Supreme Court Greenlights Skinny Labels In Hikma v. Amarin

On June 4, 2026, the Supreme Court published a long-awaited decision providing guidance to the pharmaceutical industry on the status of so-called “skinny labels” permitted under 21 U.S.C. 355(j)(2)(A)(viii) (Section viii). Under Section viii, a generic pharmaceutical company may “carve-out” indications and uses in the brand drug label that are protected by patents held by the brand drug manufacturer in order to avoid the potential for infringement.

In a 9–0 decision, the Court rejected Amarin’s claim that it only needed to allege “a plausible chain of events through which” statements in Hikma’s generic product label “could lead a healthcare provider” to prescribe or dispense Hikma’s drug for Amarin’s protected uses that had been carved-out of Hikma’s generic product label. Justice Jackson, writing for the unanimous court, made clear this was not enough to demonstrate the “active” steps necessary to establish induced infringement under the Patent Act. The case citation is Hikma Pharmaceuticals v. Amarin Pharma, Inc., No. 24–889, slip op. (Jun. 4, 2026).

Background

At the center of Hikma v. Amarin lies a dispute over whether a generic manufacturer’s skinny label, public statements, and marketing materials that do not include the patented and “carved-out” indication can still be interpreted as encouraging that use by health care providers and thus induce patent infringement. Hikma secured ANDA approval of its generic icosapent ethyl product after a district court invalidated Amarin’s method-of-use patents for the product’s severe hypertriglyceridemia indication in 2020. Amarin subsequently brought suit based on alleged induced infringement of another, later-issued patent claiming a method of use to reduce cardiovascular risk in hypertriglyceridemia patients on statins, which indication had been specifically carved out of Hikma’s product label.

The facts that Amarin asserted supported its induced infringement allegation included:

1. Hikma followed Amarin in removing the Limitation of Use related to cardiovascular risk on its own generic label only after Amarin did so on its Vascepa label (the reference listed drug);
2. Hikma’s label included possible side effects for people with heart disease and noted that medicines may be “prescribed for purposes other than those listed”;
3. Hikma’s website described the category of its generic drug as “Hypertriglyceridemia” instead of “Severe Hypertriglyceridemia” and stated it was “AB” rated; and,
4. Hikma issued press releases describing its drug as “generic Vascepa” and included Vascepa’s U.S. sales numbers for the cardiovascular indications.

The United States Court of Appeals for the Federal Circuit found Hikma potentially liable for inducing infringement of Amarin’s patent on the basis that it was “at least plausible that a physician could read” the relevant statements “as an instruction or encouragement” to infringe. Amarin v. Hikma, 104 F. 4th 1370 (Fed. Cir. 2024). The Federal Circuit’s framing of the “skinny label” issue followed a recent trend of cases within the Circuit that shifted the focus of active inducement jurisprudence from the actions of the alleged inducer to how a theoretical inducee may interpret those actions. The Supreme Court granted certiorari to decide whether this change in focus was appropriate in the “skinny label” context.

Summary of the Decision

The Supreme Court focused its analysis on Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913 (2005), and two recent Supreme Court cases in the same line, rather than current Federal Circuit precedent finding skinny labels to infringe patents for uses that had been subject to full or partial carve-outs. The only patent case of the Supreme Court’s main three precedents clarified the mental state requirement of actual knowledge or willful blindness for induced patent infringement. In contrast, Grokster imported and applied the active inducement framework from patent law to copyright law, to require inducement or promotion of infringement, as compared to supplying a product with mere knowledge it may be used to infringe, to show contributory infringement in copyright law.

Distinguishing Grokster from Hikma v. Amarin, Justice Jackson noted that “statements designed to stimulate others form a narrower category than statements that could stimulate others,” reasoning that the file-sharing platforms’ promotion of their ability to locate and play copyrighted materials differ from “‘merely sell[ing] a commercial product for some lawful use.’” Hikma, No. 24–889, slip op. at 9–10 (quoting Grokster, 545 U.S. at 935–936) (emphasis added). The Court then compared this to the similar intent of generic pharmaceutical manufacturers.

Of particular note, the Court explicitly rejected the recent line of Federal Circuit cases focusing on whether statements could plausibly be understood by medical providers as instructions to infringe, emphasizing that “the key question is whether a defendant actively encouraged infringement through its statements, not merely how others may understand those statements.” Hikma, No. 24–889, slip op. at 11 n.4. Because active inducement requires affirmative statements or actions, rather than omissions, Hikma’s omission of the cardiovascular Limitation of Use on its skinny label, and of its generic drug’s limited approved uses in press releases, were not enough for Amarin to plausibly allege active inducement. The Court noted that Hikma’s action in changing the label was required by law, as the FDA requires generic labeling to be the same as the labeling for the RLD.

Further, the Court found the statements Hikma made in its leaflet and on its website that its product is a “generic Vascepa” and “AB” rated, and its use of all Vascepa sales in the U.S, were viewed as “implausibly roundabout” ways to induce infringement. Justice Jackson noted that simply describing a generic drug as a generic version of a brand-name drug is a far cry from affirmatively communicating to customers an infringing use and is common practice in the pharmaceutical industry. Similar practices exist in other consumer product industries, as is shown by the “compare to” tag seen on countless discount products, which is permitted in trademark law under the doctrine of nominative fair use.

Takeaways for the Future

Going forward, the Hikma v. Amarin decision will likely immediately impact cases that have pending motions to dismiss related to skinny labels or generic applicants considering amending their labels to carve out patented indications. In the longer term, the decision may facilitate or accelerate market entry of generics and biosimilars that would have otherwise had to first resolve infringement disputes over patented uses.

Generic drug companies should feel relieved by this decision but remain vigilant in avoiding potential induced infringement claims. They should continue to police their marketing language, ensuring it does not affirmatively promote off-label use where it may infringe method of use patents.

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