Endo Pharmaceuticals, Inc. and Grüenthal GmbH v. Teva Pharmaceuticals USA, Inc. and Barr Laboratories, Inc.
December 4, 2014
Case Number: 1:12-cv-08060-TPG-GWG
Teva delayed more than one year between answering a complaint alleging infringement of U.S. Patent No. 8,075,872 (“Heat pressing a mixture of an active ingredient with abuse potential, a high strength polymer, and a wax into a controlled release dosage form”) and seeking leave to add declaratory judgment counterclaims of invalidity and non-infringement. As the court had not yet issued a scheduling order, Judge Griesa applied Rule 15’s standard (“when justice so requires”) rather than Rule 16’s good cause standard.
Judge Griesa found Teva’s delay, stated to be based on a failure to appreciate that the ‘872 patent constituted a barrier to regulatory approval of a generic product, to be inadvertent. Inadvertence, he said, “is not a wrongdoing and not so invalid a reason for delay as to bar amendment.” He observed that Endo was defending the validity of the ‘872 patent in a trial to be held alongside the instant matter, and so prejudice to Endo would be slight.
