Antimonopoly Law Regulations On Reverse Payment Agreements For Pharmaceutical Patents

A drug patent reverse payment agreement refers to a type of agreement in which the two parties in the settlement agree that the original drug manufacturer as the patentee will make reverse payment to the generic drug manufacturer to delay its entry into the relevant drug market.Occasionally,it is judged to violate anti-monopoly law because it has the effect of eliminating or restricting competition.In 1984,the HatchWaxman Act of the United States created a drug patent link system,and the implementation of this system led to a surge in the number of drug patent reverse payment agreements.On July 4,2021,our country established the drug patent link system through the "Implementation Measures for the Early Resolution Mechanism of Drug Patent Disputes(Trial)".The main task of this master’s thesis is to analyze how the anti-monopoly law regulates the reverse payment agreement for pharmaceutical patent in our country.This thesis expounds the background,main features and common types of the drug patent reverse payment agreement,and demonstrates the necessity of the anti-monopoly law to regulate the drug patent reverse payment agreement in our country.This thesis analyzes the characteristics of my country’s pharmaceutical industry,the special setting of the drug patent link system,the current situation of anti-monopoly legislation and judicial practice,and summarizes the current situation and shortcomings of the antimonopoly laws,and regulations of our country’s drug patent reverse payment agreement.At the same time,this thesis combs the experience of Europe and the United States,studies the application cases of the US’s own violation principle,the patent exclusion scope test rule and the reasonable principle,and discusses the EU’s "prohibition+exemption" anti-monopoly law framework.The practice of judging the legitimacy of the reverse payment agreement for pharmaceutical patents.This thesis argues that the "rational prohibition+exemption" model should be adopted for the anti-monopoly law regulation of reverse payment agreements for pharmaceutical patents in our country.When using the principle of rationality to judge the legitimacy of the drug patent reverse payment agreement,in addition to considering the traditional anti-monopoly law considerations,innovation and efficiency,the time point of generic drug manufacturers entering the market,and the scale of reverse payment should also be considered.And reasonableness and other factors should also be added into the scope of consideration.The relevant system for triggering and losing the market exclusivity period of the first generic drug should be added to the drug patent link system to realize the prior regulation of the drug patent reverse payment agreement.At the same time,in the field of anti-monopoly administrative law enforcement,an administrative declaration and centralized review system should be established to achieve timely discovery of drug patent reverse payment agreements.In addition,the private litigation system in the anti-monopoly field should also be improved as a supplement to the administrative enforcement force.