Tag: ANDA
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Janssen v. Teva: Federal Circuit Affirms Validity of Paliperidone Palmitate Dosing Regimen Patent
In a significant ruling for pharmaceutical patent litigation, the Federal Circuit in Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Nos. 25-1228, 25-1252 (Fed. Cir. July 8, 2025), affirmed the district court’s determination that U.S. Patent No. 9,439,906 (“the ’906 patent”)—which claims specific dosing regimens for long-acting injectable formulations of the antipsychotic paliperidone palmitate—is not…
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Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals: Clarifying the Limits of Injunctive Relief Under the Hatch-Waxman Safe Harbor
In the recent Federal Circuit decision Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, the court provided critical guidance on the limits of injunctive relief relating to FDA submissions and clinical trials under the Hatch-Waxman Act. Background and Procedural History Jazz Pharmaceuticals manufactures Xywav®, currently the only FDA-approved drug for treating idiopathic hypersomnia (IH). Avadel…
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Actavis v. United States: When Patent Litigation Meets Tax Law
In a significant March 2025 opinion, the Federal Circuit affirmed the Court of Federal Claims’ decision in Actavis Laboratories FL, Inc. v. United States, addressing a complex intersection of patent litigation, FDA regulatory processes, and the tax code. While the case originated in the context of Hatch-Waxman pharmaceutical litigation, its reasoning may offer guidance for…
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Merck v. Aurobindo: Patent Term Extensions and Reissued Patents
Introduction The Federal Circuit recently issued a significant ruling in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., clarifying how patent term extensions (PTEs) apply to reissued patents under the Hatch-Waxman Act. The court upheld the U.S. Patent and Trademark Office’s (PTO) decision to calculate the PTE for a reissued patent based on…
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Galderma v. Lupin: CAFC Weighs In on ANDA Infringement and the Doctrine of Equivalents
The Federal Circuit recently affirmed a district court ruling in Galderma Laboratories, L.P. v. Lupin Inc., a patent dispute over the rosacea treatment Oracea®. The decision highlights key issues in Hatch-Waxman litigation, including claim construction, infringement analysis, and the doctrine of equivalents. Background: The Patents and ANDA Dispute Galderma Laboratories owns patents for Oracea®, medication…