On April 30, 2009, the Federal Circuit issued a per curiam opinion in Amgen, Inc. v. ITC, No. 2007-1014.  Sitting en banc, Judges Newman, Lourie and Linn revised a portion of the March 19, 2008 opinion issued in this case.

By way of background, Amgen holds several U.S. patents relating to recombinant human erythropoietin and derivatives (“EPO”) and processes for making EPO.  Roche produces EPO in Europe and was seeking FDA approval for its own EPO drug in the U.S.  As part of its effort to generate data for its regulatory submissions to the FDA, Roche began importing EPO into the U.S.  Roche continued importing EPO after its FDA application was complete, although not for sale or contract to sell in the U.S.  Amgen initiated a Section 337 action, asserting that Roche’s imported EPO and the process by which it is produced in Europe are covered by one or more claims of six of Amgen’s U.S. patents.

In response, Roche moved for summary determination of non-infringement on the ground that the imported EPO is exempt from infringement by operation of 35 U.S.C. § 271(e)(1) which excuses infringing uses of a patented invention that “reasonably relate to the development and submission of information under a Federal Rule which regulates the manufacture, use, or sale of drugs or veterinary biological products.”  In other words, § 271(e)(1) provides a “safe harbor” from claims of patent infringement based on activities reasonably related to the pursuit of FDA approval of drug products.  The ITC determined that Roche’s activities fell within the safe harbor of § 271(e)(1), including the foreign production of the imported EPO and thus did not infringe Amgen’s U.S. patents.

On appeal, Amgen made three arguments: (1) § 271(e)(1) provides no exemption for the importation of articles made abroad by patented processes in Section 337 actions; (2) § 271(e)(1) does not provide blanket protection for all pre-FDA-approval conduct; and (3) the ITC has jurisdiction whenever sale of the accused product is imminent.  In its 2008 opinion, the Federal Circuit unanimously agreed with Amgen in connection with its second and third arguments, but the majority disagreed with Amgen on its first argument.  With respect to Amgen’s first argument, the majority accepted the ITC’s position that § 271(e)(1)’s safe harbor provision should operate the same in ITC actions as in district court litigation.  This decision was made despite the Federal Circuit’s opinion in Kinik Co.v. ITC, distinguishing between the Patent Act and the Tariff Act with regard to importation of a product made by a patented process as it applies to 35 U.S.C. § 271(g).  Noting that while the importation of a product made by an infringing process constitutes infringement under § 271(g), the Federal Circuit stated that § 271(e)(1) exempts from infringement certain acts reasonably related to obtaining regulatory approval by the FDA.  Accordingly in its 2008 opinion, the Federal Circuit held that Roche’s imported EPO was not subject to exclusion based on infringement of Amgen’s product or process patents, to the extent that the imported EPO was used to develop information that was reasonably related to the submission of information to the federal regulatory authority.

Following the 2008 opinion, Amgen petitioned for a rehearing en banc.  Granting the petition for the limited purpose of reviewing a portion of the previous opinion, the Federal Circuit affirmed the ITC’s ruling that the safe harbor provided by § 271(e)(1) applies in ITC proceedings under Section 337 relating to process patents as well as product patents, for imported product that is used for the exempt purposes.  Amgen argued otherwise, noting the long-standing authority of Section 337 to reach importation based on offshore practice of a U.S. patented process, and asserting that Congress intended to limit the safe harbor provision to process patents that would be enforced under § 271(g).  Specifically, Amgen stated that the ITC’s authority was not changed by enactment of § 271(g), in that process patent infringement would give way to the safe harbor when enforced in the district courts under Section 271(g), while remedy is retained for process patent infringement enforced under Section 337 at the ITC.  Despite such arguments, the Federal Circuit held that the ITC’s ruling is consistent with congressional policy as set forth in enactment of § 271(g), and as elaborated by the Supreme Court in its applications of the safe harbor statute in Merck v. Lifesciences I, Ltd. and Eli Lilly & Co. v. Medtronic, Inc.  Thus, the majority affirmed the ITC’s ruling that § 271(e)(1) applies to process patents in ITC actions under Section 337, and held that the safe harbor provision insulates the Roche EPO from Section 337 exclusion to the extent the EPO is used for the development of information for submission to the FDA.

The Federal Circuit remanded the case to the ITC because the evidence Roche presented about its activity with the EPOs was “conflicting and required closer analysis than it received.”  It directed the ITC to “consider the exempt status of each study for which question has reasonably been raised.”

In a separate opinion concurring in part and dissenting in part with the majority opinion, Judge Linn stated that the majority overstepped its authority in assuming that Congress meant for process patents to be granted the same safe-harbor protections as product patents.