AMGEN's ERYTHROPOIETIN PRODUCTION PLANT START-UP TARGETED FOR SEPTEMBER of this year in anticipation of a "fast track" approval. Amgen filed a product license application with FDA on October 30 for the treatment of anemia in kidney dialysis patients, an orphan indication. Amgen expects the new plant, under construction near the company's Thousand Oaks, Calif. headquarters, to supply all of the approximately 1,600 dialysis centers in the U.S. As of last October 18% of Amgen's R&D personnel have been devoting their efforts to recombinant erythropoietin, the firm said in a recent complaint filed with the International Trade Commission (ITC). Amgen currently has a total of 325 employees. Amgen's ITC complaint, filed Jan. 4, seeks a commission investigation into the importation of recombinant erythropoietin by Tokyo-based Chugai Pharmaceuticals. The biotech firm claims that the Chugai product infringes on Amgen's recombinant erythropoietin patent, granted Oct. 27, 1987. In its complaint, Amgen said that Chugai is believed to be only months behind Amgen in obtaining FDA approval for recombinant erythropoietin. Chugai is conducting clinical trials on the substance. The complaint contends that Chugai's activities will prevent Amgen from obtaining a "fair return" on its investment in erythropoietin, the biotech firm's first major commercial product. "Chugai has the wherewithal and necessary capital to rapidly penetrate the U.S. market for recombinant erythropoietin," Amgen maintains. The complaint further argues that Amgen "has taken all the risks" and that Chugai is taking "a 'free ride' on Amgen's already rprven successful results." Chugai has obtained a license in the U.S. from Genetics Institute for use of recombinant erythropoietin in dialysis patients. Amgen contends that the agreement with Genetics Institute is being used to bypass Amgen's patent rights. According to the complaint, Genetics Institute President Gabriel Schmergel said at a November analysts meeting that Chugai would be able to avoid Amgen's patent rights by manufacturing recombinant erythropoietin in facilities outside the U.S. "Such product, by implication, would then be imported into the United States," the Amgen complaint maintains. Because ITC investigations into illegal importations can take up to a year, Amgen is also asking for an exclusionary order prohibiting any further Chugai importation of recombinant erythropoietin into the U.S. Last October, Amgen filed suit in Massachusetts against Chugai and Genetics Institute regarding infringement of the patent ("The Pink Sheet" Nov. 2, 1987, p. 10). Amgen also is requesting a declaratory judgment that a patent owned by Genetics Institute, entitled, "A Method for the Purificiation of Erythropoietin and Erythropoietin Compositions," is invalid and not infringed by Amgen. The lawsuit is in the discovery stage. A day later on October 28, Chugai and Genetics Institute filed a countersuit against Amgen in the Central District of California, claiming that Amgen is infringing their patent.
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