FTC antitrust charges against Impax dismissed
A judge has found it unlikely that Impax Laboratories would launch a generic drug before a final court decision in related patent litigation and has dismissed a case against the company.
US Federal Trade Commission (FTC) chief administrative law judge D Michael Chappell dismissed antitrust charges made by the FTC in January 2017.
The FTC filed the complaint alleging that in June 2010, Impax and Endo Pharmaceuticals illegally agreed that Impax would refrain from marketing a generic version of Endo’s Opana ER (oxymorphone hydrochloride) until January 2013.
Opana ER is an extended-release opioid designed to relieve moderate to severe pain.
The FTC’s complaint said that in exchange for Impax not marketing the generic drug, Endo had paid Impax more than $112 million as of January 2017.
Chappell dismissed the administrative complaint after he found that the FTC’s complaint counsel failed to prove that the agreement between the parties violated Section 5 of the FTC Act.
The Section states that unfair or deceptive acts or practices in or affecting commerce are declared unlawful.
In particular, Chappell said that “the magnitude and extent of any anticompetitive harm is largely theoretical, based on an inference that, absent the challenged agreement, Impax’s entry date, and therefore generic competition, would have been earlier than January 2013”.
According to the FTC, Chappell said that it was unlikely Impax would launch a generic version of the drug before January 2013 as it would have been considered “at risk” because it predated final court decisions relating to patent litigation.
Chappell also said that it would be economically disadvantageous for Impax to launch the generic drug in an “at risk” scenario as it is a small company and “could not bet the company on any one product”, according to the FTC.
In addition, Chappell said that the January 2013 entry date and the patent licence provisions for Opana ER allowed Impax to introduce a generic version eight months prior to Endo’s original patents for the drug expiring.
He said: “Impax has sold generic Opana ER without interruption for more than five years, since launching its product in January 2013.”
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