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Research on the early settlement mechanism of the patent related to the registration of biologics product in the US
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Yun QI1, Yue YANG2, Hua XING1, Dian-zheng YANG1
Chinese Journal of New Drugs | 2021, 30(19) : 1801 - 1807
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收藏切换
Chinese Journal of New Drugs | 2021, 30(19): 1801-1807
Research on the early settlement mechanism of the patent related to the registration of biologics product in the US
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Yun QI1, Yue YANG2, Hua XING1, Dian-zheng YANG1
Affiliations
  • 1School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
  • 2School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China
Published: 2021-10-15
Outline
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To Explore and analyze the patent dance system related to the registration of biological products in the United States, domestic and foreign documents were consulted. The background of the US “Biologics Product Price Competition and Innovation Act” was reviewed, and the reasons, characteristics, and the challenges of system implementation were analyzed regarding the design of biological product patent dance system that is different from the chemical drug patent linkage. The patent dance system is based on good faith negotiation between the original research company of biological products and the biosimilar drug company. The scope of patent litigation is determined by the patent information exchange process. At the same time, two different stages are designed to enter the patent litigation, in order to speed up the similar biological products coming into the market, so as to improve the public accessibility.

BPCIA  /  biologics  /  patent dance  /  patent disputes
齐云, 杨悦, 邢花, 杨殿政. 美国生物制品注册相关专利早期解决机制研究. 中国新药杂志, 2021 , 30 (19) : 1801 -1807 .
Yun QI, Yue YANG, Hua XING, Dian-zheng YANG. Research on the early settlement mechanism of the patent related to the registration of biologics product in the US[J]. Chinese Journal of New Drugs, 2021 , 30 (19) : 1801 -1807 .
Year 2021 volume 30 Issue 19
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2
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  • Online Date:2026-10-30
  • Published:2021-10-15
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  • Accepted:2021-03-30
Affiliations
    1School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
    2School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
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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