Animal Drug Patent Owners Had No Notice Of Methodology Change, Federal Judge Says

(August 12, 2024, 10:47 AM EDT) -- WASHINGTON, D.C. — The U.S. Food and Drug Administration violated the Administrative Procedure Act (APA) by changing, without notice, the methodology it uses to calculate regulatory review periods for new animal drug patents that are later used to extend the terms of such patents, a District of Columbia federal judge found in granting a patent owner’s motion for summary judgment....