By Andrew Williams --
Last year, a panel of the Federal Circuit affirmed the International Trade Commission's (ITC's) grant of summary judgment against Amgen in its attempts to block importation of Roche's Mircera® peglylated erythropoietin product. At the time, Patent Docs provided a detailed report of the decision and its implications. As a review, in an decision authored by Judge Newman, and joined by Judge Lourie, the Federal Circuit affirmed the ITC's interpretation of the interactions of 19 U.S.C. § 1337, 35 U.S.C. § 271(e)(1) and § 271 (g), finding that the safe harbor provision of § 271(e)(1), which protects activities that are "reasonably related" to producing information for submission in support of obtaining regulatory approval, is as applicable to actions under Section 337 of the Tariff Act as it is to patent infringement actions in district courts under § 271 (g). At issue was whether the Mircera® drug product produced by Roche offshore using a process covered by claims in the United States would fall under the safe harbor provision in an action brought before the ITC. Judge Linn dissented from this ruling as it applied to those process claims. Even though he believed that the Court's decision was consistent with the apparent intent of Congress, Judge Linn pointed out that the safe harbor provision provides that the activities covered by the provision "shall not be an act of infringement," but that the statute governing process claims before the ITC does not actually require an act of infringement. Therefore, based on the plain meaning of the statute, the fact that the safe harbor provision protects what otherwise would have been an act of infringement is irrelevant for the determination of whether the ITC can issue an exclusion order related to method claims. Judge Linn was, however, pleased to join the remainder of the opinion.
In its previous opinion, the Federal Circuit reversed and remanded on the question of whether any portion of the imported Mircera® drug product fell outside of the safe harbor because the ITC had not considered whether the imported Mircera® had been used for activities other than those related to obtaining FDA approval. Specifically, Amgen alleged that it did not bring the action until Roche has completed its submission to the FDA, and that Roche had shifted its attention in the United States to infringement analysis experiments, market-seeding trials, and litigation-related activity. Because the ITC had incorrectly held that all importation and uses of the Mircera® drug product are exempt while FDA approval is pending, the Federal Circuit remanded.
Finally, in Part II of its prior opinion, the panel held that the ITC had the power to use its authority prophylactically to ban importation, so as to prevent harm to American industry "in its incipiency." The ITC had determined that it lacked jurisdiction to "investigate and resolve" Amgen's charges of infringement because its jurisdiction was limited to acts of importation and the sale of infringing articles (or articles made by using an infringing process) and there was no evidence that any of Roche's Mircera® drug product had been sold or the subject of a contract for sale in the U.S. -- an observation that was true because Roche had not yet received FDA approval for Mircera®. The panel provided detailed reasoning for its decision, including pointing out that the purpose of an ITC action was to prevent infringing articles from getting into the stream of commerce, and that actions before the ITC unify actions against accused infringers before commercial activities require a profusion of individual suits to prevent infringement. The panel also noted that where the infringing acts are reasonably likely to occur, such as the present case where a party undertakes systematic efforts to meet regulatory requirements to market an imported drug product, the ITC has jurisdiction to consider infringement during the safe harbor period. Thus, the panel concluded that the ITC erred in holding that it lacked jurisdiction under the Tariff Act absent actual sale or contract for sale of the imported Mircera®.
At the urging of both the ITC and Roche, an en banc Federal Circuit "authorized" the panel in the earlier Amgen Inc. v. ITC case to revise Part II of its opinion related to the jurisdictional question, vacated the previous judgment and withdrew the accompanying opinion, and returned the appeal to the original panel. Correspondingly, on Thursday of last week, that panel issued a revised opinion to accompany that order from the en banc court. It appears from a comparison of the two opinions that the panels conclusions reached in Parts I.A and I.B were left unchanged, as well as Judge Linn's dissent from Part I.A. The only difference in the two opinions was that the panel revised its response to the jurisdictional question, which was apparently informed by further briefing from both parties. The panel noted that there was actually no dispute as to whether Roche had imported Mircera® -- even Roche had acknowledged this while at the same time arguing that the importation fell within the safe harbor provision of § 271(e)(1). Moreover, the panel pointed out that that this was a jurisdictional issue, and as such, it should not depend on the merits of Amgen's complaint. Simply put, Amgen alleged that Roche imported Mircera®, an article made by a process that is patented in the U.S. This was enough to overcome the jurisdictional hurdle. The question of whether such importation was entitled to the protection of the safe harbor provision, or whether there was actually any importation at all, goes to the merits of Amgen's complaint. The panel concluded that it did not need to address whether the ITC would have had jurisdiction based on "imminent importation," because Amgen had asserted actual importation. As a reader of the revised opinion will note, the outcome from Part II of the opinion remained unchanged -- the ITC had and has jurisdiction to decide this case. However, the reasoning behind the original decision (as well as the holding that it is possible for the ITC to have jurisdiction absent actual sale or a contract for sale) was replaced with the simple observation that jurisdiction is conferred by a simple allegation of importation. In the case of the importation of drug products, however, as long as the accused drug product is being imported prior to FDA approval, the patent holder should still be able to avail themselves of the ITC without worry. Whether the patent holder will be successful will obviously depend on the merits of the case.
Panel: Circuit Judges Newman, Lourie, and Linn
Per curiam, dissenting opinion as to Section I.A. by Circuit Judge Linn
Amgen Inc. v. International Trade Commission (Fed. Cir. 2009)
Panel: Chief Judge Michel and Circuit Judges Newman, Mayer, Lourie, Rader, Schall, Bryson, Gajarsa, Linn, and Prost
Per curiam (order)
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