The Application Problems And Improvement Of Bolar Exception System In China

Bolar exception system refers to the behaviors which are not regarded as infringement for the purpose of administrative examination and approval,that in order to avoid the patent period being unreasonable extended.therfore,it achieves a balance of interests between pharmaceutical patent enterprises,generic enterprises and public.When the patent law was amended in 2008,the Bolar exception system was introduced,and the patent link system and extension of patent system were not,which was based on various considerations.Nearly a decade later,Bolar system has rarely been used in practice,and it has produced many problems in particular pharmaceutical industry background and administrative environment of our country.In conclusion,it does not play a proper role.Taking medicine as an example,this paper starts with the problems of drug patents in administrative examination and approval,contrastes the system with the United States,analyzes causes of the problems of Bolar exception system in China,puts forward suggestions for the reconstruction of the Bolar exception and supporting system in China.This paper is divided into four parts:The first part is asking questions.Firstly,this paper introduces the meaning and function of Bolar exception system,and the introduction of Bolar exception system in China is as the basis for the analysis and discussion.Then,it will return to China's national conditions,and introduce the special medical administrative examination and approval system and patent system of China.Finally,the problems existing in the application of Bolar exception system are proposed.The second part is analyzing the problem.First,taking the United States as an example,this paper introduces the rules and functions of the system,and the mechanism of its action,which is as a big premise;Then this paper analyzes the Bolar exception system and the corresponding institutional environment in our country as a minor premise.Finally,the causes of the problem in China are obtained by the analysis method of syllogism.The third part is solving the problem.According to the above statement,combining the situation of our country,the paper suggests to reshape the Bolar exception system in China,such as to clarify the applicable conditions of the Bolar exception system,to introduce the extension of patent system and the patent link system,to clear the concept of the first copy medicine.The fourth part is the conclusion.This paper analyzes the recent documents issued in China and the prospect of the Bolar exception system and its supporting system.