美国药品跳转的反垄断审查法律制度研究  

Research on the Antitrust Review System of Pharmaceutical Product Hopping in the United States

作　　者：徐毅华 Xu Yihua

机构地区：[1]澳门科技大学法学院,中国

出　　处：《医学与法学》2023年第2期45-55,共11页Medicine and Jurisprudence

摘　　要：美国司法实践对药品跳转的反垄断规制尚未达成共识,法官们虽采用了合理规则,但分析重点和法律推理并不相同,甚至美国联邦贸易委员会表达了与保罗·戴蒙德法官截然相反的观点,故分析美国药品市场结构、反垄断法与知识产权法的关系以及界定品牌药相关市场,有助于厘清药品创新与反垄断法的关系;其药品创新虽受到联邦贸易委员会质疑,但过度的反垄断干预,反致错误成本增加。鉴于该行业的复杂性,法官应在考虑药品跳转“新增临床效益”的基础上适用本身合法规则。In the United States,there is no consensus on the antitrust regulation of pharmaceutical product hop⁃ping in judicial practice.Judges have used the rule of reason,but their analytical focus and legal reasoning vary.Even the Federal Trade Commission has expressed views that contradict those of Judge Paul Diamond.Analyzing the structure of the US pharmaceutical market,the relationship between antitrust and intellectual property law,and the definition of the relevant market for brand-name drugs can help clarify the relationship between drug innovation and antitrust law.While drug innovation has been questioned by the Federal Trade Commission,excessive antitrust inter⁃vention may increase error costs.Due to the complexity of the industry,judges should consider"additional clinical benefits"when applying per se legal rules to review pharmaceutical product hopping cases.

关 键 词：药品跳转 反垄断 品牌药 市场失灵 

分 类 号：D971.2[政治法律—法学] DD912.29