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Internal Revenue Service Pharmaceutical Industry

The United States Internal Revenue Service is a bureau of the United States Department of the Treasury. The IRS is charged with collecting revenue and enforcing the Internal Revenue Code.  
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

Goodwin

Federal Circuit Confirms Deductibility of Hatch-Waxman Litigation Expenses

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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

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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

Keating Muething & Klekamp PLL

Benefits Monthly Minute - February 2024

The February Monthly Minute discusses a class action suit alleging a breach of fiduciary duties in connection with ERISA benefit plan prescription drug pricing and the latest IRS guidance on defined contribution plan...more

ArentFox Schiff

There’s One for You, Nineteen for Me: IRS Issues Guidance on 1900% Pharmaceutical Excise Tax

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The Internal Revenue Service (IRS) has issued guidance on the pharmaceutical excise tax that may apply to certain drug manufacturers, producers, and importers that fail to negotiate a drug-pricing agreement with the US...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

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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

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

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

Husch Blackwell LLP

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

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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

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 16

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In Washington: The White House may split a $3 trillion economic recovery proposal into two bills, The New York Times reported Monday. The proposal comes as the economy struggles through the coronavirus pandemic-caused...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 13

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In Washington: The Internal Revenue Service (IRS) is planning to extend the tax-filing deadline to mid-May, according to two top House Democrats. A news release Wednesday from House Ways and Means Committee Chairman Richard...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 12

Hogan Lovells on

In Washington: President Biden on Tuesday began what is expected to be a weeks-long sales pitch to tout the new coronavirus relief package. Biden visited Smith Flooring in Chester, Pennsylvania, a small business that received...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 8

Hogan Lovells on

In Washington: The House voted 232-197 to impeach President Trump for a second time on a charge of inciting insurrection over the Jan. 6 siege on the U.S. Capitol that left five people, including a Capitol Police officer,...more

Robins Kaplan LLP

Financial Daily Dose 8.21.2020 | Top Story: Court Stays CA Gig-Worker Law; Uber and Lyft to Keep Operating in State During Appeal

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A state appeals court in California has preempted Uber and Lyft’s threatened state-wide shutdown over a new state law ordering them to reclassify their drivers as employees by “allowing them to continue operating [under their...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

HHS Proposed Guidance Would Clarify Rules for Drug Manufacturer Coupons

The Department of Health and Human Services (HHS) revisited the treatment of prescription drug manufacturer coupons in a proposed rule, published on February 6, 2020, that could be welcome news for employers that have been...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

Clark Hill PLC

Window On Washington - Vol. 4, Issue 3

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Outlook for This Week in the Nation’s Capital - Congress. The House is in recess this week and the Senate will begin the impeachment trial later this afternoon. ...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

Snell & Wilmer

Must Drug Manufacturer Coupons Count Toward Annual Maximum Out-Of-Pocket Limits? Stay Tuned …

Snell & Wilmer on

What is the Annual Maximum Out-Of-Pocket Limit (“MOOP”)? MOOP is the most a participant must pay for covered services under a group health plan in a plan year. After a participant spends this amount on deductibles,...more

McGuireWoods Consulting

Washington Healthcare Update - September 2019 #1

This week in Washington: Senate to markup the Labor, Health and Human Services, Education and Related Agencies Appropriations Act; House to hold hearings on improving maternal health and the Administration's apparent...more

Robins Kaplan LLP

Financial Daily Dose 7.29.2019 | Top Story: Pfizer and Mylan Join Forces to Create Generics Powerhouse

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Drug giants Pfizer and Mylan have inked a deal that will merge the former’s off-patent drugs with the latter’s generics business, a tie-up that creates a mammoth global seller of lower-priced medicines....more

Clark Hill PLC

Window On Washington - Vol. 3, Issue 24

Clark Hill PLC on

Outlook for This Week in the Nation's Capital - Congress. House Majority Leader Steny Hoyer announced last week that the full House of Representatives will vote this week on whether to hold Attorney General William Barr...more

McDermott Will & Schulte

Corporate Law & Governance Update - March 2019

NEW AG ACTION FOCUSES ON CHARITABLE PURPOSES - New legal action by the Pennsylvania Attorney General against a prominent nonprofit health system is grounded in allegations of violation of charitable purposes. The...more

Clark Hill PLC

Window On Washington - Vol. 2, Issue 32

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Outlook for This Week in the Nation's Capital - Appropriations. The Senate is expected to begin work this week on its next minibus appropriations bill- a package that would contain the Defense and Labor-HHS spending bills....more

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