Takeda Pursues Lawsuit Against FDA Over Gout Drug Colchicine

Takeda Pharmaceutical Company Ltd. and its wholly owned subsidiary, Takeda Pharmaceuticals USA, provided an update regarding litigation against the US Food and Drug Administration regarding Colcrys (colchicine), the company’s drug to prevent and treat gout. Takeda had filed a lawsuit against the FDA on October 6, 2014, for violation of he Administrative Procedure Act (APA) for the agency’s approval of a colchicine product by Hikma Pharmaceuticals and West-Ward Pharmaceuticals. The APA allows parties to challenge improper actions by government agencies. A hearing in the case is scheduled for November 19, 2014.

Takeda had filed a separate patent-infringement lawsuit against Hikma and West-Ward on October 3, 2014, over those companies’ colchicine product, citing several patents that extend through 2028 and 2029. On November 4, 2014, a federal district court denied Takeda’s request for a preliminary injunction in that lawsuit. Takeda then filed an expedited appeal, and the court agreed to extend a previously issued temporary restraining order to prohibit Hikma and West-Ward from marketing their colchicine produc at this time.

“Takeda stands by its assertion that the FDA's approval of Hikma's colchicine product is legally impermissible. We also believe that we can prove patent infringement.” said Kenneth D. Greisman, senior vice president and general counsel, Takeda Pharmaceuticals USA., Inc., in a company release. “We have confidence in Colcrys and remain committed to pursuing our ongoing lawsuits against the FDA and Hikma.”

Source: Takeda Pharmaceutical

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