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Pharmaceutical Industry › Food and Drug Administration (FDA) › Internal Revenue Service

Axinn, Veltrop & Harkrider LLP

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

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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

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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

Tarter Krinsky & Drogin LLP

Hatch-Waxman Litigation Costs Both Capital Expenditures And Ordinary Business Expenses

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Under the Internal Revenue Code (“Code”) Section 162, ordinary and necessary business expenses are deductible, but Code Section 263 disallows a deduction for capital expenditures (“no deduction shall be allowed” for a capital...more

Husch Blackwell LLP

Tax Court Rules In Favor Of Generic Drug Manufacturer On Deductibility Of Patent Litigation Expenses In Connection With ANDAs

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On April 27, 2021, the United States Tax Court held that legal fees incurred by generic drug manufacturers in connection with “Section 271(e)(2)” patent infringement suits are deductible as ordinary business expenses and need...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 12

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In Washington: President Biden on Tuesday began what is expected to be a weeks-long sales pitch to tout the new coronavirus relief package. Biden visited Smith Flooring in Chester, Pennsylvania, a small business that received...more

McGuireWoods Consulting

Washington Healthcare Update - September 2019 #1

McGuireWoods Consulting on

This week in Washington: Senate to markup the Labor, Health and Human Services, Education and Related Agencies Appropriations Act; House to hold hearings on improving maternal health and the Administration's apparent...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

McGuireWoods LLP

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

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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

McDermott Will & Emery

IRS Office of Chief Counsel Treated Collaboration Arrangement as Partnership

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In a newly released Chief Counsel Advice, the Internal Revenue Service (IRS) Office of Chief Counsel treated a collaboration arrangement relating to the development and commercialization of a drug as a deemed partnership for...more

King & Spalding

IRS Releases Final Rule on Medical Device Tax

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Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more

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