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Measures of January 1, 2006, for Compulsory License on Patent Implementation Concerning Public Health Problems (promulgated by Order No. 37 of the State Intellectual Property Office (SIPO)), China

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Repealed Text 
Details Details Year of Version 2005 Dates Entry into force: January 1, 2006 Adopted: November 29, 2005 Type of Text Implementing Rules/Regulations Subject Matter Patents (Inventions), Utility Models, Industrial Designs, IP Regulatory Body

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Main text(s) Main text(s) Chinese 2006年1月1日,涉及公共健康问题的专利实施强制许可办法 (国家知识产权局局令第37号发布)        

涉及公共健康问题的专利实施强制许可办法

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第一条 为了解决我国面临的公共健康问题,并帮助有关国家、地区解决其面临的公共健康问题,落实世界贸易组织多哈部长级会议《关于TRIPS协议与公共健康的宣言》(下称“多哈宣言”)和世界贸易组织总理事会《关于实施TRIPS协议与公共健康的多哈宣言第6段的决议》(下称“总理事会决议”),根据《中华人民共和国专利法》(下称“专利法”),制定本办法。

第二条 本办法所称传染病,是指导致公共健康问题的艾滋病、肺结核、疟疾以及《中华人民共和国传染病防治法》规定的其他传染病。

本办法所称药品,是指在医药领域用于治疗本条第一款所述传染病的任何专利产品或者通过专利方法制造的产品,包括制造前述产品所需的有效成分和使用前述产品所需的诊断试剂。

第三条 在我国预防或者控制传染病的出现、流行,以及治疗传染病,属于专利法第四十九条所述为了公共利益目的的行为。

传染病在我国的出现、流行导致公共健康危机的,属于专利法第四十九条所述国家紧急状态。

第四条 治疗某种传染病的药品在我国被授予专利权,我国具有该药品的生产能力,国务院有关主管部门可以依据专利法第四十九条的规定,请求国家知识产权局授予实施该专利的强制许可(下称强制许可)。

第五条 治疗某种传染病的药品在我国被授予专利权,我国不具有生产该药品的能力或者生产能力不足的,国务院有关主管部门可以请求国家知识产权局授予强制许可,允许被许可人进口世界贸易组织成员利用总理事会决议确定的制度为我国解决公共健康问题而制造的该种药品。

第六条 国家知识产权局授予本办法第五条所述强制许可的,被许可人以及其他任何单位或者个人不得将依照该强制许可决定进口的药品出口到其他任何国家或者地区。

第七条 国家知识产权局授予本办法第五条所述强制许可的,被许可人应当向专利权人支付合理的报酬。但该药品的生产者已经向该专利权人支付报酬的,被许可人可以不向专利权人支付报酬。

第八条 治疗某种传染病的药品在我国被授予专利权,任何单位或者个人在其他国家或者地区购买专利权人制造并售出的或者经专利权人许可而制造并售出的该种药品,将其进口到我国的,无需请求国家知识产权局授予强制许可。

第九条 世界贸易组织成员按照总理事会决议确定的机制通报世界贸易组织TRIPS理事会,希望进口治疗某种传染病的药品的,或者非世界贸易组织成员的最不发达国家通过外交渠道通知我国政府,希望从我国进口治疗某种传染病的药品的,国务院有关主管部门可以请求国家知识产权局授予强制许可,允许被许可人利用总理事会决议确定的制度制造该种药品并将其出口到上述成员或者国家。

第十条 国家知识产权局授予本办法第九条所述专利强制许可的,应当在其作出的强制许可决定中明确记载总理事会决议规定的有关要求。被许可人应当遵守该强制许可决定规定的要求。

第十一条 国家知识产权局授予本办法第九条所述强制许可的,被许可人应当向该药品的专利权人支付合理的报酬。

第十二条 依照本办法第四条、第五条和第九条请求强制许可的,除本办法有专门规定的以外,适用《专利实施强制许可办法》的规定。

第十三条 本办法自200611日起施行。


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