Roche Considering Legal Options In Patent Litigation Case

Roche announced today that a jury in the U.S. District Court in Massachusetts found in favour 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 verdict is disappointing because in the end, it is U.S. patients with chronic kidney disease who lose. Amgen has had an extended monopoly for the last 20 years in the U.S. blocking new therapeutic options to treat anaemia from being introduced,” said William M. Burns, CEO of the Pharma Division at Roche.

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 haemogloblin levels as well as existing ESAs but with fewer injections than currently available erythropoiesis-stimulating agents (ESAs). One of the pivotal studies from its Phase III program was just published in The Lancet .