Luke Pettit

July 2026

As a reminder, this case addresses how the Hatch-Waxman act “carve-out” provisions (which has led to the emergence of “skinny labels”) interacts with US law on induced patent infringement.

This case is the first time the US Supreme Court has had the opportunity to directly address how the “carve-out” provisions factor into claims of induced patent infringement involving the use of “skinny label” products for patented medical indications.

Briefly, for context, the pharmaceutical products at issue in this case are:

• Vascepa® which is marketed by Amarin, approved by the FDA for:
  • Severe hypertriglyceridemia (unpatented), and
  • Cardiovascular risk reduction (patented method of use).
• Hikma launched a generic Vascepa® with a carve-out for the patented cardiovascular indication from its FDA label.

Amarin alleged that Hikma induced infringement by encouraging use of generic Vascepa® for the patented cardiovascular indication. This case centred on whether the sale of a generic drug, despite its skinny label, resulted in induced infringement of the patented use.

At the time of our last update, the US Supreme Court had agreed to decide two core questions, which were:

1. i) When a generic drug label fully carves out a patented use, are allegations that the generic manufacturer simply describes its product as a ‘generic version’ and references publicly available information about the branded drug (such as sales data) enough to plead induced infringement of the patented use?
2. ii) Does a complaint include enough factual allegations to make a plausible 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?

In answering the first question the Court found that Hikma’s actions and statements had “obvious alternative explanations”. For instance, Hikma was legally required to use labelling nearly identical to Amarin’s, and referring to its product as “generic Vascepa®” was standard industry practice. Moreover, the Court found that citing Vascepa® sales figures in investor-facing press releases was also deemed too remote from any encouragement of a specific medical use to count as inducement.

In answering the second question the Court clarified that inducement need not be “express” and stated that a company can implicitly encourage infringement, but that any encouragement, whether implicit or explicit, must be “clear” and “affirmative”. The Court held that Amarin’s argument, that a doctor might read Hikma’s statements as instructions to infringe, was not enough to establish induced infringement. Rather, Amarin needed to show that Hikma took affirmative steps specifically intended to encourage the patented use.

In its decision, the Court decided that generic drug manufacturers should not face liability merely for complying with the Hatch–Waxman framework or engaging in ordinary, industry‑standard marketing practices, stating that:

“We decline to put generic manufacturers between a rock and a hard place by turning adherence to the law and industry standards into building blocks for illegal conduct.”

In other words, the Court made clear that regulatory compliance and routine generic marketing cannot, on their own, constitute the “affirmative steps” required to prove induced infringement.

This statement surely provides significant relief for generic drug manufacturers, as the Federal Circuit’s earlier decision risked exposing them to liability based on ordinary, lawful behaviour. If simply describing a product as a “generic version” could amount to inducement, generic manufacturers could risk infringement even when they fully carved out patented uses.

By rejecting that approach, the Supreme Court has reinforced the integrity of the skinny label system and reaffirmed that only deliberate, intentional acts of encouragement constitute inducement.