by Mark P. Walters
On December 13, the U.S. Government, in a joint brief filed by the Solicitor General and the Department of Justice, and Teva, in a separate brief, urged the Supreme Court not to grant certiorari to Apotex's petition for writ of certiorari regarding 180-day, generic drug forfeiture under Federal Food, Drug, and Cosmetic Act ("FD&C Act") (21 U.S.C. § 355(j)(5)(D)). As reported in our previous blog, Apotex filed its petition, arguing that based on "unilateral" action by the holder of the challenged patent to delist a patent from the Orange Book, Teva had forfeited its 180-day exclusivity.
Apotex's petition followed a final decision by the D.C. Circuit, where the Circuit Court rejected Apotex's challenge to Teva's claim of market exclusivity, following a long-running battle over Merck's decision to delist U.S. Patent No. 5,608,075 ("the '075 patent") from Cozaar® ((losartan potassium)'s entry in the Orange Book. Merck's decision to delist the '075 patent led FDA in 2009 to take the position that market exclusivity had been forfeited under the plain language of the statute.
The Government agrees with Apotex that the D.C. Circuit erred, when it held that Merck's unilateral action, delisting a patent subject to a paragraph IV certification and allowing such a patent to expire for nonpayment of fees, may serve as basis for forfeiture of the first ANDA applicant's presumptive 180-day period of marketing exclusivity. Notwithstanding this error, the Government claims that "FDA has applied the MMA's forfeiture provisions on only a few occasions, and the D.C. Circuit is the only court of appeals to have construed those provisions." As a result, argues the Government, "[i]f future controversies materialize, they are likely to be heard by another court of appeals, giving the Court greater assurance that the question presented is of recurring significance and the legal issues have fully percolated in lower courts."
Taking a decidedly different approach from the Government, Teva argues that Apotex's petition should be denied because it is moot. According to Teva, Apotex's complaint sought only prospective relief challenging Teva's entitlement to 180-day marketing exclusivity. And since Teva's 180 days of exclusivity have come and gone, Teva claims that Apotex "can't turn back time," and there is thus no case or controversy left for the Court to resolve. Teva further argues that this case "would be a poor vehicle to address the question it purports to present, because it arises in the interlocutory context of a preliminary injunction proceeding." In any event, argues Teva, the D.C. Circuit got it right, "because Apotex's interpretation of the statute would allow brand companies to manipulate the exclusivity incentive despite the absence of any suggestion in the text, history, or structure of the statute that Congress intended to give brand companies that power."