皮包骨头的标签并不能防止侵权责任

2020年11月2日 医药专利 博客
作者: 考特尼·布林克霍夫

联邦巡回法院的裁决 GlaxoSmithKline LLC v. 梯瓦 Pharmaceuticals USA, Inc.,正在吸引潜在的关注“endangering” the practice of 瘦标签ling. Indeed, the Federal Circuit held that 梯瓦’s 瘦标签 did not shield it from liability for inducing infringement of an Orange Book-listed method of use patent. 普罗斯特首席法官’反对意见认为多数决定使“critical balance”在促进制药领域的创新与允许低成本仿制药进入市场之间,但是处方药实践的现实使得当创新者开发并为已知药物的新用途申请专利时,很难站在一边。

The g®专利和批准的用途

涉及GSK橙皮书所列使用方法专利的基础诉讼’s g®(卡维地洛)产品。 FDA最初批准Coreg®用于治疗高血压。橙皮书列出的第一项专利是美国专利4,503,067,该专利要求使用卡维地洛及其治疗方法“高血压和/或心绞痛。”1997年,葛兰素史克(GSK)获得了Coreg的批准®用于治疗充血性心力衰竭。 1998年,葛兰素史克(GSK)获得了美国专利号5,760,069,该专利要求“降低由充血性心力衰竭引起的死亡率的方法,” by administering “卡维地洛与一种或多种其他[特定]治疗剂的结合。” 葛兰素史克 listed the ’橙皮书中的069专利,其使用代码为“降低由充血性心力衰竭引起的死亡率。”根据联邦巡回法院的多数意见,2003年FDA批准了“Coreg® combination” for “由患有心肌梗塞的左心功能不全的患者使用。”

In 2002, 梯瓦 filed an Abbreviated New Drug Application (ANDA) seeking approval of its generic carvedilol product, making a Paragraph III certification for the ’067专利(定于2007年到期)和’069 patent. 梯瓦’s proposed labeling did not include the indication and prescribing information for treatment of congestive heart failure, but in 2011 FDA required 梯瓦 to amend its label to be identical to 葛兰素史克’s g® label.

In 2003, 葛兰素史克 sought reissue of the ’067号专利,并最终在2008年获得了重新发行的专利号RE40,000。’069 patent, the ’000项专利申请了“降低由充血性心力衰竭引起的死亡率的方法, by administering “卡维地洛与一种或多种其他[特定]治疗剂的结合,”但是重新发布的权利要求列举了附加的协议详细信息。它是’000 patent that was asserted against 梯瓦 in the underlying litigation.

陪审团裁决

In 2014, 葛兰素史克 sued 梯瓦 for inducing infringement of the ’000 patent. In its defense, 梯瓦 argued that it could not be liable for inducing infringement of that patent because its original product had a “skinny label”没有提到充血性心力衰竭,并且在需要修改其标签以包括该适应症时,要求医生开具处方 已经知道了 from 葛兰素史克 and elsewhere that carvedilol was useful for treating congestive heart failure. Thus, according to 梯瓦, it could not have “caused”他们侵犯了’000 patent.

陪审团不同意,采用了部分提供的陪审团指示:

葛兰素史克 must prove that 梯瓦’的行为导致医师直接侵犯了对’000 patent, but 葛兰素史克 may do so with circumstantial—as opposed to direct—evidence.

如联邦巡回法院多数意见所概述:

The jury found that 梯瓦 induced infringement of claims 1-3 during the period starting January 8, 2008 (the date of the ’000 patent’s issuance) to April 30, 2011 (the last day before 梯瓦 amended its label); and that 梯瓦 induced infringement of claims 1–3 and 6–9在自2011年5月1日至2015年6月7日(标签有效期届满)’000专利)。陪审团根据利润损失和特许权使用费的组合评估损害赔偿,裁定侵权是故意的。

地方法院’s Grant of JMOL

地方法院批准了Teva’根据葛兰素史克(GSK)未能证明“Teva’与其他因素相反,所谓的诱因实际上导致了医生”开通用卡维地洛治疗充血性心力衰竭。例如,地方法院指出“开处方医生可以使用的许多信息来源,” including “GSK’s g®卡维地洛的标签和促销,” that “had already informed physicians about the uses of g®.”地方法院的结论是:

A reasonable factfinder could only have found that these alternative, non-Teva factors were what 造成 医生们 to prescribe generic carvedilol for an infringing use.

联邦巡回决定

The Federal Circuit decision was authored by Judge Newman and joined by Judge Moore. 普罗斯特首席法官 filed a 33页 反对意见。

多数意见指出,陪审团作出裁决后授予JMOL的最高标准,并找到了支持陪审团的充分证据’s finding of induced infringement. While the majority opinion reviews a number of pieces of supporting evidence, it notes in particular evidence that 梯瓦 promoted its products “与AB等级相当” of 葛兰素史克’s g® tablets and as “Generic g® Tablets” and testimony that physicians would have understood this to mean that the 梯瓦 product was “治疗上可互换” with g®.

The majority opinion also quotes testimony from a 梯瓦 employee acknowledging that 梯瓦 knew it would get sales from prescriptions written to treat congestive heart failure:

Question: And so to make it specific to the issues here, if 梯瓦 has carved out congestive heart failure, but not hypertension and not post MILVD, 梯瓦 still expects to get sales where the doctor prescribed carvedilol for congestive heart failure, correct?

答:是的,除非医生感觉强烈。

问题:只写品牌?

答:可以。

总而言之,大多数发现“充分记录促销材料,新闻稿,产品目录,FDA标签以及双方证人的证词,以支持陪审团对在该期间内指定指称的侵权做出的裁决。’000 reissue patent.”

普罗斯特首席法官’s Dissent

普罗斯特首席法官 strongly disagreed with the majority decision, which she characterizes as “允许以非专利用途销售的药物引起诱因。”普罗斯特法官批评多数法官“nullifying” 21 U.S.C. §355(j)(2)(A)(viii),即使存在使用专利的方法,通用公司也可以获得批准“分割”他们标签上的指示.根据普罗斯特法官的说法,that provision was intended to make it “这样,’000专利不会阻止人们获得负担得起的卡维地洛。”

普罗斯特法官也不同意多数意见’发现大量证据支持陪审团的裁决:

The district court got it right: no evidence established that 梯瓦 actually 造成 医生们’ infringement for either label. No communication from 梯瓦 encouraged doctors to use generic carvedilol to practice the patented method. And no evidence showed that doctors relied on 梯瓦’s label. Indeed, 葛兰素史克’s own expert admitted that he had not read 梯瓦’处方通用卡维地洛前使用s标签。

普罗斯特首席法官 also finds the damages award to be unfair, noting that “在涉嫌侵权的期间,Teva仅售出了价值7400万美元的卡维地洛(主要用于非专利用途),但现在仅凭一次迹象就销售了2.34亿美元的损害赔偿。”普罗斯特法官评论说“他的讽刺意味反映了特瓦’产品明显便宜—costing less than 4 cents per pill as compared with g®’每片至少$ 1.50的价格。”根据普罗斯特法官的说法,“Teva做的一切正确—using a 瘦标签, taking care not to encourage infringing uses—and yet, given today’结果,Teva出售用于非专利用途的非专利药物的成本最终要比完全排除在市场之外要高得多。”

为批准药物的新用途申请专利

普罗斯特首席法官’意见表明,《美国法典》第21卷第§355(j)(2)(A)(viii)体现了国会的政策决定,即在就先前批准的产品的新用途授予专利时,如何在促进创新与许可仿制药之间平衡竞争利益,但国会是否真的决定创新者应否针对新的侵权用途规定的通用产品求助?专注于“skinny label”忽略了医师可以出于任何目的自由开处方药。确实,多数人和异议人士都引用了医生没有读过Teva的证词 ’s label before writing prescriptions. While a 瘦标签 may circumscribe the activities for which a generic company can be found liable for infringement under 35 U.S.C. § 271(e)(2)(A), I’我不被多数人所困扰’根据《美国法典》第35篇,它未必一定会使通用公司免于承担实际侵权责任。§ 271(b).

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