Justices to Consider Patent Case on ‘Skinny’ Drug Labels (1)

The US Supreme Court will hear generic drug maker Hikma Pharmaceuticals USA Inc.'s challenge of an appeals court holding that it induced doctors and pharmacists to prescribe its heart medicine for off-label treatments that would infringe a rival’s patents.

The government urged the high court to reverse the US Court of Appeals for the Federal Circuit’s ruling reviving a lawsuit from Amarin Pharma Inc. Amarin claimed that Hikma infringed its patents despite the generic company’s use of a “skinny label” instructing users only to take the drug to treat severe hypertriglyceridemia, a method-of-use no longer covered by any Amarin patent.

Amarin sells Vascepa, a heart medicine approved by the US Food and Drug Administration in 2012 to treat severe hypertriglyceridemia and in 2019 to treat cardiovascular risk. Its patents covering a treatment for high triglyceride levels were canceled in 2020 after an earlier legal dispute with Hikma. Later that year, Hikma began selling generic Vascepa with a label indicating it should be taken to treat excessive triglycerides only—the noninfringing use.

A district court in Delaware dismissed Amarin’s suit, but the Federal Circuit reversed in a July 2024 opinion. The reversal came in part because of Hikma press releases discussing Vascepa sales figures and its progress toward getting a generic alternative to market, as well as additional messaging on Hikma’s website. The appeals court wrote that Amarin had made a plausible showing that a “physician could read Hikma’s press release—touting sales figures attributable largely to an infringing use, and calling Hikma’s product the ‘generic version’” of Vascepa as “an instruction or encouragement to prescribe that drug for any of the approved uses.”

The US Solicitor General’s office, however, urged the Supreme Court to hear Hikma’s challenge to the appeals court ruling, saying it undermined a section in the Hatch-Waxman Act governing generic drugs and allowing for skinny labels.

That law “cannot function as Congress intended if a generic manufacturer’s anodyne descriptions of its product create a serious risk of massive patent liability,” says the office’s brief.

Michael Carrier, a law professor at Rutgers who previously joined an amicus brief critical of the Federal Circuit’s approach, welcomed the justices’ planned review.

“The Federal Circuit expanded liability far beyond what it was intended to be” for skinny labels, Carrier said Friday.

He said the earlier ruling had a chilling effect on generic manufacturers and without a correction they will “abandon this essential pathway, and consumers will pay more as a result.”

Drought Over

The grant also ends a multi-year stretch in which the Supreme Court hadn’t taken up a patent case.

The court last agreed to review a patent dispute in November 2022. The ensuing opinion in Amgen v. Sanofi grapples with how much information a patent must include to meet the Patent Act’s requirement for enablement.

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, cert. granted 1/16/26.