Health Law Daily Wrap Up, SUPREME COURT NEWS—Supreme Court told that ruling on ‘inducement’ standards will impact more than just pharmaceuticals, (May 1, 2026)

By Thomas Long, J.D.Court heard arguments in dispute over “skinny labels” for generic drugs and pleading requirements for infringement by inducement under Patent Act Section 271(b).On April 29, the Supreme Court heard arguments in a case that could have significant impacts on the availability and cost of generic versions of prescription drugs, as well as patent infringement litigation more broadly. In questions for counsel representing the parties in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889), Justices wrestled with the problem of maintaining the compromise between brand-name and generic manufacturers by the Hatch-Waxman Act while also pondering whether the case needed to be decided via “special rules” or if general “plausibility” standards of pleading were enough. They noted that the implications of their decision will go beyond drug patent disputes.

While counsel for both sides emphasized that an adverse decision could devastate their clients’ industries, Justices seemed wary of creating a new standard for pleading patent infringement by inducement. In addition, they appeared unwilling to treat the Hatch-Waxman Act “skinny labeling” provisions as a safe harbor for generic drug makers, instead preferring a more general-purpose approach.

It came up repeatedly during argument that the case is only at the pleadings stage, and the complaining brand-name drug maker is only required to meet “plausibility” standards, but they struggled with what that means in this case. In particular, they questioned counsel as to what kinds of allegations would plausibly indicate the defending generic company’s intent to induce doctors to infringe the plaintiff’s patent, without sending clear signals regarding their own views, if any, on that question.

The Justices seemed open to the idea that, if they reverse the Federal Circuit (and rule against the brand-name company), they wouldn’t declare the case “over”; rather, the case would be remanded, and the brand-name company would have the opportunity at the district court to request leave to file an amended complaint. So regardless of the decision, the lawsuit is likely to go on for some time.

Hikma’s generic drug. At the center of the case is a generic version of a branded drug marketed by Amarin (Vascepa) with an active ingredient initially indicated for treatment of severely high triglycerides but later patented for use in reduction of cardiovascular disease risk. Hikma obtained Food and Drug Administration approval for the non-patented triglyceride indication and carved out (that is, omitted) the patented cardiovascular indication from the label, pursuant to 21 U.S.C. § 355(j)(2)(A)(viii), a portion of the provision relating to abbreviated applications for new drugs that is commonly referred to as “Section viii.” Section viii states that an applicant for a new generic drug that has uses covered by a patent does not infringe that patent if the applicant carves out the patented uses from its labeling.

Infringement dispute. Although Hikma followed the section viii carve-out rules for its generic drug by only indicating unpatented uses for treatment of high triglycerides, Amarin accused it of infringing its patent on use of the drug for prevention of cardiovascular problems. The issue was whether Hikma could be liable for “actively inducing” doctors to infringe Amarin’s patent in violation of 35 U.S.C. § 271(b).

Federal Circuit decision. In a June 2024 decision (104 F.4th 1370), the Federal Circuit said “yes,” reasoning that Amarin plausibly alleged that Hikma had engaged in conduct that could show specific intent to induce infringement, despite the label carveout. These included distributing promotional materials that referenced the brand-name drug's commercial profile, referred to Amarin's drug by name, and called Hikma's product a generic version of it. The Federal Circuit reversed a district court’s 2022 dismissal of the case. Hikma petitioned for review to the Supreme Court, arguing that the Federal Circuit’s holding will gut the carve-out mechanism of the Hatch-Waxman Act and hinder the introduction of lower-cost generic drugs, chilling competition. The Court granted certiorari on January 16.

Petitioner’s argument. Winston & Strawn partner Charles B. Klein opened the argument session on behalf of Hikma. Klein told the Court that Congress enacted Hatch-Waxman Section viii to ensure that the existence of an infringing use for a generic drug will not prevent sale of the drug for noninfringing uses. “So public statements entirely consistent with selling skinny-label generic drug products under Section viii cannot actively induce infringement,” he said. According to Klein, the phrase "actively induce infringement" in Section 271(b) “requires a clear message that necessarily promotes infringement.” He mentioned the Court’s recent rearticulation of this general requirement for inducement liability for others’ IP infringement in Cox Communications, Inc. v. Sony Music Entertainment (No. 24-171, March 25, 2026).

“Active inducement cannot depend on whether doctors might read infringing instructions into product descriptions that, on their face, are entirely consistent with non-infringing use,” he said. “Amarin argues that generic drug companies must constantly discourage infringement with disclaimers that are explicit. But that turns the statute on its head.” Allowing patent lawsuits like Amarin’s to survive the pleading stage will shut down the Section viii pathway, he argued because generic companies will not elect that option “if, at best, it means paying millions in legal fees and, at worst, a massive damages award.” Klein urged the Court to reverse the Federal Circuit “to harmonize Section viii with Section 271(b) and to encourage legitimate competition that reduces drug prices.”

In response to a question by Justice Sotomayor, Klein said that Amarin’s complaint did not meet the general “plausibility” pleading standards set forth in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) and Ashcroft v. Iqbal, 556 U.S. 662 (2009), and that Hikma would not need “special rules” to prevail in this case.

Klein emphasized the harm an adverse ruling would do to the generic drug industry. “As a practical matter, under the decision below, you can get FDA approval of your skinny product label,” he said, “but as soon as you put that product into commerce and you say anything about that product, anything, you call it a generic version, even if you have disclaimers, you can be sued.” And under the Federal Circuit’s holding, these lawsuits will survive pleadings challenges. Klein noted that profits for generic products are much lower than those for branded drugs. Therefore, a lost profits award in an infringement suit would be “devastating.”

Argument of U.S. government. Deputy Solicitor General Malcolm L. Stewart provided the views of the government as amicus curiae. He started by pointing out that, although the Federal Circuit correctly said that Hikma’s label itself was not enough to get Amarin’s complaint past a motion to dismiss, the appellate court “erred in giving any weight at all to the label.” He pointed out that the contents of the label were largely dictated by federal law, so “to treat the generic manufacturers' compliance with those requirements as any evidence of intentional inducement to infringe would be wrong.”

He also brought up the fact that Amarin said in its brief that it had not sued other generic drug companies over similar products because their press releases contained explicit disclaimers that their drugs were not to be used for the patented cardiovascular indication. However, Stewart said, there is no requirement to warn people away from infringement in order to avoid liability for “active” inducement.

Thomas asked Stewart what, in his view, Amarin would have to allege to survive a motion on the pleadings. Stewart said Amarin would need to identify “statements or actions that clearly revealed a purpose to induce infringement.” Chief Justice Roberts opined that the test articulated by Stewart created “a pretty broad safe harbor.” Stewart replied that this was by design, referring to previous Court decisions holding that “when a product is capable of both infringing and noninfringing uses, it's important that a patent on one method of use not become a de facto monopoly on the product as a whole.” Stewart reiterated that “mere knowledge that it will be done or the expectation that some people will infringe is not enough” for inducement liability.

Justice Kavanaugh asked about the government’s concerns about the broader market implications of the decision. Stewart said “the FDA's view is it is too soon to tell exactly what the effects of the Federal Circuit's decision would be on the willingness of other generic manufacturers to enter the marketplace,” but affirming the Federal Circuit “would create a substantial disincentive to entering the generic market.”

Respondent’s argument. Perkins Coie partner Michael R. Huston spoke for Amarin. He expressed the view that the case had far-reaching implications beyond the pharmaceutical industry and was not really a Hatch-Waxman or “skinny labeling” case. But he pointed out that Hikma had gotten the benefit of the skinny labeling provision and was required in exchange “to promise not to promote its product for any still patented use of Amarin's branded drug.” According to Huston, Hikma broke this promise in press releases to investors and other statements that repeatedly referred to the brand name Vascepa “when that name was synonymous in the market with treating cardiovascular risk.” Those statements, he argued, gave rise to a plausible inducement claim.

Huston told Justice Gorsuch that Hikma’s website disclaimers about its generic not being approved for all uses of Vascepa were insufficient to shield it from liability. “It doesn't disclaim that Hikma's product can and should be used to treat the most famous use of Vascepa,” he said, “the billion-dollar use, which is saving patients' lives by treating cardiovascular risk.” Permitting Hikma to make statements that would allow doctors to connect the dots and prescribe the generic for the patented cardiovascular treatment use would undermine Amarin’s ability to capitalize on the massive investment required to develop new lifesaving medicines.

Justice Barrett suggested that the case was a “pretty fact-bound case about the plausibility standard,” and asked Huston whether it was “just kind of applying ‘Twiqbal’ to this particular complaint.” Huston agreed and said that “the Court [should] not adopt a new induced infringement standard with words like ‘express promotion’ [being] required.” If the Court decided that Amarin’s allegations of intentional statements by Hikma were not enough to state a claim, it would “make it much, much harder to plead induced patent infringement,” Huston said.

Justice Kavanaugh asked Huston about the market impacts on the other side. He pointed out that former congressman Harry Waxman—co-drafter of the Hatch-Waxman Act—asserted in an amicus brief that “the Federal Circuit's decision here leaves generic drug companies in the dark about what might expose them to liability." Huston asserted that Hatch-Waxman was a compromise between brand-name manufacturers and generic manufacturers, and Amarin’s decision not to sue several other generic drug makers for similar products indicated that the Federal Circuit’s holding would not disrupt this compromise.

Huston argued that limiting the evidence to the skinny label and taking other evidence “off the table,” such as Hikma’s statements to investors, would amount to creating a safe harbor, which is a legislative function. He said that the skinny label was not at the heart of the case but was only one element. According to Huston, Hikma had used its skinny label to reduce its liability risk from its marketing statements.

Huston also urged the Court, if it were to reverse the Federal Circuit, not to render a definitive resolution to the case, but to remand so that Amarin could request leave at the district court to file amended pleadings. He noted that the parties had engaged in discovery during the pendency of the appeal, and Amarin had uncovered new facts showing inducement by Hikma. The Justices appeared to agree that their decision, regardless of which party it favors, will not bring the lawsuit to a close.

Attorneys: Charles Bennett Klein (Winston & Strawn LLP) for Hikma Pharmaceuticals USA Inc. Michael Robert Huston (Perkins Coie LLP) for Amarin Pharma, Inc. Malcolm L. Stewart, Deputy Solicitor General, Department of Justice, for the United States.

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

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