Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889 (U.S. June 4, 2026)
On June 4, 2026, a unanimous Supreme Court reversed the Federal Circuit and held that Amarin failed to plausibly allege that Hikma induced infringement of Amarin’s method-of-use patents. The decision clarifies what a branded manufacturer must plead to keep a “skinny label” inducement case alive: to survive a motion to dismiss, the patent owner must allege statements designed to stimulate others to infringe, not merely statements that could be read as encouraging infringement. The ruling reinforces the skinny-label pathway that generic manufacturers rely on and makes clear that allegations of active encouragement—not merely communications that could be interpreted as encouraging infringement—are required at the pleading stage.
Background: The Skinny-Label Framework
To appreciate what the Court decided in Hikma, it helps to understand the regulatory structure that produced the dispute.
The Hatch-Waxman Act of 1984 was designed to strike a balance: to speed low-cost generic drugs to market while preserving the patent incentives that fund pharmaceutical innovation. Under that framework, a brand-name manufacturer that obtains FDA approval through a New Drug Application must list in the FDA’s Orange Book the patents that claim the drug or an approved method of using it. A generic manufacturer then seeks approval through an Abbreviated New Drug Application (ANDA), which relies on the brand’s safety and efficacy data, and must address each listed patent through one of several routes.
For method-of-use patents specifically, Hatch-Waxman offers a distinct option: the Section viii statement. Rather than challenging the patent, an ANDA filer states that the patent does not cover the uses for which the generic seeks approval. This option is used when some — but not all — of a drug’s approved uses remain patented. Along with the Section viii statement, the generic manufacturer submits proposed labeling that omits the still-patented indication. Because the patented use is removed, the resulting label is commonly called a “skinny label,” and the practice is referred to as a “carve-out.”
Two features of this pathway matter for any litigation that may follow. First, the carve-out is defined by the “use code” the brand lists in the Orange Book: the FDA will approve the skinny label only if the patented material can be removed without rendering the drug’s labeling unsafe or ineffective for the remaining, unpatented uses. Second — and critically — unlike a Paragraph IV certification (which challenges a patent and can trigger a 30-month stay of FDA approval), a Section viii statement does not delay approval. This lets a generic enter the market for the unpatented indications while the brand’s method-of-use patent remains in force for the patented one.
The skinny label is therefore one of the most important competitive tools in the generic drug manufacturer’s playbook, though it carries a built-in tension. Even when a generic properly carves out a patented indication, physicians remain free to prescribe any approved drug for any medically appropriate purpose, including the carved-out use. That reality raises the central question: when, if ever, does a generic manufacturer’s conduct cross the line from lawfully marketing an unpatented use into actively inducing infringement of the patented one?
The Road to Hikma: GSK v. Teva and a Decade of Uncertainty
For much of the last decade, that question was governed by the shadow of GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.
GSK’s Coreg® (carvedilol) was approved for three indications, including congestive heart failure (CHF). GSK held a reissue patent covering a method of decreasing mortality from CHF by administering carvedilol with other agents. When Teva launched its generic after the compound patent expired, it initially used a skinny label that carved out the CHF indication; later, the FDA required Teva to amend its label to match GSK’s full label, restoring the CHF indication. GSK sued in the District of Delaware, and a jury found that Teva had induced infringement during both the skinny-label and full-label periods, awarding roughly $235 million.
The district court set the verdict aside on judgment as a matter of law, concluding that GSK had not proven Teva’s conduct actually caused physicians to infringe — noting, among other things, that generic substitution is often automatic and that prescribers did not necessarily rely on Teva’s materials. A divided panel of the Federal Circuit reversed and reinstated the verdict, holding that substantial evidence supported the jury’s finding of inducement. The court pointed to the content of the product label together with Teva’s marketing — including press releases and catalogs describing the generic as therapeutically equivalent to Coreg® — as evidence that Teva had encouraged the infringing use. The Federal Circuit then denied rehearing en banc in a 6-3 split, over dissents warning about the ruling’s implications for the carve-out system, and in May 2023 the Supreme Court denied certiorari, ending a nearly nine-year battle.
The lesson the industry drew from GSK v. Teva was unsettling for generics: a technically proper Section viii carve-out might not, by itself, insulate a manufacturer from inducement liability once the product was on the market, because the combination of a generic’s label and ordinary marketing statements — including routine equivalence claims — could, depending on the circumstances, be viewed as evidence of encouragement to infringe. That uncertainty over “how skinny is skinny enough” is the backdrop against which Hikma arose.
The Facts of Hikma
The dispute in Hikma concerned icosapent ethyl, sold by Amarin as the cardiovascular drug Vascepa®. Amarin held method-of-use patents covering a cardiovascular (CV) indication. Hikma launched a generic version under a skinny label that carved out the patented CV use.
Amarin nonetheless sued in the District of Delaware, advancing a “totality of the communications” theory: it alleged that Hikma’s skinny label, patient information leaflet, website, and press releases — taken together — actively induced physicians to prescribe the generic for the patented CV use, in violation of § 271(b). The district court dismissed the complaint under Rule 12(b)(6). In 2024, the Federal Circuit reversed, reasoning that it was at least plausible a physician could read the combination of Hikma’s label, website, and press releases as encouragement to prescribe the generic for the patented indication. The Supreme Court granted certiorari on January 16, 2026.
The Decision
The Supreme Court reversed. Importantly, the Court did not rewrite or recharacterize the substantive elements of induced infringement. Instead, it applied the familiar Twombly/Iqbal pleading standard to those long-established elements and found Amarin’s allegations wanting.
The heart of the opinion is a distinction between statements designed to stimulate infringement and statements that merely could stimulate it. Describing a product as a “generic version” of the brand and citing publicly available information — such as the branded drug’s sales — are routine, industry-standard communications. Standing alone, they do not amount to the active encouragement that inducement requires. The Court made clear that encouragement can be shown implicitly or explicitly, but that omissions, vague statements, and ordinary generic-marketing language do not, without more, plausibly allege purposeful encouragement of the carved-out use.
In doing so, the Court distinguished the Federal Circuit’s approach in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., which had upheld a substantial jury verdict based on the totality of Teva’s labeling and marketing evidence.
The decision did not appear in isolation. The Court’s reasoning echoed its March 2026 decision in Cox Communications, Inc. v. Sony Music Entertainment, a contributory copyright case in which the Court likewise emphasized that mere knowledge of underlying infringement is not enough to establish secondary liability. Read together, the two decisions suggest a consistent reluctance to expand secondary-liability theories across intellectual property law.
What This Means for Clients
For generic manufacturers. The Hikma decision provides greater clarity and certainty for manufacturers relying on the skinny-label pathway. A properly executed carve-out, paired with neutral, factual marketing, is on considerably firmer footing at the pleading stage. That said, the protection is not unlimited: statements that actively promote the carved-out, patented use — as opposed to describing the product in ordinary terms — can still expose a generic to an inducement claim. Marketing review before launch remains essential.
For branded manufacturers. The decision makes clear that boilerplate allegations built around a generic’s skinny label and routine marketing are unlikely to survive a motion to dismiss. Brands contemplating an inducement suit should develop concrete, specific facts showing purposeful encouragement, for example, targeted promotional materials, sales-force messaging, or communications that steer prescribers toward the patented indication. Building that factual record before filing, rather than relying on the label and public statements alone, may be the difference between a case that proceeds and one that is dismissed.
For pharmaceutical companies navigating skinny-label strategies, careful attention to product labeling, marketing communications, and potential inducement risks can help reduce exposure and strengthen enforcement positions. Contact Conley Rose to discuss how your organization can develop a strategy for navigating skinny-label and induced-infringement issues in light of the Supreme Court’s Hikma decision.
This article is provided for general informational purposes and does not constitute legal advice. For guidance on how these developments may affect a specific product, portfolio, or litigation strategy, please contact a member of our Life Sciences practice.