向仿制药厂商提供专利活性药物成分是否侵犯专利权:欧盟的安斯泰来诉波尔制药案与Bolar例外的适用

摘要

我国与欧盟的Bolar例外规则存在着诸多差别.从欧盟安斯泰来诉波尔制药案提出的问题,即第三方供应商向仿制药厂商提供专利活性药物成分时能否主张Bolar例外来看,欧盟及其成员国的立法仍隐晦不明.相比之下,我国专利法的Bolar例外规则给出了肯定的答案,从而为仿制药市场的发展提供了更好的法律预期.但为了更好地平衡专利权人与仿制药产业的利益,针对这种提供行为,应突出强调供应商的相关注意义务,确保其提供的活性药物成分仅用于Bolar例外所允许的为获取行政审批所需信息的研究和试验活动.%There are many differences in term of the Bolar exemption between EU and China.As to the dispute raised by Astellas v.Polpharma that whether the supply of patented active pharmaceutical ingredients to generic drug producers can enjoy the Bolar exemption,the law in EU Directive and EU member states offer no clear answer.By contrast,Bolar rule in Chinese Patent Act give a positive and clear answer which offers a better legal certainty to the generics industry.However,to strike a better balance between the patentee and the generics industry,China should place emphasis on the supplier's duty of case,make sure the active substance he supplies will exclusively be used for privileged approval studies.