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Internal Revenue Code (IRC) Food and Drug Administration (FDA)

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

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

ArentFox Schiff

Federal Cannabis Regulation - What to Expect in 2025

ArentFox Schiff on

On January 13, the chief administrative law judge of the US Drug Enforcement Administration (DEA), John Mulrooney, postponed the highly anticipated hearing on the rescheduling of cannabis under the Controlled Substances Act...more

Mandelbaum Barrett PC

Reclassifying Cannabis as Schedule III: Unpacking the Impact on Taxation, Medical Research, and Social Justice

Mandelbaum Barrett PC on

On April 30, 2024, the Associated Press reported a significant development in cannabis policy:  the U.S. Drug Enforcement Administration (“DEA”) is recommending reclassifying cannabis from Schedule I to Schedule III. This...more

Greenbaum, Rowe, Smith & Davis LLP

Will Rescheduling Cannabis Open the Industry to Increased Financing, Real Estate and Banking Opportunities?

On May 16, 2024, the U.S. Department of Justice (DOJ) issued its proposed rules to transfer cannabis from Schedule I of the Controlled Substances Act (CSA) to Schedule III of the CSA. The DOJ’s proposal follows the U.S....more

Akin Gump Strauss Hauer & Feld LLP

High Stakes: HHS Shakes Things Up on Marijuana Scheduling and DEA Abides

On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug. The NPRM, which was published in...more

Mintz

Rescheduling Madness: Key Takeaways from the Proposed Rule to Reschedule Marijuana under the CSA

Mintz on

Moving marijuana under the Controlled Substances Act (“CSA”) from Schedule I to Schedule III will bring celebrated changes to the beleaguered state-sanctioned cannabis industries currently operating in 37 states, but will...more

Sheppard Mullin Richter & Hampton LLP

Bridging the Gap: Cannabis Rescheduling to Align Policy with Research

In a much-anticipated move, sources recently reported that the Drug Enforcement Administration (“DEA”) will recommend rescheduling cannabis from a Schedule I substance to a Schedule III substance under the federal Controlled...more

McCarter & English, LLP

DEA’s Plan to Reschedule Cannabis: Implications and Insights

Earlier this week, the Department of Justice proposed reclassifying cannabis from Schedule I to Schedule III under the Controlled Substances Act. The move follows an August 2023 recommendation from the Department of Health...more

Falcon Rappaport & Berkman LLP

Cannabis Rescheduling – A Look Towards the Future of the Industry

The Drug Enforcement Administration (DEA) will call for cannabis to be rescheduled according to a report by the Associated Press. The anticipated rescheduling follows the Department of Health & Human Services’ (HHS) August...more

Tonkon Torp LLP

DEA Reportedly Set to Reschedule Marijuana to Schedule III

Tonkon Torp LLP on

Big news for the cannabis industry: on April 30, 2024, the Drug Enforcement Administration (DEA) announced that it will reschedule marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA). The Biden...more

The Rodman Law Group, LLC

HHS Releases Support for Rescheduling Marijuana

Marijuana is currently classified as a Schedule I drug under the Controlled Substances Act (“CSA”), defined as a substance having “no currently accepted medical use” and “a high potential for abuse.” Other Schedule I...more

Warner Norcross + Judd

HHS Recommends DEA Reschedule Marijuana from Schedule I to Schedule III – Now What?

Warner Norcross + Judd on

A year ago today on October 6, 2022, President Joe Biden asked the U.S. Secretary of Health and Human Services (HHS) and the U.S. Attorney General to initiate an administrative process to review how marijuana is scheduled...more

Neal, Gerber & Eisenberg LLP

Client Alert: HHS Recommends Rescheduling Marijuana to Schedule III: Implications and Uncertainties for the Industry

Marijuana has long been classified as a Schedule I controlled substance under the Controlled Substances Act of 1970 (the “CSA”), which is defined as a substance with no accepted medical use and a high potential for abuse,...more

McGlinchey Stafford

From Schedule I to Schedule III: Potential Shift in Marijuana’s Legal Status

McGlinchey Stafford on

Major news broke on August 30, 2023, as the U.S. Department of Health and Human Services (HHS) announced that it would recommend moving marijuana from Schedule I to Schedule III, as first reported by Riley Griffin for...more

ArentFox Schiff

US Senators Seeking Input on Comprehensive Federal Cannabis Reform Legislation

ArentFox Schiff on

The majority of states in the US have either decriminalized cannabis or enacted laws authorizing its use for medical or non-medical (aka “recreational” or “adult”) use. However, in the absence of federal guidance beyond the...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

Skadden, Arps, Slate, Meagher & Flom LLP

The Tax Court Offers a Mixed Bag in the Mylan Case

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

Foley & Lardner LLP

Reading the Leaves: What's in Store for Cannabis in 2021

Foley & Lardner LLP on

On the heels of a year beset by turmoil and the myriad challenges caused by the global pandemic, the cannabis industry nevertheless entered 2021 poised for significant growth amid a landscape teeming with opportunity. Public...more

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