Manufacturers, Food and Drug Administration (FDA), IRS

Mintz IRA Update — Basics of the Medicare Drug Price Negotiation Program

Mintz - Health Care Viewpoints on 9/21/2023

The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more

Third Circuit Rejects IRS Assertion That Generic Manufacturers Must Capitalize Legal Fees Incurred in Hatch-Waxman Litigation

Dechert LLP on 8/2/2023

Although legal fees spent preparing Paragraph IV notice letters must be capitalized (and thus amortized over 15 years), legal fees spent defending ANDA suits launched in response to those letters may be taken as deductions in...more

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

Husch Blackwell LLP on 4/28/2021

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

Manufacturers › Food and Drug Administration (FDA) › Internal Revenue Service

Mintz IRA Update — Basics of the Medicare Drug Price Negotiation Program

Third Circuit Rejects IRS Assertion That Generic Manufacturers Must Capitalize Legal Fees Incurred in Hatch-Waxman Litigation

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

Washington Healthcare Update

Foley Hoag and AdvaMed Collaborate on Industry Guidance on Retail Exemption in Final Device Tax Regulations

IRS Releases Final Rule on Medical Device Tax

Medical Devices To Be Taxed: Manufacturers and Importers Be Prepared

Manufacturers › Food and Drug Administration (FDA) › Internal Revenue Service

Mintz IRA Update — Basics of the Medicare Drug Price Negotiation Program

Third Circuit Rejects IRS Assertion That Generic Manufacturers Must Capitalize Legal Fees Incurred in Hatch-Waxman Litigation

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

Washington Healthcare Update

Foley Hoag and AdvaMed Collaborate on Industry Guidance on Retail Exemption in Final Device Tax Regulations

IRS Releases Final Rule on Medical Device Tax

Medical Devices To Be Taxed: Manufacturers and Importers Be Prepared

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