Why is this case and the Supreme Court’s decision to hear it important?
This is at least the third major case in recent years to address the standard for induced patent infringement in the context of “carve outs” or “skinny labeling” under 21 U.S.C. § 355(j)(2)(A)(viii) (popularly known as “section viii”). The other two cases, Grunenthal GmbH v. Alkem Laby’s Ltd., 919 F.3d 1333 (Fed. Cir. 2019), and GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021) together left some uncertainty in the pharmaceutical industry over whether and how generic drug manufacturers can avoid induced infringement liability by removing patented uses/indications from their drug labels and only pursuing uses/indications where the innovator’s patents have expired or where patents were never granted. From the generic company perspective, skinny labeling is part of the Hatch-Waxman Act bargain, and gets lower-cost medications in the hands of patients faster. From the innovator perspective, however, the realities of modern pharmaceutical marketing make this procedure a back-door way for generics to encourage substitution of their drugs for all uses of a drug, not just non-patented uses, since physicians in the U.S. can legally prescribe drugs for off-label uses and generic manufacturers can communicate with those physicians both publicly and privately.
Many in the field thought the Supreme Court would take on the issue in the GlaxoSmithKline v. Teva case, since in 2022 the Court invited the Solicitor General to file a brief expressing the views of the United States. Only about a dozen cases each term receive this “call for the views of the SG,” or a “CVSG.” The Supreme Court grants certiorari for only around 1% of the petitions it receives, but when the Solicitor General urges the Court to take a case following a CVSG, the Court has historically followed the SG’s advice nearly 80% of the time – making it roughly 40 times more likely that the Court will take the case. Then-Solicitor General Elizabeth Prelogar urged the Court to grant certiorari in GlaxoSmithKline v. Teva in March 2023, but two months later the Court instead denied certiorari. We don’t know the Court’s reasoning for the decision; all we know is that Justice Brett Kavanaugh dissented from the denial decision and would have granted the petition.
So now, two years later, the same issue is back in Hikma v. Amarin, albeit under a slightly different procedural posture. Again, the Supreme Court issued a CVSG, and again, the Solicitor General (this time, newly-appointed Solicitor General D. John Sauer) urged the Court to hear the case in December 2025. This time, the Court heeded the call, granting Hikma’s petition on January 16, 2026. We will finally (hopefully) get some resolution on this long-simmering issue.
What impact could it have on the industry?
It’s impossible to know exactly how many generic manufacturer Abbreviated New Drug Applications (“ANDAs”) contain a section viii carve-out, but it is becoming an increasingly common practice, especially in an era where drugs – especially large-molecule biologics – are becoming ever more complex and approved for ever more indications. As an example, Merck’s KEYTRUDA®—the best-selling drug worldwide in 2025—is approved in the U.S. for nearly 50 different indications.
Off-label prescribing isn’t going away anytime soon. So innovators and generics alike need guidance as to where the guard rails are for inducement of infringement, be it in the generic labels themselves or in public statements and marketing materials that the generic company produces as part of its business. Interestingly, the Hikma case focuses more on the public statements and marketing materials, which will arguably have an even larger impact on how generic manufacturers do business and how they market their products to physicians, insurance companies, and patients. The Federal Circuit held that Hikma’s press releases and website described and promoted its ANDA product as “generic VASCEPA®” without qualification as to which indications it would be approved to treat. Together with sections of the label (which Hikma is required to copy), those statements allowed Amarin to plausibly state a claim for induced infringement. The Federal Circuit – pointing to GSK v. Teva – held that what those statements ultimately mean to prescribing physicians is a question of fact, not law, and can’t be resolved on a Rule 12(b) motion to dismiss. The procedural posture of the Hikma case, which is different from those of Grunenthal and GSK, is really important here, because it will set the threshold for what keeps a Hatch-Waxman litigation involving a section viii carve-out in court. Grunenthal and GSK were based on post-trial motions; Hikma is about the very beginnings of a case, and whether or not the parties will have to bear the costs (and regulatory holdups) of an expensive, multi-year litigation.
What are you hoping will come from this?
Those of us who litigate in this field are looking for a clear statement from the Supreme Court of where the line of plausibility lies in pleading, not just proving, induced infringement. Hikma, and its fellow generic manufacturers, have argued this issue is a matter of life or death for section viii. But as the Federal Circuit panel pointed out in Hikma, the Hatch-Waxman Act strikes a balance that benefits all industry players. That balance is only rightfully available if communications from generic companies regarding their skinny-label products possess the necessary “clarity and consistency” to avoid induced infringement liability. We’ll soon find out (we hope) just how clear and consistent those statements will need to be going forward.
