-
Federal Circuit Reverses Dismissal Of Induced Infringement Claim Based On Skinny Label And Marketing Materials
07/17/2024On June 25, 2024, the United States Court of Appeals for the Federal Circuit (“CAFC”) reversed a decision by the United States District Court for the District of Delaware dismissing Amarin Pharma, Inc.’s induced infringement claims against Hikma Pharmaceuticals USA Inc. Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., No. 2023-1169 (Fed. Cir. June 25, 2024). The CAFC held that the totality of Amarin’s allegations plausibly stated a claim for induced infringement of patents allegedly covering Hikma’s generic version of Amarin’s Vascepa® product.
Amarin markets Vascepa (icosapent ethyl) for two approved indications: the treatment of severe hypertriglyceridemia and reducing cardiovascular risk, the latter use of which is patented. Hikma obtained FDA approval for a generic version with a “skinny label” that carved out the patented cardiovascular risk indication. After Hikma began marketing its ANDA product, Amarin sued Hikma for inducing infringement of its cardiovascular risk patents based on Hikma’s label, press releases, and marketing materials.
The district court dismissed Amarin’s complaint, finding that neither Hikma’s label nor its public statements plausibly showed active steps to induce infringement. The CAFC disagreed, emphasizing that, on a motion to dismiss, all well-pleaded facts must be accepted as true and viewed in the light most favorable to the plaintiff.
While acknowledging that Hikma’s label alone may not induce infringement, the CAFC distinguished the case from those cases based solely on the contents of an ANDA, where the infringement inquiry is hypothetical and based on what may happen in the future if the ANDA is approved. Instead, the CAFC noted that the case at bar was a “run-of-the-mill induced infringement case” in which the “totality” of the allegations must be considered to determine whether they plausibly state a claim of induced infringement. Using this approach, the CAFC found that Amarin plausibly alleged that Hikma’s press releases and marketing encouraged physicians to prescribe its generic for off-label, patented uses. The court noted that Hikma’s press releases—allegedly referring to its product as a “generic version” of Vascepa without specifying that its label was only for the unpatented indication and “touting sales figures attributable largely to an infringing use”—were sufficient at the pleading stage to plausibly constitute “an instruction or encouragement to prescribe that drug for any of the approved uses of icosapent ethyl,” including the patented one.
The CAFC rejected Hikma’s argument that reversing the dismissal would “eviscerate” the carve-out provisions of the Hatch-Waxman Act. The court emphasized that its holding was limited to the specific allegations before it at the pleading stage and noted that “clarity and consistency in a generic manufacturer’s communications regarding a drug marketed under a skinny label may be essential in avoiding liability for induced infringement.”
The case will now return to Delaware for merits proceedings. This decision highlights the challenges generic manufacturers face in marketing carved-out products without risking induced infringement claims. It suggests that courts may look beyond the product label to a generic’s overall marketing strategy and statements when evaluating such claims, especially at the pleading stage.
