Research On The Perfection Of Pharmaceutical Patent Linkage System In China

Pharmaceutical patent protection is an important way for patentees to obtain feedback on R&D investment.However,excessive protection standards will have a certain impact on public health.How to balance public health and the interests of patentees is a contradiction that must be resolved by the drug patent legal system and policy.In the process of the fourth revision of the Patent Law,the discussion of pharmaceutical patent linkage system was heated.On the one hand,some countries in the current international community are still dissatisfied with the level of pharmaceutical patent protection in China.Some scholars in China advocate the use of this system to further improve the level of patent protection in the pharmaceutical field.On the other hand,some scholars expressed concern about the excessive protection standards that may be caused by the system and the incompatibility with China’s national conditions.Since 2017,the relevant policies on encouraging the protection of the rights and interests of innovators of pharmaceutical medical devices(draft for comments),the Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation of Pharmaceutical Medical Devices,and the Measures for the Administration of Drug Registration(Revised Draft)have been designed for the system.It can be seen that this system has been relatively clear in China’s construction.However,from the current regulations,the system is still in the initial stage,and more rules need to be improved.Therefore,this paper studies the improvement of the system from the following four parts.The first part is a general analysis of pharmaceutical patent linkage system.Firstly,the concept and historical development of the system are analyzed,the development of the system is clarified,and the related concepts involved in the system are compared and analyzed.Secondly,it analyzes the new mechanism of the system,discusses the related subjects and interests involved in the process of the system,and the specific rules on which the system operates.Finally,from the perspective of the value of the system and the necessity of perfection in China,the legitimacy of the system in China is discussed.The second part is the analysis of the status quo and problems of pharmaceutical patent linkage system in China.Firstly,it analyzes the documents about the construction of the system in China’s existing laws and regulations,and draws the current preliminary institutional framework of China.Secondly,it analyzes the problems that need to be improved in China’s existing system design,including the lack of legal policy coordination at the macro level and the cooperation mechanism between different entities.There are also problems in the specific rules on the protection of patent holders and the lack of incentives for generic drugs companies,and the need to refine the collection of patent information disclosure rules and supporting mechanisms.The third part is a comparative study of the international practice of pharmaceutical patent linkage system.The measures on the system were analyzed in detail,and the implications for the improvement of China’s system were summarized in order to better relate to the research of this paper and better play the enlightenment effect on the problems in the design of China’s system,from the aspects of coordinated operation mechanism,patentee protection and generic enterprise incentive system to the United States,Canada,the European Union,Japan,TPP,etc.The fourth part is the perfect proposal for pharmaceutical patent linkage system in China.Combining with China’s specific problems and foreign practical experience,it puts forward some suggestions on improving pharmaceutical patent linkage system in China from four aspects:improving the mechanism of coordinated operation of the system,improving the protection level of patent holders,improving the generic drug enterprise system and refining patent information disclosure and patent litigation rules.