简明标签与第二医药用途专利侵权认定:从规范构造到标准选择  

Skinny Label and Second-Medical-Use Patents:from Legal Constructure to Attribution Standard

作　　者：吴柯苇 Wu Kewei(School of Law, Peking University, Beijing 100871, China)

机构地区：[1]北京大学法学院,北京100871

出　　处：《科技进步与对策》2022年第2期101-110,共10页Science & Technology Progress and Policy

摘　　要：第二医药用途发明可被专利已成为世界立法趋势。中国现有立法中狭义的第二医药用途专利可以获得专利保护。英美司法实践发展出主观意图测试、客观意图测试和外在表现测试3种侵权认定标准,分别对应过错和无过错侵权原则。中国需在原研药创新、仿制药产业和药品可及性三元平衡视角下,选择综合进路。在第二医药用途专利直接侵权认定标准上,应坚持无过错标准,仅考虑仿制药厂的简明标签行为是否符合法定要求,以此判断是否落入第二医药用途专利保护范围。在间接侵权认定上,应坚持过错标准和因果考察。Since the implementation of the Hatch-Waxman Act,which pioneered the pharmaceutical patent linkage system in the United States,the"cat and mouse game"between the original research drug and the generic drug manufacturer has lasted for more than 30 years.As part of this system,U.S.legislation provides a way for generic drug companies to enable them to obtain marketing approvals that are less than the number of indications for brand-name drugs through skinny labeling.In this way,the patent linkage is connected with the patent protection of the second-medical-use patents.However,this rule cannot eliminate the possibility of off-label use of second-medical-use patents.The key to balancing the interests of the three parties lies in the infringement attribution standard for the infringement of the second medical use patents.It is one of the key issues in the practice of international pharmaceutical patent affairs,and it is also a new issue emerging in China.Despite the controversy,the patentability of second-medical inventions has been gradually reached the same standard around the world.The essence of Swiss-type claims is to break through the basic doctrine of"Prohibition of granting patents monopoly on diagnosis and treatment of diseases",which is prevailing in the civil law paradigm,and provide the possibility of obtaining patent protection for medical-use inventions.From 2017,this kind of patent claim can be also protected by China's patent legislation.Infringement attribution standards of Swiss-type claims is also a hit and tough matter in the UK.In Warner-Lambert v.Actavis,the British court proposed and reviewed the following three standards for the determination of infringement:subjective intention test,objective intention test,and outward presentation test.The judges of the Supreme Court of the UK showed a certain consistency in the judicial choice of infringement standards and the value judgments based on the existing facts,that is,they all tend to deny the harsh objective intention test.In Warner-Lambert v.Act

关 键 词：第二医药用途专利 侵权归责 药品可及性 简明标签 标签外使用 专利链接 

分 类 号：D923.42[政治法律—民商法学]