District of New Jersey Resets KUDCos ANDAs Final Approval in Protonix Litigation, Notwithstanding Outstanding Defenses of Teva and Sun
By Joseph M. O'Malley & Isaac S. Ashkenazi
On August 13, 2010, the United States District Court for the District of New Jersey granted a motion for reconsideration and entered an order pursuant to 35 U.S.C. § 271(e)(4)(A) against KUDCo Ireland, Ltd. (KUDCo), a defendant generic pharmaceutical company in the consolidated Protonix® litigation, resetting the date of any final approval of KUDCos Abbreviated New Drug Application (ANDA) to a date not earlier than January 20, 2011, the date on which the plaintiffs pediatric exclusivity period for the Protonix® patent ends. Altana Pharma AG and Wyeth v. Teva Pharmaceuticals USA, Inc., No 04-2355, slip. op. (D.N.J. August 13, 2010). The Order was entered despite the fact that 1) other defendants in that same consolidated action still had outstanding unenforceability defenses and 2) KUDCo had already obtained final approval of its ANDA in March 2009.