Amgen v. International Trade Commission : The 271(e)(1) Safe Harbor Provision and ITC Jurisdiction in Section 337 Proceedings

CERA, the name of Roche's product, stands for Continuous Erythopoiesis Receptor Actuator.

Section 337 of the Tariff Act declares unlawful 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 infringe a valid and enforceable United States patent or 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…. See 19 U.S.C. § 1337(a)(1)(B)(i) and (ii).

35 U.S.C. § 271(e)(1) states: 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.

When a section 337 proceeding is instituted, ‘the Chief Administrative Law Judge at the Commission assigns an Administrative Law Judge to preside over the proceedings and to render an initial decision (referred to as an “Initial Determination”) as to whether section 337 has been violated’. The US International Trade Commission: Section 337 Investigations — Answers to Frequently Asked Questions (March 2009) at 1–2 (found at http://www.usitc.gov/intellectual_property/documents/337_faqs.pdf). The following discussion of the Initial Determination is based on a non-confidential version in which several sections have been redacted.

35 U.S.C. § 271(g) states: 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.

Only a decision by the full Commission (that is, a final determination) can be appealed to the Federal Circuit. However, by refusing to review the ALJ's Initial Determination, the Initial Determination becomes the final determination of the Commission, which can then be appealed to the Federal Circuit. See The US International Trade Commission: Section 337 Investigations — Answers to Frequently Asked Questions (March 2009) at 3 (found at http://www.usitc.gov/intellectual_property/documents/337_faqs.pdf).

In footnote 1 of its petition, Roche noted that ‘[i]n Amgen, Inc. v. F. Hoffman-La Roche Ltd. (Civ. Action No. 05-12237 WGY), which involves the same patents and accused product at issue here, the US District Court for the District of Massachusetts preliminarily enjoined Roche from selling CERA in the United States. Roche has appealed that preliminary injunction to this Court’ Id. at *4, footnote 1. In view of the entry of the preliminary injunction, the authors query whether launch of Roche's product was indeed ‘reasonably likely to occur’. On 17 October 2008, the District Court entered a permanent injunction against Roche. The case was appealed to the Federal Circuit. On 15 September 2009, the Federal Circuit issued an opinion vacating and remanding several of the District Court's findings but did not disturb the District Court's permanent injunction.

Roche also noted that contrary to the statement in the majority opinion that ‘The Commission … ruled that it did not have jurisdiction to investigate and resolve the charges of infringement’ the Commission had exercised ‘jurisdiction to investigate Amgen's charges, conducted an investigation, and ruled on the merits that there was no violation of section 337’ Id.

The Supreme Court's ruling in Chevron USA, Inc. v. Natural Resources Defense Council, Inc., 467 US 837 (1984), set forth the legal test for determining whether to grant deference to a government agency's interpretation of its own statutory mandate. In a subsequent decision the Supreme Court summarized Chevron deference by stating ‘[w]hen a statute speaks clearly to the issue at hand we “must give effect to the unambiguously expressed intent of Congress”, but when the statute “is silent or ambiguous” we must defer to a reasonable construction by the agency charged with its implementation’. Barnhart v. Thomas, 540 US 20, 26 (2003).

‘CCPA’ stands for the United States Court of Customs and Patent Appeals, which existed from 1909 to 1982. In 1982, the CCPA was abolished by the Federal Courts Improvement Act, and its jurisdiction, docket and judges were transferred to the Federal Circuit.

It is clear from the Federal Circuit decision, however, that US District Courts may address these questions under the Declaratory Judgment Act. See cases cited in Amgen, 519 F.3d at 1352.