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ARTICLE · 02 JANUARY 2025

Noteworthy Hatch-Waxman Decisions From 2024

Taft, Stettinius & Hollister LLP
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Over the past twelve months, the Federal Circuit has issued a number of noteworthy decisions that will impact litigation strategy and business planning.

United StatesIntellectual Property
Luke T. Shannon
Luke T. Shannon
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Originally published on 12/20/2024, updated on 12/23/2024 to reflect updates pertaining to Teva v. Amneal.

Over the past twelve months, the Federal Circuit has issued a number of noteworthy decisions that will impact litigation strategy and business planning. Several of those cases pertain particularly to cases brought under the Hatch-Waxman Act. Here, Taft provides a brief overview of a few key Hatch-Waxman decisions from 2024.

Salix v. Norwich: Polymorph Patent Claims Are Susceptible to Obviousness Challenges

About the case

In April, the Federal Circuit breathed new life into the use of obviousness challenges to claims drawn to a drug compound's solid state form.

At issue in Salix Pharmaceuticals Ltd. v. Norwich Pharmaceuticals Inc., 98 F.4th 1056 (Fed. Cir. 2024), was Norwich's proposed generic version of rifaximin, which is the active ingredient in Salix's commercial product Xifaxan®, used to treat hepatic encephalopathy (HE) and irritable

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