Declaratory Action Requires Affirmative Act Beyond Mere Notice of the Patent and Institution of Litigation Against Others In Field

Teva is a generic drug manufacturer and filed an Abbreviated New Drug Application (“ANDA”) pursuant to the provisions of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act in order to manufacture a generic version of the drug sertraline hydrochloride, which is sold by Pfizer under the name Zoloft®.  Since Pfizer holds patents for sertraline hydrochloride, Pfizer listed these patents in the Orange Book in compliance with the Hatch-Waxman Act, 21 U.S.C. §355.  In filing the ANDA, Teva acknowledged the existence of the patents, but asserted in the ANDA that Teva did not infringe these patents and/or that they were not valid.  After filing the ANDA, Teva initiated a Declaratory Judgment based upon Pfizer’s previously having sued another company for the manufacture of sertraline hydrochloride and due to Teva’s having filed the ANDA.  The Federal Circuit held that, in order to show a reasonable apprehension of being sued, the Declaratory Judgment Act, 28 U.S.C. §2201(a) requires a showing of actual controversy between the parties. The mere fact that Pfizer complied with 21 U.S.C. §355 did not, in and of itself, present an actual controversy since this provision does not require that the patent owner enforce the listed patent.  As such, without an affirmative act by Pfizer against Teva, Teva does not have standing to bring a declaratory judgment.  Teva Pharmaceuticals USA v. Pfizer, Inc., Civ. Case No. 04-1186 (Fed. Cir. January 21, 2005) petition for reh’g en banc denied Civ Case. No. 04-1186o (Fed. Cir. April 4, 2005).


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