Amarin Pharma Inc. on Tuesday asked the U.S. Supreme Court to decline review of a patent dispute involving generic drug “skinny labels,” arguing that the case centers on fact-specific issues that are not appropriate for high court consideration.
Amarin’s filing responds to a brief submitted earlier this month by U.S. Solicitor General D. John Sauer, who urged the justices to hear an appeal brought by generic drugmaker Hikma Pharmaceuticals USA Inc. The company said the court has long held that it does not grant review merely to reassess factual determinations.
“This case comes to this court with no meaningful legal dispute, just an application of established law” to whether Hikma’s label and marketing induced infringement of Amarin’s patents, the company said.
The Supreme Court said Tuesday that it will consider whether to take up the case at its Jan. 9 conference.
So-called skinny labels allow generic drugmakers to omit patented uses from their labels and seek U.S. Food and Drug Administration approval only for unpatented indications. Amarin’s heart drug Vascepa is approved for two uses, one covered by patents and one that is not.
Although Hikma’s generic label did not reference Vascepa’s patented use, the Federal Circuit ruled last year that Amarin plausibly alleged induced infringement. The appeals court pointed to Hikma’s marketing of its product as a full generic equivalent of Vascepa and its reliance on Amarin sales data that included patented uses.
In his brief, Sauer warned that skinny labels cannot function as intended if generic manufacturers face “a serious risk of massive patent liability” based on neutral descriptions of their products. He said the Federal Circuit’s decision could deter use of skinny labels and reduce access to lower-cost generic drugs.
Amarin countered that the government’s position repeats policy arguments previously rejected by the court.
“The government’s brief recycles often verbatim the same policy concerns it offered unconvincingly three terms ago,” Amarin said.
The company noted that Sauer’s predecessor, former Solicitor General Elizabeth B. Prelogar, raised similar concerns in 2023 when urging the court to hear Teva v. GlaxoSmithKline. The Supreme Court declined review in that case, and Amarin said the predicted harm to generic competition has not materialized.
“Those arguments have not aged well,” Amarin said, adding that the government has not shown that generic manufacturers have abandoned the skinny label pathway since that decision.
According to Amarin, Sauer is asking the court to decide only whether the company plausibly alleged that Hikma’s label and marketing encouraged infringement.
“That is classic fact-bound error correction” that the Supreme Court generally does not undertake, Amarin said. The company also argued that the government raised arguments Hikma itself did not make and that there is no basis for interlocutory review.
Later Tuesday, Hikma filed a short notice disputing Amarin’s characterization of the appeal as interlocutory. Hikma said the Federal Circuit reversed a district court’s dismissal of the case with prejudice, meaning the pleadings cannot be amended.
Hikma petitioned the Supreme Court in February, arguing that the Federal Circuit’s decision means “no skinny label is safe” because patent holders will always be able to claim that generic marketing induced infringement.
The government echoed that concern, asserting that similar infringement claims would arise in most skinny label cases if the ruling stands.
Amarin rejected that argument, saying other generic manufacturers “can and do avoid” marketing their products in ways that encroach on patent claims.
Representatives for Amarin, Hikma, and the solicitor general’s office did not immediately respond to requests for comment.
The patents at issue are U.S. Patent Nos. 9,700,537 and 10,568,861.
Hikma is represented by Charles B. Klein, Claire Fundakowski, Eimeric Reig Plessis, and Alison King of Winston & Strawn LLP, and by Samuel S. Park. Amarin is represented by Michael R. Huston, Nathan Kelley, and Jonathan I. Tietz of Perkins Coie LLP.
The case is Hikma Pharmaceuticals USA Inc. et al. v. Amarin Pharma Inc. et al., Case No. 24-889, in the Supreme Court of the United States.
