The U.S. Supreme Court has ruled unanimously that Hikma Pharmaceuticals' generic version of Amarin's cardiovascular drug Vascepa did not infringe Amarin's patents.

The court’s decision delivers a significant victory for the generic drug industry and potentially reshapes how courts evaluate so-called "skinny label" patent disputes.

The 9-0 decision, authored by Justice Ketanji Brown Jackson, overturned a previous lower appellate court ruling that had sided with Amarin and sent a strong signal that generic manufacturers who follow FDA labeling requirements cannot be held liable for induced infringement solely based on standard industry communications.¹

What is a skinny label and why does it matter?

At the heart of the case is a legal mechanism known as the skinny label, a provision under the Hatch-Waxman Act designed to encourage generic drug competition by allowing manufacturers to omit patented uses from their product labels.¹

FDA has previously approved Hikma's generic Vascepa solely to treat severe hypertriglyceridemia, a condition involving excess fats in the blood, while requiring the company to exclude from its label Vascepa's use for less-severe hypertriglyceridemia, which remained under Amarin patent protection.²

Amarin then sued Hikma in Delaware federal court in 2020, arguing that even though Hikma's label omitted the patented use, the company's press releases and website references to its drug as "generic Vascepa," without clarifying it was approved only for the severe indication, effectively encouraging doctors to prescribe it for the infringing use.¹ The U.S. Court of Appeals for the Federal Circuit agreed, reinstating the case after a lower court dismissed it.

What did the Supreme Court decide?

The Supreme Court reversed the Federal Circuit, finding that Amarin had not met the legal standard required to establish induced infringement. Writing for the court, Jackson said the central question was "whether Amarin plausibly alleged that Hikma actively encouraged infringing uses, not merely whether doctors could plausibly read the alleged statements as instructions to infringe."¹

The court found Amarin had shown no more than a "sheer possibility" that Hikma's statements induced infringement.

Jackson also addressed what she described as a normal industry practice, noting that generic manufacturers routinely 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," she wrote.

What does the ruling mean for drug prices and generic competition?

Generic drug advocates and patient groups welcomed the decision as a win for affordability, as Hikma had argued before the court that generic drugs have saved patients and insurance payers an estimated $2.9 trillion over the past decade, and that allowing suits like Amarin's to proceed would discourage manufacturers from bringing lower-cost alternatives to market.¹

"This decision helps restore certainty to the skinny-label pathway and will encourage more lower-cost generic competition to enter the market more quickly," said Lauren Aronson, executive director of the Campaign for Sustainable Rx Pricing, a group whose members include Blue Cross/Blue Shield, CVS Health, Kaiser Permanente, and AARP.

Sam Park, Hikma's general counsel, said the company was grateful the court "unanimously upheld Hikma's right to continue providing millions of American patients with safe, affordable, high-quality generic medicines."

Sources

1. US Supreme Court backs generic drugmaker in 'skinny label' patent case Reuters June 4, 2026 https://www.reuters.com/world/us-supreme-court-backs-generic-drugmaker-skinny-label-patent-case-2026-06-04/
2. Hikma receives FDA approval for its generic Vascepa® Hikma Pharmaceuticals USA Inc. May 22, 2020 https://www.prnewswire.com/news-releases/hikma-receives-fda-approval-for-its-generic-vascepa-301064061.html