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Food and Drug Administration (FDA) › Tax Deductions › Pharmaceutical Industry

Axinn, Veltrop & Harkrider LLP

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

Axinn, Veltrop & Harkrider LLP on

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

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

Eversheds Sutherland (US) LLP

Third Circuit holds patent infringement fees do not facilitate ANDA approval

Eversheds Sutherland (US) LLP on

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

Freeman Law

The Tax Court Addresses the Origin-of-the-Claim Doctrine and Legal Fees

Freeman Law on

A recent Tax Court decision addressed the deductibility of legal expenses and the so-called “origin-of-the-claim” doctrine.  The Mylan decision demonstrates that the deductibility of a legal expense generally depends on the...more

Skadden, Arps, Slate, Meagher & Flom LLP

CARES Act Provides Much-Needed Stimulus for U.S. Businesses, Individuals

Skadden, Arps, Slate, Meagher & Flom LLP on

On March 27, 2020, Congress approved the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to provide financial assistance to individuals and businesses, which in aggregate greatly exceeds the financial package...more

BakerHostetler

Capitol Hill Healthcare Update

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Highlights this week: Nearly 7,000 FDA employees are furloughed amid the ongoing government shutdown; lawmakers introduce a slew of anti-pharma bills; 18 new Democrats land plum spots on key healthcare committees; and more....more

McGuireWoods LLP

IRS Informally Rules Disgorgement Payments Under FDA Consent Decree May Be Deductible

McGuireWoods LLP on

In Internal Revenue Service Field Attorney Advice released May 22, 2015 (FAA 20152103F), the IRS Office of Chief Counsel expressed its informal view that the evidence suggests that the amount the taxpayer paid the United...more

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