论Bolar例外在非人用药领域的扩张  

On the expansion of Bolar exemption in the field of non-human drug

作　　者：徐棣枫[1] 李健 XU Difeng;LI Jian(Law School,Nanjing University,Nanjing 210093,P.R.China)

机构地区：[1]南京大学法学院,江苏南京210093

出　　处：《重庆大学学报(社会科学版)》2025年第1期217-232,共16页Journal of Chongqing University(Social Science Edition)

摘　　要：随着专利保护期限的临近,我国有一大批农兽仿制药面临为行政审批目的实施专利行为的侵权风险。解决非人用药上市的侵权困境成为当下药品专利制度的现实需求与重点调整方向。从美国Bolar例外制度的创立与演进历程看,其在近40年的发展过程中随着产业变革进行了多次扩张,以实现仿制药企、原研药企和社会公众之间的利益平衡。然而,我国Bolar例外制度可否扩张至非人用药领域?扩张方式、扩张限度及其应当遵循的原则和限制性标准等问题均存在理论与制度空白,亟待系统研究。通过深入分析可知,Bolar例外制度在非人用药领域的扩张具有理论正当性与现实可行性。就正当性而言,首先,该扩张符合产业政策导向。基于实验性用途专利豁免发展而来的Bolar例外,其创制与发展均以产业变革为基本遵循。通过将农兽药行政审批相关的专利实施行为纳入“安全港”范畴,能够促进我国农兽仿制药的及时上市,优化现行产业结构。其次,有助于提升健康食品的可及性。在食品安全战略背景下,作为专利政策调节工具的Bolar例外蕴含公共政策属性,可有效规制农兽药专利的过度垄断,协调专利权人与社会公众在健康食品可及性方面的利益张力。此外,从国际规则看,该扩张具有国际法层面的合规性。农兽药Bolar豁免符合《TRIPS协议》第30条规定的三重检验标准,是国际条约框架下的合规性调整。就扩张限度而言,首先,从制度层面看,Bolar例外具有独立的制度价值,不应与专利期限补偿制度混同。原研药企常以利益平衡为由将二者划上等号,这种极具迷惑性的表观平衡背后更多地隐藏着对自身利益的呼吁。其次,从对象层面看,基于产业政策理论的比较优势,在农兽药领域的扩张应当局限于具有当下产业上市需求的化学药领域,不宜过早延伸至农兽生物制药,避免制度调整�As patent protection periods approach their end,a large number of generic veterinary and agricultural drugs in China face patent infringement risks when implementing patents for administrative approval purposes.Resolving the infringement dilemma for non-human drug market entry has become a practical need and key adjustment direction in the current drug patent system.Looking at the establishment and evolution of the Bolar exemption system in the United States,it has undergone multiple expansions over the past 40 years in response to industry changes to achieve a balance of interests among generic drug companies,original drug companies,and the public.However,there are theoretical and institutional gaps regarding whether China’s Bolar exemption system can be expanded to non-human drug fields,the methods of expansion,expansion limits,and the principles and restrictive standards that should be followed,all of which require systematic research.Through in-depth analysis,it’s clear that expanding the Bolar exemption system to non-human drug fields has both theoretical legitimacy and practical feasibility.Regarding legitimacy,first,this expansion aligns with industrial policy orientation.The Bolar exemption,which developed from experimental use patent exemptions,has followed industry changes in its creation and development.By including patent implementation activities related to veterinary and agricultural drug administrative approval within the safe harbor scope,it can promote the timely market entry of generic veterinary and agricultural drugs in China and optimize the current industrial structure.Second,it helps improve the accessibility of healthy food.Under the food safety strategy background,the Bolar exemption,as a patent policy regulation tool with public policy attributes,can effectively regulate excessive monopolies of veterinary and agricultural drug patents and coordinate the tension between patent holders and public interests regarding healthy food accessibility.Furthermore,from an international rules per

关 键 词：BOLAR例外 非人用药 产业政策 制度扩张 竞争格局 

分 类 号：D923.42[政治法律—民商法学]