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Generic Drugs Internal Revenue Service Abbreviated New Drug Application (ANDA)

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

Troutman Pepper Locke

Tax Court Finds Legal Fees Incurred in Defending Hatch-Waxman Lawsuits are ‎Deductible Expenses

Troutman Pepper Locke on

On April 27, 2021, the U.S. Tax Court issued its decision in Mylan, Inc. v. Comm’r of Internal Revenue regarding which legal fees that a generic-drug manufacturer incurs in connection with its Abbreviated New Drug Application...more

Husch Blackwell LLP

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

Husch Blackwell LLP on

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

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