US Supreme Court hears patent case with potentially sweeping implications for generics
29/04/2026 22:38
Justices consider impact on generic drug industry and scope of "skinny labels" Hikma and U.S. government warn ruling for Amarin could deter generic competition Amarin argues Hikma's actions were atypical, not suing other generic makers By Blake Brittain WASHINGTON, April 29 (Reuters) - The U.S. Supreme Court on Wednesday heard a patent dispute over a generic version of Amarin Pharma's AMRN.O cardiovascular drug Vascepa that could have broad consequences for the pharmaceutical industry. The justices considered whether British drugmaker Hikma encouraged doctors to prescribe its generic in ways that infringe patents covering some uses of the drug despite "carving out" those uses from the generic's label. Hikma and the U.S. government both argued that a ruling for Amarin would discourage generic drugmakers from making and selling their lower-cost drugs, while Amarin told the justices that Hikma's alleged promotion of patent-infringing uses of the drug was atypical, noting that it had not sued seven other companies that also make generic Vascepa. Hikma told the high court in a brief that generic drugs have saved patients and insurance payers an estimated $2.9 trillion in the past decade. Hikma and the federal government both said that allowing lawsuits like Amarin's could disincentivize generic drugmakers and lead to increased drug prices. "Generic companies won't choose that pathway if, at best, it means paying millions in legal fees and, at worst, a massive damages award," Hikma attorney Charles Klein of Winston & Strawn told the justices on Wednesday. Justice Sonia Sotomayor questioned whether the case's potential effects on generic drugmakers should affect the court's analysis despite "a whole lot of discussion about congressional policy" in both sides' court briefs. "I always have problems when we use policy reasons to set a standard," Sotomayor said. "That's not our job. If they're infringing a patent, they're infringing a patent. If they're not infringing a patent, they're not." Vascepa, derived from fish oil, has been approved by the U.S. Food and Drug Administration to lower triglycerides, a common type of fat, and reduce the risk of heart issues. It is currently Amarin's only product. Amarin earned $213.6 million in revenue from Vascepa sales last year, according to a company filing with the U.S. Securities and Exchange Commission. The FDA approved Vascepa in 2012 to treat severe hypertriglyceridemia, a condition involving an excess of fats in the blood, before approving it for less-severe hypertriglyceridemia in 2019. Pharmaceuticals can be protected by patents covering both the drug's active ingredient and specific methods of using it. The FDA allows generic drugmakers to launch generics with "skinny labels" that omit uses that would infringe the brand-name drugmaker's patents. Hikma said in a Supreme Court brief that skinny labels saved Medicare an estimated $1.5 billion over a five-year period. The FDA approved 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. 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 it for the less severe condition. 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 one specific use, which could have encouraged doctors to prescribe it for infringing uses. Justices including Clarence Thomas and Samuel Alito questioned whether Hikma could have avoided liability by simply choosing its words more carefully. Chief Justice John Roberts told government attorney Malcolm Stewart that he had proposed "a pretty broad safe harbor" for generic drugmakers. "You really just have to have a seminar on your first day of work and say, 'whatever you do, don't do that,'" Roberts said. (Reporting by Blake Brittain in Washington)