Yesterday, the U.S. Supreme Court issued its decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, unanimously reversing the Federal Circuit and holding that Amarin failed to state a claim “more than a sheer possibility” for active inducement of patent infringement under 35 U.S.C. § 271(b) to
Lena Hughes
Lena Hughes is a partner in the Litigation Department and a member of the Appellate group.
Lena is an experienced litigator with extensive experience handling complex commercial disputes and appeals in federal and state courts across the country. She has presented oral arguments before federal courts of appeals and state appellate courts and has drafted numerous appellate briefs, including in U.S. Supreme Court cases. Lena has particular experience in the Second Circuit, where she clerked on both the appellate and district courts.
Lena recently served as Associate Counsel in the White House Counsel’s Office where she provided legal guidance to White House policy councils on key Administration policies. She previously served as a Bristow Fellow in the Office of the U.S. Solicitor General at the Department of Justice, where she participated in litigation in the U.S. Supreme Court, advised on government appeals, and successfully argued a case before the D.C. Circuit. Before joining Proskauer, Lena clerked for the Hon. Justice Kagan on the U.S. Supreme Court, the Hon. Gerard Lynch on the Court of Appeals for the Second Circuit, and the Hon. Denise Cote on the U.S. District Court for the Southern District of New York.
Lena earned her J.D. from Columbia Law School, where she received the Ruth Bader Ginsburg Prize for academic excellence and the Wilfred Feinberg Prize for her work in federal courts. She received her Bachelor of Arts from the University of Chicago.
Supreme Court Hears Oral Argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.: Induced Infringement and “Skinny Labels” at a Crossroads
Yesterday, the U.S. Supreme Court heard oral argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, a case that could reshape the landscape of pharmaceutical patent enforcement and generic drug competition. The case concerns the scope of induced infringement liability under 35 U.S.C. § 271(b) in the context of “skinny labels” — the mechanism by which generic drug manufacturers may carve out patented indications from their FDA-approved labeling and enter the market for unpatented uses under Section viii of the Hatch-Waxman Act. A decision is expected by the end of the Supreme Court’s current term in June 2026. As we discussed in our earlier blog post on The Patent Playbook, this case squarely implicates the enforceability of method-of-use patents for later-developed drug indications, and the viability of the Section viii pathway for generic drug manufacturers.