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Internal Revenue Code (IRC) Pharmaceutical Industry

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

Haug Partners LLP

Defend & Deduct: How the Federal Circuit's Actavis Decision Changes Tax Implications for ANDA Filers

Haug Partners LLP on

In Actavis Labs. FL, Inc. v. U.S.  (“Actavis”), a recent precedential decision, the Federal Circuit answered an important practical question regarding the interplay between the Hatch-Waxman Act and the Internal Revenue Code:...more

McDermott Will & Emery

Hatch-Waxman Litigation Expenses Are Deductible Under Internal Revenue Code § 162(a)

The US Court of Appeals for the Federal Circuit upheld a US Court of Federal Claims ruling that Hatch-Waxman Act litigation expenses are ordinary and necessary business expenses under § 162(a) of the Internal Revenue Code,...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

Morgan Lewis - As Prescribed

Venture Philanthropy More Important Than Ever for Rare Disease Care

Private foundations providing support, resources, and advocacy for individuals and families affected by rare diseases have played an important role for more than 30 years in the advancement of treatments for rare diseases....more

Vicente LLP

US Officially Recognizes Medical Use and Safety of Cannabis: The Top 6 Things to Know About Schedule III and the Process Ahead

Vicente LLP on

On August 30, 2023, the federal government formally acknowledged the medical use and low potential of abuse for cannabis, with the US Department of Health and Human Services (HHS) recommending that cannabis be rescheduled to...more

McDermott Will & Emery

Welcome (But Last Minute) Relief for Prescription Drug Reporting Originally Due December 27

McDermott Will & Emery on

Section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 amended the Internal Revenue Code, the Employee Retirement Income Security Act of 1974 and the Public Health Service Act to add rules...more

Tarter Krinsky & Drogin LLP

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

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

Fenwick & West LLP

Fenwick’s Top 10: Our Most Popular Articles of 2019

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In 2019, we published analysis to help tech and life sciences companies navigate U.S. tax law changes, an evolving IP landscape and new privacy regulations such as the California Consumer Privacy Act. We also tracked venture...more

Epstein Becker & Green

Is the Affordable Care Act a House of Cards? If Yes, What Does the Recent Texas Court Decision Mean for the US Health Insurance...

Epstein Becker & Green on

In an unexpectedly broad ruling issued December 14, 2018, the U.S. District Court for the Northern District of Texas declared the Affordable Care Act (“ACA”) as unconstitutional in its entirety. This decision, if ultimately...more

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