Argument Preview / Panel Activity

As we have been reporting, four cases being argued in April at the Federal Circuit attracted amicus briefs. One of these cases is Amarin Pharmaceuticals, Inc. v. Hikma Pharmaceuticals USA Inc. In this patent case, the Federal Circuit will review a determination by a judge in the District of Delaware to grant Hikma’s motion to dismiss Amarin’s inducement claims under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. This is our argument preview.

In its opening brief, Amarin explains that “[t]his case involves Hikma’s so-called skinny-label generic version of Amarin’s breakthrough Vascepa®.” Amarin goes on to describe how it “alleged that Hikma’s skinny label was not skinny enough”–meaning that Hikma “covered patented methods of treatment” –and also how its allegations went further. Amar asserts it alleged Hikma took “active steps to influence prescribing physicians to replace Vascepa® with its generic for the patented use.” Amarin argues that the district court erred by: “(1) weighing Amarin’s allegations separately and in isolation against the plausibility pleading standard rather than considering whether, as Amarin pled, Hikma’s conduct as a whole induced infringement; (2) making implicit factual findings on the key question of what Hikma’s conduct communicated to prescribing physicians; and (3) misapplying skinny-label precedent.” It contends these errors “effectively and improperly elevated the pleadings standard” and prevented Amarin from pursuing a “more than plausible claim for induced infringement. 

In its response brief, Hikma asserts that, for Amarin to survive the pleadings stage, its “complaint must plausibly allege each element of induced infringement, including that Hikma took active steps to encourage infringement of all limitations in at least one claim.” It argues the district court correctly dismissed Amarin’s complaint because “[n]one of Amarin’s inducement evidence plausibly satisfies this requirement. Hikma contends that “combining Amarin’s meritless theories cannot state a claim for relief.” Furthermore, Hikima argues, contrary to Amarin’s argument that inducement hinges on factual determinations, “[c]ourts have repeatedly resolved induced infringement claims before trial and even at the pleadings stage where, as here, the patentee failed to raise a material issue of fact.” It asks the Federal Circuit to reject Amarin’s position because it “would eviscerate . . . a path to expedite generic-drug competition.”

In its reply brief, Amarin contends that the lower court’s approach “dismembered Amarin’s theory and weighed each pled fact separately against the inducement threshold.” Moreover, says Amarin, “Hikma dwells on its incorrect views of the law, the district court’s analysis, and Amarin’s argument on appeal.” According to Amarin, “Hikma took active steps” encouraging infringement, including communicating through its website and releasing press releases, and other statements. Amirin asserts that “[w]hether those communications actually encouraged healthcare providers to infringe Amarin’s patents . . .is a question of fact that cannot be resolved on the pleadings.” Amirin maintains “[t]he district court misapplied the plausibility pleading standard by isolating and weighing individual pled facts against the standard for induced infringement” and is requiring “too much from the pleading stage.” Finally, Amirin argues, Hikima incorrectly labeled this a “test case” when it was a” “routine debate about the sufficiency of Amarin’s pleadings.” 

The Association for Accessible Medicine filed an amicus brief in support of affirmance. It argues that, if the Federal Circuit “finds that Amarin has stated a claim for inducement based on omitted label language and ‘generic equivalence,'” the court may discourage generics from entering the market. 

Oral argument will be heard on Tuesday, April 2. We will keep track of this case and report on any developments.