High Court Denies Apotex Petition on 180-Day Exclusivity

January 18, 2011

By Kurt R. Karst –      

On January 18th, the U.S. Supreme Court denied Apotex Inc.’s Petition for Writ of Certiorari asking for a review of the U.S. Court of Appeals for the District of Columbia Circuit’s decision involving Teva’s 180-day exclusivity for generic versions of Merck’s COZAAR and HYZAAR (i.e., losartan).  Teva’s 180-day exclusivity for losartan expired on October 3, 2010, the day before Apotex filed its petition with the Supreme Court.  Justice Kagan took no part in the consideration or decision of Apotex’s petition.

The Supreme Court’s decision leaves intact the D.C. Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius, in which a 3-judge panel of the D.C. Circuit ruled in a 2-1 decision that there is “no reason to conclude that the 2003 addition of forfeiture provisions meant to give the brand manufacturer a right to unilaterally vitiate a generic’s [180-day] exclusivity.”  Both FDA (Federal Respondents) and Teva opposed (here and here) the Supreme Court’s review, while AARP and the Consumer Federation of America urged review.  According to FDA, although the “court of appeals’ methodology, reasoning, and holding are incorrect,” the Supreme Court “should defer review of the question presented.”  “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.  If 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,” says Acting Solicitor General Neal Katyal in the government’s brief.  According to Apotex’s Reply Brief, however, “[a] [circuit] split is exceedingly unlikely to develop.”