U.S. Supreme Court Rules in Favor of Generic Drug Patents
The unanimous ruling says Amarin did not show Hikma actively induced infringement, a standard that may narrow patent suits over generic drug labels.
- On Thursday, the Supreme Court unanimously ruled that Drugmaker Hikma's generic version of Amarin Pharma's cardiovascular medication Vascepa did not infringe on Amarin's patents in a closely watched case over generic drug labeling.
- Central to the case was the Hatch-Waxman Act, which allows generic drugmakers to sell drugs using a 'skinny label' before all brand-name patents expire. Amarin argued Hikma's marketing encouraged doctors to prescribe the drug for infringing uses.
- Writing for the court, Justice Ketanji Brown Jackson stated that Amarin failed to show more than a 'sheer possibility' of induced infringement. "We decline to put generic manufacturers between a rock and a hard place," Jackson wrote.
- Amarin reported $213.6 million in Vascepa revenue for 2025, while Hikma general counsel Sam Park said the company is grateful the court "unanimously upheld Hikma" right to provide affordable medicines.
- The ruling may make generic manufacturers less vulnerable to patent lawsuits, potentially protecting lower drug prices. The Donald Trump administration supported Hikma's appeal, arguing lawsuits like Amarin's could disincentivize competition and increase costs.
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55 Articles
SHALL MEANS SHALL — Supreme Court Blockbuster 9-0 Ruling
Justice Ketanji Brown Jackson authored an opinion joined by the court’s eight other members and handed down on Thursday in a closely watched case involving a dispute over pharmaceutical patents. The justices ruled unanimously in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., reversing a lower court decision and sending the case back for further proceedings. The decision was notable because Jackson is a frequent dissenter from the remaind…
US Supreme Court Sides With Generic Drugmaker Hikma in ‘Skinny Label’ Patent Case
The U.S. Supreme Court on June 4 ruled that drugmaker Hikma Pharmaceuticals’ generic version of Amarin Pharma’s cardiovascular medication Vascepa did not infringe Amarin’s patents, in a case that centered on the use of “skinny labels” for generic drugs. 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 …
Supreme Court Backs Maker of Generic Heart Drug in 'Skinny Label' Case
(MedPage Today) -- Amarin Pharma has not done enough to definitively show that its generic competitor, Hikma Pharmaceuticals, is infringing on Amarin's patents for its anti-hypertriglyceridemia drug icosapent ethyl (Vascepa), the Supreme Court...
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