Challenge

Alkermes sought approval from the FDA to market ARISTADA® (aripiprazole lauroxil), an extended-release injectable used to treat schizophrenia. As part of the new drug application for ARISTADA, Alkermes relied in part on prior FDA findings of safety and effectiveness for tablet forms of a competing drug with a different active ingredient. The manufacturer of the competing drug objected to the FDA’s initial approval of ARISTADA and sued the FDA, arguing that Alkermes’ reliance on FDA’s findings for its competing drug, and an existing marketing exclusivity for an injectable form of that competing drug, barred ARISTADA from entering the market.

Approach

The FDA sided with Alkermes, granting marketing approval for ARISTADA. When the competitor sued the FDA to block the decision, Goodwin assembled an experienced team of appellate and pharmaceutical litigators who have previously handled similar litigation in the D.C. Circuit and others courts with success. The team worked to intervene in the case, review the administrative record, and file and argue a motion for summary judgment on an expedited basis.

Outcome

The District Court sided with the FDA and Alkermes, agreeing with the FDA and Goodwin’s argument that the marketing exclusivity provisions were ambiguous, and that the FDA’s interpretation of the exclusivity provisions was reasonable. The competitor then appealed to the U.S. Court of Appeals for the D.C. Circuit, where Goodwin argued and ultimately obtained a decision upholding the district court’s grant of summary judgment, thus allowing Alkermes to continue providing ARISTADA for people living with schizophrenia.