Pharmaceutical Patents, CAFC, Food and Drug Administration (FDA)

Reissued patents get Hatch-Waxman PTE based on original patent date, CAFC rules

Hogan Lovells on 4/9/2025

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently considered a novel question regarding calculation of the regulatory review period for patent term extension (PTE) under 35 USC § 156 for reissued patents....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

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

Labeling carve-out does not shield generic drug makers from induced infringement claims, CAFC rules

Hogan Lovells on 10/29/2020

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug sponsor did not preclude a finding of...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

Can FDA Implement The BPCIA As The CAFC Suggested?

Foley & Lardner LLP on 7/22/2016

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more