Patents, CAFC, Abbreviated New Drug Application (ANDA)

Hard to Stomach: Things You Say to Prosecute a Patent Can and Will Be Used Against You

Knobbe Martens on 4/24/2025

AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD. Before Murphy, Moore, and Chen. Appeal from the United States District Court for the District of Delaware. Arguments and amendments made during prosecution of a parent...more

CAFC Decision on Orange Book Listings for Drug/Device Combination Patents

Wolf, Greenfield & Sacks, P.C. on 12/26/2024

On December 20th, 2024, the Court of Appeals for the Federal Circuit issued an important decision in Teva Branded Pharmaceutical Products R&D v. Amneal Pharmaceuticals that impacts Orange Book (OB) listings for patents...more

Can Enablement and Written Description Bars be Lower for Method-Of-Treatment Patent Claims?

Mintz - Intellectual Property Viewpoints on 8/24/2023

Patent offices may reject a patent application with claims reciting using a composition to treat a disease, based on the requirement that the claimed treatment is not fully supported by the application. In the U.S., such...more

Federal Circuit affirms GSK labeling carve-out ruling in favor of innovator

Hogan Lovells on 8/26/2021

Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more

CAFC Finds ANDA Infringement Despite Differences Between FDA Labeling And Claim Language

Foley & Lardner LLP on 5/30/2017

In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and...more

AIA On-Sale Bar Applies to Publicized Sales, Even When Knowledge of Sale Did Not Disclose the Underlying Invention

Troutman Pepper Locke on 5/30/2017

The Court of Appeals for the Federal Circuit (CAFC) recently construed the on-sale bar provision of 35 U.S.C. 102(a) in a way that will make it easier for petitioners to challenge third party patents. While in an inter-partes...more