Bolar例外规则的源起、移植与创制  

The Origin,Transplantation and Creation of Bolar Exception Rule

作　　者：刘庆 LIU Qing(School of Law,Hangzhou Dianzi University,Hangzhou Zhejiang 310018,China)

机构地区：[1]杭州电子科技大学法学院,浙江杭州310018

出　　处：《杭州电子科技大学学报（社会科学版）》2021年第6期65-71,共7页Journal of Hangzhou Dianzi University：Social Sciences

基　　金：国家社会科学基金青年项目(17CFX050)。

摘　　要：Bolar例外规则起源于美国,经过Medtronic案等一系列案例的发展,在适用范围和行为认定等方面都有所扩展。Bolar例外规则与专利链接制度、专利期补偿制度、仿制药简化申请程序制度、首仿药市场独占期制度共同促进美国的医药市场发展,使其成为全球最大的药品市场,也为新兴药品市场提供了良好的学习样板。Bolar例外规则规定在我国《专利法》69条第1款第5项。若想获得与美国的Bolar例外规则相同的效果,我国应将与Bolar例外规则相配套的专利链接制度、试验数据保护制度、专利补偿期制度移植并进行本土化改造,在法律规范中明确其适用范围,构建完整的专利挑战制度。The Bolar Exception Rule originated in the United States.With the development of the Medtronic case and a series of other cases,its scope of application and behavior recognition have been gradually expanded to some extent.The Bolar exception rule,the patent link system,the patent period compensation system,the generic drug simplified application procedure system,and the first generic drug market exclusive period system have jointly promoted the development of the US pharmaceutical market,making it the world's largest pharmaceutical market and also offering a good example for the new type of pharmaceutical market.China's Bolar Exceptional Rule stipulates in Article 69(5)of the Patent Law.If wanting to achieve the same effect as the US Bolar exception Rule,China should transplant and restructure local systems matched with the Bolar exception,including the patent link system,the test data protection system,the patent compensation period system to define the scope of application in the legal norms and build a complete patent challenge system for generic drug manufacturers.

关 键 词：Bolar例外规则 专利权限制 医药专利 仿制行为 公共健康 

分 类 号：D523.2[政治法律—政治学]