The U.S. Court of Appeals for the Federal Circuit has upheld a District of Delaware ruling affirming that Alkem's generic drinkable antibiotic did not infringe on Azurity Pharmaceuticals' patents. The court determined that Azurity had distinctly disclaimed the inclusion of propylene glycol in the flavoring agents of its claimed patents during the patent prosecution process. Thus, despite earlier negative claim amendments and stipulations, the absence of propylene glycol in Alkem's product meant it could not infringe the patent. This case underscores critical aspects of patent prosecution and public notice.
Judging these circumstances through the lens of public notice, Azurity's unilateral and belated statement carries no weight.
The Federal Circuit found that the plaintiff clearly and unmistakably disclaimed the presence of propylene glycol from flavoring agents claimed in Azurity's patents.
In his ruling, U.S. District Judge Mitchell Goldberg determined that Alkem's generic product could not infringe the '948 patent as Azurity disclaimed propylene glycol.
Azurity asserted multiple claims of U.S. Patent No. 10959948, directed to non-sterile drinkable liquid drugs containing vancomycin for pediatric and geriatric patients.
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