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中国建立药品专利纠纷早期解决机制 发布试行实施办法

发表时间: 2021-07-05 17:34:52 近日浏览量: 13260
深圳宝安区福永服务(美女)外出这真的一晚多少钱联系方式,【葳芯★877⒋7_45⑴★】大学生·多少钱·一晚·特殊·一次·宾馆·酒店·服务·护士·包夜·少妇·【葳芯★877⒋7_45⑴★】  不可否认,不安全施工,很可能要为之付出代价。这份代价“最坏的可能”也许不堪设想,即便如此,在“应然”的代价里,肯定不应包括“妻子改嫁、孩子被家暴”这样的羞辱选项。

  中新社北京7月4日电 (记者 孙自法 李纯)根据《中华人民共和国专利法》,国家药品监督管理局、国家常识产权局组织制定《药品专利纠纷早期解决机制实施办法(试行)》,经国务院同意,于7月4日发布并施行,以保护药品专利权人合法权益,鼓励新药研究和促进高水平仿制药发展,建立药品专利纠纷早期解决机制。

  新发布施行的该《办法》提出,国务院药品监督管理部门组织建立中国上市药品专利信息登记平台,供药品上市许可持有人登记在中国境内注册上市的药品相关专利信息。国家药品审评机构负责建立并维护中国上市药品专利信息登记平台,对已获批上市药品的相关专利信息予以公开。

  化学仿制药申请人提交药品上市许可申请时,应当对照已在中国上市药品专利信息登记平台公开的专利信息,针对被仿制药每一件相关的药品专利作出声明。

  据了解,可以在中国上市药品专利信息登记平台中登记的具体药品专利包括:化学药品(不含原料药)的药物活性成分化合物专利、含活性成分的药物组合物专利、医药用途专利;中药的中药组合物专利、中药提取物专利、医药用途专利;生物制品的活性成分的序列结构专利、医药用途专利。相关专利不包括中间体、代谢产物、晶型、制备方法、检测方法等的专利。

  中国组织制定《药品专利纠纷早期解决机制实施办法(试行)》的官方两部门提供的政策解读称,药品专利纠纷早期解决机制是指将相关药品上市审批程序与相关药品专利纠纷解决程序相衔接的制度,旨在为当事人在相关药品上市审评审批环节提供相关专利纠纷解决的机制,保护药品专利权人合法权益,降低仿制药上市后专利侵权风险。

  该《办法》主要内容包括:平台建设和信息公开制度、专利权登记制度、仿制药专利声明制度、司法链接和行政链接制度、批准等待期制度、药品审评审批分类处理制度、首仿药市场独占期制度等。(完)

【编辑:苑菁菁】
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