Earlier this month the Federal Circuit issued its opinion in Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., a patent case that attracted an amicus brief. In this case, the Federal Circuit reviewed a district court’s grant of a motion to dismiss inducement claims under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. The Federal Circuit reversed the judgment of the District of Delaware in an opinion authored by Judge Lourie that was joined by Chief Judge Moore and Western District of Texas Judge Alan Albright, who sat by designation. This is our opinion summary.
Judge Lourie began by outlining the procedural and factual background of the case:
Amarin markets and sells icosapent ethyl . . . under the brand name Vascepa®. . . . In 2012, the U.S. Food and Drug Administration (“FDA”) approved Vascepa for the treatment of severe hypertriglyceridemia (“SH”), a condition in which a patient’s blood triglyceride level is at least 500 mg/dL. . . . In 2019, following the success of Amarin’s additional research and clinical trials, the FDA approved Vascepa for a second use: as a treatment to reduce cardiovascular risk (“CV”) in patients having blood triglyceride levels of at least 150 mg/dL. . . . In 2016, when Vascepa was still only approved for the SH indication, Hikma submitted an Abbreviated New Drug Application (“ANDA”) for approval of its generic icosapent ethyl product. . . . [In 2019] Hikma was required to either amend its proposed label to match the revised Vascepa label including the CV indication and corresponding information . . . or file a ‘section viii statement’ to ‘carve-out’ that indication. . . . Hikma opted for the latter and submitted a statement seeking FDA approval only for uses not covered by Amarin’s newly listed CV indication patents. . . . The FDA approved. Although Hikma’s original proposed label included the CV Limitation of Use, Hikma later amended the label to remove that limitation . . . . In November 2020, less than a month after Hikma launched its generic icosapent ethyl product, Amarin sued . . . alleging that Hikma had induced infringement . . . . According to Amarin . . . Hikma’s specific intent [is] to actively encourage physicians to directly infringe the asserted patents by prescribing its generic icosapent ethyl product for the off-label CV indication, an indication for which Hikma did not get FDA approval. . . . Hikma moved to dismiss . . . [b]ecause [the district court] found that Amarin’s complaint failed to plead inducement based on either Hikma’s label or public statements, the district court granted Hikma’s motion to dismiss.
Judge Lourie began his analysis for the court by explaining how the panel reviews “a district court’s grant of a motion to dismiss for failure to state a claim . . . de novo, accepting all well-pleaded factual allegations as true and drawing all reasonable inferences from such allegations in favor of the complainant.”
With respect to the law governing claims for inducement of infringement, he explained that, “a patent owner must plausibly allege facts establishing that there has been direct infringement by a third party and that the alleged infringer affirmatively induced that infringement with knowledge that the induced acts constituted patent infringement.”
Judge Lourie noted how “it is undisputed that Amarin’s complaint sufficiently alleges (1) that healthcare providers directly infringe the asserted patents by prescribing Hikma’s generic icosapent ethyl product for the off-label CV indication, and (2) that Hikma had the requisite intent and knowledge to induce that infringement.” Judge Lourie explained that this means the court must “focus narrowly on the question whether Amarin’s complaint plausibly pleads that Hikma ‘actively’ induced healthcare providers’ direct infringement.”
On this point, Judge Lourie noted that “the complaint alleges that Hikma’s removal of the CV Limitation of Use (despite not being approved for the CV Indication), as well as its warning of potential side effects for patients with cardiovascular disease, communicate to physicians that Hikma’s generic product could be used for the off-label CV indication.” he conceded that, “taken on its own . . . the label does not, as a matter of law, ‘recommend[], encourag[e], or promot[e] an infringing use.’” he noted, however, that “Amarin’s theory of induced infringement is not based solely on the label.” Judge Lourie then explained that Hikma’s press releases “consistently referred to Hikma’s product as a ‘generic equivalent to Vascepa®,’” and “referred to Vascepa as indicated ‘in part’ for the SH indication.”
In light of these allegations, Judge Lourie concluded that all of them “taken together . . . at least plausibly state a claim for induced infringement.”
As a result of this analysis, the Federal Circuit reversed the district court’s judgment.