通过 纳根德拉·塞蒂(Nagendra Setty) 马克·麦格拉思

在最近的决定中 阿斯利康 Pharmaceuticals LP v. Apotex Corp。,第2011-1182号– 2011-1190 (Fed. Cir. Feb. 9, 2012) (hereinafter 的“阿斯利康 决断”) (Rader*, Bryson & Linn), 的Federal Circuit affirmed a District of Delaware decision dismissing an infringement case for failure to state a claim, pursuant to Fed. R. Civ. P. 12(b)(6). Defendants/appellees (collectively, “Appellees”)各自提交了新药简述(“ANDA”) with 第八节声明s, seeking approval for methods of use not claimed in a patent listed in 的Orange Book.

原告/上诉人AstraZeneca Pharmaceuticals LP,AstraZeneca AB,IPR Pharmaceuticals,Inc.和The Brigham 和 Women’s Hospital,Inc.(统称,“AstraZeneca”) hold certain patents relating to 的cholesterol-lowering drug rosuvastatin calcium, which 阿斯利康 marketed under 的name CRESTOR®。其中两项专利已提起诉讼— 美国专利6,858,618 (“the ’618 Patent”)声称用于治疗杂合性家族性高胆固醇血症(“HeFH”), 和 美国专利7,030,152 (“the ’152 Patent” 和, together with 的’618 Patent, 的“Patents-in-Suit”) claims methods of use to lower 的cardiovascular disease risk for individuals who have elevated circulating C-reactive protein (“CRP”). When 的FDA approved 阿斯利康’的新药申请(“NDA”) to treat 跳频 和 elevated C反应蛋白, 的FDA also approved rosuvastatin calcium to treat homozygous familial hypercholesterolemia (“HoFH”)和高甘油三酸酯血症。

When 被上诉人 filed their respective 安达s with 的FDA seeking to market generic rosuvastatin calcium, 被上诉人 limited 的claimed methods of use to those seeking to treat 跳频 和 hypertriglyceridemia, neither of which was 的subject of a claim in either of 的Patents-in-Suit. Pursuant to U.S.C. 21§ 355(j)(2)(A)(viii), an applicant filing an 安达 is permitted to file a statement (a “第八节声明”) that 的ANDA excludes all methods of use claimed in a patent contained in 的Orange Book. Since 被上诉人 limited their respective 安达s to methods of use that were not claimed in a patent by 阿斯利康, 被上诉人 each filed 第八节声明s.

After commencing an action against 被上诉人 relating to another patent relating to rosuvastatin calcium owned by 阿斯利康, 阿斯利康 commenced another action against 被上诉人 alleging infringement of 的Patents-in-Suit pursuant to 35 U.S.C.§ 271(e)(2)。特别是,“阿斯利康声称:(1)被上诉人’提起的ANDA被违反§ 271(e)(2) as ‘application[s] for 毒品the use of which is claimed’ in 的’618 和 ’152项专利; (2)如果获得FDA批准,被上诉人’拟议的活动将导致侵权’618 和 ’152项专利; (3)FDA将要求被上诉人做出标签修改,明确纳入以下内容:’618 和 ’152 patents.” 阿斯利康 决断,在10点。被上诉人基于以下几个理由撤职,包括:(1)地区法院缺乏标的物管辖权,因为被上诉人’ANDA不包含与专利诉讼有关的第IV段证明,并且(2)投诉未能提出索赔,因为被上诉人’ANDA并未寻求批准专利中要求的使用方法。地方法院驳回阿斯利康’根据美联储R. Civ。 P. 12(b)(1)和12(b)(6),认为它缺乏主题管辖权,因为ANDA排除了在售专利中主张的所有使用方法,因此不存在根据第271(b)节提出的主张e)(2),并且即使法院确实具有标的物管辖权,阿斯利康也无法提出索赔。

On appeal, 的Federal Circuit held that 的district court did have subject matter jurisdiction because 阿斯利康 alleged that 被上诉人’ 安达s infringed under Section 271(e)(2). As 的联邦巡回法院指出, U.S.C. 28§ 1338(a) 规定地区法院对根据美国国会法与专利有关的任何民事诉讼拥有原始管辖权。 阿斯利康 决断,在12点。国会颁布第271(e)(2)条时,它创建了新的“‘高度人为的侵权行为’ … so that court could promptly resolve infringement 和 validity disputes before 的ANDA applicant had engaged in 的traditional statutorily defined acts of infringement.” 阿斯利康 决断,第12-13页(引用 礼来&诉Medtronic,Inc.496 U.S. 661,678(1990);和引用 Glaxo,Inc.诉Novopharm,Ltd.,110 F.3d 1562,1569(Cir。1997)。因此,并与其在 Allergan公司诉Alcon Labs公司, 324 F.3d 1322 (Fed. Cir. 2003), 的Federal Circuit held that 上ce a patent holder alleges that an 安达 infringes its patents listed in 的Orange Book under Section 271(e)(2), district courts have subject matter jurisdiction over 的action. 阿斯利康 决断,在13-14岁。

The Federal Circuit held, however, that 阿斯利康 failed to state a claim under Section 271(e)(2). The Federal Circuit’s holding was based 上 的language of Section 271(e)(2) 和 its decision in 华纳·兰伯特 Co.诉Apotex Corp.。, 316 F.3d 1348 (Fed. Cir. 2003).联邦巡回赛began by setting forth 的language contained in Section 271(e)(2), which provides, in pertinent part, that:

提交属于侵权行为– (A) an application [i.e., an 安达] under section 505(j) of 的Federal Food, Drug, 和 Cosmetic Act [codified at U.S.C. 21§ 355(j)] for 毒品claimed in a patent or 的use of which 申请专利… if 的purpose of such submission is to obtain approval under such Act to engage in 的commercial manufacture, use, or sale of 毒品…专利或 的use of which 申请专利before 的expiration of such patent.

阿斯利康 决断,第14-15页(引用了35 U.S.C.§ 271(e)(2)) (alterations 和 emphasis added in original).联邦巡回赛then explained that it has previously “construed 的term ‘the use’ as used in §271(e)(2)(A)的意思是‘the use listed in 的ANDA.’” 阿斯利康 决断,在15(引用 华纳·兰伯特,316 F.3d at 1356-60)。

联邦巡回法院拒绝了阿斯利康’s试图浓缩第271(e)(2)节的语言。阿斯利康(AstraZeneca)辩称,根据第271(e)(2)条提出的可行索赔仅要求ANDA用于“a drug …专利要求其使用….”联邦巡回赛“拒绝对此法规进行解析,因为它‘通过合并法规的第一条和第二条排除了法律规定的重要部分§ 271(e)(2)(A),’”因此,也驳回了对任何声称拥有专利使用权的药物提出ANDA构成侵权的论点。 阿斯利康 决断,在15-16(引用 华纳·兰伯特, 316 F.3d at 1355).联邦巡回赛then stated:

当我们举行 华纳·兰伯特, a patented method of using 毒品can 上ly be infringed under §271(e)(2),通过提交ANDA寻求批准对该药物进行市场营销。 [316 F.3d] at 1358–59. Thus, an 安达 seeking to market 毒品not covered by a composition patent for unpatented methods of treatment cannot infringe under §271(e)(2)。阿斯利康没有声称,也不能声称被上诉人’ANDA寻求FDA批准使用瑞舒伐他汀钙,其范围包括’618 or ’152项专利,它们将证明一个可行的解决方案§ 271(e)(2) claim.

阿斯利康 决断,在17。

阿斯利康 attempted to distinguish 华纳·兰伯特 上 的grounds that 的patent asserted in that case claimed a use that had not been approved by 的FDA whereas 的Patents-in-Suit contained uses that were approved by 的FDA.联邦巡回赛rejected that argument because Section 271(e)(2) requires courts to analyze 的scope of approval sought in 的ANDA, 和 的statute defines infringement as filing an 安达 for “a drug专利或专利要求其使用.” 35 U.S.C.§ 271(e)(2)(A).

作为  联邦巡回法院指出, Congress permitted generic manufacturers to limit 的scope of 安达s by excluding patented methods of use 和, therefore, permitted generic manufacturers to avoid filing Paragraph IV certifications 和 a Section 271(e)(2) claim. To hold otherwise would have reduced 的import of seeking approval of a generic based 上 a 第八节声明.