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Executive Summary

AMGEN WINS SECOND ROUND OF ITC EPO PROCEEDING V. CHUGAI, and intervenor Upjohn, in a summary judgment handed down on Sept. 28. At an International Trade Commission hearing on economic issues relating to Amgen's production of Epogen (erythropoietin), Administrative Law Judge Sidney Harris granted Amgen's motion for summary judgment on economic issues. He concluded that "there are no remaining material questions of fact concerning the existence of a developing domestic industry, [as it relates to] the '008' patent" for Epogen. International Trade Commission investigative staff supported Amgen's contention that the biotech company meets the requirements of a domestic industry as defined by the recently-enacted Omnibus Trade Act, which includes "(1) significant investment in plant and equipment; (2) significant employment of labor or capital; (3) or substantial investment in its exploitation, including engineering, research development, or licensing." ITC staff maintained that Amgen had made a "substantial investment . . . in its commercial manufacturing facility for recombinant erythropoietin." In its amended complaint, Amgen revealed that it had expended $ 23 mil. "to date" for its 24,000 sq. ft. "state of the art" mammalian cell culture facility for erythropoietin production and will have spent "approximately $ 70 mil." in R&D for Epogen "by the time the product reaches the market." Prior to the decision, Phase II hearings on economic issues had been scheduled to begin on Oct. 3. Amgen filed a motion for summary determination in the economic phase of the ITC proceedings upon passage in August of the Omnibus Trade Act, while eliminated demonstration of injury and broadened the criteria for domestic industry. Although Amgen has prevailed in one area of the patent infringement investigation, a judgment on Phase I patent issues, which took place in June, has yet to be rendered. A final decision from Judge Harris on the case is expected by Nov. 10. Amgen is the second U.S. pharmaceutical/biotech company to benefit from the new Omnibus Trade Act's elimination of injury requirements and broadened definition of domestic industry. Last week, ITC granted Upjohn's request to block entry of foreign-produced minoxidil into the U.S. to prevent infringement of the Rogaine patent ("The Pink Sheet" Sept. 26, "In Brief"). Ironically, Upjohn, acting as intervenor on the behalf of Chugai and licensee of Chugai's erythropoietin, argued for a narrower meaning of domestic industry, a position antithetical to the company's argument in recent ITC proceedings concerning Rogaine. In that case, Upjohn had argued that domestic industry can preclude FDA approval of the product, whereas in the case of Amgen, Upjohn attempted to argue that Amgen did not meet the requirements of a domestic industry due to its lack of requirement for domestic industry under the new trade law.

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