Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc: Turning Ballyhoo into Boo Hoo

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc: Turning Ballyhoo[1] into Boo Hoo

In Amarin Pharma v. Hikma Pharmaceuticals USA Inc[2]., the Court of Appeals for the Federal Circuit reversed the District Court’s dismissal of Amarin Pharma, Inc.’s complaint alleging that generic drug company Hikma Pharmaceuticals USA Inc. induced infringement of two of its patents directed to reducing the risk of cardiovascular events in adults with elevated triglyceride levels (the “CV Indication”)[3]. This case illustrates how a generic drug company can be exposed to potential liability for inducing patent infringement even if it carves out a patented use from its FDA-approved “skinny label,”[4] and even in absence of explicit instructions or encouragement to use the drug for the patented use.

Amarin markets and sells the Vascepa® icosapent ethyl drug and, in 2012, obtained FDA-approval for use of Vascepa® for treating adults with severe hypertriglyceridemia (the “SH Indication”). Later, in 2019, Amarin obtained FDA-approval for use of Vascepa® for a second indication — reducing cardiovascular risk in patients with high triglyceride levels (the “CV Indication”). Both indications call for the administration of the same dose of the drug (i.e., 4 g/day) and have overlapping patient populations. Indeed, patients presenting with the CV Indication have triglyceride levels above 150 mg/dL, while patients presenting with the SH Indication have triglyceride levels over 500 mg/dL.[5]

In 2016, Hikma filed an Abbreviated New Drug Application (ANDA) for its generic version of icosapent ethyl capsule for treating patients with the SH Indication. When Hikma’s ANDA was approved by the FDA in 2019,  Hikma submitted a section viii statement seeking to carve out the CV Indication from its approval and label due to two Amarin patents covering this use.[6].

The resulting “skinny label” included only the SH Indication thus enabling Hikma to come to market with the goal of avoiding patent infringement.

The relevant timeline is shown here:

Amarin sued Hikma in the District of Delaware alleging that Hikma induced or encouraged physicians to prescribe Hikma’s generic drug for infringing uses, namely, for the CV Indication. According to Amarin, despite the absence of the CV Indication, Hikma’s purported “skinny label” retained warnings regarding CV diseases along with clinical studies describing statin-treated patients at risk for cardiovascular events. Moreover, Amarin pointed to various statements attributed to Hikma touting its generic drug as “the generic equivalent to Vascepa” and “our generic version of Vascepa.” What is more, Hikma reported the total U.S. sales of Amarin’s Vascepa® in one of its press releases despite most of the reported sales being attributed to the CV Indication. Hikma’s website included the statement that its generic drug was AB rated[7] for hyperglyceridemia. Amarin did not allege that Hikma’s label included any explicit instructions to administer the drug for the CV Indication nor did it allege that Himka’s statements included such instructions.

Hikma filed a 12(b)(6) motion to dismiss the complaint at the pleading stage. In granting Hikma’s motion, the District Court found that Amarin’s complaint failed to sufficiently plead inducement.[8] On appeal to the Federal Circuit, the sole remaining issue on appeal was whether Amarin’s complaint plausibly pled that Hikma “actively” induced healthcare providers’ direct infringement.

The Federal Circuit stated that Amarin’s complaint sufficiently alleged direct infringement by the healthcare providers and that Hikma had the requisite intent and knowledge to induce that infringement. It was not the skinny label alone, however, that doomed Hikma’s motion, but rather the skinny label combined with the public statements mentioned above.

The Court highlighted the various statements made by Hikma that equated its generic drug to the Vascepa® drug and noted that the sales figures used by Hikma included sales from both patented uses and non-patented uses of the Vascepa® drug. Finally, Hikma’s website statement that Hikma’s generic drug was AB rated for hyperglyceridemia would encompass both mild TG and severe TG and thus covered the patented use.

The Court held that the Hikma label combined with the marketing statements were sufficient to state a plausible[9] claim for inducement of patent infringement. As recognized by the Court, “[t]hough the merits of Amarin’s allegations have not yet been tested or proven, we cannot say at this stage that those allegations are not at least plausible.” Indeed, Hikma was not been found liable . . . yet. However, this sets a low bar for patent owners to survive dismissal at the pleading stage, which has caused concern among generic drug companies since now avoiding liability will cost greater resources and time.

Indeed, generic drug companies approved for generic versions of drugs under a skinny label may still find themselves having to defend a patent infringement lawsuit as the result of “ambitious” statements made in the press and during its marketing campaign. This case highlights the trouble that generic drug companies can get into when their marketers and regulatory/intellectual property counsel are not on the same page. Generic drug companies would be wise to run all proposed labels by regulatory counsel to ensure that all portions that “teach” the infringing use are cut out, if possible. Further, marketers should avoid broad characterizations and statements that encompass both infringing and non-infringing uses. For instance, “our generic version of Vascepa” becomes “our generic version of Vascepa for treating severe hypertriglyceridemia.”

It will be interesting to see how this case ultimately plays out. After losing its request for a rehearing en banc by the Federal Circuit,[10] Hikma recently filed a petition for writ of certiorari with the Supreme Court of the United States.[11]

[1] One definition of ballyhoo is “a clamorous and vigorous attempt to win customers or advance any cause; blatant advertising or publicity.” Dictionary.com available at https://www.dictionary.com/browse/ballyhoo (last visited Feb. 21, 2025).
[2] 104 F.4th 1370 (Fed. Cir. 2024).
[3] Patent No. 9,700,537 and Patent No. 10,568,861.
[4] Under the Hatch-Waxman Act, a “section viii statement” certifies that the uses of the generic drug are not covered by the brand owner’s patents. See 21 U.S.C. § 355(j)(2)(A)(viii). The resulting “skinny label” will only mirror that portion of the brand drug’s label that covers the non-patented use.
[5] Amarin Pharma, 104 F.4th at 1372-74.
[6] In a separate litigation, Hikma was successful in invalidating several Amarin patents directed to the SH Indication. Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 819 F. App’x 932 (Fed. Cir. 2020). As such, those patents were not at issue in this case.

[7] The phase “AB rated” reflects the FDA determination that it is the generic equivalent to a branded drug when used as labeled.
[8] Amarin Pharma, Inc. v. Hikma Pharms USA Inc., 578 F. Supp. 3d 642, 648 (D. Del. 2022).

[9] Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 104 F.4th 1370, 1381 (Fed. Cir. 2024).
[10] Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 104 F.4th 1370, 1381 (Fed. Cir. 2024), reh’g en banc denied, 2023-1169 (Fed. Cir. Oct 17, 2024).
[11] Hikma Pharms. USA Inc. v. Amarin Pharma, Inc., No. 24-889, On Petition for Writ of Certiorari to the United States Court of Appeals for the Federal Circuit, Petition for Writ of Certiorari (docketed Feb. 19, 2025).