Benefit Balance and System Construction of In novation and Accessibility of Pharmaceutical Products in China : Taking the Patent Linking System as an Example
HAN Xinyue, NIE Hongtao. Benefit Balance and System Construction of In novation and Accessibility of Pharmaceutical Products in China : Taking the Patent Linking System as an Example[J]. China Pharmacy, 2021,32(18).
HAN Xinyue, NIE Hongtao. Benefit Balance and System Construction of In novation and Accessibility of Pharmaceutical Products in China : Taking the Patent Linking System as an Example[J]. China Pharmacy, 2021,32(18).DOI:
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.
关键词
药品专利创新性可及性利益平衡原研药仿制药专利链接制度
Keywords
Drug patentInnovationAccessibilityInterest balanceOriginal drugsGeneric drugsPatent linking system