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Food and Drug Administration (FDA) Tax Deductions

Harris Beach Murtha PLLC

Trump May Ease Federal Restrictions by Rescheduling Marijuana

President Trump has indicated he may ease federal restrictions on marijuana, specifically by rescheduling cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). This would be the first move his...more

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

King & Spalding

DEA's Proposed Rule to Reschedule Marijuana Could Reduce Obstacles to Medical Research but Public Input Is Needed to Fill in...

King & Spalding on

On May 16, 2024, the U.S. Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to reclassify marijuana from Schedule I to Schedule III under the federal Controlled Substances Act (“CSA”) and...more

Mintz

Rescheduling Madness: Key Takeaways from the Proposed Rule to Reschedule Marijuana under the CSA

Mintz on

Moving marijuana under the Controlled Substances Act (“CSA”) from Schedule I to Schedule III will bring celebrated changes to the beleaguered state-sanctioned cannabis industries currently operating in 37 states, but will...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

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

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

BakerHostetler on

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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