Vascepa® (icosapent ethyl)
Case Name: Hikma Pharms. USA Inc. v. Amarin Pharma, Inc., No. 24-889, 2026 WL 1593307 (Supreme Court June 4, 2026) (Justice Jackson delivering the unanimous opinion of the Court) (On writ of certiorari from Fed. Cir., Lourie, C.J.)
Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S. Patent Nos. 9,700,537 and 10,568,861
Nature of the Case and Issue(s) Presented: Amarin markets Vascepa, a branded icosapent ethyl product. In 2012, the FDA approved Vascepa for treatment of severe hypertriglyceridemia (“the SH indication”). At that time, Vascepa’s label stated that its effect on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia had not been determined. In 2019, the FDA approved Vascepa for a second, broader use: reducing cardiovascular risk in hypertriglyceridemia patients already taking statins (“the CV indication”). Amarin obtained the two method-of-use patents-in-suit covering that CV indication.
Hikma submitted an ANDA for generic icosapent ethyl in 2016. Hikma initially filed a Paragraph IV certification challenging Amarin’s SH-indication patents, which were later invalidated. After Amarin obtained approval and patent protection for the CV indication, Hikma supplemented its ANDA with a section viii statement and sought approval of a skinny label that carved out the still-patented CV indication while retaining only the unpatented SH indication. In 2020, the FDA approved Hikma’s ANDA with the skinny label and assigned Hikma’s generic product an “AB” rating.
Amarin sued Hikma, alleging induced infringement under 35 U.S.C. § 271(b). Amarin did not rely solely on Hikma’s skinny label. Instead, it argued that the totality of Hikma’s statements across the skinny label, patient information leaflet, website, and press releases encouraged healthcare providers to prescribe or dispense Hikma’s generic for the patented CV indication. The district court granted Hikma’s Rule 12(b)(6) motion to dismiss, holding that Amarin failed to plead active inducement. The Federal Circuit reversed, concluding that it was at least plausible that a physician could read Hikma’s statements as instructions or encouragement to infringe. The Supreme Court granted certiorari and reversed.
Why Hikma Prevailed: The Supreme Court held that the Federal Circuit applied the wrong focus for induced infringement. The question is not merely whether healthcare providers could plausibly understand a generic manufacturer’s statements as encouraging infringement. Rather, the key question is whether the defendant itself actively encouraged infringement through affirmative statements or actions. The Court emphasized that inducement requires more than knowledge that a product may be used in an infringing way and more than ordinary acts incident to selling a lawful product.
The Court held that Amarin failed to plead more than a sheer possibility that Hikma actively induced infringement. Several of Hikma’s challenged statements had obvious lawful explanations. For example, Hikma’s skinny label retained information from Amarin’s label and omitted the CV limitation of use because generic labels generally must be the same as the brand label except for carved-out patented uses. Likewise, Hikma’s description of its product as “generic Vascepa” or the “generic equivalent” of Vascepa was consistent with normal industry practice and did not itself amount to active encouragement to infringe.
The Court also rejected Amarin’s reliance on omissions. Amarin argued that Hikma failed to make clear that its generic was approved only for the SH indication and omitted the prior CV limitation of use from the skinny label. But the Court held that active inducement cannot rest on mere omissions, inaction, or nonfeasance. Section 271(b) requires affirmative steps to bring about infringement, and treating omissions as inducement would risk imposing liability on ordinary commercial conduct based on attenuated chains of events.
Finally, the Court found Hikma’s remaining statements too vague to plausibly plead active inducement. The patient information leaflet warned of possible side effects for people with cardiovascular disease and stated that medicines are sometimes prescribed for purposes other than those listed in a patient leaflet, but the Court viewed those as warnings and disclaimers, not affirmative encouragement to infringe. Hikma’s website listed the therapeutic category as “hypertriglyceridemia” and stated that the product was “AB” rated, but the Court held that those statements did not plausibly encourage use for the patented CV indication, particularly because the website clarified that Hikma’s generic was indicated for fewer than all approved uses of Vascepa. And Hikma’s press releases reporting Vascepa sales figures were, in the Court’s view, too vague and too directed to investors to plausibly induce medical providers to prescribe Hikma’s product for the patented use.
The Supreme Court’s reversal rejected the Federal Circuit’s trend of focusing on whether a physician could read a generic manufacturer’s statements as encouraging infringement and instead reaffirmed that inducement requires clear, affirmative conduct by the alleged inducer.
