UPDATE 2-US FDA clears new Roche anemia drug; sale blocked
(Adds Amgen comment)
NEW YORK, Nov 14 (Reuters) - U.S. health officials have approved Roche Holding AG's (ROG.VX) anemia-fighting drug, Mircera, a Food and Drug Administration spokeswoman said on Wednesday.
But Roche has said it will not launch the drug in the United States after a Boston jury found the patents on Amgen Inc's (AMGN.O) top-selling anemia drugs to be valid.
The decision effectively blocks Mircera sales in the United States.
Roche, which had expected a U.S. green light for Mircera, has not yet decided whether to appeal the Amgen ruling, Roche Chief Executive Officer Franz Humer told the Reuters Health Summit in New York earlier this week.
The company could, alternatively, wait until Amgen's patents expire before launching its drug, Humer added.
Amgen said it has asked the court to grant an injunction preventing Roche from selling its drug in the United States in violation of its patents.
"The injunction hearing is scheduled to start on November 15th," an Amgen spokesman said. "The jury was very clear that (Mircera) infringes Amgen's intellectual property, and the jury's decision is consistent with previous court rulings that have repeatedly upheld our intellectual property rights." (Reporting by Lisa Richwine, Bill Berkrot and Sam Cage, editing by Leslie Gevirtz)
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