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.
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.
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.
The Commission also ruled that it did not have jurisdiction to investigate and resolve the charges of infringement, reasoning that the product subject to the safe harbor had not been sold in the United States and was not the subject of an existing contract for sale, and ruling that sale as well as importation is required for Section 337 jurisdiction. Amgen appeals this ruling, arguing that Roche's announced imminent FDA approval of the imported EPO and the accompanying end of safe harbor protection, as well as Roche's extensive arrangements to sell in and to the United States market upon FDA approval, suffice to establish Commission jurisdiction. In this connection Amgen complains about the Commission's denial of discovery of Roche's marketing arrangements, thereby preventing Amgen from meeting the Commission's requirement of proving sale or contract for sale.
We reverse the Commission's ruling that it had no jurisdiction to determine violation of Section 337 in the posture of this case.
The Commission's statutory interpretations and rulings of law receive plenary review, applying the standards of the Administrative Procedure Act. See 19 U.S.C. '1337(c); 5 U.S.C. '706; e.g., Jazz Photo Corp. v. United States Int'l Trade Comm'n, 264 F.3d 1094, 1099 (Fed. Cir. 2001). Plenary review is given to the Commission's summary determinations, which are governed by the criteria of summary judgment and are reviewed accordingly. See 19 C.F.R. '210.18(b) (authorizing summary determination by the Commission if there is no genuine issue of material fact and the moving party is entitled to prevail as a matter of law); Hazani v. United States Int'l Trade Comm'n, 126 F.3d 1473, 1476 (Fed. Cir. 1997) (reviewing the Commission's summary determinations in accordance with the standards for summary judgment).
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