Court Orders Eagle Bendeka Orphan Exclusivity
The DC federal court has granted summary judgment to Eagle Pharmaceuticals in its case challenging FDA’s denial of orphan drug exclusivity for the company’s Bendeka (bendamustine), which has been designated as an orphan drug and approved to treat two rare forms of cancer. FDA had argued that it properly denied exclusivity because Bendeka has the same active ingredient as Teva’s Treanda, which previously had orphan drug exclusivity.
The court’s 6/8 decision, which was just unsealed, reviewed the case in light of a 2014 case in which Depomed challenged FDA’s requirement that manufacturers seeking orphan drug exclusivity for a second drug with the same active ingredient demonstrate clinical superiority at the marketing approval stage. At that time the court held that the law was unambiguous and required the agency to recognize orphan drug exclusivity once a drug is designated and approved.
Eagle had argued in 2014 that Bendeka would be clinically superior to Treanda. FDA designated Bendeka as an orphan drug 7/2014, concluding that Eagle had shown a plausible hypothesis of clinical superiority. FDA denied the company’s request for exclusivity 3/24/16, saying that Eagle had not substantiated its claims of clinical superiority with adequate evidence and saying that as a matter of policy it had decided not to follow the earlier Depomed decision.
In its latest decision, the court held that the law in place at the time of the previous litigation is not ambiguous on the subject of serial exclusivity and requires FDA to grant exclusivity to any product that has been designated as an orphan drug and approved for marketing to treat a rare disorder. “The statute makes no distinction between the first manufacturer to meet those conditions and the second,” the court wrote. “If a second manufacturer meets the statutory requirement of designation and approval, then it enjoys a duopoly alongside the first, because the Orphan Drug Act does not require FDA to rescind the approval it previously granted to the first manufacturer…. Here, the statute sets out requirements for orphan drug exclusivity, Bendeka meets those requirements, and the statute does not authorize FDA to invent new ones. Therefore, the statutory text is not silent, but in fact answers the question of whether, following the prior grant of exclusivity for Treanda, Bendeka is also entitled to orphan drug exclusivity. The answer is ‘yes.’”