Article(id=1322906789896925992, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887806737825858, 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=1617033600000, acceptedDateStr=2021-03-30, onlineDate=1793335157131, onlineDateStr=2026-10-30, pubDate=1634227200000, pubDateStr=2021-10-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793335157131, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793335157131, creator=13701087609, updateTime=1793335157131, updator=13701087609, issue=Issue{id=1322887806737825858, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='19', pageStart='1729', pageEnd='1824', issueExtLink='null', onlineDate='null', pubDate='1634227200000', pubDateStr='2021-10-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793330631192, creator='13701087609', updateTime=1793337389212, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322916151994495727, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887806737825858, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322916151994495728, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887806737825858, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1801, endPage=1807, ext={EN=ArticleExt(id=1322906790094058282, articleId=1322906789896925992, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Research on the early settlement mechanism of the patent related to the registration of biologics product in the US, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

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.

, authors=Yun QI¹, Yue YANG², Hua XING¹, Dian-zheng YANG¹, authorsList=Yun QI, Yue YANG, Hua XING, Dian-zheng YANG, authorCompany=null, correspAuthors=Hua XING, 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=1322906790404436779, articleId=1322906789896925992, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=美国生物制品注册相关专利早期解决机制研究, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

探索并分析美国生物制品注册相关的专利舞蹈制度。通过查阅国内外文献，回顾美国《生物制品价格竞争与创新法案》颁布的背景，分析生物制品专利舞蹈制度设计区别于化学药品专利链接的原因、特点以及制度实施的挑战。专利舞蹈制度以生物制品原研企业与生物类似药企业双方诚意协商为基础，通过专利信息交换程序确定专利诉讼范围，同时设计2个不同的阶段进入专利诉讼，尽量厘清专利纠纷，加快生物类似药上市，从而提高公众用药可及性。

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齐云，女，硕士研究生，研究方向：药事法规与药品政策。E-mail：dongqiy24@163.com。

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齐云，女，硕士研究生，研究方向：药事法规与药品政策。E-mail：dongqiy24@163.com。

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