United States,then in Europe,South Korea and other countries in the world.Starting from the general analysis of reverse payment protocols,this paper analyzes the background,characteristics,types and other basic problems.Based on the fact that the reverse payment agreement is related to the competition of the pharmaceutical industry and the national public health,this paper analyzes the defects of the intellectual property law in adjusting the market competition order in a macro way.This paper summarizes the necessity of regulating reverse payment agreement according to anti-monopoly law.Although the level of research and development of patent drugs in China is still not high at present,there will not be a sharp contradiction between generic drugs and patent drugs for the time being.In practice,however,there have been cases involving reverse payment agreements between foreign patent drug companies and domestic generic drugs.At the same time,from the perspective of our policies,the development of generic drug enterprises will be encouraged.The establishment of the new patent link system will form a link between patent drugs and generic drugs,while strengthening the protection of drug patents,but also stimulate generic drug enterprises to challenge the weak drug patents.The emergence of reverse payment agreement in China means that the balance of competition order of pharmaceutical industry in China will be broken,and patent pharmaceutical enterprises can use this to hinder the development of generic pharmaceutical enterprises in China.This not only threatens the competitive order of Chinese pharmaceutical market,but also affects the upgrading of Chinese pharmaceutical industry on a deeper level,and endangers the social public interests and consumersundefined interests.A reasonable solution to this problem in China should be returned to our legal system.Therefore,the nuclear issue of this paper is put forward:first of all,China does not have an exact anti-monopoly guide for intellectual property rights,so it is impossible to define the abuse of intellectual property rights here accurately;Secondly,Chinaundefineds anti-monopoly law does not exactly analyze the analysis model of reverse payment agreement;third,the academic and practical circles lack a consistent understanding of the exemption conditions of Article 15 of the anti-monopoly law;finally,China lacks a safe harbour system.In view of the above analysis,our country should draw lessons from the relevant law enforcement and judicial experience of foreign judicial regions and choose a road suitable for our country.This paper analyzes the changes in the regulation of reverse payment agreements in American anti-monopoly law,and the changes of EU from judging that reverse payment agreements are form-based violations to gradually admitting that such agreements should be analyzed on the basis of effect illegality.The advantages and disadvantages of various analytical models are comprehensively compared.In response to the questions raised above,it is suggested that in regulating reverse payment agreements,Chinaundefineds anti-monopoly law should clearly define the limits of abuse of intellectual property rights,apply the rapid review and analysis model,and determine the factors that should be considered.Define exemption conditions and set up safe havens for reverse payment protocols.