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Induced Infringement Appeals Food and Drug Administration (FDA)

Jones Day

U.S. Supreme Court Invites Solicitor General to Submit Briefing on "Skinny Labels"

Jones Day on

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...more

Robins Kaplan LLP

Janssen Pharms., Inc. v. Mylan Labs. Ltd.

Robins Kaplan LLP on

Invega Trinza® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 2023-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) (Circuit Judges Dyk, Prost, and District Judge Goldberg presiding;...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Reverses Motion to Dismiss—Generic Manufacturer’s Label Combined with its Expansive Public Statements Plausibly...

The Federal Circuit reversed a decision from the District of Delaware dismissing a case for failing to plead induced infringement because the totality of the evidence raised fact questions that could not be resolved on a...more

A&O Shearman

SCOTUS denies cert in skinny label appeal from the Federal Circuit

A&O Shearman on

On May 15, 2023, the Supreme Court of the United States denied Teva Pharmaceuticals USA, Inc.’s (“Teva”) petition for certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, LLC, ending a nearly nine-year court...more

McDermott Will & Schulte

Federal Circuit Divided on Whether Skinny Labeling Compliance Precludes Inducement or Supports Equitable Estoppel

The US Court of Appeals for the Federal Circuit denied a generic drug manufacturer’s petition for en banc review of a panel opinion finding induced infringement liability despite the manufacturer’s adherence to skinny...more

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