Amgen v. ITC and Roche (CAFC 2007-1014)

Judge Newman writes for the majority, including Judge Lourie.

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).

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.

However, Roche's uses of imported EPO unrelated to obtaining FDA approval are not shielded by the exemption.

So the matter was remanded back to the ITC whether all of Roche's uses were within safe harbor.

The ITC whined "that it did not have jurisdiction to investigate and resolve the charges of infringement," thus denying discovery to Amgen. The CAFC ruled that the ITC did have jurisdiction.

Judge Linn, in dissent, highlights the uncertainty of which law applied, 35 U.S.C. §271 or 19 U.S.C. §1337? The majority had ruled §271, even though ITC action is covered under §1337, the Tariff Act.

The thrust of the majority's position is that Congress probably intended § 271(e)(1) to apply in section 337 proceedings the same way it applies in patent infringement litigation under Title 35. While I agree that it would make sense for section 337 to apply that way, the problem remains that if that is what Congress intended, it is not what Congress unambiguously said.

The language of § 1337(a)(1)(B)(ii) contrasts with the language of § 1337(a)(1)(B)(i), the corresponding provision governing proceedings regarding patented products. Section 1337(a)(1)(B)(i) declares unlawful the importation of articles that "infringe a valid and enforceable United States patent." Thus, there is no dispute that the safe harbor of § 271(e) applies to product claims before the Commission; the unlawfulness under section 337 of the importation of a patented product hinges on whether the importation is itself an act of infringement.

It appears that this difference in language is not accidental.

Linn traced the legislative history, and saw an incongruity beyond the province of the court to resolve.

Whether deliberately or through oversight, when Congress passed § 271(g), it enacted statutory text that is not consistent with the majority's interpretation of congressional policy.

In short, I see no basis for concluding that Congress did not intend what it said. I do not disagree with the majority's policy judgment that § 1337 and § 271 should be brought into synchrony. But that is not a decision for a court to make, particularly in light of the legislative history. "[I]t is not our function to eliminate clearly expressed inconsistency of policy and to treat alike subjects that different Congresses have chosen to treat differently." W. Va. Univ. Hosps., Inc. v. Casey, 499 U.S. 83, 101 (1991). Indeed, it is worth noting that there are also potential policy arguments in support of the textual reading of the statute. Congress may not have intended to extend the same benefits of § 271(e)(1) to foreign pharmaceutical companies as it extended to domestic ones, or it may have intended to discourage the importation of pharmaceuticals that have not yet been approved by the FDA. But "[i]t is not our job to speculate upon congressional motives." Riegel v. Medtronic, Inc., No. 06-179 (U.S. Feb. 20, 2008).

By contrast, the majority had relied upon Supreme Court precedent in broadly applying §271(e)(1), based upon stated legislative policy.

In enacting '271(g) the legislative history included the policy statement that:

Specifically, the Committee does not intend that it shall be an act of infringement to import a product which is made by a process patented in the United States "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." See 271(e)(1) of title 35, United States Code. Congress previously decided that certain actions do not constitute patent infringements and this Act does not change that prior policy decision.

S. Rep. No. 100-83, 48 (1987). Implementing in other contexts this broadly stated congressional policy, in Merck KgaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005) the Court explained that Congress intended that the immunity of regulatory activity not be inhibited, stating that "§271(e)(1)'s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA." Id. at 202 (emphasis in original). And in Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990) the Court held that '271(e)(1) includes medical devices, although the statute mentions only drugs and veterinary products; the Court stated that "[t]he phrase 'patented invention' in §271(e)(1) is defined to include all inventions, not drug-related inventions alone." Id. at 665. In both Merck and Eli Lilly the Court stressed the congressional purpose of removing patent-based barriers to proceeding with federal regulatory approval of medical products. This purpose and its application in precedent weigh heavily against selectively withholding the §271(e)(1) exemption depending on whether the infringement action is in the district court or the International Trade Commission. We thus affirm the Commission's ruling that the safe harbor statute applies to process patents in actions under Section 337, when the imported product is used for the exempt purposes of §271(e)(1).