U.S. Supreme Court to Weigh Induced Infringement Case Regarding ‘Generic Version of Vascepa®’

In early 2026, the U.S. Supreme Court (the “Court”) agreed to hear a case at the heart of pharmaceutical intellectual property that could have significant implications for the manufacturers of both patented and generic drugs.

Oral argument is scheduled for Wednesday, April 29.

Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. asks the Court to consider whether a generic drugmaker’s alleged marketing activities are sufficient for the patent owner to plead active inducement to infringe a drug with patented as well as unpatented uses, when the “skinny label” for the generic drug correctly “carves out” the patented uses in accordance with the Hatch-Waxman Act.

In a June 2024 decision, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) concluded that Amarin Pharma (“Amarin”) plausibly alleged an active inducement to infringe patented uses of its drug Vascepa® in its lawsuit against Hikma Pharmaceuticals (“Hikma”).

Hikma allegedly marketed its drug as “a generic version of Vascepa®” and included Amarin’s sales records of the drug on its website. Yet Amarin has extended patent exclusivity for certain uses of Vascepa®, including cardiovascular risk reduction. The borrowed sales records, Amarin argues, reflect the patented use of its drug, whereas the “skinny label” of Hikma’s generic drug does not. We unpack the issues and the implications below.

The Federal Circuit Opinion

“We begin by noting what this case is not,” Federal Circuit Judge Alan Lourie wrote in 2024. It is not, he noted, a “traditional” abbreviated new drug application (“ANDA”) case “in which the patent owner seeks to establish that if a generic manufacturer’s drug is put on the market, it would infringe the asserted patent.” Hikma received approval from the U.S. Food and Drug Administration (“FDA”) for its generic product in May 2020 and was already in the process of marketing the drug, the judge noted. And it was not a case where the label alone induces infringement.

Amarin secured FDA approval for Vascepa® for the treatment of severe hypertriglyceridemia (“SH”) in 2012 and the reduction of cardiovascular (“CV”) risk in 2019, according to the Federal Circuit opinion. Amarin timely listed two patents regarding Vascepa®, relating to the CV use only.

Hikma received FDA approval for a “skinny label” for its generic version, which included only the SH use, and as summarized in the Federal Circuit opinion allegedly issued press releases describing its product as “the generic version of” or “the generic equivalent to” Vascepa®. It also allegedly referenced numbers accounting for Vascepa® sales for all uses—when CV indication “undisputedly made up more than 75 [percent] of the drug’s sales.” Hikma allegedly clarified in a later press release that its product was not approved for any other indication than SH use and added a disclaimer to its website that the product was “indicated for fewer than all approved indications of the Reference Listed Drug.”

Amarin filed its lawsuit claiming induced infringement in November 2020, and the U.S. District Court for the District of Delaware ultimately granted Hikma’s motion to dismiss the case. Yet the Federal Circuit reversed in 2024, calling the matter “nothing more than a run-of-the-mill induced infringement case arising under 35 U.S.C. § 271(b)” (which simply states that “[w]hoever actively induces infringement of a patent shall be liable as an infringer.”) The appellate court held that “Amarin’s complaint sufficiently alleges (1) that healthcare providers directly infringe the asserted patents by prescribing Hikma’s generic…product for the off-label CV indication, and (2) that Hikma had the requisite intent and knowledge to induce that infringement.”

Weighing the narrow question of “whether Amarin’s complaint plausibly pleads that Hikma ‘actively’ induced healthcare providers’ direct infringement, i.e., that Hikma ‘encourage[d], recommende[d], or promote[d] infringement,” the Federal Circuit concluded that it did. The judge noted that while Hikma’s label did not provide an express or implied instruction to prescribe the drug for the CV indication, Amarin alleged that parts of the label would be understood by physicians that the product could be used to treat CV risk.

Competing Interests

The case is certain to have implications for the pharmaceutical industry. Hikma’s petition for a writ of certiorari, which has been granted by the Supreme Court, frames the questions presented as follows:

1. When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a “generic version” and cites public information about the drug (e.g., sales) enough to plead induced infringement of the patented use?
2. Does a complaint state a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use?

Hikma contends that the Federal Circuit’s decision, among other things, conflicts with controlling precedent; creates a circuit split over whether inducement can be decided on the pleadings as a matter of law; and “effectively nullifies labeling carve-outs…threatening severe harm to generic drug competition.”

The solicitor general was invited to file a brief expressing the views of the United States; that brief, filed in December 2025, called for Supreme Court review: “The decision below subverts Congress’s balance between competing interests by subjecting Hikma to a substantial threat of infringement liability for statements that either (a) are integral to the [Hatch-Waxman] section vii [carveout] pathway  or (b) have no meaningful likelihood of increasing the prevalence of infringing off-label uses.”

Amarin, of course, argues that the Federal Circuit got it right: “Petitioners act like they were hit with a judgment, but this case is just beginning,” states the Brief for Respondents in Opposition. “Infringement and any defenses to it are not yet decided, nor are any remedies. What petitioners really want is a safe-harbor from having to litigate at all—a sort of qualified immunity for generic pharmaceuticals that has no basis in statute or case law.”

Takeaways

Pending the Supreme Court’s decision, pharmaceutical companies on both sides of the brand-generic divide may wish to reassess their practices. Generic manufacturers marketing skinny label products should exercise caution in how they describe their products in press releases, promotional materials, and website content, as statements characterizing a product as “a generic version of” or “equivalent to” a branded drug with patented indications may be construed as evidence of intent to induce infringement of those patented uses. Generic manufacturers may also reconsider referencing sales data or market information that predominantly reflects patented indications and should ensure that any disclaimers regarding the scope of approved indications are prominent and unambiguous.

Brand manufacturers, for their part, should consider documenting and preserving evidence of generic competitors’ marketing statements, website content, and press releases that could support induced infringement claims, particularly any materials that reference the brand product without clearly limiting the discussion to unpatented uses.

With oral argument coming soon, the Supreme Court’s decision could reshape the landscape for skinny label generic drugs and the scope of induced infringement liability for years to come. We will keep you posted.

Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.