Article(id=1236360795639050726, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236360790672986545, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1690128000000, acceptedDateStr=2023-07-24, onlineDate=1772700984153, onlineDateStr=2026-03-05, pubDate=1703865600000, pubDateStr=2023-12-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772700984153, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772700984153, creator=13701087609, updateTime=1772700984153, updator=13701087609, issue=Issue{id=1236360790672986545, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='24', pageStart='2441', pageEnd='2543', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772700982968, creator=13701087609, updateTime=1772701059772, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236361112883622634, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236360790672986545, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236361112883622635, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236360790672986545, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2517, endPage=2525, ext={EN=ArticleExt(id=1236360795882320362, articleId=1236360795639050726, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Supplementing experimental data, a double-edged sword in pharmaceutical patent protection, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

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.

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本文结合国家知识产权局(CNIPA)在药品专利保护中对实验数据的要求、国家知识产权局近期的行政决定、“重磅炸弹”药物研发中实验数据的反复性以及美国联邦巡回法院的相关案例,对补充实验数据在药品专利保护中的两面性进行了探讨。

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杨悦,女,博士生导师,教授,主要从事药物政策与监管科学研究。联系电话:(010)62780224,E-mail:
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共同第一作者

许磊,女,一级调研员,博士研究生,主要从事专利复审和无效审查工作。联系电话:(010)62411134,E-mail:

尹昕,女,研究员,主要从事专利政策研究。联系电话:(010)68907023,E-mail:

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补交实验数据在药品专利保护中的两面性研究
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许磊 1, 2 , 尹昕 3 , 杨悦 1, 4
中国新药杂志 | 新药述评与论坛 2023,32(24): 2517-2525
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中国新药杂志 | 新药述评与论坛 2023, 32(24): 2517-2525
补交实验数据在药品专利保护中的两面性研究
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许磊1, 2 , 尹昕3 , 杨悦1, 4
作者信息
  • 1沈阳药科大学工商管理学院,沈阳 110016
  • 2国家知识产权局专利复审和无效审理部,北京 100086
  • 3首都师范大学,北京 100037
  • 4清华大学药学院/国家药品监督管理局创新药物研究与评价重点实验室,北京 100084
  • 许磊,女,一级调研员,博士研究生,主要从事专利复审和无效审查工作。联系电话:(010)62411134,E-mail:

    尹昕,女,研究员,主要从事专利政策研究。联系电话:(010)68907023,E-mail:

通讯作者:

杨悦,女,博士生导师,教授,主要从事药物政策与监管科学研究。联系电话:(010)62780224,E-mail:
Supplementing experimental data, a double-edged sword in pharmaceutical patent protection
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
出版时间: 2023-12-30
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本文结合国家知识产权局(CNIPA)在药品专利保护中对实验数据的要求、国家知识产权局近期的行政决定、“重磅炸弹”药物研发中实验数据的反复性以及美国联邦巡回法院的相关案例,对补充实验数据在药品专利保护中的两面性进行了探讨。

药品  /  专利  /  补充实验数据  /  两面性  /  实用性  /  公开充分  /  创造性

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
许磊, 尹昕, 杨悦. 补交实验数据在药品专利保护中的两面性研究. 中国新药杂志, 2023 , 32 (24) : 2517 -2525 .
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 .
2023年第32卷第24期
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  • 首发时间:2026-03-05
  • 出版时间:2023-12-30
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  • 录用日期:2023-07-24
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作者信息
    1沈阳药科大学工商管理学院,沈阳 110016
    2国家知识产权局专利复审和无效审理部,北京 100086
    3首都师范大学,北京 100037
    4清华大学药学院/国家药品监督管理局创新药物研究与评价重点实验室,北京 100084

通讯作者:

杨悦,女,博士生导师,教授,主要从事药物政策与监管科学研究。联系电话:(010)62780224,E-mail:
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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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