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Hatch-Waxman Internal Revenue Service Generic Drugs

Axinn, Veltrop & Harkrider LLP

Federal Circuit Holds Generic’s Hatch-Waxman Litigation Expenses Deductible

A March 21 Federal Circuit decision in Actavis Laboratories FL, Inc. v. United States, No. 23-1320 (Fed. Cir. Mar. 21, 2025) marked a victory for generic drug developers, affirming that legal expenses incurred defending...more

Eversheds Sutherland (US) LLP

Tax Bytes: Week of March 24, 2025

Tax developments - Actavis and deductible expenses - On March 21, 2025, the Court of Appeals for the Federal Circuit released a decision in Actavis Laboratories FL, Inc. v. United States, holding that taxpayers could...more

Goodwin

Federal Circuit Confirms Deductibility of Hatch-Waxman Litigation Expenses

Goodwin on

On March 21, the Court of Appeals for the Federal Circuit held in a precedential opinion that legal fees incurred by generic drug companies in defending against patent infringement suits brought under the Hatch-Waxman Act...more

Fenwick & West LLP

A Recent Tax Ruling Has Made ANDA Litigation Less Burdensome for Generics

Fenwick & West LLP on

In Actavis v. U.S., a case at the intersection of tax law and patent law, the Federal Circuit held that generic drug companies’ Hatch-Waxman litigation expenses are “ordinary and necessary business expenses” and can be...more

Troutman Pepper Locke

Tax Court Finds Legal Fees Incurred in Defending Hatch-Waxman Lawsuits are ‎Deductible Expenses

Troutman Pepper Locke on

On April 27, 2021, the U.S. Tax Court issued its decision in Mylan, Inc. v. Comm’r of Internal Revenue regarding which legal fees that a generic-drug manufacturer incurs in connection with its Abbreviated New Drug Application...more

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