Antitrust Regulation Of Drug Patent Reverse Payment Agreement

The conclusion of the drug patent reverse payment agreement has caused the expensive patented drug products to occupy the market for a long time,while increasing the cost of living for consumers,while delaying or preventing the launch of generic drugs may even have a monopoly effect of excluding or limiting competition.Imminent.The regulation of the agreement involves the conflict of interests between competition law and intellectual property law.The Patent Law has limitations on the mediation of legal relations after the litigation and settlement agreement is reached,so the Antimonopoly Law is necessary for the regulation of the agreement.In the process of determining the principles and standards of antitrust regulations,we will learn from the development experience of the United States and the European Union,and combine the development status of pharmaceutical reverse payment agreements in China to further improve our antitrust law system.This article mainly analyzes from the perspective of antitrust law,and explores the perfect path of China's anti-monopoly drug patent reverse payment agreement starting from the negative impact of the drug patent reverse payment agreement on China's market competition.First,the drug patent reverse payment agreement was incorporated into the "Antitrust Regulations on Abuse of Intellectual Property Rights" and specifically regulated to improve the status quo of China's regulation of the agreement without relevant laws and regulations.Second,the drug patent reverse payment agreement involves the delicate relationship between intellectual property rights and monopolies,and it is necessary to determine the boundaries and regulations of abuse of intellectual property rights.Whether intellectual property is used reasonably is mainly in terms of its scope of use,and the effect of abusing intellectual property on excluding or restricting competition pays more attention to its impact on market competition.Therefore,it is more appropriate to apply the "Antitrust" to regulate it.Third,due to the lack of a unified analysis model for anti-monopoly drug patent reverse payment agreements,anti-monopoly cases are subject to different judgments and affect the anti-judgment of anti-monopoly laws.By comparing with its own illegal principles,reasonable principles,exclusive patent testing methods,and fast review principles,it is determined that the factors to be considered are more comprehensive,and the reasonable principles that comprehensively compare thequalitative nature of the agreement,the characteristics of the behavior,and the effects produced as a unified analysis mode.Fourth,on the basis of determining a unified analysis model,the scope of determining factors for applying reasonable principles should include the characteristics and performance forms of analysis behavior,the market dominance of pharmaceutical companies in relevant markets,and their impact on efficiency and innovation.Fifth,the premise of clearly applying the exemption conditions is the determination of the nature of the monopoly agreement,so as to straighten out the logical relationship between Articles 13 and 15 of the Anti-Monopoly Law.The current draft of the Anti-Monopoly Law Amendment(Public Consultation Draft),which was introduced in January 2020,encourages innovation as one of the legislative purposes and coincides with the viewpoint of patent right protection.