OREANDA-NEWS. Takeda Pharmaceutical Company Limited (“Takeda”) and its wholly - owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) stated today that TPUSA will continue its patent infringement litigation against Hikma Pharmaceuticals (“Hikma”) and its lawsui t against the U.S. Food and Drug Administration (FDA) despite two recent court rulings that allowed Hikma to launch its colchicine product.

“We remain committed to pursuing our patent infringement lawsuit against Hikma,” said Kenneth D. Greisman, senior vice president and general counsel, Takeda Pharmaceuticals U.S.A., Inc. “We also believe that the FDA inappropriately approved Hikma’s product and we will continue to challenge that approval.”

On January 9, 2015, the United States Court of Appeals for the Federal Circuit upheld an earlier decision by the United States District Court for the District of Delaware that affirmed the denial of Takeda’s request for a preliminary injunction. The requested injunction would have prohibited the sale of Hikma’s colch icine product during the pendency of Takeda’s patent infringement litigation against Hikma. Colcrys ® (colchicine, USP) is sold by TPUSA and is protected by patents that extend through 2028 and 2029. A trial date in the patent case has not been set.

“Alt hough the trial and appellate courts have not given Takeda preliminary relief, we remain confident that after a trial, Takeda will prevail,” Greisman said. Also on January 9, 2015, the United States District Court for the District of Columbia denied Taked a’s request to overturn the FDA approval of Hikma’s product. Takeda intends to appeal.

Gout affects more than 8 million Americans, and the prevalence is rising. Colcrys is part of Takeda’s gout treatment portfolio, and was launched commercially in the U.S . in 2009. Colcrys is a prescription medicine and was the first FDA - approved single - ingredient oral colchicine product available in the U.S.