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ARTICLE · 06 JULY 2023

Obviousness And Written Description Take Down An Infringed Patent

Finnegan, Henderson, Farabow, Garrett & Dunner LLP
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In Azurity Pharms., Inc. v. Alkem Labs. Ltd., 2023 U.S. Dist. LEXIS 22848 (D. Del. Feb. 10, 2023), the district court held that Alkem's ANDA infringes Azurity's asserted claims, but the claims are invalid...

United StatesIntellectual Property
Adriana Burgy
Adriana Burgy
Stacy Lewis
Stacy Lewis
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Holdings

In Azurity Pharms., Inc. v. Alkem Labs. Ltd., 2023 U.S. Dist. LEXIS 22848 (D. Del. Feb. 10, 2023), the district court held that Alkem's ANDA infringes Azurity's asserted claims, but the claims are invalid due to lack of written description support and obviousness.

Background

Azurity's claims relate to enalpril formulations. The individual claimed ingredients were known prior in the art. Azurity based its patentability on combining those ingredients into a liquid that would be stable for 12 to 24 months. Id. at *2. Representative claim 4 of the '621 patent reads:

A stable oral liquid formulation, consisting essentially of:

(i) about 0.6 to about 1.2 mg/mL enalapril or a pharmaceutically acceptable salt or solvate thereof;

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