2026年6月4日14:07:34.914 UTC / 路透社
2026年5月28日摄于美国华盛顿的美国最高法院大楼全景。路透社/乔纳森·恩斯特/档案照片
华盛顿6月4日电（路透社）——美国最高法院周四作出裁决，赫克马制药的仿制药版本——阿莫林制药的心血管药物凡泽卡（Vascepa）——未侵犯阿莫林的专利权。这一判决可能会让仿制药制造商在涉及所谓“瘦身标签”的专利诉讼中面临的风险降低。
这份以9票全票通过的裁决由自由派大法官凯坦吉·布朗·杰克逊起草，推翻了下级法院支持阿莫林的判决。仿制药制造商曾辩称，如果本案中法院支持阿莫林，将会阻碍他们生产和销售低价药品，并推高美国药品价格。
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唐纳德·特朗普政府时期支持赫克马向最高法院提起上诉。
赫克马总法律顾问萨姆·帕克表示，公司感谢最高法院“一致支持赫克马继续为数百万美国患者提供安全、可负担、高质量仿制药的权利”。
阿莫林未立即回应置评请求。
药品可以通过专利保护其活性成分以及特定使用方法。
旨在鼓励仿制药竞争的“瘦身标签”，是指允许仿制药制造商在其仿制药标签省略其所仿制品牌药的侵权使用用途时，避免专利诉讼。
美国食品药品监督管理局仅批准总部位于伦敦的赫克马的仿制药凡泽卡用于治疗严重高甘油三酯血症，并要求其使用瘦身标签，省略该药物用于治疗非严重高甘油三酯血症的用途，而这一用途仍在阿莫林的专利保护范围内。
美国食品药品监督管理局于2012年批准凡泽卡——一种从鱼油中提取的药物——用于治疗严重高甘油三酯血症（一种血液中脂肪过量的病症）并降低心脏疾病风险，并于2019年批准其用于治疗病情较轻的高甘油三酯血症。
目前该药物是爱尔兰裔美国生物制药公司阿莫林的唯一产品。根据该公司向美国证券交易委员会提交的文件，阿莫林2025年凡泽卡销售收入达2.136亿美元。
阿莫林于2020年在特拉华州联邦法院起诉赫克马。阿莫林辩称，赫克马的标签加上其在新闻稿和网站上的声明，会鼓励医生为病情较轻的患者开具该药物。
美国联邦巡回上诉法院推翻了特拉华州法院驳回此案的裁决。联邦巡回法院称，赫克马公开将其药物称为“仿制药凡泽卡”，却未明确说明其仅获批用于一种特定用途，这可能会鼓励医生为侵权用途开具该药物。
在推翻联邦巡回法院裁决的判决书中，杰克逊写道，阿莫林未能证明“不止是一种纯粹的可能性”，即赫克马的声明诱导了专利侵权行为。
“核心问题是阿莫林是否合理地指控赫克马积极鼓励了侵权使用，而非仅仅是医生是否可以合理地将所谓的声明解读为侵权指示，”杰克逊说道。
杰克逊还表示，仿制药制造商将其产品描述为与品牌竞争对手等效是行业常规做法。
“我们拒绝将遵守法律和行业标准视为非法行为的依据，从而将仿制药制造商置于进退两难的境地，”杰克逊说道。
赫克马在提交给最高法院的案情摘要中称，过去十年中，仿制药为患者和保险支付方节省了约2.9万亿美元。该公司与特朗普政府均辩称，允许类似阿莫林提起的诉讼可能会打击仿制药制造商的积极性，并导致药品价格上涨。
阿莫林告诉大法官，赫克马所谓的侵权行为是非典型的，并指出其未起诉另外七家同样生产仿制药凡泽卡的公司。
布莱克·布里坦在华盛顿报道；威尔·邓汉姆编辑
布莱克·布里坦为路透社法律版报道知识产权法，包括专利、商标、版权和商业秘密。他此前曾为彭博法律和汤森路透实务法律撰稿，并曾担任执业律师。
US Supreme Court backs generic drugmaker in ‘skinny label’ patent case
2026-06-04T14:07:34.914Z / Reuters
A general view of the U.S. Supreme Court building in Washington, D.C., U.S., May 28, 2026. REUTERS/Jonathan Ernst/File Photo
WASHINGTON, June 4 (Reuters) – Drugmaker Hikma’s
generic version of Amarin Pharma’s
cardiovascular medication Vascepa did not infringe Amarin’s patents, the U.S. Supreme Court ruled on Thursday in a decision that may make generic drugmakers less vulnerable to patent lawsuits involving so-called “skinny labels.”
The 9-0 ruling, authored by liberal Justice Ketanji Brown Jackson, overturned a lower court’s decision in favor of Amarin. Generic drugmakers had argued that a ruling in favor of Amarin in the case would have discouraged them from making and selling their lower-cost drugs and increased U.S. drug prices.
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President Donald Trump’s administration supported Hikma’s Supreme Court appeal.
Sam Park, Hikma’s general counsel, said the company is grateful that the Supreme Court “unanimously upheld Hikma’s right to continue providing millions of American patients with safe, affordable, high-quality generic medicines.”
Amarin did not immediately respond to a request for comment.
Pharmaceuticals can be protected by patents covering both the drug’s active ingredient and specific methods of using it.
“Skinny labels,” meant to encourage generic competition, are intended to allow generic drugmakers to avoid patent lawsuits if the label of their generic omits infringing uses of the brand-name drug it replicates.
The U.S. Food and Drug Administration approved London-based Hikma’s generic Vascepa solely to treat severe hypertriglyceridemia, and required it to include a skinny label that omitted the drug’s use to treat non-severe hypertriglyceridemia, which was still covered by Amarin patents.
The FDA approved Vascepa, derived from fish oil, in 2012 to treat severe hypertriglyceridemia, a condition involving an excess of fats in the blood, and reduce the risk of heart issues, and in 2019 approved it for less-severe hypertriglyceridemia.
It is currently Irish-American biopharmaceutical company Amarin’s only product. Amarin earned $213.6 million in revenue from Vascepa sales in 2025, according to a company filing with the U.S. Securities and Exchange Commission.
Amarin sued Hikma in Delaware federal court in 2020. Amarin argued that Hikma’s label, combined with statements in press releases and on its website, encouraged doctors to prescribe it for the less-severe condition.
The U.S. Court of Appeals for the Federal Circuit overturned the Delaware court’s decision to dismiss the case. The Federal Circuit said Hikma publicly referred to its drug as “generic Vascepa” without clarifying that it was approved only for one specific use, which could have encouraged doctors to prescribe it for infringing uses.
In the court’s ruling reversing the Federal Circuit’s decision, Jackson wrote that Amarin failed to show “more than a sheer possibility” that Hikma’s statements induced infringement of its patents.
“The central question is whether Amarin plausibly alleged that Hikma actively encouraged infringing uses, not merely whether doctors could plausibly read the alleged statements as instructions to infringe,” Jackson said.
Jackson also said that it was normal industry practice for generic drugmakers to describe their products as equivalent to brand-name competitors.
“We decline to put generic manufacturers between a rock and a hard place by turning adherence to the law and industry standards into building blocks for illegal conduct,” Jackson said.
Hikma told the Supreme Court in a brief that generic drugs have saved patients and insurance payers an estimated $2.9 trillion in the past decade. The company and the Trump administration both argued that allowing lawsuits like Amarin’s could disincentivize generic drugmakers and lead to increased drug prices.
Amarin told the justices that Hikma’s alleged infringement was atypical, noting that it had not sued seven other companies that also make generic Vascepa.
Reporting by Blake Brittain in Washington; Editing by Will Dunham
Blake Brittain reports on intellectual property law, including patents, trademarks, copyrights and trade secrets, for Reuters Legal. He has previously written for Bloomberg Law and Thomson Reuters Practical Law and practiced as an attorney.
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