Endo Announces Agreement to Resolve Federal Trade Commission Investigation and Litigation

Endo International and the U.S. Federal Trade Commission (FTC) filed a joint motion in the U.S. District Court for the Northern District of California seeking the entry of a ten-year Stipulated Order for Permanent Injunction.  The Stipulated Order resolves all disputes between the FTC and Endo relating to the patent infringement settlements Endo entered into in connection with its Opana® ER and Lidoderm® products.  It also resolves the FTC's claims against Endo's subsidiary Par Pharmaceutical Companies, Inc. in the action FTC v. Actavis, Inc., et al. pending in the U.S. District Court for the Northern District of Georgia.

The FTC first asserted claims against Endo and certain generics manufacturers relating to the Opana® ER and Lidoderm® patent settlements in March 2016.  The FTC's complaint, filed in the U.S. District Court for the Eastern District of Pennsylvania, alleged that certain aspects of the Opana® ER and Lidoderm® settlements constituted unfair methods of competition in violation of federal law and sought injunctive and declaratory relief, as well as other remedies including restitution and disgorgement.  The FTC voluntarily dismissed its lawsuit in October 2016 but stated its intention to refile elsewhere.  Endo subsequently filed declaratory judgment actions against the FTC in the U.S. District Court for the Eastern District of Pennsylvania seeking rulings on, among other things, whether the FTC has the statutory authority to initiate litigation against Endo in federal court with respect to the settlements and whether the FTC is able to seek disgorgement.  The FTC today re-filed claims against Endo and other defendants in the U.S. District Court for the Northern District of California and also filed the Stipulated Order dismissing the claims against Endo.   

Under the Stipulated Order, Endo will make no monetary payment to the FTC and will dismiss its claims in the declaratory judgment actions.  The FTC has agreed that the prior dismissal of its claims against Endo in the U.S. District Court for the Eastern District of Pennsylvania will be treated as being with prejudice, that it will bring no other claims against Endo arising from the Opana® ER and Lidoderm® settlements and that it will also dismiss with prejudice its claims against Par in FTC v. Actavis, Inc., et al.

Endo made no admission of liability in the Stipulated Order and agreed to certain covenants relating to the future settlement of patent infringement litigation for a period of 10 years.  These covenants, which are consistent with Endo's current practices in settling patent infringement cases, include a prohibition on agreements that prevent the marketing of authorized generic products or that involve payments to generics manufacturers in connection with delaying the market entry of their products.  The Stipulated Order also requires the FTC to consider in good faith any requested modifications proposed by Endo in the event of a material change in the law governing the antitrust implications of patent infringement settlements.

"Endo is extremely pleased with the FTC settlement.  We believe the absence from the Stipulated Order of any requirement that Endo make payment to the FTC, as well as the absence of any admissions of liability by Endo, are consistent with the Company's position that the Lidoderm® and Opana® ER settlements fully complied with the law both at the time they were executed and today," said Matthew J. Maletta, Executive Vice President, Chief Legal Officer, Endo. "We further believe that the covenants in the Stipulated Order relating to future patent infringement settlements align with how Endo currently approaches such settlements and with general pharmaceutical industry practices following the U.S. Supreme Court's 2013 decision in FTC v. Actavis."