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Patent Litigation › Internal Revenue Code (IRC) › FDA Approval

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

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)

McDermott Will & Emery on

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

Skadden, Arps, Slate, Meagher & Flom LLP

The Tax Court Offers a Mixed Bag in the Mylan Case

Skadden, Arps, Slate, Meagher & Flom LLP on

In Mylan, Inc. & Subsidiaries v. Commissioner, 156 T.C. No. 10 (April 27, 2021), the Tax Court held that legal expenses incurred by a manufacturer of generic pharmaceutical drugs for the preparation, assembly and transmittal...more

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