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UPDATE 2-US patent appeals court rules on Roche, Amgen fight
March 19, 2008 / 7:39 PM / 10 years ago

UPDATE 2-US patent appeals court rules on Roche, Amgen fight

(Recasts, adds background, analyst comment)

WASHINGTON, March 19 (Reuters) - A U.S. appeals court that specializes in patent cases handed Roche Holding Ltd ROG.VX on Wednesday a small win in a fight with Amgen Inc (AMGN.O) over EPO anemia drugs, but Amgen won the right to have the lower court decide if the patent was infringed, said court documents.

In a parallel legal fight, Amgen had asked the U.S. District Court in Boston to bar Roche from selling its drug Mircera and was granted a preliminary injunction.

As part of that litigation, Roche said it would pay a 22.5 percent royalty to Amgen, but Amgen has not agreed.

Amgen’s shares fell to their lowest level since 2002 on Tuesday after Roche agreed to the royalty payment and the U.S. government cut the rate it pays for Amgen’s anemia drug Aranesp.

Amgen’s shares, battered over the past year by concerns about the safety of its top-selling anemia drugs Epogen and Aranesp, were down nearly 5 percent on Tuesday and fell another three percent on Wednesday to close at $39.97. A year ago the stock stood at $59.14.

Amgen had asked the International Trade Commission, which hears patent cases over imported products, to bar Roche from importing recombinant human erythropoietin, or EPO, and its derivatives.

The ITC allowed the imports and the U.S. Appeals Court for the Federal Circuit agreed, on the grounds they were legal because they were not for sale but part of an effort to get approval from the Food and Drug Administration.

But the trade commission also said it did not have jurisdiction to judge whether the EPO infringed an Amgen patent because the product was not being sold in the United States.

The appeals court disagreed and ordered the ITC to hear the case, saying: “The issues of infringement and injury were properly before the commission for resolution.”

Citigroup analyst Yaron Werber said the ITC could bar importation of Roche’s drug Mircera if it rules that the drug infringes Amgen’s EPO patents.

“This is a slight positive for Amgen,” the analyst said.

Roche said in a statement that they were “studying the Federal Circuit Court opinion and are reviewing it in light of our ongoing litigation.”

Amgen said it was pleased with the ruling.

“Roche has set a course to export Amgen’s hard-earned jobs and income through the sale of peg-EPO in the United States in violation of our patents,” said company spokesman Daniel Whelan. “Today Amgen’s position that the ITC has the authority to protect domestic industry from threatened patent infringement has been vindicated.”

Amgen sells EPO drugs under the names Aranesp and Epogen. Sales of Aranesp alone topped $3.6 billion in 2007. Roche has U.S. FDA approval to sell Mircera but has not yet launched the product amid a patent fight with Amgen. (Reporting by Diane Bartz; Editing by Andre Grenon, Leslie Gevirtz)

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