Supreme Court Takes Up Hikma v. Amarin

On Friday, the Supreme Court granted certiorari in Hikma Pharmaceuticals v. Amarin Pharma, ending an almost three-year lull in patent cases at the Court. The case presents two related questions, one framed specifically in the context of generic drugs and the other framed more broadly about induced patent infringement in general. In Hikma’s words, the questions presented are:

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 branded 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’s Carveout

Hikma v. Amarin is a pharmaceutical patent case involving a so-called “skinny label.” The case concerns a drug with multiple approved medical uses, or “indications.” When the FDA approves a drug, it approves the drug only for specified indications that appear on the product’s labeling. Brand‑name drug companies may later obtain approval and patent protection for additional indications, expanding both their markets and their patent coverage.

Amarin markets a branded drug approved for two indications, but the patents in this case cover only one of them. Hikma sought FDA approval to market a generic version of Amarin’s drug for only the non‑patented indication, thus “carving out” the patented use to create a “skinny label.” That move gave Hikma some level of protection from infringement claims based on the Hatch‑Waxman Act’s specialized provisions, which generally tie infringement to the contents of the generic’s FDA submission.

Amarin’s Allegations

After Hikma launched its generic, Amarin sued for induced infringement based on statements Hikma allegedly made outside its FDA submission. Even though Hikma’s generic was approved for only one indication, pharmacists could dispense it for the patented indication as well, and they often do so automatically as required under some states’ laws. Amarin alleged Hikma encouraged such patented use in various ways, including:

• A press release that described Hikma’s product as the “generic version” of Amarin’s drug without specifying that Hikma’s product was approved for fewer indications than Amarin’s;
• A press release that gave information about Amarin’s total sales for its drug, not sales tied to certain indications; and
• Website materials that noted therapeutic equivalence to Amarin’s product for a “therapeutic category” that was broader than Hikma’s approved indication.

The Federal Circuit deemed these allegations sufficient to state a claim for induced infringement.

The Parties’ Cert.-Stage Positions

Hikma’s petition for certiorari argued that the Federal Circuit’s decision conflicts with Supreme Court precedent requiring active encouragement of infringement. In Hikma’s view, statements that never mention the patented indication—but instead merely describe the product in general terms—cannot plausibly induce infringement. Hikma warns that the decision threatens to chill lawful generic entry by making it risky to market a generic drug whenever any indication remains patented, even if the generic has properly carved that use out of its labeling. The Solicitor General also filed a brief at the cert. stage, generally siding with Hikma.

Amarin responded that Hikma’s marketing went beyond passive conduct and affirmatively encouraged both patented and unpatented uses. According to Amarin, the Federal Circuit simply applied settled inducement law to detailed factual allegations, and generic manufacturers remain free to avoid liability through more precise marketing that clearly limits promotion to non‑patented indications.

Pharma-Specific Resolution or Broader Induced Infringement Guidance?

The case squarely implicates the reach of induced infringement claims by brand-name drug makers against generics based on statements outside the approved labeling. Those extra-label claims come up in the skinny-label context. That reach alone is modest, but far from trivial—one study found two dozen drugs whose first available generics used skinny labels when they came to market between 2015 and 2019.

At the same time, the case brings more general induced infringement questions before the Court, at least in terms of what allegations may suffice in a complaint. The case asks how specific a statement must be to amount to active encouragement of infringement and whether inducement requires allegations (and ultimately proof) that direct infringers would actually rely on the defendant’s statements. Those issues matter to patent litigation across industries.

The Court could tailor its decision to skinny-label disputes, or it could use the case to develop induced infringement standards more generally. The Court has taken up multiple cases on secondary liability in the past few years, signaling it may be broadly interested in inducement.

What Happens Next

With certiorari granted, the case now moves into merits briefing. Merits briefing, from both the parties and any amici, is expected to finish in time for the case to be argued in the current term, likely in April 2026. The Supreme Court will likely issue its decision on the merits before the Court’s summer recess, which begins in early July 2026.