Supreme Court Protects ‘Skinny Label’ Generic Drug Pathway (1)

The Supreme Court raised the bar for branded pharmaceutical companies seeking to sue over competitor’s generic versions of their drugs marketed using what’s called a skinny label.

The justices unanimously concluded that a district court judge was right to dismiss Amarin Pharma Inc.'s infringement suit over claims Hikma Pharmaceuticals USA Inc. was encouraging doctors to prescribe its generic version of Amarin’s Vascepa heart health drug for a still-patented treatment method.

Drugmakers frequently obtain patents not just on chemical compounds they discover for novel drugs but separately for methods of using such drugs to treat various medical conditions. When some uses are covered by active patents while others aren’t, generics can get government approval of a “skinny label” that carves out the patented uses.

Thursday’s ruling ramps up the evidence branded drugmakers need to sue when they think the generic label in combination with a generic company’s marketing statements or other communications cross a line into actively inducing patent infringement.

Amarin said Hikma had encouraged doctors to prescribe its generic for reducing cardiovascular risk—a still-patented use. The company pointed to language Hikma used in a part of its label that described potential side effects; Hikma’s failure to affirmatively warn against prescribing for the still-patented uses of the drug in its label and in press releases; statements to potential investors; and references in Hikma press releases that described its product as “generic Vascepa” or the “generic equivalent of Vascepa.”

“Our case law leaves generic manufacturers more breathing room than that,” wrote Justice Ketanji Brown Jackson for a unanimous court.

Amarin sued Hikma in 2020 in the US District Court for the District of Delaware shortly after Hikma began marketing a generic version of Vascepa with a skinny label, approved by the US Food and Drug Administration, that described using the drug—a fish oil derivative—to treat severe hypertriglyceridemia. The label carves out mentions of using the drug to treat cardiovascular risk.

The US Court of Appeals for the Federal Circuit reversed the district judge’s dismissal, but Jackson said the appeals court had applied the wrong test for evaluating induced infringement.

“The central question is whether Amarin plausibly alleged that Hikma actively encouraged infringing uses, not merely whether doctors could plausibly read the alleged statements as instructions to infringe,” Jackson wrote.

Winston & Strawn represents Hikma. Amarin is represented by Perkins Coie.

The case is Hikma Pharm. USA Inc. v. Amarin Pharma Inc., U.S., 24-889, reversed 6/4/26.