FDA Sued Over Refusal to Approve Generic DEPAKOTE After 30-Month Stay Allegedly Expires

January 17, 2008

On January 14, 2008, Nu-Pharm Inc., a Canadian drug company formerly owned by Apotex, Inc., filed a complaint in the U.S. District Court for the District of Columbia against FDA seeking declaratory and injunctive relief with respect to the company’s Abbreviated New Drug Application (“ANDA”) for divalproex sodium delayed-release 500 mg tablets.  The drug is marketed by Abbott Laboratories under the trade name DEPAKOTE for the treatment of mania, migraine, and epilepsy, and was first approved in 1983 under NDA #18-723.

According to the complaint, Nu-Pharm submitted ANDA #77-615 to FDA in March 2005 with paragraph IV certifications to two Orange Book-listed patents covering DEPAKOTE: U.S. Patent #4,988,731 (“the ‘731 patent”) and #5,212,326 (“the ‘326 patent”).  These patents are scheduled to expire on January 29, 2008; however, in December 2007, FDA granted Abbott pediatric exclusivity for the drug, thereby delaying generic approval under certain circumstances until July 29, 2008. 

Earlier, Abbott sued Nu-Pharm in the U.S. District Court for the Northern District of Illinois (Eastern Division) for infringement of both patents, thereby triggering a 30-month stay of approval of Nu-Pharm’s ANDA.  According to Nu-Pharm, the 30-month stay expired on November 13, 2007, without any substantive merits ruling on patent infringement.  Nu-Pharm then contacted FDA requesting that the Agency grant final ANDA approval. 

According to the complaint, in December 2007, FDA informed Nu-Pharm that the Agency would not grant final approval based on an order entered in a contempt proceeding in the U.S. District Court for the Northern District of Illinois (Eastern Division) in Abbott Labs v. Apotex.   In that proceeding, the charged conduct was the submission of repetitive ANDAs by Apotex and Nu-Pharm to FDA for generic DEPAKOTE.  In October 2007, the U.S. Court of Appeals for the Federal Circuit reversed the district court’s judgment of contempt “because the district court erred in finding Apotex in contempt when the conduct at issue was not within the express terms of the injunction.”  By way of background, in previous paragraph IV patent litigation in that case concerning Apotex’s ANDA #75-112 for generic DEPAKOTE, Judge Richard Posner, sitting by designation in the U.S. District Court for the Northern District of Illinois, ruled that Apotex’s product infringed the ‘731 and ‘326 patents, enjoined the company from manufacturing, using, selling, or offering to sell generic divalproex sodium, and stated that the effective date of approval of ANDA #75-112 would be no earlier than January 29, 2008 when the patents expire – without pediatric exclusivity.  The decision was affirmed in 2005.  Apotex subsequently entered into an agreement with Nu-Pharm under which Apotex would pay for the costs associated with preparing and submitting a new ANDA (i.e., ANDA #77-615) for generic DEPAKOTE and Nu-Pharm would take on the “litigation risks” arising from the submission of the ANDA. 

According to the Nu-Pharm complaint, FDA orally refused to grant final approval for ANDA #77-615 on January 9, 2008.  Considering FDA’s decision to be final agency action, the company filed a complaint.  Nu-Pharm alleges that FDA’s refusal to approve the company’s ANDA violates the FDC Act and the Administrative Procedure Act because “FDA’s decision violates the plain and unambiguous language of the [FDC Act], which provides that FDA shall immediately approve an ANDA where, as in this case, the applicable 30-month stay has expired” and there has been no finding of infringement or validity, and that FDA “has no lawful basis or authority to withhold final approval . . . based on a court order in a wholly separate contempt proceeding to which Nu-Pharm was not a party.”

By Kurt R. Karst


  • A copy of Nu-Pharm’s memorandum supporting the company’s motion for a temporary restraining order and/or preliminary injunction is available here.  FDA is expected to file its brief soon.

Categories: Hatch-Waxman