Amgen holds at least six US patents that relate to erythropoeitin and its derivatives (“EPO”) and processes for making EPO, protecting the Amgen drugs Aranesp and Epogen. Sales of Aranesp alone topped $3.6 million last year. Roche produces EPO in Europe and has been seeking FDA approval for its own EPO drug, Mircera, in the US.
Roche began importing EPO as part of its effort to generate data for its regulatory submissions to the FDA. Amgen did not object to these acts of importation. However, Roche continued importing EPO even after its FDA application was complete (though Roche has not yet sold or contracted to sell any of its EPO in the US). Amgen responded by filing a Section 337 action with the International Trace Commission (ITC), asking the ITC to enjoin Roche’s further importation and future sale in the US of its European-produced EPO.
The ITC denied Amgen’s injunction request because (1) the ITC determined that Roche’s importation of EPO was protected by the FDA “safe harbor” provision of Section 271(e)(1), which provides that conduct cannot infringe a patent when it is reasonably related to securing FDA approval; and (2) the ITC has no jurisdiction absent a sale or contract for sale of EPO in the US. In a decision Wednesday, the Federal Circuit affirmed in part, reversed in part, and remanded the case to the ITC.
Amgen made three arguments on appeal: (1) Section 271(e)(1) provides no exemption for the importation of articles made overseas by patented processes in Section 337 actions before the ITC; (2) Section 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 article is imminent. All three Federal Circuit panelists sided with Amgen on the second and third points. On the first point, however, Judges Newman and Lourie agreed with the ITC, while Judge Linn dissented to express his agreement with Amgen’s argument.
On Amgen’s first point, the majority accepted the ITC’s argument, i.e., that the Section 271(e)(1) safe harbor should operate identically in ITC litigation as in federal district court litigation. The importation of an article made by an infringing process constitutes an act of infringement under Section 271(g). But the safe harbor of Section 271(e)(1) holds that certain acts related to gaining regulatory approval are not acts of infringement. Therefore, 271(e)(1) cuts back on 271(g) by declaring that certain types of conduct do not constitute infringement. The ITC, however, does not look to Section 271(g) for its authority. Instead the ITC looks to 19 USC § 337(a)(1)(B)(ii), which declares unlawful the importation of any article “made . . . by means of a process covered by the claims of a valid and enforceable United States patent.” In contrast, Section 271(g) only forbids the importation of articles made by means of a process that infringes the claims of a valid and enforceable US patent. Because the safe harbor of Section 271(e)(1) only addresses infringement, Judge Linn (in dissent) argues that the safe harbor applies to infringement liability under Section 271(g) but not to unlawful trade practices under Section 337(a)(1)(B)(ii). The majority’s holding elects to gloss over these key differences between Section 271(g) and Section 337.
On the other hand, the majority’s holding probably does comport more closely with the policy rationales that support having the regulatory safe harbor. As the majority notes, the legislative history supports this proposition that the 271(e)(1) safe harbor applies identically to importation under Section 271(g) and to importation under Section 337(a)(1)(B)(ii). Moreover, the Supreme Court’s broad reading of the scope of the regulatory safe harbor in Integra v. Merck and Eli Lilly v. Medtronic lends further support for the majority’s policy judgment. Judge Linn even agrees that the majority reaches the policy outcome that makes the most sense. Nevertheless, the text of Section 337(a)(1)(B)(ii) is clearly at odds with such a policy outcome.
On Amgen’s second point, the Court agreed with Amgen. The safe harbor of Section 271(e)(1) does not provide blanket protection for all pre-FDA-approval conduct. For each separate act, the accused party must demonstrate that each act is reasonably related to gaining regulatory approval. Amgen asserted that Roche continued importing EPO after its FDA application was complete and used the imported EPO to conduct marketing studies. The Court remanded the case to the ITC for an act-by-act evaluation of whether Roche’s conduct was indeed within the ambit of Section 271(e)(1).
On Amgen’s third point, the Federal Circuit held that the ITC jurisdiction is invoked “[w]hen it has been shown that infringing acts are reasonably likely to occur . . . .” The court went to great lengths to point out that this standard is not new, and is, in fact, consistent with nearly three decades of ITC precedent. Because Section 337 provides for a prospective remedy, it makes no sense for the complainant to wait for an actual sale to occur, so long as an actual sale is imminent.
The link for decision is as follows: http://www.cafc.uscourts.gov/opinions/07-1014.pdf
(As per the article published on Orange book Blog)
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