Mircera Gets FDA Approval But Will Not Be Launched

Law360, New York (November 15, 2007, 12:00 AM EST) -- Roche Holding AG said Thursday that the U.S. Food and Drug Administration had approved its anemia treatment Mircera but that it won't launch the drug until a patent dispute with Amgen Inc. is resolved.

The lawsuit is not going well for Roche.

Last month, a federal jury ruled that Mircera had literally infringed nine of Amgen's patent claims and had infringed another claim under the doctrine of equivalents. The jury in the U.S. District Court for the District of Massachusetts also found that all of Amgen's...
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