Supreme Court Issues Unanimous Decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.

On June 4, 2026, the Supreme Court issued a unanimous decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.  While the Court reaffirmed existing law on pleading standards, it reversed the Federal Circuit’s decision that had focused on how relevant statements could be understood by medical providers as instructions to infringe. The amicus brief filed by AIPLA on March 27, 2026, advocated for affirmance and cautioned the Court not to change the patent infringement pleading standard or adopt any categorical exemption from inducement for a particular industry. To read the opinion of the Court, please click here.

BACKGROUND

Amarin markets icosapent ethyl under the brand name Vascepa®. The FDA approved Vascepa in 2012 for the treatment of severe hypertriglyceridemia (the SH indication) and later approved a second use in 2019 for reducing cardiovascular risk in certain patients with elevated triglyceride levels (the CV indication). Amarin listed patents covering the CV indication in the FDA's Orange Book.

Hikma sought approval to market a generic version of icosapent ethyl through an Abbreviated New Drug Application. After the FDA approved the CV indication, Hikma submitted a Section viii statement and omitted the patented CV use from its labeling, resulting in a so-called "skinny label" that sought approval only for the SH indication. The FDA approved Hikma's application in May 2020.

In November 2020, Amarin sued Hikma for induced infringement, alleging that Hikma's product labeling, press releases, and marketing materials encouraged use of the generic product for the patented CV indication. The district court dismissed the complaint, but the Federal Circuit reversed, holding that Amarin had plausibly alleged induced infringement. The Supreme Court granted certiorari to consider when a generic manufacturer that markets a skinny-label product may nevertheless be liable for induced infringement.

OPINION OF THE COURT

In a unanimous opinion authored by Justice Jackson, the Supreme Court reversed the Federal Circuit and held that Amarin failed to plausibly allege induced infringement under 35 U.S.C. § 271(b). The Court concluded that Hikma's skinny label, website statements, and press releases did not constitute the type of affirmative conduct required to show that a generic manufacturer of a skinny-label product actively encouraged infringement of a patented method of use.

The Court emphasized that the relevant inquiry is not whether physicians could potentially interpret a generic manufacturer's statements as encouraging an infringing use, but whether the manufacturer itself took affirmative steps to promote or encourage infringement. Applying the pleading standards of Twombly and Iqbal, the Court found that Hikma's statements were either required by law, consistent with standard industry practice to describe a generic drug as equivalent to an approved reference drug, or too vague and attenuated to plausibly constitute active steps to bring about infringement. The Court rejected the Federal Circuit's focus on how healthcare providers might understand Hikma's communications, explaining that inducement requires clear affirmative encouragement—whether express or implied—not mere speculation about how third parties might interpret otherwise lawful statements. As a result, the Court held that Amarin's complaint could not survive Hikma's motion to dismiss.