Start the Clock: NJ Court Holds Declaratory Judgment Available to Later ANDA Filers
Yesterday, the United States District Court for the District of New Jersey held that patents listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”), but not asserted under the Hatch-Waxman framework, are subject to declaratory judgment actions by later ANDA filers seeking to trigger the first ANDA filer’s exclusivity period.