Article(id=1321425854064874092, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425847911830056, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.17.003, 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=1757865600000, acceptedDateStr=2025-09-15, onlineDate=1792982074514, onlineDateStr=2026-10-26, pubDate=1789401600000, pubDateStr=2026-09-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982074514, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982074514, creator=13701087609, updateTime=1792982074514, updator=13701087609, issue=Issue{id=1321425847911830056, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='17', pageStart='1793', pageEnd='1904', issueExtLink='null', onlineDate='null', pubDate='1789401600000', pubDateStr='2026-09-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982073047, creator='13701087609', updateTime=1792982858328, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321429141673586821, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425847911830056, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321429141673586822, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425847911830056, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1811, endPage=1815, ext={EN=ArticleExt(id=1321425854245229166, articleId=1321425854064874092, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Practical research on the compensation system for drug patent term in China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

China's drug patent term compensation system has officially been implemented, but numerous hot-button issues remain unresolved in practice. This paper delves into several key problems through specific case studies, offering reflections and recommendations on corporate patent strategy and term compensation application approaches. It begins by introducing the legal origins of the drug patent term compensation system, including practices in countries such as the United States, Japan, and Europe. Then, it elaborates on the legal framework of China's system regarding scope of application, compensation duration, calculation methods, and eligibility criteria. Subsequently, it focuses on analyzing practical operational challenges in China, such as the definition of "new drugs", the meaning of "one drug", whether claims encompass new drug technical solutions, and protection scope limitations, while proposing corresponding solutions. Finally, based on legal significance, it provides enterprises with multiple patent strategy recommendations and adjustments to new drug application strategies, aiming to help them better safeguard their rights under the drug patent term compensation system.

, authors=Yong-feng ZHENG1, Hai-hua TU2, authorsList=Yong-feng ZHENG, Hai-hua TU, authorCompany=null, correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1321425854786294383, articleId=1321425854064874092, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=我国药品专利期限补偿制度相关实务研究, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

我国药品专利期限补偿制度已正式实施,但在实务中仍存在诸多热点问题亟待解决。本文结合具体案例,深入探讨部分关键问题,并对企业专利布局、期限补偿申请策略等方面提出思考与建议。首先介绍药品专利期限补偿制度的法律渊源,包括美国、日本、欧洲等国家/地区的制度情况。其次,阐述我国在该制度适用范围、补偿期限、计算方法及获得条件等方面的法律制度构建。重点分析我国实务操作中出现的问题,如“新药”定义、“一个药品”含义、权利要求是否涵盖新药技术方案以及保护范围限制等,并给出相应解决方案。最后,从法律意义角度为企业提出多项专利布局策略和调整新药申报策略等建议,以助力企业在药品专利期限补偿制度下更好地保护自身权益。

, authors=郑永锋1, 涂海华2, authorsList=郑永锋, 涂海华, authorCompany=null, correspAuthors=null, authorNote=

郑永锋,男,医学硕士,法学博士,主要从事专利审查、企业知识产权管理等工作。E-mail: 。

涂海华,男,硕士,副研究员,主要从事专利审查、新药开发与医药知识产权工作。E-mail: 。

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郑永锋,男,医学硕士,法学博士,主要从事专利审查、企业知识产权管理等工作。E-mail: 。

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郑永锋,男,医学硕士,法学博士,主要从事专利审查、企业知识产权管理等工作。E-mail: 。

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涂海华,男,硕士,副研究员,主要从事专利审查、新药开发与医药知识产权工作。E-mail: 。

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涂海华,男,硕士,副研究员,主要从事专利审查、新药开发与医药知识产权工作。E-mail: 。

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我国药品专利期限补偿制度相关实务研究
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郑永锋 1 , 涂海华 2
中国新药杂志 | 新药述评与论坛 2026,35(17): 1811-1815
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中国新药杂志 |新药述评与论坛 2026 , 35 (17) : 1811 -1815
我国药品专利期限补偿制度相关实务研究
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郑永锋1 , 涂海华2
作者信息
  • 1天士力生物医药产业集团有限公司,天津 300410
  • 2天士力医药集团股份有限公司,天津 300410
作者简介:

郑永锋,男,医学硕士,法学博士,主要从事专利审查、企业知识产权管理等工作。E-mail: 。

涂海华,男,硕士,副研究员,主要从事专利审查、新药开发与医药知识产权工作。E-mail: 。

Practical research on the compensation system for drug patent term in China
Yong-feng ZHENG1 , Hai-hua TU2
Affiliations
  • 1Tasly Biomedical Industry Group Co., Ltd., Tianjin 300410, China
  • 2Tasly Pharmaceutical Group Co., Ltd., Tianjin 300410, China
出版时间: 2026-09-15 doi: 10.20251/j.cnki.1003-3734.2026.17.003
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我国药品专利期限补偿制度已正式实施,但在实务中仍存在诸多热点问题亟待解决。本文结合具体案例,深入探讨部分关键问题,并对企业专利布局、期限补偿申请策略等方面提出思考与建议。首先介绍药品专利期限补偿制度的法律渊源,包括美国、日本、欧洲等国家/地区的制度情况。其次,阐述我国在该制度适用范围、补偿期限、计算方法及获得条件等方面的法律制度构建。重点分析我国实务操作中出现的问题,如“新药”定义、“一个药品”含义、权利要求是否涵盖新药技术方案以及保护范围限制等,并给出相应解决方案。最后,从法律意义角度为企业提出多项专利布局策略和调整新药申报策略等建议,以助力企业在药品专利期限补偿制度下更好地保护自身权益。

药品专利期限补偿  /  补偿权利保护范围  /  权利属性  /  专利布局  /  申请策略

China's drug patent term compensation system has officially been implemented, but numerous hot-button issues remain unresolved in practice. This paper delves into several key problems through specific case studies, offering reflections and recommendations on corporate patent strategy and term compensation application approaches. It begins by introducing the legal origins of the drug patent term compensation system, including practices in countries such as the United States, Japan, and Europe. Then, it elaborates on the legal framework of China's system regarding scope of application, compensation duration, calculation methods, and eligibility criteria. Subsequently, it focuses on analyzing practical operational challenges in China, such as the definition of "new drugs", the meaning of "one drug", whether claims encompass new drug technical solutions, and protection scope limitations, while proposing corresponding solutions. Finally, based on legal significance, it provides enterprises with multiple patent strategy recommendations and adjustments to new drug application strategies, aiming to help them better safeguard their rights under the drug patent term compensation system.

patent term extension compensation for pharmaceuticals  /  scope of rights protection  /  nature of rights  /  patent landscaping  /  application strategies
郑永锋, 涂海华. 我国药品专利期限补偿制度相关实务研究. 中国新药杂志, 2026 , 35 (17) : 1811 -1815 . DOI: 10.20251/j.cnki.1003-3734.2026.17.003
Yong-feng ZHENG, Hai-hua TU. Practical research on the compensation system for drug patent term in China[J]. Chinese Journal of New Drugs, 2026 , 35 (17) : 1811 -1815 . DOI: 10.20251/j.cnki.1003-3734.2026.17.003

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doi: 10.20251/j.cnki.1003-3734.2026.17.003
  • 首发时间:2026-10-26
  • 出版时间:2026-09-15
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    1天士力生物医药产业集团有限公司,天津 300410
    2天士力医药集团股份有限公司,天津 300410
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2种不同金属材料的力学参数
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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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