2024 Federal Circuit IP Appeals – Amarin Pharma, Inc. v. Hikma Pharm. USA Inc., 104 F.4th 1370 (Fed. Cir. 2024) (Moore, Lourie, Albright)

Amarin sells the drug icosapent ethyl under the brand name Vascepa. Vascepa is approved by the FDA for two indications: (i) to treat severe hypertriglyceridemia, a condition characterized by blood triglyceride levels greater than 500 mg/dL (the SH indication) and (ii) to reduce cardiovascular risk in patients with blood triglyceride levels greater than 150 mg/dL (the CV indication). Hikma sought and received FDA approval to market a generic version of icosapent ethyl with a “skinny label” that includes only the SH indication.

After Hikma launched its generic product, Amarin sued Hikma for inducing infringement of patents covering the CV indication. Amarin alleged that:

• Hikma’s label did not state that the product was not approved for the CV indication;
• Hikma had issued press releases that referred to its product as a “generic version” of Vascepa and cited sales figures for Vascepa that included both the SH and CV indications; and
• Hikma’s website listed its generic product in the “hypertriglyceridemia” therapeutic category (which was broad enough to include both approved indications) and stated that it was “AB” rated to Vascepa.

The district court dismissed the complaint, holding that Amarin’s allegations did not plausibly show that Hikma intended to actively induce infringement.

The Federal Circuit reversed. The court concluded that the totality of Amarin’s allegations, taken as true, plausibly made out a claim for induced infringement. The court noted that the allegations “depend on what Hikma’s label and public statements would communicate to physicians and the marketplace,” which was “a question of fact … not proper for resolution on a motion to dismiss.” Specifically, the court found it “at least plausible that a physician could read Hikma’s press releases—touting sales figures attributable largely to an infringing use, and calling Hikma’s product the ‘generic version’ of [Vascepa]—as an instruction or encouragement to prescribe that drug for any of the approved uses of icosapent ethyl, particularly where the label suggests that the drug may be effective for an overlapping patient population.” “Further,” the court reasoned, “it is at least plausible that a physician may recognize that, by marketing its drug in the broad therapeutic category of ‘Hypertriglyceridemia’ on its website, Hikma was encouraging prescribing the drug for an off-label use.”

Hikma had argued that the requisite intent could not be inferred because its website referred to its product “as AB rated, indicating generic equivalence for only labeled uses,” and included a disclaimer stating that its product was approved for fewer than all uses of Vascepa. But the court rejected these arguments. It noted that Hikma’s press releases “broadly refer[red] to the product as a ‘generic version’ of Vascepa and provide[d] usage information and sales data” that included both indications. Those facts, the court concluded, made it plausible that Hikma was encouraging physicians to use its product “for purposes beyond the approved SH indication.”

This article appeared in the 2024 Federal Circuit IP Appeals: Summaries of Key 2024 Decisions report.