Citing “more than enough evidence," the U.S. Court of Appeals for the Fifth Circuit has upheld the Federal Trade Commission’s determination that Impax Laboratories, LLC engaged in an illegal pay-for-delay settlement to block consumers’ access to a lower-cost generic version of Endo Pharmaceuticals Inc.’s Opana ER, an extended-release opioid pain reliever. Entering into what is known as a “reverse payment” arrangement, Impax had agreed to accept funds from Endo to stay out of the market for two-and-a-half years.
Judge Gregg Costa wrote in the Fifth Circuit’s opinion that the commissioners correctly found sufficient evident of the scheme and that “a less restrictive alternative was viable.”
A key factor considered by the court was whether the reverse payment was "substantial and unjustified." It concluded that Endo’s payment to Impax of $112 million was substantial, and that the only permissible justifications for a reverse payment are savings in litigation expenses and the fair market value of any promised services in the settlement agreement.
FTC Acting Chair Rebecca Kelly Slaughter said this marks another in a series of actions the Commission has taken to stop harmful pay-for-delay agreements. The Commission’s held that the FTC staff had proven that the agreement between Impax and Endo violated Section 5 of the Federal Trade Commission Act. The Commission reversed Chief Administrative Law Judge D. Michael Chappell’s initial decision.
The final order bars Impax from entering into any type of reverse payment that defers or restricts generic entry, including no-Authorized Generic commitments, as well as certain business transactions entered with the branded pharmaceutical manufacturer within 45 days of a patent settlement. The order also bars Impax from entering any agreement with another oxymorphone ER manufacturer that prevents or restricts competition between oxymorphone ER products.
The FTC filed another case against the companies, plus Impax’s owner, Amneal Pharmaceuticals, Inc., in U.S. District Court for the District of Columbia in January 2021, alleging similar violations of antitrust laws involving the same drug.
Edited by Tom Hagy for MoginRubin LLP.