Article(id=1322180331122307832, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180330556076791, 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=1620835200000, acceptedDateStr=2021-05-13, onlineDate=1793161955862, onlineDateStr=2026-10-28, pubDate=1628956800000, pubDateStr=2021-08-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793161955862, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793161955862, creator=13701087609, updateTime=1793161955862, updator=13701087609, issue=Issue{id=1322180330556076791, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='15', pageStart='1345', pageEnd='1440', issueExtLink='null', onlineDate='null', pubDate='1628956800000', pubDateStr='2021-08-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793161955726, creator='13701087609', updateTime=1793162082189, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322180861076816464, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180330556076791, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322180861076816465, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180330556076791, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1345, endPage=1354, ext={EN=ArticleExt(id=1322180333131379449, articleId=1322180331122307832, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=The system design for early resolution mechanism for drug patent disputes with Chinese characteristics—From the perspective of comparison between foreign experience and domestic current situation, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The drug patent link system has been implemented in our country with the implementation of the new Patent Law of China on June 1st, 2021 and the implementation of “Early Resolution Mechanism for Drug Patent Disputes” on July 4th. To ensure the successful implementation of the patent link system, this paper analyzes the key elements of early resolution mechanism for drug patent disputes with Chinese characteristics, based on a comparative study of the overall framework of the drug patent link system in the United States, South Korea and Canada, combined with the development status and legislation of China's pharmaceutical industry at this stage. On the basis of the above, according to the reality of pharmaceutical industry, the characteristics of judicial and administrative systems in our country, this paper explores the early resolution mechanism for drug patent disputes suitable for China's national conditions under the framework principles established by the new Patent Law.

, authors=Cong WEI1, Tian TIAN1, Guo-shun DU1, Xin YIN2, authorsList=Cong WEI, Tian TIAN, Guo-shun DU, Xin YIN, authorCompany=null, correspAuthors=Xin YIN, 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=1322180333567587066, articleId=1322180331122307832, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=中国特色药品专利纠纷早期解决机制的制度设计——以国外经验与国内现状的对比为视角, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

2021年6月1日开始实施的专利法以及7月4日开始实施的《药品专利纠纷早期解决机制实施办法(试行)》标志着药品专利链接制度已在我国落地。为使专利链接制度能够在我国顺利实施,本文通过对美国、韩国和加拿大的专利链接制度比较研究,结合我国现阶段医药行业的发展现状以及立法情况,分析了中国特色药品专利纠纷早期解决机制的关键要素,在借鉴各国制度的基础上,针对我国药品行业的现状、司法与行政制度体制的特点,在专利法确定的框架原则下探索构建适合中国国情的药品专利纠纷早期解决机制体系。

, authors=魏聪1, 田甜1, 杜国顺1, 尹昕2, authorsList=魏聪, 田甜, 杜国顺, 尹昕, authorCompany=null, correspAuthors=尹昕, authorNote=

田甜,女,专利审查研究员,研究方向:医药生物领域专利审查。联系电话:(010)62412718,E-mail:。

魏聪,男,专利审查研究员,研究方向:医药生物领域专利审查。联系电话:(010)62412573,E-mail:。

杜国顺,男,专利审查研究员,研究方向:化学医药领域专利审查。联系电话:(010)62412588,E-mail:。

, correspAuthorsNote=
尹昕,女,研究员,课题负责人,研究方向:专利政策研究。联系电话:(010)66070584,E-mail:。
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魏聪,男,专利审查研究员,研究方向:医药生物领域专利审查。联系电话:(010)62412573,E-mail:。

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魏聪,男,专利审查研究员,研究方向:医药生物领域专利审查。联系电话:(010)62412573,E-mail:。

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杜国顺,男,专利审查研究员,研究方向:化学医药领域专利审查。联系电话:(010)62412588,E-mail:。

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杜国顺,男,专利审查研究员,研究方向:化学医药领域专利审查。联系电话:(010)62412588,E-mail:。

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中国特色药品专利纠纷早期解决机制的制度设计——以国外经验与国内现状的对比为视角
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魏聪 1 , 田甜 1 , 杜国顺 1 , 尹昕 2
中国新药杂志 | 新药述评与论坛 2021,30(15): 1345-1354
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中国新药杂志 |新药述评与论坛 2021 , 30 (15) : 1345 -1354
中国特色药品专利纠纷早期解决机制的制度设计——以国外经验与国内现状的对比为视角
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杜国顺,男,专利审查研究员,研究方向:化学医药领域专利审查。联系电话:(010)62412588,E-mail:。

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杜国顺,男,专利审查研究员,研究方向:化学医药领域专利审查。联系电话:(010)62412588,E-mail:。

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魏聪1 , 田甜1 , 杜国顺1 , 尹昕2
作者信息
  • 1国家知识产权局复审和无效审理部,北京 100088
  • 2首都师范大学,北京 100037
通讯作者:
尹昕,女,研究员,课题负责人,研究方向:专利政策研究。联系电话:(010)66070584,E-mail:。
作者简介:

田甜,女,专利审查研究员,研究方向:医药生物领域专利审查。联系电话:(010)62412718,E-mail:。

魏聪,男,专利审查研究员,研究方向:医药生物领域专利审查。联系电话:(010)62412573,E-mail:。

杜国顺,男,专利审查研究员,研究方向:化学医药领域专利审查。联系电话:(010)62412588,E-mail:。

The system design for early resolution mechanism for drug patent disputes with Chinese characteristics—From the perspective of comparison between foreign experience and domestic current situation
Cong WEI1 , Tian TIAN1 , Guo-shun DU1 , Xin YIN2
Affiliations
  • 1Reexamination and Invalidation Department of the Patent Office, China National Intellectual Property Administration, Beijing 100088, China
  • 2Capital Normal University, Beijing 100037, China
出版时间: 2021-08-15
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2021年6月1日开始实施的专利法以及7月4日开始实施的《药品专利纠纷早期解决机制实施办法(试行)》标志着药品专利链接制度已在我国落地。为使专利链接制度能够在我国顺利实施,本文通过对美国、韩国和加拿大的专利链接制度比较研究,结合我国现阶段医药行业的发展现状以及立法情况,分析了中国特色药品专利纠纷早期解决机制的关键要素,在借鉴各国制度的基础上,针对我国药品行业的现状、司法与行政制度体制的特点,在专利法确定的框架原则下探索构建适合中国国情的药品专利纠纷早期解决机制体系。

药品专利链接  /  药品专利纠纷早期解决机制  /  双轨制  /  橙皮书  /  批准等待期  /  首仿独占期

The drug patent link system has been implemented in our country with the implementation of the new Patent Law of China on June 1st, 2021 and the implementation of “Early Resolution Mechanism for Drug Patent Disputes” on July 4th. To ensure the successful implementation of the patent link system, this paper analyzes the key elements of early resolution mechanism for drug patent disputes with Chinese characteristics, based on a comparative study of the overall framework of the drug patent link system in the United States, South Korea and Canada, combined with the development status and legislation of China's pharmaceutical industry at this stage. On the basis of the above, according to the reality of pharmaceutical industry, the characteristics of judicial and administrative systems in our country, this paper explores the early resolution mechanism for drug patent disputes suitable for China's national conditions under the framework principles established by the new Patent Law.

drug patent link system  /  early resolution mechanism for drug patent disputes  /  dual track system  /  orange book  /  approval waiting period  /  market exclusivity period for the first generic drug
魏聪, 田甜, 杜国顺, 尹昕. 中国特色药品专利纠纷早期解决机制的制度设计——以国外经验与国内现状的对比为视角. 中国新药杂志, 2021 , 30 (15) : 1345 -1354 .
Cong WEI, Tian TIAN, Guo-shun DU, Xin YIN. The system design for early resolution mechanism for drug patent disputes with Chinese characteristics—From the perspective of comparison between foreign experience and domestic current situation[J]. Chinese Journal of New Drugs, 2021 , 30 (15) : 1345 -1354 .
  • 2020年国家知识产权局重大专项课题资助项目《药品专利链接制度下的行政确权与行政裁决研究》(ZX202002)
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2021年第30卷第15期
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  • 首发时间:2026-10-28
  • 出版时间:2021-08-15
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  • 录用日期:2021-05-13
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2020年国家知识产权局重大专项课题资助项目《药品专利链接制度下的行政确权与行政裁决研究》(ZX202002)
作者信息
    1国家知识产权局复审和无效审理部,北京 100088
    2首都师范大学,北京 100037

通讯作者:

尹昕,女,研究员,课题负责人,研究方向:专利政策研究。联系电话:(010)66070584,E-mail:。
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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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