ITC to look at Amgen complaint on Roche drug
Tue May 9, 2006 4:14 PM ET

NEW YORK, May 9 (Reuters) - The U.S. International Trade Commission said on Tuesday it has agreed to look into a request by Amgen Inc. to prohibit Swiss drug maker Roche Holding AG from importing its experimental anemia drug Cera into the United States.

Amgen, the world's largest biotechnology company, claims that Roche's pegylated recombinant human erythropoietin (peg-EPO), which is used to boost red blood cells, violates U.S. patents Amgen holds on its anemia drug Epogen.

Amgen asked the ITC to issue a permanent exclusion order to prohibit importation of Roche's peg-EPO drug Cera into the United States.

The ITC, a federal agency that protects U.S. companies and industries from unfair trade practices, said it voted to launch the investigation based on Amgen's complaint.

The ITC said in a statement that by instituting the investigation it "has not yet made any decision on the merits of the case."

The agency said within 45 days it will set a target date for completing the investigation.

The case will be referred to an ITC administrative law judge, who will make the initial determination on whether Roche has committed a violation. The judge's finding will be subject to review by the Commission.

Cera has not yet been approved for sale in the United States or Europe. The complaint filed with the ITC was the second preemptive strike launched by Amgen, which last November filed a patent infringement lawsuit against Roche seeking an injunction preventing the manufacture or sale of recombinant human erythropoietin in the United States.

Roche has argued that its pegylated version of EPO does not infringe Amgen's patents because it is linked to a chemical that makes it last longer in the body than Epogen.

Amgen also sells Aranesp, a longer-lasting version of Epogen used to treat anemia in kidney dialysis patients and cancer patients undergoing chemotherapy.

Amgen's combined sales of Epogen and Aranesp reached nearly $6 billion last year.