The pharmaceutical industry has been watching Hikma Pharmaceutical USA Inc. v. Amarin Pharma, Inc. (No. 24-889) closely for its potentially sweeping implications for generic drug competition, as discussed in our prior posts – Supreme Court to Address ‘Skinny Label’ Patent Disputes and Supreme Court Hears Skinny Label Arguments in Hikma v. Amarin, Signaling Impact
The Supreme Court heard oral argument on April 29, 2026, in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889), the closely watched skinny-label case for which the Court granted certiorari earlier this year. As discussed in our prior post, Supreme Court to Address ‘Skinny Label’ Patent Dispute,the case has significant implications
Introduction
On January 16, 2026, the U.S. Supreme Court agreed to hear Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., a patent dispute that could reshape the landscape of generic drug competition and patent enforcement.
This case centers on a contentious question: If a generic drug is labeled only for non-infringing uses (a so-called
On January 4, 2022, the District Court for the District of Delaware granted Hikma Pharmaceuticals USA Inc.’s (“Hikma”) motion to dismiss Amarin Pharma Inc.’s (“Amarin”) infringement claims, finding that Hikma’s “skinny label” for its generic heart drug, icosapent ethyl, did not induce infringement of Amarin’s three patents. This decision comes on the heels of the
On February 23, 2021, a Federal Circuit panel of Chief Judge Prost, Judge Newman, and Judge Moore reheard oral argument in GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. As discussed in our previous post, on February 9, 2021, the panel issued an order granting Teva’s petition for rehearing, vacating the prior October 2,
A panel of the Federal Circuit agreed on February 9, 2021, to rehear arguments in a case between GlaxoSmithKline LLC (“GSK”) and Teva Pharmaceuticals USA, Inc (“Teva”) regarding Teva’s generic to GSK’s carvedilol product, Coreg®. As discussed below and in our previous post, the three-judge panel previously held in a 2-1 decision in October
The Federal Circuit recently held[1] in a 2-1 decision that there was substantial evidence supporting a jury finding that Teva was liable for induced infringement for an indication carved out of its skinny label for its generic version of carvedilol.
The case concerned GSK’s United States Patent No. 4,503,067 (“the ’067 patent”) and Reissue