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Hatch-Waxman Food and Drug Administration (FDA) Tax Deductions

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

Axinn, Veltrop & Harkrider LLP

Cost of Hatch-Waxman Litigation Decreases (via tax deduction)

As Benjamin Franklin famously remarked, “nothing is certain except death and taxes.” Recently, the U.S. Court of Appeals for the Third Circuit provided more certainty about the latter by holding that legal expenses incurred...more

Eversheds Sutherland (US) LLP

Third Circuit holds patent infringement fees do not facilitate ANDA approval

In an opinion released July 27, 2023, the Third Circuit affirmed a 2021 Tax Court decision upholding a pharmaceutical company’s immediate deduction of patent defense litigation costs in suits brought under the Hatch-Waxman...more

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