104年2月號 道 法 法 訊 (274) |
DEEP & FAR |
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ANDA-論及藥學組合物與第八條聲明~Fed. Cir.2012 (十三) |
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 |
由於被上訴人們從其ANDA ([1]) 排除任何已專利之治療適應症，地區法院之論結: 阿斯利捷利康並無根據§ 271(e)(2) 之請求。([2])
阿斯利捷利康首先主張地區法院，過於狹窄地讀取§ 271(e)(2)。其宣稱 § 271(e)(2) 之”平素用語和明確語言”(“plain
and unambiguous” language)支援著其侵權之請求，引述法規”之相關部分”，如下所示：”根據聯邦食品、藥物和化妝品法規，亦即21 U.S.C. §355(j)，只要遞交(A) ANDA申請.....一種專利所主張使用之藥物，.....則視為侵權行為。([3])
阿斯利捷利康因此辯稱其係根據 §271(e)(2) 可認知之主張而控訴，被上訴人申請”藥物之簡化新藥申請 (Abbreviated New Drug
Applications, ANDA)”，即”例如第’618號和第’152號等專利所主張瑞舒伐他汀鈣之使用”。然而，阿斯利捷利康之選擇性引證，省略§ 271(e)(2) 之關鍵性用語，而將法定基礎濃縮為”遞交一種專利所主張藥物用途ANDA申請案之責任”，而非使用條文之實際語言，以讀取(actual language of the statute reading)”一種專利所主張或專利所主張用途之藥物(a drug claimed in a patent or the use of which is claimed in
a patent)”。([4])
事實上，阿斯利捷利康之辯解源自於相同之誤導，亦即依照§ 271(e)(2) 而由Warner-Lambert原告所提供”刪節之引用 (abridged quotation)”([5])。然後現在，本院駁回法律之如此解析，因其剪接§ 271(e)(2)(A) 之第一和第二句而”剝除法定條文之重要部分”(eviscerated an important part of the statutory provision by
conflating the first and second clauses of §
271(e)(2)(A) [6])。
而本院再駁回論述: 根據§ 271(e)(2) 遞交任何已專利用途藥物之ANDA，自然足以構成侵權(filing an ANDA for a drug
having any patented use automatically constitutes infringement under § 271(e)(2)。
[1]. In deciding Appellees’ motions
to dismiss, the district court held that it could consider certain documents
beyond the pleadings, including Appellees’ ANDA filings, Section viii
statements, and proposed labeling. Astra-Zeneca, 2010 WL 5376310, at *8–9.
AstraZeneca complains that the district court committed legal error by
considering such documents without allowing it to take discovery. However, the
district court was entitled to examine documents “integral to or explicitly
relied upon in the complaint” in evaluating motions to dismiss. In re
Burlington Coat Factory Sec. Litig.,
[2]. Id.
[3]. Non-Confidential Br. for Plaintiffs-Appellants at 23(formatting in original)
[4]. 35 U.S.C. § 271(e)(2)(A) (emphasis added).
[5]. See
[6]. id.