by Dennis Crouch
The Supreme Court has granted certiorari in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, likely the only patent case this term. In doing so, it takes up the question of whether a generic drug manufacturer can face induced infringement liability when it markets a product using a "skinny label" that fully carves out patented uses.
The case presents the Court's first opportunity to directly address the intersection of patent inducement doctrine and the Hatch-Waxman Act's section viii carve-out provisions, which allow generics to obtain FDA approval for non-patented indications while omitting still-patented methods of use from their labeling. Hikma's generic version of Amarin's Vascepa (icosapent ethyl) received FDA approval only for severe hypertriglyceridemia, with the more valuable cardiovascular risk reduction indication carved out pursuant to section viii.
The Federal Circuit nonetheless permitted Amarin's inducement claims to proceed, finding that Hikma's marketing statements and press releases, combined with its label, plausibly alleged that Hikma encouraged doctors to prescribe the generic for the patented cardiovascular use.
The grant follows the Solicitor General's December 2025 brief recommending review, which argued that the Federal Circuit's approach threatens to undermine Congress's purpose in creating the skinny-label pathway.
In my view, the generic Hikma is likely to win before the Supreme Court. But, the court is unlikely to create an express skinny-label exception. Rather, I believe the court will decide the case based upon traditional inducement liability doctrine. That means that the resolution will shape not only pharmaceutical competition but potentially the scope of inducement liability across all patent-intensive industries.