1044月號 道 法 法 訊 (276)

DEEP & FAR

 

 

 

 

ANDA-論及藥學組合物與第八條聲明

~Fed. Cir.2012 (十五)

 

 

陳榮福 專利代理人

•中國醫藥學院藥學系學士

•日本福岡大學生藥學所碩士

•陽明大學醫學藥理所博士

 

在本案,阿斯利捷利康,不僅使擁有專利者,從事該法所尋求鼓勵之精確創新活動,且該專利權者聲稱獲得美國 FDA 核准之醫療用途已經熟悉於市場也面臨着比Warner-Lambert所主張未經核准許可之藥物用途專利權,更緊迫之侵權風險(not only has the patent holder engaged in precisely the type of innovative activity that the Act sought to encourage, but such patentees—claiming FDA-approved therapeutic applications already familiar in the market—also face more compelling infringement risks than a patentee claiming unapproved uses for a drug as in Warner-Lambert.)。阿斯利捷利康因此辯稱不應比照Warner-Lambert案,而不會強迫本院要排除一切,根據§ 271(e)(2) 用途專利方法之請求,且其ANDA並未明確地敘述專利之方法(Warner-Lambert is inapposite and does not compel us to preclude all § 271(e)(2) claims based on method of use patents where the ANDA does not expressly recite a patented method.)