Circuit Watcher

07-1014 Amgen, Inc. v. ITC
Before NEWMAN, LOURIE, and LINN, Circuit Judges.
NEWMAN, Circuit Judge. By complaint to the International Trade Commission under Section 337 of the Tariff Act of 1930 as amended, 19 U.S.C. § 1337, Amgen, Inc. charged that certain importations of recombinant human erythropoietin and derivatives thereof (collectively “EPO”) are in violation of Section 337. Amgen charged that the imported EPO and the process by which it is produced in Europe are covered by one or more claims of the following Amgen United States patents: Patent No. 5,411,868 (claims 1 and 2); Patent No. 5,547,933 (claims 3, 4, 5, and 11); Patent No. 5,618,698 (claims 4-9)¹; Patent No. 5,621,080 (claims 4 and 6); Patent No. 5,756,349 (claim 7); and Patent No. 5,955,422 (claim 1). The Intervenors Roche Holding Ltd., F. Hoffmann-La Roche, Ltd., Roche Diagnostics GmbH, and Hoffmann-La Roche, Inc. (collectively “Roche”) are producers and importers of the accused EPO.
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Roche moved for summary determination of noninfringement as to all claims, on the ground that the imported EPO is exempt from infringement by operation of 35 U.S.C. § 271(e)(1), the “safe harbor” statute, because the imported EPO is used only for the statutorily exempt purpose of the development and submission of information under a federal law regulating the manufacture, sale, and use of drugs. The Commission granted the motion for noninfringement, holding that all of Roche’s activities are within the safe harbor, including the foreign production of the imported product. Amgen appeals this ruling, on the principal ground that the safe harbor statute does not apply to Tariff Act violations based on foreign practice of patented processes, and also on the ground that not all of the imported EPO was used for the statute’s exempt purposes.
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We affirm the Commission’s ruling that the safe harbor provided by § 271(e)(1) applies in proceedings under the Tariff Act relating to process patents as well as product patents, for imported product that is used for exempt purposes. … Amgen, Inc. v. ITC.

1. Claims 4 and 5 of Patent No. 5,618,698 were removed from the case during the pendency of this appeal. [↩]