News & Analysis as of

Hatch-Waxman Induced Infringement Abbreviated New Drug Application (ANDA)

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

Hogan Lovells

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

Hogan Lovells on

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

Kilpatrick

GSK v. Teva: The Skinny On Induced Infringement And Label Carve-Outs

Kilpatrick on

Statutory Basis For Label Carve-Outs - Section viii of the Hatch-Waxman Act permits an Abbreviated New Drug Application (ANDA) applicant to obtain FDA approval to market a generic version of a drug for a non-patented use...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - October 2019 #2

PATENT CASE OF THE WEEK - HZNP Medicines LLC v. Actavis Laboratories UT, Inc., Appeal Nos. 2017-2149, et al. (Fed. Cir. Oct. 10, 2019) - In a lengthy decision following a bench trial, the Court addressed a matter of...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more

McDermott Will & Emery

ANDA Update - July 2015

McDermott Will & Emery on

Supreme Court Holds Good Faith Belief of Patent Invalidity Is Not a Defense to Induced Infringement - Commil USA, LLC v. Cisco Systems, Inc. (Supr. Ct. May 26, 2015): Pharmaceutical patents commonly include...more

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