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Analysis of the influence of the implementation of patent linkage system on the generic drug industry
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Xuan WANG1, Ling-yun DONG2, Li-ping QIAN3, Ying ZHANG3, Wen-tao ZHU4
Chinese Journal of New Drugs | 2023, 32(17) : 1712 - 1718
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Chinese Journal of New Drugs | 2023, 32(17): 1712-1718
Analysis of the influence of the implementation of patent linkage system on the generic drug industry
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Xuan WANG1, Ling-yun DONG2, Li-ping QIAN3, Ying ZHANG3, Wen-tao ZHU4
Affiliations
  • 1Yifan Pharmaceutical Research Institute (Beijing) Co., Ltd., Beijing 100176, China
  • 2Yeedozencom (Beijing) Co., Ltd., Beijing 100053, China
  • 3Hefei Yifan Biopharmaceutical Co., Ltd., Hefei 230093, China
  • 4Beijing University of Chinese Medicine, Beijing 100029, China
Published: 2023-09-15
Outline
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Patents have long been considered as the most important way to protect pharmaceutical innovations, and the drug patent system has exerted a profound impact on the development of the pharmaceutical industry. In the context that domestic effective drug regulations and patent laws and regulations have covered the provisions on drug patent linkage system, this paper, by taking the first case of domestic drug patent linkage litigation as an instance, analyzes the trial effect of the newly launched drug patent linkage system in China, explores its impact on the generic drug industry, and tries to give suggestions to generic drug enterprises on the choice of patent application types and the authenticity of application materials. The research-based pharmaceutical enterprises need to seize the opportunity to safeguard their rights and protect themselves against patent infringement by choosing an appropriate method to resolve patent disputes. Moreover, given the constraints of China's binary separation of procedures of patent infringement and patent invalidation on the early solution of pharmaceutical patent disputes and the problems awaiting to be solved in different types of patent applications, this paper also puts forward related suggestions on patent protection, including the necessity of timely review and analysis of the implementation of the patent linkage system, enhancement of the legal status of administrative adjudication to enable some authorities of administrative confirmation, and the necessity for clearer definition of types of patent applications and further standardization of patent infringement cases under different circumstances.

patent linkage  /  generic drugs  /  policy advise
Xuan WANG, Ling-yun DONG, Li-ping QIAN, Ying ZHANG, Wen-tao ZHU. Analysis of the influence of the implementation of patent linkage system on the generic drug industry[J]. Chinese Journal of New Drugs, 2023 , 32 (17) : 1712 -1718 .
Year 2023 volume 32 Issue 17
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Article Info
  • Online Date:2026-03-05
  • Published:2023-09-15
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History
  • Accepted:2023-02-27
Funding
Affiliations
    1Yifan Pharmaceutical Research Institute (Beijing) Co., Ltd., Beijing 100176, China
    2Yeedozencom (Beijing) Co., Ltd., Beijing 100053, China
    3Hefei Yifan Biopharmaceutical Co., Ltd., Hefei 230093, China
    4Beijing University of Chinese Medicine, Beijing 100029, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
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占总种数比例
Percentage of
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Number of
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Percentage of total
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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