By Blake Brittain
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.
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 said in a statement that it was “deeply disappointed” by the decision and was evaluating its next steps.
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.
‘BETWEEN A ROCK AND A HARD PLACE’
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.
Lauren Aronson, executive director of the interest group Campaign for Sustainable Rx Pricing, said that Thursday’s decision “helps restore certainty to the skinny-label pathway and will encourage more lower-cost generic competition to enter the market more quickly.”
Among the group’s members are insurers such as Blue Cross/Blue Shield and healthcare companies such as CVS Health and Kaiser Permanente, as well as advocacy group AARP.
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.
Alex Schriver, a spokesperson for the pharmaceutical industry trade group PhRMA, said the ruling could put at risk the “careful balance” provided under the Hatch-Waxman Act, the U.S. law that governs generic drug approval.
“Skinny labeling under Hatch-Waxman was designed to let generics enter the market for non-patented uses, not as a free pass to promote patented ones,” Schriver said. “It is important to be able to protect patented uses of a medicine to provide the incentives needed to invest in researching new uses for existing medicines.”
(Reporting by Blake Brittain in Washington; Editing by Will Dunham)
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