AIPLA Files Amicus Brief in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc

Arlington, VA. March 27, 2026 – The American Intellectual Property Law Association (AIPLA) filed an amicus curiae brief with the Supreme Court in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889. AIPLA urges the Court to affirm the Federal Circuit’s application of the established Iqbal/Twombly pleading standard and inducement law in reviewing Hikma’s motion to dismiss Amarin’s claim that Hikma’s conduct, in combination with its “skinny label,” induced infringement of Amarin’s patented treatment methods.

The brief argues that this case presents a straightforward inducement of infringement claim under 35 U.S.C. § 271(b). While § 271(b) limits liability to conduct that actively induces infringement through affirmative steps, allegations must be evaluated under a totality-of-the-circumstances analysis, rather than by examining each act in isolation. Here, that includes consideration of the label in combination with Hikma’s alleged conduct. The brief further notes that, to survive a motion to dismiss, a complaint need only allege sufficient facts to state a plausible, not probable, claim for relief.

AIPLA also argues that while the Hatch-Waxman Act permits generic manufacturers to seek approval via the section viii “skinny label” pathway by omitting patented methods of use from their labels, it did not create a wholesale exemption from induced infringement liability. AIPLA cautions against creating industry-specific exclusions for generic drug manufacturers entering the market via the “skinny label” pathway, arguing that excluding certain types of evidence from the inducement inquiry would undermine the uniformity of inducement law, effectively create a safe harbor not authorized by Congress, and invite similar requests from other industries. AIPLA urges the Court to leave policy decisions regarding exemptions from induced infringement liability to Congress.