The Tinderbox Ignites: Supreme Court to Decide Whether Generic Equivalence Statements Constitute Inducement

"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."

The Supreme Court granted certiorari in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. to determine whether a generic manufacturer can face induced infringement liability when using a skinny label that carves out patented uses. Hikma's generic Vascepa received FDA approval only for severe hypertriglyceridemia, excluding the cardiovascular risk reduction indication. The Federal Circuit allowed Amarin's inducement claims to proceed based on Hikma's marketing statements and label. The Solicitor General recommended review, warning that the Federal Circuit's approach could undercut Congress's skinny-label framework. The case will be resolved under traditional inducement doctrine and may affect inducement liability across industries.

Read at Patently-O