Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., Appeal No. 2023-1169 (Fed. Cir. June 25, 2024)

In the Court’s only precedential patent opinion last week, the Federal Circuit reversed the district court’s dismissal of Appellant Amarin’s induced infringement claim based on off-label use of a generic drug. Amarin had asserted patents against Appellee Hikma directed to one of the pharmaceutical indications for Amarin’s drug Vascepa®.

Vascepa® had received FDA approval for two distinct indications: (1) treatment of hypertriglyceridemia in 2012, and (2) reduction of cardiovascular disease risk in 2019. After previous litigation held that Amarin’s patents relating to the hypertriglyceridemia treatment were invalid as obvious, Hikma sought FDA approval of their generic drug for the treatment of hypertriglyceridemia only, and not for the reduction of cardiovascular disease. Accordingly, the approved label for Hikma’s generic drug does not contain the indication for reducing cardiovascular disease risk. However, in press releases and on their website, Hikma made several statements referring to their drug as the “generic version” of Vascepa® and highlighted sales data of Vascepa® that included data for both pharmaceutical indications. Because Hikma’s promotion of their generic drug was not limited to the first indication alone, Amarin asserted that Hikma had induced infringement of the patents that protect the second indication for reduction of cardiovascular disease risk.

The district court granted Hikma’s motion to dismiss. Hikma argued that Amarin failed to allege sufficient facts to show that Hikma had taken steps to specifically encourage infringement. The district court agreed and was unpersuaded that Amarin’s pleaded allegations showed active efforts by Hikma to encourage infringement. Amarin appealed. The Federal Circuit found that, taking into consideration the totality of allegations, and accepting them as true, it was plausible that Hikma had induced infringement. The Federal Circuit highlighted that a dismissal on Rule 12(b)(6) is at the most nascent stages of a case and cited Bell Atl. Corp. v. Twombly for the precedent that “a well-pleaded complaint may proceed even if it strikes a savvy judge that actual proof of those facts is improbable . . . .” Since Amarin’s complaint alleged that healthcare providers directly infringe the asserted patents, and that Hikma had the requisite intent and knowledge to induce the infringement, the Federal Circuit held that the complaint plausibly pled that Hikma had induced infringement and that the case could not be dismissed under Rule 12(b)(6).

Accordingly, the Federal Circuit reversed the District Court’s dismissal. The opinion can be found here.

By Ann C. Bernert

This article summarizes aspects of the law and does not constitute legal advice. For legal advice for your situation, you should contact an attorney.

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