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OBJECTIVE：To provide reference for constructing a patent linking system in line with international standards and balancing the interest conflict between original drug enterprises and generic drug enterprises. METHODS ：The relevant supporting systems of patent link in the United States were introduced ；combined with the development status and relevant systems of drug patent protection at home and abroad ，the existing problems of China ’s drug patent management system were analyzed to put forward suggestions for improvement. RESULTS & CONCLUSIONS ：The United States patent linking system included Orange book system ，generic drug patent declaration system ，generic drug approval waiting period and market monopoly period system of the first generic drug. The innovation and accessibility in the field of pharmaceutical products were facing the dilemma of “commons tragedy ”and“anti commons tragedy ”. There were many problems in China ’s drug patent protection ，such as insufficient R&D and innovation ability inhibited the development of the pharmaceutical industry ，imperfect laws and regulations were not conducive to the settlement of medical professional disputes. It is suggested to establish a digital information database of patented drugs ，standardize the existing generic drug patent declaration system ，promote the coordination between patent litigation cycle and approval waiting period ，increase the independent innovation ability of the pharmaceutical industry ，promote the coordination between pharmaceutical innovation and drug accessibility ，and jointly promote the improvement of intellectual property legislation and the development of medical and health undertakings.
RESUMO
Bolar exception is a patent infringement exemption principle .The article explored the origin ( market failure ) of Bolar ex-ception from the view of government regulation theory , and introduced the production , development and application status of Bolar excep-tion in the world.At the same time, the Bolar exception clauses in our country were also introduced , and the relative regulations in time, place and application scope were discussed in order to provide reference for the perfection of Bolar exception in China .
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The technical solution-oriented patent analysis method was retrieved from patent texts according to the corresponding data mining rules by analyzing the structure and descriptive model characteristics of key techniques in drug patents with HBV drug patent data as the empirical study object .The coincidence of effective information mined using this method and recognized by the experts was good, indicating that this method can be used as an auxiliary tool in mining the key techniques in drug patents.
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To provide references for implementing drug patent strategy in China,we introduced the drug patent strategies of America,Japan and Germany,which rank the first three in the amount of patent in the world,and analyzed their successful experiences.
RESUMO
OBJECTIVE: To seek approach for the protection of domestic pharmaceutical enterprises with immature creativity and to ensure drug accessibility. METHODS: An analysis was performed applying the theory of demand elasticity by comparing the attributes of health right and patent right etc based on TRIPS protocol and the related practice abroad. RESULTS & CONCLUSIONS: For a developing country, China should give top priority to the short-term urgent needs, such as to meet people's medication demands, followed by meeting the long-term demands, such as to encourage independent intellectual property rights. Hence, drug accessibility-related system in drug patent system should be evolved step by step.