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1 June 2022

北京知识产权法院审理全国首例药品专利链接诉讼案件

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北京知识产权法院审理全国首例药品专利链接诉讼案件.
China Intellectual Property

<<strong>日期:2022-04-15

近日,中外制药株式会社(以下简称"中外制药")诉温州海鹤药业有限公司(以下简称"海鹤药业")专利权保护范围纠纷案一审宣判,北京知识产权法院经审理认为,涉案仿制药并未落入涉案专利权的保护范围,判决驳回原告的诉讼请求。该案为新《专利法》实施以来全国首例药品专利链接诉讼案件

该案中,原告中外制药系第200580009877.6号,名为"ED-71制剂的专利权人,也是相关上市专利药品"艾地骨化醇软胶囊"的上市许可持有人,原告就上述药品和涉案专利登记在中国上市药品专利信息登记平台。原告发现,被告海鹤药业向国家药监部门申请注册了名称为"艾地骨化醇软胶囊"的仿制药上市许可申请,还在中国上市药品专利信息登记平台就上述仿制药作出了第4.2类声明,声明其仿制药未落入相关专利权保护范围。原告向北京知识产权法院提起诉讼,请求确认被告申请注册的仿制药"艾地骨化醇软胶囊"落入涉案专利的保护范围。

法院经审理认为,涉案仿制药使用的技术方案与涉案专利权利要求1的技术方案既不相同,亦不等同,故该技术方案未落入涉案专利权利要求1的保护范围;权利要求2-6为权利要求1的从属权利要求,在涉案仿制药的技术方案未落入权利要求1的保护范围的情况下,其亦不落入权利要求2-6的保护范围。据此,法院对原告的主张不予支持。

案件来源:知产力  https://www.zhichanli.com/newsflashes/307571397

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