Abbott Moved Patent Infringement Complaint Against Wockhardt

Abbott Laboratories - the RLD status holder of Depakote ER has filed a patent infringement complaint in the US District Court for the District of New Jersey against India-based generic drug manufacture - Wockhardt Ltd. alleging that Wockhardt’s ANDA # 78-705 submitted to the US FDA for generic approval of divalproex sodium extended release tablets infringes Abbott’s US Patent No. 6,713,086 (the ‘086 patent) expiring on December 18, 2018. The complaint is intended to prevent the FDA from approving Wockhardt’s generic version of Depakote ER before expiry of the ‘086 patent. In its complaint, Abbott alleged submission of ANDA # 78-705 for approval to sell divalproex sodium extended-release tablets in 500mg dosage strength before the expiration of the ‘086 patent will constitutes an act of infringement pursuant to 35 USC § 271(e)(2). The ‘086 patent is directed to controlled release formulation of divalproex sodium.