Research On The Application Of Bolar Exception In Our Country

The Bolar exception means that the import,manufacture and use of patented drugs or medical devices for the purpose of passing administrative examination and approval,and the import and manufacture of patented drugs or medical devices for the purpose are not regarded as patent infringement.The system is designed to give generic drug manufacturers a certain space to use the patent or patent method of the patentee,avoid the extension of the patent right of the patentee due to the generic drug in the process of applying for administrative approval,promote the rapid entry of generic drugs or medical devices into the market,and ensure the balance of interests of the patentee,generic drug manufacturers and the public.Bolar exception originated from the United States,and through a series of judicial precedents enriched the connotation of Bolar exception.Based on national conditions,this system was introduced in the third revision of the Patent Law in 2008,but in practice,Bolar exceptions are rarely used due to various factors,and have not played the role of the system itself.By combing the development vein of Bolar exception at home and abroad and discussing the basis of the system existence,this paper enumerates the problems in the judicial practice in our country and combines the international practical experience and our actual national conditions to offer solutions.The structure of this paper is divided into five parts:The first part is introduction.The second part is an overview of Bolar exceptions.Mainly through the origin and connotation of the system,the development of Bolar exception in our country and the theory and legal basis of the system.In terms of the origin and connotation of the system,the author combs the original legislation of Bolar exception in America,clarifies the origin of Bolar exception,and analyzes the connotation of Bolar exception through the construction of American system.In terms of the development of Bolar exception,this paper combs the Patent Law of mother Law and the legislation and development of Bolar exception clauses to give consideration to the introduction of Bolar exception.Later,the foundation of Bolar exception is demonstrated in theory and law.The third part of our Bolar exception exists problem.By using the case analysis method and through the existing relevant cases,the defects of judicial practice inquiry system involving Bolar exception and test exception are sorted out.Part IV: The development of extraterritorial Bolar exceptions.This chapter analyzes the development and supporting mechanism of Bolar exception.In terms of the development of Bolar exception,by comparing the practice of relevant legislation and judicial development in typical countries such as the United States,Japan,Germany and international organizations,the international development status of Bolar exception is analyzed,and it is clear that the scope of application of its system construction is different due to the specific national conditions of the country,but at the same time it is in line with the interest balance of domestic pharmaceutical companies and the public.In terms of supporting mechanism,patent linking and patent extension system are introduced,and the necessity of related system for Bolar exception is explored.The fifth part puts forward the improvement suggestion for Bolar exception.The improvement suggestions of Bolar exception are to reasonably divide the application method,broaden the application object,attach importance to the application of medical devices,take "commercial purpose" into consideration,make clear the infringement of "registration act",and flexibly adapt the application time of Bolar exception.The detailed supporting system mainly includes: first,perfect patent link information registration system,build inter-department contact,establish fictitious infringement,improve the waiting period system.Second,improve the patent extension system.