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Supplementing experimental data, a double-edged sword in pharmaceutical patent protection
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Lei XU1, 2, Xin YIN3, Yue YANG1, 4
Chinese Journal of New Drugs | 2023, 32(24) : 2517 - 2525
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Chinese Journal of New Drugs | 2023, 32(24): 2517-2525
Supplementing experimental data, a double-edged sword in pharmaceutical patent protection
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Lei XU1, 2, Xin YIN3, Yue YANG1, 4
Affiliations
  • 1School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
  • 2Reexamination and Invalidation Department of the Patent Office, China National Intellectual Property Administration, Beijing 100086, China
  • 3Capital Normal University, Beijing 100037
  • 4School of Pharmaceutical Science, Tsinghua University, Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing 100084, China
Published: 2023-12-30
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Based on the requirement on the experimental data in the pharmaceutical patent examination of China National Intellectual Property Office (CNIPA), some recent administrative decisions of CNIPA, the repetition of experimental data in the development of some "blockbuster" drugs, and the relevant cases of the US Federal Circuit, this paper discusses the two sides of supplementary experimental data in pharmaceutical patent protection.

medicines  /  patent  /  supplementary experimental data  /  bilaterality  /  utility  /  full disclosure  /  inventive step
Lei XU, Xin YIN, Yue YANG. Supplementing experimental data, a double-edged sword in pharmaceutical patent protection[J]. Chinese Journal of New Drugs, 2023 , 32 (24) : 2517 -2525 .
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  • Online Date：2026-03-05
  • Published：2023-12-30
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History
  • Accepted：2023-07-24
Affiliations
    1School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
    2Reexamination and Invalidation Department of the Patent Office, China National Intellectual Property Administration, Beijing 100086, China
    3Capital Normal University, Beijing 100037
    4School of Pharmaceutical Science, Tsinghua University, Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing 100084, China
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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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