The U.S. Supreme Court has decided to hear a case between Amarin Pharma and generic drug maker Hikma that puts so-called “skinny labels” back in the spotlight.
The high court has agreed to make the final call in a long-fought battle between the companies over Hikma’s generic version of Amarin’s fish-oil0derived Vascepa. Hikma first filed its copycat for FDA approval in 2016 under the reference drug’s 2012-approved use in severe hypertriglyceridemia.
Although the eventual generic approval, granted in May 2020, did not include Vascapa’s 2019 add-on indication for cardiovascular risks, Amarin, in a 2020 lawsuit, took issue with Hikma’s marketing material for its product. Specifically, Amarin argued that the “skinny label” that Hikma’s generic snagged improperly allowed the U.K. generic specialist to promote its drug under Vascepa's patent-protected follow-on use.
In 2024, a Delaware appeals court sided with Amarin, reviving the case after a prior dismissal. The court determined that Amarin had “plausibly pleaded that Hikma has induced infringement of the asserted patent” and pointed to, in part, Hikma’s proclamation of its product as “generic Vascepa” in its press releases without acknowledging the generic med’s label limitations.
The “skinny label” pathway is an oft-debated practice that allows generic drugs to launch under select indications for which reference drugs have lost patent exclusivity, speeding their approach to the market. Two years ago, the Supreme Court opted against reviewing a similar case involving Teva and GSK.
Teva had argued that the case could have “enormous” implications for the industry, but the court ultimately turned down the Israeli generics giant's bid despite the Biden administration’s solicitor general arguing that the case would be a “suitable vehicle” to address the common practice.
Hikma took a similar route to the Supreme Court, arguing that the case “urgently warrants review” as it “exposes every generic drugmaker marketing the ‘generic version’ of a branded drug to potentially catastrophic damages, even if the generic omits all patented uses from its label,” the company wrote in a 2025 petition.
Amarin, for its part, fought against Hikma’s petition and its rationale surrounding broader industry implications, noting that other generics “can and do avoid” practices such as “featuring their drugs on websites in ways that encroach on patent claims.”
Hikma and Amarin’s feud has previously extended past skinny labeling. In 2023, Hikma threw an antitrust suit at the Vascepa maker, accusing its rival of “deliberately and meticulously” locking up supply of active ingredient icosapent ethyl to block competition.
Vascepa is Amarin’s sole commercial product. After mass layoffs, two CEO departures and an activist investor takeover, the company last year agreed to the sale of Vascepa’s European rights to Italian pharma Recordati.
Amarin’s attempts to build out a sizable Vascepa market in Europe hadn’t moved the needle much for the company after generics entered the U.S. market back in 2020. In 2024, the company reported sales of $229 million, a far cry from 2020’s peak sales of $614 million.