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This paper analyzed the relationship between the early resolution of patent disputes and the patent linkage regime in United States and conducted research on the judicial application of “artificial infringement” under § 271(e)(2), the disputes and legal reasoning of United States courts in regard to the issues that whether the Paragraph Ⅳ statement is a necessary prerequisite to determine jurisdiction and whether to extend the infringement object to the later-issued patents. Based on the perception of the function of the mechanism for early resolution of patent disputes in the United States, the status quo of China's pharmaceutical reformation policy, its legislation and legal practice in the field of pharmaceuticals, this paper proposed a better path to build the dispute resolution mechanism under the ongoing drug patent linkage system in China, that is, to solve the patent disputes between the brand-name company and the generic drug company in the specific case related to disputes over confirming the absence of infringement on patent rights, and to provide opportunity for the drug patentees to petition administrative objections.

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本文分析美国药品专利纠纷早期解决机制与专利链接制度的关系，研究第271（e）（2）款“拟制侵权”条款在司法适用中，美国法院对是否以提出第Ⅳ段专利无效或不侵权声明作为立案要件，是否将侵权客体扩展至在后授权专利等问题的分歧和法律推理，并在理解美国早期纠纷解决机制功能价值和我国医药改革发展政策、医药领域立法实践现状的基础上，提出建设我国药品专利链接制度中纠纷解决机制的较优路径，即以确认不侵害专利权纠纷之诉解决仿制药企与原研药企间的专利纠纷，并为药品专利权人提供行政异议机会。

, authors=杨婧, 曹丽荣, authorsList=杨婧, 曹丽荣, authorCompany=null, correspAuthors=曹丽荣, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=wFHWQbL+pik/dRZbaLEccg==, magXml=N63nqkHCMkJX5u7D+CSKzA==, pdfUrl=null, pdf=2XC3G9RGwQiW4EnzVQQPSA==, pdfFileSize=2032631, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=ub3aXOnGa0gOvsCJZkvnTw==, mapNumber=null, fund=null)}, authors=[Author(id=1322180290051682767, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180288818557384, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=jingyang308@tongji.edu.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322180290135568849, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180288818557384, authorId=1322180290051682767, language=EN, stringName=Jing YANG, firstName=Jing, middleName=null, lastName=YANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Shanghai International College of Intellectual Property of Tongji University, Shanghai 200092, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322180290219454930, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180288818557384, authorId=1322180290051682767, language=CN, stringName=杨婧, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=同济大学上海国际知识产权学院，上海　200092, bio={"content":"

杨婧，女，硕士研究生，研究方向：知识产权与不正当竞争、药品专利链接。E-mail：jingyang308@tongji.edu.cn。

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杨婧，女，硕士研究生，研究方向：知识产权与不正当竞争、药品专利链接。E-mail：jingyang308@tongji.edu.cn。

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