Health Law Daily Wrap Up, HATCH WAXMAN ACT—U.S.: Supreme Court agrees to review Hikma’s certiorari petition in ‘skinny label’ induced infringement dispute with Amarin, (Jan 21, 2026)

By Saurabh Kashyap, B.A., M.A., LL.B., LL.M.

High Court to address scope of inducement liability where generic omits patented use under Section viii carve-out.

The U.S. Supreme Court has granted Hikma Pharmaceuticals’ petition for a writ of certiorari, agreeing to review a closely watched Federal Circuit decision that revived Amarin Pharma’s induced infringement claims based on Hikma’s sale of a generic version of Vascepa®. The case presents important questions regarding the scope of 35 U.S.C. § 271(b) and whether a generic drug manufacturer can be held liable for inducement of patent infringement despite compliance with the Hatch-Waxman Act’s Section viii carve-out by omitting all references to the patented indication from its FDA-approved label (Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., Dkt. No. 24-889 (U.S. cert. granted Jan. 19, 2026)).

Background. Amarin Pharma, Inc. markets Vascepa®, an FDA-approved drug containing icosapent ethyl, initially indicated for the treatment of severe hypertriglyceridemia. In subsequent years, Amarin secured additional method-of-use patents covering Vascepa’s use for reducing cardiovascular risk. Hikma Pharmaceuticals, a manufacturer of generic drugs, obtained FDA approval through an Abbreviated New Drug Application (ANDA) to market a generic version of Vascepa for the non-patented triglyceride indication, relying on the Hatch-Waxman Act’s Section viii carve-out to exclude the patented cardiovascular indication from its label.

Following Hikma’s launch, Amarin filed suit in the District of Delaware, asserting induced infringement of its U.S. Patent Nos. 9,700,537 (the ’537 patent) and 10,568,861 (the ’861 patent). The complaint alleged that despite omitting the patented use from its label, Hikma had taken affirmative steps to encourage off-label prescribing for CV risk reduction.

In its March 2023 decision, the district court dismissed Amarin’s complaint under Rule 12(b)(6), holding that the allegations failed to plausibly show the specific intent required for inducement under 35 U.S.C. § 271(b). The court observed that Hikma’s label did not mention the patented use and that the conduct cited by Amarin—including marketing references to Vascepa, public pricing information, and statements identifying Hikma’s product as a “generic equivalent”—did not rise to the level of affirmative acts directed at infringing use.

The court further distinguished Hikma’s actions from the conduct at issue in GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021), where the generics manufacturer had included the patented indication in promotional materials. Emphasizing that § 271(b) liability cannot rest on passive commercial behavior or downstream conduct by third parties, the court held that the allegations, even taken collectively, did not establish a plausible claim of inducement.

Federal Circuit’s reversal. Amarin appealed, and in a 2024 panel decision, the Federal Circuit reversed. The appellate court concluded that Amarin’s complaint had plausibly alleged that Hikma, despite the carve-out label, had engaged in conduct that could support a finding of specific intent to induce infringement.

The court noted that while the label itself excluded the CV indication, other aspects of Hikma’s conduct warranted scrutiny. Specifically, it pointed to Hikma’s consistent use of the term “generic version of Vascepa,” the omission of disclaimers clarifying the absence of CV approval, and promotional materials that referenced Vascepa’s commercial profile. The court viewed these elements in combination as potentially suggestive of an implicit message that the generic could be used for all of Vascepa’s indications.

The panel acknowledged that generic manufacturers may lawfully pursue skinny labels and that mere availability on the market does not, without more, amount to inducement. However, it found that the cumulative allegations plausibly supported the inference that Hikma intended to encourage off-label prescribing, especially given the commercial dominance of the CV indication and Hikma’s alleged awareness of that fact.

Citing GSK v. Teva, the court reiterated that inducement may be inferred from circumstantial evidence and that labels are not the exclusive source of inducement content. The panel emphasized that Amarin’s complaint alleged more than passive sale or knowledge—it detailed an alleged marketing posture that, if proven, could amount to active encouragement. Accordingly, the Federal Circuit remanded the case for further proceedings, holding that dismissal at the pleading stage was premature.

Hikma’s petition. Hikma filed its petition for a writ of certiorari in February 2025, urging the Supreme Court to review what it characterized as a legally erroneous and practically destabilizing expansion of the inducement doctrine. The petition argued that the Federal Circuit’s approach undermines the predictability Congress sought to promote through the Hatch-Waxman Act’s Section viii carve-out. According to Hikma, the decision exposes generics to infringement claims despite strict adherence to regulatory procedures, thereby deterring use of the carve-out pathway and impeding timely generic entry.

Relying on Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011), Hikma emphasized that § 271(b) requires proof of both knowledge of the patent and specific intent to encourage infringement. Hikma maintained that its conduct—marketing a product under a label that excluded the patented use—did not satisfy this standard. The company contended that generalized awareness of off-label prescribing is insufficient and that statements like “generic Vascepa” merely reflect therapeutic equivalence, not intent to induce.

The petition also cited DSU Med. Corp. v. JMS Co., 471 F.3d 1293 (Fed. Cir. 2006), to support its argument that inducement requires affirmative acts of persuasion or encouragement. It warned that allowing liability based on indirect cues or market context would introduce intolerable uncertainty, encouraging brands to plead around carve-outs and use litigation as a lifecycle management tool.

Hikma concluded by stressing the broader implications: if left uncorrected, the Federal Circuit’s approach would “gut” the carve-out mechanism and frustrate the balance between patent exclusivity and generic access embodied in Hatch-Waxman.

Amarin’s opposition. In its May 2025 opposition brief, Amarin urged the Court to deny review, characterizing Hikma’s petition as raising factual disagreements rather than pure legal questions. Amarin argued that the Federal Circuit’s decision was consistent with precedent and did not, as Hikma claimed, impose liability for passive conduct. Instead, Amarin maintained that the Federal Circuit merely held that its complaint plausibly alleged inducement based on Hikma’s overall behavior—including the removal of non-infringement disclaimers, use of Vascepa sales data dominated by the patented use, and marketing characterizations that omitted any limitation on approved indications. It also emphasized that the case remained at the pleading stage and that no liability had yet been imposed. According to Amarin, the case did not warrant Supreme Court intervention because it presented no circuit split and involved case-specific factual allegations.

United States amicus brief. The Supreme Court invited the views of the Solicitor General in June 2025. In its December 2025 amicus brief, the United States supported Hikma’s petition and urged the Court to grant review. The government argued that the Federal Circuit’s decision created significant uncertainty for the generic drug industry and undermined the Section viii carve-out by allowing inducement claims based on conduct not directed at promoting infringing use. The brief warned that the Federal Circuit’s reasoning could chill generic competition by exposing manufacturers to litigation despite full compliance with regulatory carve-out provisions. It urged the Court to clarify that inducement liability under § 271(b) requires active encouragement or instruction to infringe—not merely compliance with substitution laws or pricing practices that make generics interchangeable with branded drugs.

Conclusion. With certiorari granted, the Supreme Court is now poised to address the legal boundaries of induced infringement in the Hatch-Waxman context. The decision could have far-reaching implications for the viability of the Section viii carve-out, the balance between brand and generic competition, and the evidentiary threshold for pleading inducement under § 271(b).

The Case is Dkt. No. 24-889.

Attorneys: Charles Bennett Klein (Winston & Strawn LLP) for Hikma Pharmaceuticals USA Inc. Michael Robert Huston (Perkins Coie LLP) for Amarin Pharma, Inc.

Companies: Hikma Pharmaceuticals USA Inc.; Amarin Pharma, Inc.

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