Amgen, Inc. v. International Trade Comm'n

• Decision Date: 30 April 2009
• Docket Number: No. 2007-1014.,2007-1014.
• Citation: 565 F.3d 846
• Parties: AMGEN, INC., Appellant, v. INTERNATIONAL TRADE COMMISSION, Appellee, and Roche Holding Ltd., F. Hoffmann-La Roche Ltd., Roche Diagnostics GmbH, and Hoffman-La Roche Inc., Intervenors.
• Court: U.S. Court of Appeals — Federal Circuit

565 F.3d 846

AMGEN, INC., Appellant, v. INTERNATIONAL TRADE COMMISSION, Appellee, and Roche Holding Ltd., F. Hoffmann-La Roche Ltd., Roche Diagnostics GmbH, and Hoffman-La Roche Inc., Intervenors.

No. 2007-1014.

United States Court of Appeals, Federal Circuit.

April 30, 2009.

Linda A. Sasaki-Baxley, Day Casebeer Madrid & Batchelder LLP, of Cupertino, CA, argued for appellant. On the brief was Lloyd R. Day, Jr. Of counsel were

David M. Madrid and Katie J.L. Scott. Of counsel on the brief were Cecilia H. Gonzalez and Margaret D. MacDonald, Howrey LLP, of Washington, DC.

Christal A. Sheppard, Attorney, Office of the General Counsel, United States International Trade Commission, of Washington, DC, argued for appellee. With her on the brief were James M. Lyons, General Counsel, and Wayne W. Herrington, Assistant General Counsel.

Michael P. Dougherty, Morgan & Finnegan, LLP, of New York, NY, argued for intervenors. With him on the brief were Bartholomew Verdirame, Tony V. Pezzano, and John C. Vassil, of New York, NY; and Kent R. Stevens, of Washington, DC. Of counsel on the brief were Leora Ben-Ami, Patricia A. Carson, Thomas F. Fleming, Howard S. Suh, and Manvin Mayell, Kaye Scholer LLP, of New York, NY; and V. James Adduci II, Adduci, Mastriani & Schaumberg, LLP, of Washington, DC. Of counsel were Tom M. Schaumberg and Maureen F. Browne, of Washington, DC.

Before NEWMAN, LOURIE, and LINN, Circuit Judges.

PER CURIAM.¹

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)²; 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. In part II, we reverse the Commission's ruling that Roche was entitled to summary determination, because there was a genuine dispute of material fact concerning whether all of Roche's activities fell within this safe harbor. Accordingly, we affirm in part, reverse in part, and remand.

I

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. 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).

A

Section 337 assigns to the Commission the authority and obligation to investigate and prohibit importation based on unfair competition derived from patent, trademark, and copyright infringement, including:

19 U.S.C. § 1337(a)(1) Subject to paragraph (2), the following are unlawful, and when found by the Commission to exist shall be dealt with, in addition to any other provision of law, as provided in this section:

* * *

(B) The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consignee, of articles that—

(i) infringe a valid and enforceable United States patent or a valid and enforceable United States copyright under title 17, United States Code; or

(ii) are made, produced, processed, or mined under, or by means of, a process covered by the claims of a valid and enforceable United States patent. ...

* * *

(b)(1) The Commission shall investigate any alleged violation of this section on complaint under oath or upon its initiative. ... The Commission shall conclude any such investigation and make its determination under this section at the earliest practicable time. ...

The issues on this appeal center on the safe harbor statute for drug products, on application to the imported EPO of the following provisions of Title 35:

35 U.S.C. § 271(e)(1) It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

* * *

§ 271(e)(3) In any action for patent infringement brought under this section, no injunctive or other relief may be granted which would prohibit the making, using, offering to sell, or selling within the United States or importing into the United States of a patented invention under paragraph (1).

The Commission held that the safe harbor statute applies to products produced offshore by a process patented in the United States. Amgen argues that this statute does not bar the exclusion of such importation, reasoning that the § 271(e)(1) reference to importing "a patented invention" is necessarily limited to importation of product, for a process cannot be imported. Amgen states that it is incorrect to assume that Congress, by silence, changed the long-standing Section 337 right and obligation of the Commission to reach importation based on offshore practice of a United States patented process. Amgen argues that the 1988 enactment of 35 U.S.C. § 271(g), whereby the Patent Act provided remedy in the district courts for offshore practice of a patented process but explicitly applied the safe harbor to § 271(g), shows congressional intent to limit the safe harbor to process patents that would be enforced under § 271(g):

35 U.S.C. § 271(g) Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent. ... A product which is made by a patented process will, for purposes of this title, not be considered to be so made after—

(1) it is materially changed by subsequent processes; or

(2) it becomes a trivial and nonessential component of another product.

Amgen states that the enactment of § 271(g) makes clear that the Commission's authority under Section 337 was not changed by enactment of § 271(g), because in adding § 271(g) to Title 35 when Congress enacted the Process Patent Amendments of 1988, Congress stated that "[t]he amendments made by this subtitle shall not deprive a patent owner of any remedies available under subsections (a) through (f) of section 271 of title 35, United States Code, under Section 337 of the Tariff Act of 1930, or under any other provision of law." Pub.L. 100-48, § 9006(c) (1988). That is, Congress preserved both the safe harbor, 35 U.S.C. § 271(e)(1), and the Tariff Act's Section 337, in enacting § 271(g). Amgen states that this means that process patent infringement would give way to the safe harbor when enforced in the district courts under § 271(g), while remedy is retained for process patent infringement enforced under Section 337. Amgen stresses that Section 337 was enacted several decades before § 271(g) was added to the Patent Act, and that the legislative record is clear that the Tariff Act remedy was intended to continue undiminished.

The Commission rejected these arguments, and held that the safe harbor statute fully applies to process patent liability under the Tariff Act. In support the Commission cited Glaxo Inc. v. Novopharm Ltd., 110 F.3d 1562 (Fed.Cir.1997) and Bio-Technology General Corp. v. Genentech, Inc., 80 F.3d 1553 (Fed.Cir.1996). Novopharm related to determinations of infringement based on the filing of an ANDA for product produced offshore; and this court remarked that the "artificial" acts of infringement that are created by § 271(e)(2) — concerning the conditions under which the patentee can sue for infringement during the pendency of the ANDA — relate only to "a drug claimed in a patent or the use of which is claimed in a patent" but not to the process for making the drug. However, the issues in that case did...