Study On Early Settlement Mechanism Of Patent Dispute Of Chemical Drugs ——From The Perspective Of The Implementation Of Bolar Exception System

In order to encourage the development of generic drugs and enable the public to obtain affordable generic drugs timely,China introduced the bolar exception clause.However,the existence of drug patent jungle will cause the generic drug production process to fall within the potential peripheral patent protection scope of patented drugs,and thus be involved in infringement disputes after the market.At this time,if there is an early settlement mechanism for drug patent disputes,the marketing approval and patent infringement disputes can be linked.Use the patent information registration system to register all related patents of drugs so that all patents of reference drugs can be declared one by one when generic drugs apply for marketing.The relevant departments then judge whether the patent challenge procedure is started according to the type of declaration.In this way,the risk of patent infringement can be solved before listing,the worry of being sued after listing can be solved,and the bolar exception system can be implemented.However,the early settlement mechanism of drug patent disputes established in China has a series of problems: First of all,the drug patent information registration system plays a fundamental role in realizing the purpose of the mechanism.However,there is inconsistency between the registered patent right and the actual patent right.In this paper,some suggestions are put forward,such as the implicit regulation of registration type,strengthening the function connection between drug evaluation agency and patent administration department,and establishing the system of post-registration correction.Secondly,the procedure to confirm whether it falls into the scope of patent protection plays a decisive role in realizing the purpose of the mechanism.First,this paper considers that this lawsuit belongs to a new type of lawsuit,and determines the interests of litigation.This laid a good foundation for this lawsuit to play its role.Second,results of the procedure to confirm whether it falls into the scope of patent protection should be consistent with the outcome of subsequent patent infringement lawsuits against identical drug patents and generic drugs.However,in the patent infringement lawsuit,there are some cases where the generic drug technical plan is inconsistent with the submission of the above procedure,which leads to the fact that the determination result cannot truly reflect whether it falls into the scope of patent protection.This paper determines a reasonable way of evidence submission to ensure the consistency of the cognizance result and the follow-up lawsuit.Third,the connection between lawsuit and patent administrative procedure is not clear.It includes the problems caused by the dual-track judicial and administrative settlement mechanism,as well as the connection between the lawsuit and patent invalidation procedure.This paper puts forward some suggestions on the choice of judicial and administrative adjudication procedures,and analyzes the feasibility of the suggestion that the judicial authority should confirm the patent validity when hearing the lawsuit,so as to ensure the connection between the lawsuit and the patent administrative procedure.The convergence method shall clarify and solve the above problems,try to solve the patent infringement risks of both parties before the generic drugs are put on the market,and thoroughly implement the implemention of bolar exception system.