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Prescription Drugs › Hatch-Waxman › Appeals

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Hatch-Waxman Requires Patent Term Extension for Reissued Patents To Be Based on Original Patent

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...more

McDermott Will & Schulte

Hatch-Waxman Litigation Expenses Are Deductible Under Internal Revenue Code § 162(a)

McDermott Will & Schulte on

The US Court of Appeals for the Federal Circuit upheld a US Court of Federal Claims ruling that Hatch-Waxman Act litigation expenses are ordinary and necessary business expenses under § 162(a) of the Internal Revenue Code,...more

McDermott Will & Schulte

The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

McDermott Will & Schulte on

Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a...more

A&O Shearman

Federal Circuit affirms district court finding of no induced or contributory infringement of generic depression drug

A&O Shearman on

In H. Lundbeck A-S v. Lupin Ltd., Case No. 2022-1194 (Fed. Circ. December 7, 2023), Plaintiffs, H. Lundbeck A/S (“Lundbeck”) and Takeda Pharmaceutical Company Ltd., Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals...more

WilmerHale

Unprecedented State Law on Pharmaceutical “Reverse Payments” Goes Into Effect

WilmerHale on

A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more

Robins Kaplan LLP

INO Therapeutics LLC v. Praxair Distribution Inc.

Robins Kaplan LLP on

BUT FOR A CLERICAL ERROR TO BE ADDRESSED ON REMAND, THE FEDERAL CIRCUIT AFFIRMS FINDINGS OF INELIGIBLE SUBJECT MATTER AND NON-INFRINGEMENT. Case Name: INO Therapeutics LLC v. Praxair Distribution Inc., 2019 U.S. App. LEXIS...more

Robins Kaplan LLP

Merck Sharp & Dohme Corp. v. Hospira, Inc.

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Case Name: Merck Sharp & Dohme Corp. v. Hospira, Inc. 874 F.3d 724, No. 17-1115, 2017 U.S. App. LEXIS 21201 (Fed. Cir. Oct. 26, 2017) (Circuit Judges Newman, Lourie, and Hughes presiding; Opinion by Lourie, J.; Dissent by...more

Troutman Pepper Locke

Third Circuit Focuses on Relevant Product Market and Lack of Anticompetitive Conduct in Doryx Product-Hopping Case

Troutman Pepper Locke on

To prevail in a product-hopping case, a plaintiff must be prepared to establish both monopoly power and anticompetitive effects. On September 28, a unanimous panel of the U.S. Court of Appeals for the Third Circuit...more

McDermott Will & Emery

Contract Manufacturing Is a Commercial Transaction for Purpose of “On-Sale” Bar - The Medicines Company v. Hospira, Inc.

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Addressing the application of the on-sale bar under § 102(b), the U.S. Court of Appeals for the Federal Circuit found that the claims of an asserted patent were invalid based on an agreement, dated more than one year prior to...more

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