Research On The Realization Mechanism Of Pharmaceutical Patent Linkage System

The pharmaceutical patent linkage system links the drug regulatory agency and the patent administration department,and links two types of procedures: drug application listing review and drug patent protection.In the past studies,specific practical elements and implementation methods were seldom discussed from the perspective of patent linkage implementation mechanism,and there was a lack of analysis on the interaction between the internal elements of pharmaceutical patent linkage system,and there was necessary to discuss the prediction after the implementation of patent linkage system.Based on the above problems,this paper proposes to discuss the patent linkage system from the perspective of implementation mechanism.On the one hand,it studies the internal elements of the realization mechanism of pharmaceutical patent linkage system,explores the practical difficulties of the realization mechanism of patent linkage system,discusses the internal working methods of the administrative examination and patent protection of drug patent linkage system,and the principles of the interaction of various system elements in the legal environment of our country.On the other hand,it studies the effects and potential problems of patent linkage system from establishment to implementation.There are many practical problems in the current patent linkage system.First of all,the drug supervision and administration department has insufficient experience in linking with the patent management department.Patent linkage system involves two major systems: administrative right confirmation and civil tort litigation.In the current patent civil tort litigation and administrative right confirmation litigation system in China,the drug supervision and administration department and the patent administration department have not formed a substantially effective link for the time being,which may lead to the infringement of the patent right of the brand-name drug after the generic drug is approved for listing.Secondly,it is difficult to balance the interests of the brand-name drug enterprises and generic drug enterprises.In the process of applying for listing review and approval of generic drugs,it is also difficult to bring a lawsuit to confirm non-infringement of patent rights.In addition,in practice,the patent linkage system is abused,which may lead to improper distribution of drug "evergreen" patents by patentee.In practice,the patentee has reached a reverse payment agreement with generic pharmaceutical companies for reasons such as delaying the listing of generic drugs,which hinders the complete realization of the patent linkage system.To solve the above problems,we need to study the specific path and theoretical basis to realize the patent linkage system.Based on the theoretical framework of specific rules and basic premises,a specific solution to the realization mechanism of patent linkage is proposed.we can start from four aspects.The first is to form the essential link among the drug supervision and administration department,the drug patent administration department and the court.On the one hand,the publicity mechanism of drug information should be improved,and it is suggested that drug information should be supplemented and updated regularly.On the other hand,functional departments related to the patent link system should establish a linkage mechanism of timely feedback information,so that all functional departments can share information effectively.Secondly,generic drugs are encouraged to file a lawsuit to confirm non-infringement of patent rights in the process of applying for listing review and approval.Thirdly,the unfair distribution of drug patents is regulated by administrative and judicial means.The authorization standards of improper drug patents are strictly examined,and the method patents are strictly judged in judicial trials.Finally,regulate the abuse of market dominance by the brand-name medicine enterprises,define the market dominance of the brand-name medicine enterprises and control the reverse payment agreement based on the principle of rationality,so as to reduce the monopoly of the brand-name medicine enterprises on the pharmaceutical market and hinder the complete realization of the patent linkage system.