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ITC Judge Grants Summary Determination That Roche's Activities Are Covered by Clinical Trial Exemption Judge's Decision Does Not Address the Merits of Roche's Infringement of Amgen's Patents; Amgen Can Re-file Complaint Closer to a Potential Commercial Launch
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--July 7, 2006-- Amgen (NASDAQ:AMGN), today issued the following statement: An Administrative Law Judge (ALJ) at the U.S. International Trade Commission (ITC) in Washington, D.C. issued a summary determination that Roche's importation and use of peg-EPO in the United States to date are subject to a clinical trial exemption to patent infringement. This decision will become final within thirty days unless modified by the Commission. The ALJ made no determination with respect to the merits of Amgen's claim that Roche's future importation and sale of peg-EPO will infringe Amgen's patents. The decision does not prevent Amgen from re-filing its complaint at a later time.
"Today's ITC decision does not impact Amgen's pending patent infringement lawsuit against Roche in federal court, nor does it preclude Amgen from re-filing with the ITC at a later date," stated David J. Scott, senior vice president, general counsel and secretary.
Amgen believes Roche's peg-EPO product violates six of its U.S. patents while providing no additional clinical or patient benefit over Amgen's innovative therapies, EPOGEN(R) (Epoetin alfa) and Aranesp(R) (darbepoetin alfa). Amgen revolutionized anemia treatment with the introduction of EPOGEN in 1989. EPOGEN along with Aranesp have accumulated over 4 million combined patient years of experience. Amgen continues to invest heavily in meaningful research to improve the lives of patients with kidney, cancer and cardiovascular disease.
EDITOR'S NOTE: An electronic version of this news release may be accessed via our Web site at www.amgen.com. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Media section of the Web site.
CONTACT: Amgen, Thousand Oaks Marie Fay, 805-447-0081 (media) Arvind Sood, 805-447-1060 (investors) SOURCE: Amgen