U.S. Supreme Court Invites Solicitor General to Submit Briefing on "Skinny Labels"
On June 23, 2025, the Supreme Court invited the Solicitor General to submit a brief expressing the views of the United States—dramatically increasing the likelihood that the Court will eventually grant review—in Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., 24-889, which concerns claims of induced infringement for method of treatment patents.
Hikma's abbreviated new drug application ("ANDA") seeks Food and Drug Administration ("FDA") approval for a generic version of Amarin's Vascepa®. Vascepa® is FDA-approved for two indications: (i) severe hypertriglyceridemia ("SH indication") and (ii) cardiovascular risk reduction ("CV indication"). Hikma's ANDA includes a "skinny label" that "carves out" the CV indication. Amarin asserted its patents for the SH indication, but those patents were invalidated at trial, and Hikma's ANDA received FDA approval.
After Hikma launched, and despite the "skinny label," Amarin sued again, alleging induced infringement under 35 U.S.C. § 271(b) of Amarin's CV indication patents. The Delaware District Court dismissed Amarin's complaint for failure to state a claim. On June 25, 2024, the Federal Circuit reversed, concluding that Amarin's allegations in its complaint concerning the label, coupled with Hikma's public statements and marketing materials, "at least plausibly state[d] a claim for induced infringement." On October 17, 2024, the Federal Circuit denied Hikma's en banc rehearing petition.
Hikma petitioned for certiorari on February 14, 2025, urging that the Federal Circuit's decision creates "a very permissive pleading standard for induced infringement" that conflicts with Section 271(b)'s requirement for "active" inducement, and with the Twombly pleading standard. Hikma also said the decision conflicts with Ninth Circuit decisions, and "effectively nullifies labeling carve-outs under section viii," leading to delayed generic entry and increased drug prices because "no skinny label is safe," and brands will "always find ways to allege induced infringement."
Amarin denies that the Federal Circuit applied the wrong standard and that a split exists on "whether inducement is a question of law or fact." Its opposition also disagreed with Hikma (and Hikma's supporting amici) that the decision nullified section viii carve-outs because "this is not a skinny-label case." Amarin instead called this the "rare case" where the "pleaded facts [] together make inducement plausible," which "cannot be resolved until discovery."
On June 23, 2025, the Supreme Court invited the Solicitor General to file a brief expressing the United States' views regarding Hikma's petition. This invitation demonstrates the Court's interest in the case; statistics show such invitations dramatically increase the likelihood the Court will grant review.
