Tag: pharmaceuticals
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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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Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.: Express Definitions in Patent Specs Can Limit Claim Scope
In Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., No. 23-2357 (Fed. Cir. June 4, 2025), the Federal Circuit affirmed a claim construction that doomed Alnylam’s infringement case against Moderna’s COVID-19 vaccine. The decision reinforces the primacy of clear definitional language in a patent’s specification—even when it narrows claim scope beyond what a patentee may have intended.…
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Incyte Corp. v. Sun Pharmaceutical Industries: Federal Circuit Reverses Preliminary Injunction for Lack of Irreparable Harm
In a follow-on decision reinforcing its earlier order, the Federal Circuit in Incyte Corp. v. Sun Pharmaceutical Industries, Ltd., reversed a preliminary injunction granted by the U.S. District Court for the District of New Jersey. The district court had enjoined Sun from launching its FDA-approved drug Leqselvi, a deuterated version of ruxolitinib for treating alopecia…
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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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Regeneron v. Amgen: Patent Infringement and Biologic Formulations
On March 14, 2025, the United States Court of Appeals for the Federal Circuit issued a decision in Regeneron Pharmaceuticals, Inc. v. Amgen Inc., affirming the district court’s denial of a preliminary injunction sought by Regeneron. This ruling is significant in the realm of the biologic pharmaceutical industry, as it centers on claim construction and…
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Patent Law and Drug Innovation: Federal Circuit Upholds Rejection of ImmunoGen’s Patent Application
On March 6, 2025, the Federal Circuit issued its opinion in ImmunoGen, Inc. v. Stewart, affirming the district court’s ruling that denied ImmunoGen’s patent application for a dosing regimen of its antibody drug conjugate (ADC), IMGN853. The court’s decision, rooted in key principles of intellectual property law, particularly focused on the doctrines of indefiniteness and…
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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…
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Federal Circuit Vacates District Court’s Surprise Patent Ineligibility Ruling in Astellas v. Sandoz
In a major rebuke to a district court’s handling of patent eligibility, the Federal Circuit has vacated a decision that invalidated Astellas’s pharmaceutical patent under 35 U.S.C. § 101—a ruling the lower court made on its own initiative, without either party raising the issue. The court’s strong reaffirmation of the “party presentation principle” signals a…