Client Update: Supreme Court Takes Up Skinny Labels Granting Certiorari In Hikma v. Amarin

The Supreme Court recently granted certiorari in Hikma Pharmaceuticals v. Amarin Pharma, Inc. (No. 24-889), a decision that signals the justices' willingness to revisit the contentious issues surrounding induced patent infringement liability in the context of skinny labels. The case challenges a June 2024 Federal Circuit decision (104 F.4th 1370) and raises two interrelated questions. First, the case asks whether a generic drug manufacturer's marketing of its product as a generic version of a branded drug is enough to plead induced infringement, specifically when the generic version uses a "skinny label" that omits a patented indication. Secondly, it probes the broader contours of what constitutes sufficient encouragement of infringement such as when there is no instruction or statement by the defendant that mentions the patented use.

Background & Key Points

At its core, the dispute involves whether a generic drug company's public statements and related marketing materials, which do not mention a "carved-out" indication, may nonetheless be read as encouraging off-label use that falls under the ambit of induced patent infringement. Hikma argues that marketing that stops short of explicitly referencing the patented use should not incur liability simply because doctors might infer additional therapeutic applications.

In its 2024 decision, the Federal Circuit found that the evidence—as reflected in Hikma's website listings, press releases and broader marketing campaign—plausibly established inducement of infringement claims by Amarin. According to Hikma, this ruling conflicts with the longstanding Supreme Court requirement that liability for induced infringement necessitates actions that actively encourage infringement. Hikma fears that an overly broad interpretation could chill entry of generics, even when compliant with FDA labeling carveouts.

The Certiorari Grant

The Supreme Court's grant of certiorari, issued in January 2026, confirms that the issues raised are not only timely but also bear significant implications for both patent jurisprudence and pharmaceutical competition. The Court's review is expected to address whether statements that deliberately avoid reference to a patented method or indication can satisfy the inducement standard established in earlier decisions. Now that certiorari has been granted, the case will proceed to merits briefing—from the parties and from amicus curiae—scheduled to begin in early March 2026.

Implications

A ruling favoring Amarin's position could cement the broad application of liability for induced infringement, placing greater scrutiny on any generic marketing strategies that might indirectly reference patented indications. This outcome could potentially empower patent owners to claim infringement in cases where generics rely on FDA carving out for infringement circumvention.

A decision in favor of Hikma's approach—emphasizing the separation between approved labeling and commercial communications–could safeguard generic manufacturers who comply with regulatory carve-outs.

Lastly, this case could recalibrate the balance between protecting patent rights and encouraging competitive generic entry. The Court's ultimate framework regarding "active encouragement" versus mere "promotion of a product" will be pivotal and may have long-reaching consequences beyond the pharmaceutical sector.

Conclusion

The Supreme Court's willingness to hear this case underscores the significance of clarifying the limits of inducement liability in the context of generic drug marketing. As briefing advances, industry participants should closely monitor developments, given that a decision in this case may necessitate adjustments in both litigation strategy and marketing practices.

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