In Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (June 4, 2026), the Supreme Court issued a unanimous decision clarifying the standard for induced infringement under 35 U.S.C. § 271(b) in the Hatch-Waxman context. Reversing the Federal Circuit, the Court held that Amarin failed to plausibly allege that Hikma took the requisite “active steps” to encourage use of Amarin’s patented method. The decision establishes that inducement requires “affirmative statements or actions” rather than “mere omissions, inactions or nonfeasance.”
Vascepa®, marketed by Amarin, received FDA approval in 2012 for the treatment of severe hypertriglyceridemia (the “SH indication”). To market a generic version of Vascepa®, Hikma submitted an abbreviated new drug application (ANDA) and initially filed a paragraph IV certification challenging the validity of Amarin’s patents covering the SH-indication. A district court later held these patents invalid.
In 2019, the FDA approved Vascepa® for the use of reducing cardiovascular risk in hypertriglyceridemia patients receiving statin therapy (the “CV indication”). Following that approval, Amarin removed the prior cardiovascular limitation of use from the Vascepta® label and obtained two method-of-use patents covering the CV indication. Hikma then supplemented its ANDA with a Section viii statement, carving out the patented CV-indication and seeking approval for a “skinny label” limited to the unpatented SH indication. The FDA subsequently approved Hikma’s ANDA with the skinny label.
Amarin sued Hikma for induced infringement, alleging that statements in Hikma’s skinny label, patient information leaflet, website, and press releases encouraged medical providers to prescribe Hikma’s generic product for the patented CV indication. The district court dismissed Amarin’s complaint, finding that none of Hikma’s statements constituted the affirmative acts required to establish inducement. The Federal Circuit reversed, concluding that it was “at least plausible that a physician could read” Hikma’s statements “as an instruction or encouragement to” infringe.
The Supreme Court rejected the Federal Circuit’s approach, explaining that the “central question is whether Amarin plausibly alleged that Hikma actively encouraged infringing use, not merely whether doctors could plausibly read the alleged statements as instructions to infringe.” Emphasizing that inducement requires purposeful conduct, the Court held that liability arises only where a defendant takes affirmative acts designed to bring about infringement, rather than where there exists only a “sheer possibility” that others might infer or engage in infringing conduct.
The Court determined that several of Hikma’s challenged labeling statements merely reflected compliance with FDA regulatory requirements or standard industry practices. The Court flatly rejected Amarin’s reliance on “mere omissions, inactions, or nonfeasance” as a basis for pleading inducement, holding that a generic manufacturer’s failure to disclaim a patented use does not constitute an active act of encouragement. Although the Court acknowledged that encouragement can be implicit, it emphasized that such encouragement must still be affirmative in nature and clearly directed to the relevant audience.
By reversing the Federal Circuit, the Supreme Court clarified that a patentee asserting induced infringement must identify evidence of the alleged inducer’s affirmative statements or actions specifically designed to encourage infringement, rather than relying on how third parties might interpret otherwise lawful conduct. As a result, the ruling provides greater certainty that generic manufacturers may continue to utilize the Section viii “skinny label” pathway without incurring induced infringement liability, as long as they do not take active steps to encourage the practice of patented methods.
Authors: Lingyan Wang and Hayley Yang
Edited by Kelly Hwang and James Vezeris