美国药品专利“常青”行为的规制经验及其借鉴  

Regulatory Experience of the“Evergreen”Behavior of Drug Patent in the United States

作　　者：刘宁[1] 王海霞 LIU Ning;WANG Haixia

机构地区：[1]福州大学法学院 [2]西南政法大学知识产权研究院

出　　处：《南京航空航天大学学报（社会科学版）》2024年第3期79-86,共8页Journal of Nanjing University of Aeronautics & Astronautics（Social Sciences）

基　　金：福建省社会科学基金项目(FJ2021TWB04);西南政法大学知识产权保护协同创新中心学生科研创新项目(24IP005)。

摘　　要：药品专利“常青”是专利药企业通过延长核心专利药的产品生命周期来获取高额利润的行为。目前,我国对药品专利“常青”行为的规制经验不足。为有效预防和规制该行为,有必要以首例反向支付协议案为线索,洞察药品专利“常青”行为在实务中存在的问题,探究其目的及表现形式并考察美国的规制经验。最终提出我国规制药品专利“常青”行为应秉持利益平衡原则、提高创造性授权标准、要求“反向支付协议”事先报备和事后审查以及明确并细化“专利药跳转”行为规则的应对策略。The term drug patent“evergreen”refers to the practice that pharmaceutical companies extend the lifespan of core patented drugs in order to secure substantial profits.Currently,China alacks regulatory experience in addressing this issue.To effectively prevent and regulate this behavior,it is essential to examine the landmark case of reverse payment agreements as a starting point.Through a thorough examination of the practical challenges associated with drug patent“evergreen”,an exploration of the purpose and manifestations of this practice,a study of the legal regulations in the United States.These measures should prioritize the principle of balancing interests,raise the standards for innovative patents,mandate both pre-disclosure and post-review of reverse payment agreements,and establish clear and detailed strategies to address instances of“patent hopping”behavior.

关 键 词：药品专利“常青” “专利丛林” “反向支付协议” 利益平衡原则 

分 类 号：D923.42[政治法律—民商法学]