Roche Considering Legal Options In Patent Litigation Case

Roche announced today that a jury in the U.S. District Court in Massachusetts found in favor of Amgen in the patent infringement dispute relating to the Roche erythropoiesis-stimulating agent, MIRCERA® . Roche is currently evaluating its legal options, including the possibility of an appeal.

Roche maintains its position that all of Amgen’s patents for epoetin asserted against Roche are invalid and not infringed, and believes the facts and the law support that position.

“The jury’s verdict is disappointing because it is a loss for U.S. patients with chronic kidney disease who are being deprived of the opportunity to benefit from options in the management and treatment of renal anemia. We believe it is important for there to be competition and choice in this country. Amgen has had an extended monopoly for the last 20 years not allowing for new therapeutic options to treat anemia to be introduced to patients in this country,” said George Abercrombie, president and CEO of Hoffmann-La Roche Inc.

MIRCERA is currently awaiting FDA approval which is expected on November 14th. MIRCERA was already approved in July in the European Union, and in Switzerland and Norway in September. MIRCERA has been recently launched in Austria, Sweden, Germany and the UK. Studies with MIRCERA have shown that the treatment corrected and maintained hemoglobin levels with fewer injections than currently available erythropoiesis-stimulating agents (ESAs).