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Biologic News From August 2007- News About Biologics
  Roche Plans to Launch Anemia Biologic Miceria in U.S. Despite Court Setback
 

Roche said it still plans to launch anemia biologic Mircera in the United States as soon as receives FDA approval, even though a federal court ruled on August 28th that the drug will infringe one of Amgen's erythropoietin composition patents.

Amgen, which developed anemia drugs Epogen and Aranesp, claims that Micera violates five of its patents for EPO products.

A U.S. District Court in Boston on Aug. 28th granted a motion by Amgen for a summary judgment and ruled that Roche's Micera will infringe one of Amgen's composition patents, but the lawsuit on other patents is scheduled to proceed to trial on September 4.

Roche maintains that the District Court ruling "does not determine the ultimate validity of any Amgen patents" and reiterated that Mircera is longer lasting than other anemia drugs and does not violate any patent.

"We still plan to launch the product upon FDA approval," which is expected before the end of the year, a Roche spokeswoman told Thomson Financial News.

If Roche launchs the drug "at risk," the company could pay triple damages to Amgen if it loses the case.

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Last Updated: 09/08/2007 Copyright 2004-2007 Medical Week News, Inc. All Rights Reserved

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