Ftc suit against endo pharma license#
Here, Endo had a valid patent monopoly-which had been unsuccessfully challenged-and thus had a right to give Impax an exclusive license rather than “competing or licensing other competitors.” 9 “While some patent-related activity can violate antitrust law, the FTC has alleged nothing more than the type of exclusive licensing agreement and patent monopoly expressly provided for by the patent laws and repeatedly approved of by the Supreme Court. reverse-payment settlements.” 8Īddressing the issue of first impression, Judge Lamberth found that Actavis did not apply to the 2017 settlement.7 Actavis addressed a reverse-payment or “pay-for-delay” settlement, and as Judge Lamberth noted, “o-Circuit case has applied the analysis in Actavis to patent activity beyond 6 threw the “uneasy détente” between the Sherman Act, which prohibits anticompetitive conduct, and the Patent Act, which encourages innovation through the grant of a legal monopoly, into flux. Supreme Court’s landmark decision in FTC v. Following the settlement, Endo abandoned any effort to relaunch Opana ER and the average price of Impax’s generic product increased. Under certain circumstances (some undisclosed)-including if Endo were to relaunch Opana ER-Impax’s royalty drops to zero. Endo and Impax settled the breach-of-contract suit in 2017, with Impax paying an undisclosed (but less than 85%) royalty to Endo. Impax refused and Endo sued for breach of the 2010 settlement’s good faith negotiation clause. In 2015, Endo demanded that Impax pay it an 85% royalty for its license to the later-issued patents. But not Impax the 2010 settlement licensed Impax for these additional patents. Patent and Trademark Office issued Endo additional patents covering Opana ER-including a patent that is set to expire in November 2029. Through these newly issued patent, Endo prevented all producers of generic Opana ER from launching until 2029. The settlement required Endo and Impax to “negotiate in good faith an amendment to the terms of the License to any patents.” 5 Nine other companies sought to market generic Opana ER products Endo sued and settled with each. None of these later settlements included a license for future patents as Impax had received. The settlement ensured that Impax could sell its generic even if Endo later obtained additional patents covering the drug. In the 2010 settlement, Endo provided Impax with a license to any then-issued as well as any future patents that could cover Opana ER. That withdrawal left Impax’s generic as the only available extended release oxymorphone product on the market. Food and Drug Administration’s demand that Endo pull a reformulated crush-resistant version of Opana ER from the market due to its increased intravenous abuse. The 2017 settlement, FTC alleged, resulted from the U.S. In 2017-the same year that Endo settled the first FTC suit-Endo and Impax reached another deal regarding Opana ER, resolving a breach of contract dispute over the 2010 settlement. District Court for the Northern District of Illinois against both Endo and Impax related to the 2010 settlement. 2 Private class action litigation remains pending in the U.S. In April 2021, the Fifth Circuit affirmed the FTC’s finding that the 2010 settlement was an unlawful reverse payment deal. Under that 2010 settlement, Endo paid Impax more than $100 million to keep Impax’s generic off the market until 2013. Endo settled the first FTC lawsuit in 2017 Impax did not. The FTC had previously prevailed in a challenge of a 2010 settlement between Endo and Impax that ended patent litigation over the same drug. The FTC filed this case in January 2021, claiming that Endo and Impax’s 2017 settlement, in which Endo allegedly promised to stay off the Opana ER market, violated the Sherman Act.
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