Hikma Asks Justices to Protect ‘Skinny Label’ Generic Pathway

US Supreme Court justices didn’t show all their cards Wednesday during an argument that could influence how legally treacherous or safe it is to sell generic drugs in the US when a brand-name drug maker has a patent on some but not all drug treatments.

Generic maker Hikma Pharmaceuticals USA Inc. told the high court there were reasonable and legally protected explanations for statements it made around the time it launched a generic alternative to an Amarin Pharma Inc.'s drug Vascepa.

The US Food and Drug Administration has approved the drug for treating both cardiovascular risk—the patented use—and severe hypertriglyceride levels—a use not covered by any active patents.

An attorney for Amarin, Michael Huston of Perkins Coie, told the justices the company sued when the generic drug maker put out marketing language “written by a clever lawyer to minimize Hikma’s liability” that, nevertheless, would cause doctors to prescribe the generic for off-label infringing uses.

Amarin sued after Hikma was approved to start offering a generic with a “skinny” drug label that carves out mentions of the still-patented use. Amarin contended that Hikma’s label, along with statements on its website and in press releases, could influence medical professionals to prescribe the generic for off-label use in spite of the patents.

The suit was dismissed in 2022, but revived by the US Court of Appeals for the Federal Circuit, which said Amarin marshalled sufficient evidence to get its case into discovery. That evidence included a press release that mentioned Vascepa’s total yearly US sales of “approximately $1.1 billion,” a number Amarin has said mostly captures sales to patients for the still-patented treatment of cardiovascular risk.

Hikma and the US solicitor general both told the Supreme Court there’s a high bar for induced infringement liability, including in the context of generic skinny labels.

Amarin has countered that Hikma is seeking a “safe harbor protecting a generic” that intentionally promotes treatments covered by patents.

It stressed that it hasn’t sued every generic company marketing “icosapent ethyl,” Vascepa’s active ingredient. Amarin’s brief said a number of generic makers are on the market but they were more careful to disclaim patented uses. For example, the company said Dr. Reddy’s Lab affirmatively said in a press release announcing its product that it was “not approved” for uses aside from treating severe hypertriglyceridemia.

Chuck Klein of Winston & Strawn argued the case for Hikma.

The case is Hikma Pharm. USA Inc. v. Amarin Pharma Inc., U.S., 24-889, oral argument 4/29/26.