Supreme Court to Hear 'Skinny Label' Patent Fight Over Amarin's Vascepa

The U.S. Supreme Court has agreed to hear a patent dispute involving Amarin Pharma's cardiovascular drug Vascepa that could have broad consequences for generic drug makers and so-called 'skinny labels' for their products that remove specific, patented uses of a brand-name medication. The case, Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc., centers on British generic drug maker Hikma's appeal of a lower court decision that let Amarin proceed with a lawsuit accusing Hikma of encouraging doctors to prescribe its generic version of Vascepa in ways that violated Amarin's patent rights.

The dispute involves a high-profile issue in pharmaceutical patent law. Amarin sued Hikma in Delaware federal court in 2020, arguing Hikma's label combined with statements in press releases and on its website encouraged doctors to prescribe the generic in infringing ways. U.S. District Judge Richard Andrews dismissed the case in 2022, but the U.S. Court of Appeals for the Federal Circuit revived it in 2024. The Federal Circuit said Hikma publicly referred to its drug as 'generic Vascepa' without clarifying that it was approved only for a specific use, which could have encouraged doctors to prescribe it for infringing uses.

Hikma has asked the Supreme Court to hear its appeal, arguing that the Federal Circuit's ruling endangered skinny labels and created an 'imminent threat to generic competition.' 'As a practical matter, any branded pharmaceutical company can now point to some public statement by the generic-drug manufacturer to justify a post-launch suit alleging induced infringement, even when the generic product is labeled only for unpatented uses,' Hikma said.

Skinny labeling refers to moves by generic companies that seek regulatory approval to market a medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. The tactic has been a key tool for generic companies ever since the Hatch-Waxman Act was signed into law more than four decades ago. The law established mechanisms by which generic drugs can more readily enter the marketplace, and skinny labeling, which amounts to a carve-out tactic, is one way that Congress attempted to foster more competition and benefit consumers.

Vascepa, derived from fish oil, has been approved by the U.S. Food and Drug Administration to reduce the risk of cardiovascular disease and is currently Amarin's only product. It earned Amarin $228.6 million in 2024. The FDA in 2012 approved the drug to treat severe hypertriglyceridemia, a condition involving an excess of fats in the blood, before approving it for other uses in 2019. Skinny labels, which are meant to encourage generic competition, allow generic drugmakers to avoid patent lawsuits if the label of their generic omits infringing uses of the brand-name drug it replicates. The FDA approved Hikma's Vascepa generic solely to treat severe hypertriglyceridemia, and required it to include a skinny label that omitted the drug's other uses.

The U.S. Supreme Court's ruling in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. could either discourage the development of generic drugs under a skinny label or make innovators think long and hard about investing hundreds of millions of dollars in developing new indications for drugs already on the market.