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Roche CERA does not infringe EPO patents

Executive Summary

Final International Trade Commission ruling upholds earlier conclusion that Roche's investigational Continuous Erythropoietin Receptor Activator (CERA) anti-anemia drug "does not infringe any of Amgen's U.S. patents for epoetin," the company says Aug. 31. Amgen filed a complaint April 11 asking ITC to conduct an investigation into whether Roche is illegally importing pegylated recombinant human erythropoietin into the U.S. In July, an ITC administrative law judge determined that Roche's importation is subject to a clinical trial exemption from patent infringement. CERA is currently under development in the U.S. and EU for treatment of renal anemia in chronic kidney disease patients (1"The Pink Sheet" June 26, 2006, p. 17)...

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