仿制药委托开发专利侵权的不安抗辩研究  

Research on defense of uncertainty to patent infringement of generic drug commissioned development

作　　者：金春阳[1] 何安琪 JIN Chun-yang;HE An-qi(School of Law,Xi'an Jiaotong University,Xi'an 710049,China)

机构地区：[1]西安交通大学法学院,西安710049

出　　处：《中国新药杂志》2025年第4期358-363,共6页Chinese Journal of New Drugs

基　　金：2023年陕西省社科基金年度项目(2023E064)。

摘　　要：不安抗辩旨在保护有先后履行顺序的双务合同中先履行义务一方。然而在仿制药委托开发合同中,基于专利侵权风险的不安抗辩面临认定困境。理论上法院对不安抗辩的认定主要考察主张权利一方是否尽到举证义务与通知义务。实践中法院主要通过形式与实质的分别判断,结合涉案行业本身特点予以认定。阻碍不安抗辩成立的要素有Bolar例外豁免、怠于通知以及专利侵权的举证困难。成功主张不安抗辩要求合同的订立具体、明确、全面,合同的履行诚实、信用、全面。考虑仿制药研发的特殊性,充分的事前专利侵权风险评估、管控原辅料及参比制剂以及早期解决药品专利纠纷有利于消除不安抗辩的局限性。The defense of uncertainty protects the interests of the party who performs first in a dual contract where there is an agreement on the order of performance.However,in the case of generic drug development contracts,the defense of uncertainty based on the risk of patent infringement faces a difficult determination.Theoretically,the court s determination of the defense of uncertainty mainly examines whether the party claiming the right has fulfilled the burden of proof and the duty of notification.In practice,the court mainly makes separate judgments on form and substance and identifies them according to the characteristics of the industry involved.The obstacles to establishing the defense of uncertainty include the Bolar exception exemption,failure to provide notification,and the difficulty of proving patent infringement.The successful assertion of the defense of uncertainty requires specificity and comprehensiveness in the formation of the contract and honesty and integrity in the performance of the contract.Considering the special characteristics of generic drug development,adequate prior patent infringement risk assessment,control of raw and auxiliary materials and reference preparations,as well as the early resolution of pharmaceutical patent disputes are conducive to eliminating the limitations of the defense of uncertainty.

关 键 词：不安抗辩 专利侵权 仿制药开发 

分 类 号：R95[医药卫生—药学]