Endo agreement to resolve FTE investigation and litigation
![](/46/pdcnewsitem/04/46/30/endo%20pharma.png)
No admission of wrongdoing, No monetary payment by Endo.
Endo International and the US Federal Trade Commission (FTC) have filed a joint motion in the US District Court for the Northern District of California seeking the entry of a 10-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, in the action FTC v. Actavis, Inc., et al., pending in the US 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 US 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 US 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 US 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 US 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 US Supreme Court's 2013 decision in FTC v. Actavis."
Related News
-
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs... -
News Chasing new frontiers at LEAP – The National Biotechnology Strategy Keynote
On the third day of LEAP (4–7 March 2024, Riyadh Exhibition and Convention Centre, Malham, Saudi Arabia) the CPHI Middle East team hosted the Future Pharma Forum, to set the scene for an exciting new event for the pharma community, coming to Riya... -
News Pfizer maps out plans for developing new oncology therapeutics by 2030
Pfizer dilvulges plans to investors around growing their cancer portfolio, and the drugs they will be focusing on developing after their aquisition of Seagen in 2023. -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion. -
News Bernie Sanders vs Big Pharma - the latest on drug price negotiations
In a hearing in front of the US Senate, three of the biggest pharmaceutical companies in America are challenged over exorbitant prescription drug prices, with Sanders claiming their actions are limiting the population's access to affordable healthc...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance