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Executive Summary

AMGEN EPO INFRINGMENT CLAIM V. CHUGAI DISMISSED BY ITC on April 10. The International Trade Commission dismissed the complaint for "lack of subject matter jurisdiction" on the grounds that Amgen's patent does not cover the process for producing erythropoietin (EPO). The complaint alleged that importation of Chugai's EPO represents an unfair trade practice because the product is made by a process which, if practiced in the U.S., would infringe Amgen's patent. Explaining its decision, ITC said: "We conclude that subject matter jurisdiction [under the applicable part of the Tariff Act] may be invoked only when process patent claims exist." Amgen's patent, the commission continued, "covers articles, i.e., host cells, but not processes. Under these circumstances, we determine that the commission does not have subject matter jurisdiction over Amgen's complaint." Accordingly, the order concludes, "we dismiss Amgen's complaint for lack of subject matter jurisdiction." Amgen still has a second complaint against Chugai, alleging unfair trade acts, pending at ITC. The commission has until May 11 to decide whether to consider the complaint. Amgen filed the request for relief on Feb. 3, following the Jan. 10 initial determination by ITC Administrative Law Judge Sidney Harris that importation of Chugai's EPO does not infringe Amgen's patent ("The Pink Sheet" Jan. 16, T&G-2). Amgen and Genetics Institute also have patent suits pending against each other in Boston Federal District Court. Chugai manufactures EPO for Genetics Institute's U.S. trials, and will manufacture the product for Upjohn, Genetics Institute's marketing partner, once the product is approved. The Boston patent case is expected to go before the federal court in August. In a commentary on the opinion, ITC Chairman Anne Brunsdale and Vice Chairman Ronald Cass concurred with the majority commission decision that Amgen is not entitled to relief, but maintained that the commission does have jurisdiction over the matter. "The commission plainly has jurisdiction over this matter but, because the scope of the patent is less than was alleged by complainant, we do not have statutory authority to grant a remedy for the actions of which Amgen complains," Brunsdale and Cass said. "We believe the majority needlessly engenders confusion by styling its decision as a dismissal for want of jurisdiction," they added.

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