Article(id=1236335227770040418, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236335227262529633, 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=1682179200000, acceptedDateStr=2023-04-23, onlineDate=1772694888297, onlineDateStr=2026-03-05, pubDate=1696003200000, pubDateStr=2023-09-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772694888297, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772694888297, creator=13701087609, updateTime=1772694888297, updator=13701087609, issue=Issue{id=1236335227262529633, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='18', pageStart='1801', pageEnd='1904', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772694888176, creator=13701087609, updateTime=1772694973637, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236335585770656362, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236335227262529633, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236335585770656363, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236335227262529633, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1809, endPage=1815, ext={EN=ArticleExt(id=1236335227954589795, articleId=1236335227770040418, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=The difference and influence of the "presumption" judgment method of novelty of pharmaceutical crystal patent between substantive examination and invalidation procedure, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The novelty examination of pharmaceutical crystal patents often requires the use of legal presumption as a method of finding out the facts. The process is complex because it involves the allocation and transfer of the burden of proof, the refutation and overturn of the presumed facts, and the use of legal techniques in the investigation of technical facts. Through typical cases, this paper compares the differences among different examination procedures in the judgment of evidence that is sufficient to challenge the novelty of pharmaceutical crystals and shift the burden of proof, and explores the reasons for the differences from the perspectives of the uncertainty of crystal acquisition, the purpose and value of the setting of substantive examination and invalidation procedures, the legal status of patents (applications), the burden of proof and the standard of proof, and further analyze the impacts of the presumption methods of different examination procedures and the performance of the parties' request and rebuttal on the grant and stability of the pharmaceutical crystal patent.

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药物晶体专利的新颖性审查常需借助法律推定作为查清事实的一种手段，其过程因涉及举证责任的分配与转移、推定事实的反驳与推翻等环节以及在技术事实调查中对法律技巧的把握而具备复杂性。本文通过典型案件，对比不同审查程序对于足以对药物晶体的新颖性构成质疑并使举证责任发生转移的证据把握的差异，并进一步从晶体获得的不确定性、实审与无效程序的设置目的和价值、专利（申请）的法律状态、举证责任和证明标准多个角度探究差异产生的原因，分析不同审查程序的推定方式以及当事人请求和反驳推定的表现对药物晶体专利的授予及其稳定性的影响。

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韩雅婷，女，审查员，主要从事药物化学和有机化学领域专利审查。E-mail: hanyating@cnipa.gov.cn。

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韩雅婷，女，审查员，主要从事药物化学和有机化学领域专利审查。E-mail: hanyating@cnipa.gov.cn。

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王轶，女，审查员，主要从事药物化学和有机化学领域专利无效和复审案件审理。E-mail: wangyi_2@cnipa.gov.cn。

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王轶，女，审查员，主要从事药物化学和有机化学领域专利无效和复审案件审理。E-mail: wangyi_2@cnipa.gov.cn。

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