Research On China’s Patent Law Bolar Exception

Medicine is to maintain the health and life of human being the basis andguarantee, effective and adequate supply of drugs to resolve the public health crisis iscrucial. As a developing country with large population, China is facing the problemsof public health and the pressure has been very prominent. To this end, the newsection69of the Patent Law Bolar Exception new international system. Bolarexception was first founded by the United States, is based on the particularity ofpharmaceutical patent protection, in order to balance the interests of the private rightsof the patent holder and public interests of special restrictions on the drug patentsystem innovation. Bolar exception system implementation will have a beneficialimpact on the development of China’s pharmaceutical industry as well as to ease thepublic health crisis, and is conducive to safeguarding the overall interests of thecommunity and promote the sound development of the social. Firstly combing our theBolar Exception established process, and discussed theoretically the legitimacy andlegality of its existence; then analyze the the Bolar exception to the impact of ourproduce, also pointed out that the implementation of the main obstacles; Finally, themain obstacles visits Bolar exception in the development of the extraterritorialcombined with national conditions, to make recommendations on improving China’sPatent Law Bolar exception.In the structure, this paper is divided into four chapters.The first chapter introduces the origin of Bolar exception system, has combed through the establishment of the legislation and practice of Bolar exception. Bolarexception established theoretical basis and to demonstrate the legitimacy and legality.The second chapter analyzes the Bolar Exception established the impact on Chinaand the main barriers to implementation. The Bolar exception to the influence of ourcountry: first, the pharmaceutical inventions related information can be used as earlyas possible for the Institute, is conducive to improve the innovation capacity of thedomestic pharmaceutical enterprises in developing countries; Second, can promotegenerics market, as soon as possible to expand our generics corporate profit margins;Third, to promote the public interest of our country, reduce the medical costs of thewhole society. The implementation of the major obstacles in our Bolar Exception:1,the scope is not clear;2, supporting legal mechanisms uncoordinated.The third chapter examines the Bolar exception in overseas development. Thischapter is from the scope of application and supporting legal mechanisms to examinethe Bolar Exception extraterritorial evolution. By comparing the legislation andpractice in the United States, European Union, Canada and Japan, analyzes itsinternational trends. Although the countries have recognized the scope of the Bolarexception is not the same as the social effects are not the same, but by clarifying thespecific scope of application of the Bolar exception, reaching a balance between theinterests of the pharmaceutical patent protection and the public health. Thenintroduces the pharmaceutical patent term extension system, drug patent linkagesystem content, international law development and Bolar exceptional balance,coordination, balance relationship.The fourth chapter discusses the improvement of China’s Bolar exceptionrecommendations. This chapter begins with three aspects of the behavior from theapplicable purpose for the subject and the applicable recommendations Perfection ofthe scope of the Bolar exception. In the aspect of the law making, pointed out ourcountry at present is not suitable for the formulation of patent protection periodextension system; improve the patent linkage system in four aspects:1to strengthenthe patent protection;2, to protect the interests of the generic drug manufacturer;3,the establishment of a coordination mechanism between the patent administration departments and drug administration;4, the establishment of the necessary restrictiveclauses, beware rights abuse.The innovation of this paper lies in: first, legislation and practice of the Bolarexception of China’s Patent Law established a complete comb, and the legitimacy andlegality of the Bolar exception established theoretical exposition; second, startingfrom the Bolar exception in China’s implementation of the major obstacles wereinvestigated Bolar exception in the extra-territorial development, combined withChina’s national conditions, put forward the corresponding suggestions forimprovement.