D.C. Circuit Grants FDA’s Motion for Summary Affirmance in Generic DEPAKOTE Litigation

April 22, 2008

Earlier this month, we reported on the status of litigation in the U.S. Court of Appeals for the District of Columbia Circuit concerning Nu-Pharm Inc.’s efforts to get FDA to approve the company’s ANDA for a generic version of Abbott Laboratories’ DEPAKOTE (divalproex sodium) Delayed-Release Tablets, 500 mg.  In January 2008, the U.S. District Court for the District of Columbia dismissed Nu-Pharm’s complaint against FDA.  Nu-Pharm sought both a judicial declaration that FDA’s decision not to approve ANDA #77-615 for Divalproex Sodium Delayed-Release Tablets, 500 mg, after the 30-month stay of approval reportedly expired without a court decision violated the Administrative Procedure Act, and preliminary and permanent injunctive relief requiring FDA to approve ANDA #77-615.  The district court dismissed the complaint, declining to exercise jurisdiction for “prudential reasons,” reportedly on the ground that the injunctive relief sought by Nu-Pharm would “conflict irreconcilably” with a previous order entered in a contempt proceeding.

Nu-Pharm appealed the district court decision to the U.S. Court of Appeals for the District of Columbia Circuit, and argued, among other things, that “the district court improperly refused to exercise jurisdiction over Nu-Pharm’s complaint” when it declined to exercise subject matter jurisdiction over Nu-Pharm’s complaint, and that FDA’s decision not to approve ANDA #77-615 is contrary to the language of FDC Act § 505(j)(5)(B)(iii), which states that ANDA approval “shall be made effective” after the expiration of the 30-month stay.  In February, FDA submitted a Motion for Summary Affirmance arguing that Nu-Pham’s case is “baseless” and that the district court properly declined jurisdiction.

On April 17, 2008, a 3-judge panel from the U.S. Court of Appeals for the District of Columbia Circuit issued a 1-page order granting FDA’s Motion for Summary Affirmance.  It is unclear whether Nu-Pharm will petition the court for rehearing or rehearing en banc. 

By Kurt R. Karst    

Categories: Hatch-Waxman