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.THOUSAND OAKS, Calif. -- Amgen Can Re-file Complaint Closer to a Potential Commercial Launch Amgen (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :AMGN), today issued the following statement: An Administrative Law Judge administrative law judge n. a professional hearing officer who works for the government to preside over hearings and appeals involving governmental agencies. They are generally experienced in the particular subject matter of the agency involved or of several agencies. (ALJ ALJ Administrative Law Judge ALJ Association for Legal Justice (Northern Ireland) ) at the U.S. International Trade Commission (ITC ITC (Brit) n abbr (= Independent Television Commission) → Fernseh-Aufsichtsgremium ITC n abbr (BRIT) (= Independent Television Commission) → ) 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 patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. . 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 e·po·e·tin al·fa n. A recombinant preparation of human erythropoietin used to treat some forms of anemia. epoetin alfa Epogen, Eprex (CA) (UK), Procrit Pharmacologic class: ) 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. |
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