Fdalawblog has published a very interesting article on Divalproex sodium delayed-release 500 mg tablets
Earlier this month, we reported on a complaint filed by Nu-Pharm Inc. against FDA in the U.S. District Court for the District of Columbia seeking declaratory and injunctive relief with respect to the company’s Abbreviated New Drug Application ("ANDA") #77-615 for generic divalproex sodium delayed-release 500 mg tablets. Divalproex sodium delayed-release 500 mg tablets is marketed by Abbott Laboratories under the trade name DEPAKOTE. Nu-Pharm’s ANDA contained a paragraph IV certification to the Orange Book-listed patents for DEPAKOTE, Abbott sued within the statutory 45-day period, and the 30-month stay triggered by the suit reportedly expired in November 2007. Late last week, the court dismissed the complaint in a one-page order.According to Nu-Pharm’s memorandum in support of a temporary restraining order and/or preliminary injunction, FDA must approve ANDA #77-615 because the company satisfied all requirements for final ANDA approval and the 30-month stay of approval triggered by the submission of Nu-Pharm’s ANDA with a paragraph IV patent certification expired without a substantive ruling on patent validity or infringement. FDA nevertheless refused to approve ANDA #77-615 based on an order entered in a contempt proceeding by the U.S. District Court for the Northern District of Illinois (Eastern Division) (Judge Richard Posner sitting by designation) involving an ANDA with a paragraph IV patent certification for generic DEPAKOTE submitted by Apotex Inc. (which formerly owned Nu-Pharm) that also extended to Nu-Pharm’s product.In October 2007, the U.S. Court of Appeals for the Federal Circuit reversed the district court’s contempt judgment in the Apotex case with respect to Apotex acting in concert with Nu-Pharm to submit an ANDA "because the district court erred in finding Apotex in contempt when the conduct at issue was not within the express terms of the injunction." The Federal Circuit also held, however, that the contempt procedure used by the Illinois court was proper, that Nu-Pharm’s divalproex sodium drug product was not colorably different from Apotex’s divalproex sodium drug product, and that Nu-Pharm’s product would infringe patents covering DEPAKOTE. Apotex’s request for the Federal Circuit to hear the case en banc was denied, and in January 2008, the company petitioned the Supreme Court for review.Nu-Pharm contends that notwithstanding the order in the Illinois court contempt proceeding –to which Nu-Pharm was not and is not a party- FDA is required to approve ANDA #77-615 under the plain language of FDC Act § 505(j)(5)(B)(iii), which states, in relevant part:If the applicant made a [paragraph IV certification], the approval shall be made effective immediately unless, before the expiration of 45 days after the date on which the notice described in [FDC Act § 505(j)(2)(B)] is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under FDC Act § 505(b)(1) or § 505(c)(2)] before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted. If such an action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under [FDC Act § 505(j)(2)(B)(i)] or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action, except that . . .(II) if before the expiration of such period the district court decides that the patent has been infringed . . . .Specifically, Nu-Pharm argues, among other things, that "for purposes of ANDA approval, the only action that matters is the one brought against the particular ANDA applicant within the 45-day period for infringement of the patent that is the subject of the applicant’s paragraph IV certification."FDA, in the Agency’s memorandum accompanying its motion to dismiss, comments in response to Nu-Pharm’s statutory plain meaning arguments that:FDA must give effect to the [Illinois] court’s order, which expressly pertains to Nu-Pharm. . . . While Nu-Pharm is correct that FDA must ordinarily approve an otherwise approvable ANDA upon expiration of a 30-month stay, in this case, FDA is subject to a direct court order requiring FDA to delay the approval of Nu-Pharm’s ANDA until after January 29, 2008. Thus, Nu-Pharm’s statutory arguments miss the point entirely because Nu-Pharm fails to recognize (at least before this Court) FDA’s obligation to give effect to the Illinois court’s order. For this reason, Nu-Pharm’s lengthy statutory arguments are irrelevant.FDA goes on to cite two cases in which courts have rejected arguments that FDA’s decision to follow court orders were improper because they were inconsistent with the FDC Act.Although Nu-Pharm was unsuccessful in convincing the U.S. District Court for the District of Columbia to grant declaratory and injunctive relief, the company has expressed its intent to appeal the decision. Specifically, in Nu-Pharm’s brief, the company states:[I]n the event the Court denies Nu-Pharm’s request for emergency injunctive relief, Nu-Pharm respectfully requests that any adverse FDA decision be stayed and that Nu-Pharm’s 500 mg product be finally approved pending review by, and appeal of this matter to, the United States Court of Appeals for the D.C. Circuit
