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U.S. court rules Roche infringes on an Amgen patent

U.S. court rules Roche infringes on an Amgen patent

A federal judge has ruled that Roche Holding AG's Mircera anti-anemia drug infringes upon a patent held by Amgen Inc., Amgen said Tuesday, but a trial will still begin next week to decide whether Mircera infringes upon other Amgen patents.
Judge William Young in Boston granted Amgen's motion for summary judgment that Mircera, which is undergoing U.S. regulatory review, violates an Amgen pharmaceutical composition patent. Amgen also alleges Mircera violates other patents.
Amgen, of Thousand Oaks, California, sells blockbuster anti-anemia drugs Aranesp and Epogen. It has alleged that Roche's plan to sell Mircera in the U.S. would violate its patents. Roche has disputed these allegations, saying the Amgen patents are invalid and not infringed.
In a statement Tuesday, Switzerland-based Roche said it disagreed with the judge's decision, but "the ruling does not determine the ultimate validity of any Amgen patents."
Amgen said the court also granted a summary judgment in favor of Amgen on certain Roche defenses.
Roche has applied for Food and Drug Administration approval of Mircera as a treatment for anemia associated with chronic renal failure. The FDA issued an approvable letter for Roche's Mircera application in May, which typically means the FDA wants more information before giving final approval.
Roche has previously indicated it would begin selling Mircera immediately upon approval, even if the patent dispute with Amgen is not yet resolved. The trial could run until mid-October.
Final FDA approval of Mircera could come after a scheduled Sept. 11 FDA meeting of outside experts to consider the risks and benefits of anti-anemia drugs in kidney-disease patients. Safety concerns have emerged that led the FDA to issue a stronger warning about the class of anti-anemia drugs earlier this year. The warning also applies to Johnson & Johnson's Procrit.
Shares of Amgen rose 1.8 percent to $49.89 in after-hours trading after closing the regular session down 1.8 percent at $49.01.