Benefit Balance and System Construction of In novation and Accessibility of Pharmaceutical Products in China ： Taking the Patent Linking System as an Example
- VernacularTitle:我国医药产品创新性与可及性的利益平衡及制度建构——以专利链接制度为例
- Author:
Xinyue HAN
1
;
Hongtao NIE
1
Author Information
1. School of Law，Xi’an University of Finance and Economics，Xi’an 710100，China
- Publication Type:Journal Article
- Keywords:
Drug patent;
Innovation;
Accessibility;
Interest balance;
Original drugs;
Generic drugs;
Patent linking system
- From:
China Pharmacy
2021;32(18):2177-2183
- CountryChina
- Language:Chinese
-
Abstract:
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.
