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Executive Summary

AMGEN BACK AT ITC v. CHUGAI IN CONTINUATION OF EPO WARS: the California firm filed a complaint on Feb. 3, with the International Trade Commission. The latest complaint picks up a theme raised by an Administrative Judge in a previous complaint and alleges that Chugai's EPO production in Japan is a ruse to get around U.S. patent law. Amgen declares that Chugai has engaged in "unfair methods of competition and unfair acts" by using "such patented and genetically engineered mast cells in Japan in the production of recombinant erythropoietin ]EPO[ . . . with the sole motivation and intent of circumventing the U.S. patent law and as part of a plan to unfairly compete in the U.S. biotechnology market." On Jan. 10, ITC Administrative Law Judge Sidney Harris ruled against Amgen in a previous complaint against Chugai. That claim focused on the importation of recombinant erythropoietin from Japan. Amgen charged that that importation infringed its EPO patent. The new complaint relies on a finding by Judge Harris that although Chugai's importation of EPO does not infringe Amgen's patent, "the ]ITC[ Commission may wish to reinstitute ]the[ investigation on a different basis, and determine whether there are unfair trade practices involved." Harris noted in his Initial Determination that Chugai and its collaborator Genetics Institute "were aware of potential patent problems which might hinder their joint venture, and sought to escape from U.S. laws by manufacturing recombinant EPO abroad. . . . Use of the claimed host cell in the U.S. to make EPO would be an infringement of the ]Amgen[ patent." Chugai is also accused by Amgen of disclosing confidential information on Amgen's relationship with J&J to Upjohn. Amgen says that Chugai "misappropriated and illegally disseminated Amgen's confidential business information to the extreme commercial detriment of Amgen." Amgen maintains that in April 1988 Chugai provided Upjohn with confidential information on its licensing agreements with Ortho and Kirin-Amgen in violation of court protective orders. "Upjohn, subsequent to obtaining the copies of the Amgen agreements, formed a joint venture with Chugai for marketing recombinant erythropoietin," the complaint states. Upjohn and Chugai consummated an EPO development and marketing agreement on May 12, 1988. Amgen is currently embroiled in two other court cases concerning EPO with Genetics Institute and Ortho. On Jan. 31, Ortho filed a preliminary injunction in Delaware District Court seeking to delay FDA approval of Amgen's Epogen until Amgen fulfills the terms of their 1986 licensing agreement. In a Feb. 2 Massachusetts District Court decision, a preliminary injunction brought by Amgen seeking to bar exportation of EPO by Genetics Institute was conditionally dismissed ("The Pink Sheet" Feb. 6, T&G-8).

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