By Joshua Rich and Kevin E. Noonan –

The Hatch-Waxman Act has always represented a delicate balance between the interests of innovator and generic drugmakers: innovators seek to maintain exclusivity as broadly and long as possible, generics seek to come to market as soon as possible and leverage previous marketing by the innovators as much as possible.  The strategies between the two involve a continual thrust and parry – most relevant here, generics can adopt so-called “skinny labels” by “carving out” patented uses of drugs, and innovators have then focused on the generic drugmakers’ marketing of those skinny-labeled drugs as “generic versions” of the branded drug (with a wink and a nod) and argued that the marketing pulls back in what the skinny label carves out.  In Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc.,[1] the Federal Circuit decided that those types of allegations could potentially support a claim for inducement of infringement; the Supreme Court has now granted certiorari to decide the question for itself.[2]

The basis for the dispute begins with the language of the Hatch-Waxman Act.  Concerned with the possibility that innovator drug companies could extend patent exclusivity by obtaining a series of patents on different uses of a drug, Congress codified the possibility of a generic drug being approved for less than all of the indications identified in the label of the reference-listed drug.[3]  By carving out the patented uses of the listed drug and leaving only the unpatented uses (whether patent protection was never obtained or had expired for those uses), the generic drug can come to market with a “skinny label.”  Congress intended that result, preventing innovator drug companies from making the label a game of whack-a-mole that would keep generic companies from bringing drugs to market for the treatment of conditions that are subject to no patent protection.

However, generic drug companies’ interaction with the public is not limited to the label alone.  If it were, there would be no question that the generic companies do not actively induce infringement of the patented methods by marketing a skinny labeled drug.  On the other hand, if the generic companies were to market the same drug for the patented treatment method, they would not only be potentially subject to punishment by the FDA (because marketing a drug for a use not on the approved label would generally be considered to be “adulteration”), they would also be actively inducing infringement of the patent.  But the question arises when their conduct and public pronouncements fall somewhere in between: where is the line between fair marketing practices and inducing infringement?

This dispute arises out of Amarin’s Vascepa^® (icosapent ethyl) drug, a omega-3 fatty acid purified from fish oil.  In 2012, Amarin obtained FDA approval for use of Vascepa^® for the treatment of severe hypertriglyceridemia (referred to as “SH” – triglyceride levels of over 500 mg/dL, more than three times the “normal” level), an indication for which it had obtained patent protection.  Four years later, Hikma filed an ANDA seeking approval to market its generic version of the drug based on the original Vascepa® label with a “Paragraph IV”[4] certification that the patents covering the method of treating SH were invalid.  Amarin sued Hikma; while that litigation was pending, Amarin obtained approval and patents on another indication relating to reducing cardiovascular (“CV”) disease risk.

Instead of changing its draft label to include the new CV indication, Hikma left its label essentially the same as the original SH-only label.[5]  It prevailed in the litigation, proving the patents covering the method of treating SH were invalid as obvious, and launched its generic drug with the (now) skinny label limited to the SH indication.  In launching its product, however, Hikma issued press releases that called its drug a “generic equivalent” of Vascepa^®, touted the market size for Vascepa^® – which was predominantly based on the CV indication – and referred on its website to the drug’s use as a treatment for “hypertriglyceridemia,” which was broader than the approved SH indication.  Nowhere in Hikma’s promotional materials, however, did it say that the generic drug was approved for the CV indication.

Amarin sued Hikma again (this time post-launch), arguing that the press releases and website language was intended to, and did, actively induce doctors to prescribe Hikma’s generic drug for the patented treatment within the CV indication.  Hikma moved to dismiss, arguing that Amarin failed to state a claim because nothing Hikma did in obtaining approval and marketing the skinny labeled generic drug would constitute active inducement of infringement.  The U.S. District Court for the District of Delaware agreed, finding that the skinny label was itself not even arguably infringing and that Hikma’s marketing statements were – at best – evidence of intent to get doctors to prescribe the drug in an infringing manner, but uncombined with any instruction to use the drug to treat CV.  As the District Court phrased it, Hikma’s conduct could not be considered anything more than describing the infringing use and “does not rise to the level of encouraging, recommending, or promoting taking Hikma’s generic for the reduction of CV risk.”  Accordingly, the District Court granted Hikma’s motion to dismiss.

Amarin appealed the dismissal, and the Federal Circuit ultimately decided that Amarin’s allegations could potentially support a finding of active inducement to infringe and reversed.  The Federal Circuit may have been motivated in part by the unusual posture of the case:[6] this was not an ANDA case based solely on the product label, or even a case based primarily on the indication in the product label – there really was no solid grounds for making such an argument.  Instead, it was the public statements by Hikma in combination with (or even perhaps, despite) the product label that gave rise to Amarin’s claim.  Because there was also very little dispute that the allegations of underlying direct infringement by doctors and Hikma’s intent to have doctors infringe were sufficient, the decision turned on the question of whether Hikma’s alleged statements and marketing actions could plausibly be considered “actively” inducing doctors in service of that intent.

The Federal Circuit found that the allegations of Amarin’s complaint provided enough plausibility to support a claim for active inducement of infringement.  First, other portions of the label (which Hikma was not empowered to alter when filing an ANDA) reported data on both SH and CV populations.  Second, Hikma altered the original SH-only label by removing the CV Limitation on Use and adding warnings of potential cardiovascular side effects from the newer label; those warnings would be relevant only if the drug were prescribed for the CV indication.  Even so, the Federal Circuit found those portions of the product label alone would not support a claim for active inducement of infringement – merely not discouraging infringement is not the same as actively inducing it.  Rather, it was only when the product label was viewed in combination with Hikma’s public statements that the package could be read as potentially providing the basis for a claim of active inducement of infringement.  The panel believed it could not resolve the questions of fact underlying the interpretation of the public statements and their relation to the product label on a motion to dismiss.  Thus, while it recognized that Amarin’s claim might fail on a motion for summary judgment, it reversed the District Court’s decision and remanded for further proceedings.

Hikma petitioned for certiorari, noting that some commentators viewed the case as a fundamental shift in the ground between branded drugs and generics versions thereof and a potentially chilling message to generic companies.  It argued that the Federal Circuit’s decision was not only wrong on the application of the pleading standards, but also that its approach conflicted with the Ninth Circuit’s interpretation of the pleading requirements for active inducement of infringement (as applied in the copyright context) and that it completely undermined the Hatch-Waxman Act’s skinny labeling option.  It argued that the decision would severely harm the generic drug market, raising drug prices and creating great uncertainty as to when generic drugs could launch.  Amarin opposed the petition, arguing that the case was tied tightly to very specific facts, that the Federal Circuit correctly applied the pleading standards (and in a manner that did not conflict with any other circuit’s application of the law), and that Hikma’s claims of harm to the market were overblown.  As Amarin put it:

Petitioners act like they were hit with a judgment, but this case is just beginning.  Infringement and any defenses to it are not yet decided, nor are any remedies.  What  petitioners really want is a safe-harbor from having to litigate at all—a sort of qualified immunity for generic pharmaceuticals that has no basis in statute or case law.

In its reply, Hikma pointed out that it was not the only one who foresaw the sky falling due to the decision here; in the certiorari process in an earlier, similar case,[7] the then-Solicitor General had asserted that even “the potential for inducement liability in these circumstances may significantly deter use of the section viii pathway even if such liability is rarely imposed.”  The Supreme Court then solicited the current Solicitor General’s views on the case, and he placed his thumb squarely on the scale against the Federal Circuit and for review (and reversal) by the Supreme Court.  As he argued:

The decision below subverts Congress’s balance between competing interests by subjecting Hikma to a substantial threat of infringement liability for statements that either (a) are integral to the section viii pathway or (b) have no meaningful likelihood of increasing the prevalence of infringing off-label uses.  The contents of Hikma’s “skinny label” are largely dictated by the Hatch-Waxman Amendments, and Hikma’s description of its drug as the “generic equivalent” of Vascepa is central to the Hatch-Waxman scheme.  And while the Federal Circuit identified a handful of other statements to investors that accurately described the generic drug and its brand-name counterpart, the complaint in this case did not describe any plausible sequence of events by which those statements could have led a healthcare professional to engage in direct infringement.

The Supreme Court then granted certiorari review.

Given the facts and posture of the Hikma case, it is likely that the Supreme Court will reverse the Federal Circuit’s decision.  But in doing so, it is unlikely that it will pronounce the lower court decision “merely wrong” – such cases are rarely considered by the Court – but more likely will involve establishment of a clearer boundary between what is fair to include in a skinny label and marketing information and what might give rise to an infringement claim.  That makes this situation especially rare, as it is usually the case that the Federal Circuit creates bright-line tests and the Supreme Court strikes them down in favor of a “totality of the circumstances” approach.  But here, where generic drug companies are tied to the language of the product label and the ubiquitous description of a “generic equivalent” of a reference label drug, it seems more important that the Court remove the chill that could be placed on the generic drug market by a vague pleading standard.  As a result, it is likely to find that a skinny label that does not mention a patented use will be judged to fall within a safe harbor from liability.

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[1] https://patentdocs.org/2024/08/07/amarin-pharma-inc-v-hikma-pharmaceuticals-usa-inc-fed-cir-2024/

[2] https://patentdocs.org/2026/01/16/solicitor-general-proves-persuasive-supreme-court-grants-hikmas-certiorari-petition/

[3] 21 U.S.C. § 355(j)(2)(A)(viii) provides that a generic drug company can submit an Abbreviated Drug Application and “if with respect to the listed drug referred to in clause (i) information was filed under subsection (b) or (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, [the ANDA can include] a statement that the method of use patent does not claim such a use.”

[4] 35 U.S.C. § 355(b)(2)(iv).

[5] One difference proved important to the Federal Circuit: the original Vascepa® label excluded the CV indication in the form of a CV Limitation on Use.  Hikma’s label did not include the CV Limitation on Use.  Hikma’s label also included warnings of potential cardiovascular side effects which were not included in the original Vascepa® label.

[6] The appellate panel itself was a bit unusual, as it included U.S. District Court Judge Alan Albright of the Western District of Texas, sitting by designation.  Judge Albright is one of the most prolific patent judges, and one of the ones most sought by patentees.

[7] Glaxo-SmithKline LLC v. Teva Pharms. USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021).