EPISODE · Apr 14, 2025 · 16 MIN
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., decided April 8, 2025
from CAFC News Brief
Azurity's U.S. Patent No. 10,959,948 relates to a liquid vancomycin formulation. The appeal follows a district court ruling that Alkem's Abbreviated New Drug Application (ANDA) for a generic version did not infringe Azurity's patent. The central issue revolved around whether Azurity disclaimed the inclusion of propylene glycol during the patent's prosecution. The court affirmed the lower court's decision, finding that Azurity did clearly disclaim propylene glycol, and because Alkem's proposed generic product contains it, no infringement occurred.
What this episode covers
Azurity's U.S. Patent No. 10,959,948 relates to a liquid vancomycin formulation. The appeal follows a district court ruling that Alkem's Abbreviated New Drug Application (ANDA) for a generic version did not infringe Azurity's patent. The central issue revolved around whether Azurity disclaimed the inclusion of propylene glycol during the patent's prosecution. The court affirmed the lower court's decision, finding that Azurity did clearly disclaim propylene glycol, and because Alkem's proposed generic product contains it, no infringement occurred.
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Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., decided April 8, 2025
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