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ARTICLE · 20 JUNE 2023

Prosecution Statements Rear Their Ugly Head

Finnegan, Henderson, Farabow, Garrett & Dunner LLP
Finnegan, Henderson, Farabow, Garrett & Dunner LLP
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In Azurity Pharms., Inc. v. Alkem Labs. Ltd., 2023 U.S. Dist. LEXIS 77839 (D. Del. May 4, 2023), the district court held that Azurity failed to show that Alkem's ANDA infringed the asserted claims.

United StatesIntellectual Property

Holding

In Azurity Pharms., Inc. v. Alkem Labs. Ltd., 2023 U.S. Dist. LEXIS 77839 (D. Del. May 4, 2023), the district court held that Azurity failed to show that Alkem's ANDA infringed the asserted claims.

Background

Plaintiff Azurity sued Alkem under the Hatch-Waxman Act for infringement of U.S. Patent No. 10,959,948 ("the '948 patent"). The '948 patent claims a composition and method of treatment for vancomycin oral liquid. Representative Claim 5 reads:

A non-sterile stable liquid formulation formulated for oral administration, consisting of:

(a) a buffering agent, wherein the buffering agent is selected from the group consisting of citric acid, sodium citrate, [and many other chemicals],

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