AMGEN WINS PATENT RULING AGAINST ROCHE TRIALS SET FOR NEXT WEEK.

Byline: Staff and Wire Services

BOSTON -- A federal judge ruled Tuesday that Roche Holding AG infringed upon a patent for an anemia drug held by Amgen Inc. in Thousand Oaks.

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 sells the blockbuster anti-anemia drugs Aranesp and Epogen. Trials next week will decide whether the anemia drug, Mircera, infringes upon other Amgen patents as the biotech giant claims. Epogen's U.S. patent is set to expire in 2013.

"This strengthens our position," Amgen spokesman David Polk said. "We're very confident in our ability to defend our patents."

The court ruling comes two weeks after Amgen announced a sweeping restructuring that included at least 2,200 job cuts due to federal restrictions on some of its biggest-selling drugs.

Polk declined to say how the ruling would affect Amgen's bottom line.

As part of the restructuring, Amgen said it also will scale back capital spending by about $1.9 billion, reduce research and development, and close some production operations.

The downsizing was primarily driven by a steep drop in revenue from sales of Aranesp, one of the company's top drugs, used to fight anemia, amid federal safety concerns and caps on Medicare oncology reimbursements, Amgen said.

The company is fighting to modify those federal actions, but faces another hearing in September on its anti-anemia drugs that could further affect sales.

Amgen 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 have not been infringed.

"The ruling does not determine the ultimate validity of any Amgen patents," said Switzerland-based Roche in a statement Tuesday. The company disagreed with the judge's decision.

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.

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.

Roche has previously indicated it would begin selling Mircera immediately upon approval, even if the patent dispute with Amgen isn't yet resolved. A trial could run until mid-October.

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.