The U.S. Court of Appeals for the Federal Circuit affirmed the International Trade Commission's (ITC) ruling that the safe harbor statute applies in proceedings under the Tariff Act relating to process patents, as well as product patents, for imported products that are used for the exempt purposes of § 271(e)(1). The Court, however, reversed the ITC's dismissal for lack of jurisdiction to investigate and remedy issues of infringement and injury. Amgen, Inc. v. Int'l Trade Commission, Case No. 07-1014 (Fed. Cir., March 19, 2008) (Newman J.; Linn, J., dissenting-in-part).
Amgen filed a complaint with the ITC, charging Roche with violation of Section 337 by importing certain recombinant human erythropoietin (EPO) and derivatives thereof and claiming that such importation of EPO and the process by which it was produced in Europe infringed claims in six Amgen patents. Roche moved for summary determination of noninfringement, arguing that the imported EPO is exempt from infringement under the §271(e)(1) safe harbor statute because the imported EPO was used only for the statutorily exempt purpose of developing and submitting information for federal regulatory approval of drugs. The ITC granted Roche's motion, holding that all of Roche's activities were within the safe harbor exemption, including the foreign production of the imported product.
On appeal, the Federal Circuit first addressed whether the safe harbor statute applies in proceedings under the Tariff Act relating to process patents. The Court concluded in the affirmative, reasoning that congressional policy set forth in section 271(g) and the Supreme Court's decisions intended the exemption to extend to "all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA." The Court further stressed that congressional purpose and its application "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." Next, the Court held that not all infringing activities conducted during the period before regulatory approval are automatically exempted under the safe harbor statute. Uses of infringing product unrelated to obtaining Food and Drug Administration approval are not shielded by the exemption. Citing Merck KgaA v. Integra Lifesciences I, Ltd., the Court noted that "[e]ach of the accused activities must be evaluated separately to determine whether the exemption applies.'"
Finally, the Court rejected the ITC's holding that "Roche's announced imminent FDA approval of the imported EPO, and imminent end of the safe harbor, do not suffice to establish Commission jurisdiction to determine the facts of infringement unless actual sale or contract for sale is also shown." The Court noted that both the Federal Circuit and ITC's prior rulings have provided that, when it has been established that infringing acts are reasonably likely to occur, the ITC's obligation and authority are invoked.
Practice Note: The decision further supports that Section 271(e)(1) can often involve complex factual issues that are not ripe for early determination without factual development. The decision also clarifies that the ITC may be an appropriate forum for obtaining an adjudication prior to the product actually being imported in the United States when it has been shown that infringing activities are reasonably likely to occur.
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