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.
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CONTACT: Amgen, Thousand Oaks
Marie Fay, 805-447-0081 (media)
Arvind Sood, 805-447-1060 (investors)