Gilead Sciences, Inc. v. Lee, et al., __ F.3d __ (Fed. Cir. Feb. 26, 2015) (Dyk, WALLACH, Hughes) (E.D. Va.: O’Grady) (2 of 5 stars)
Federal Circuit affirmed grant of summary judgment upholding the PTO’s calculation of a patent term adjustment (“PTA”) under 35 U.S.C. sec. 154(b)(2)(C).
During prosecution of the patent at issue, Gilead submitted a supplemental IDS 57 days after responding to a restriction requirement. Applying 37 C.F.R. 1.704(c)(8) to this supplemental submission, the PTO reduced Gilead’s PTA by 57 days under sec. 154(b)(2)(C), finding that Gilead “failed to engage in reasonable efforts to conclude prosecution” during that period. Gilead challenged the reduction, arguing that the supplemental IDS did not cause any actual delay.
Federal Circuit applied Chevron’s two-step framework and determined that the absence of actual delay was irrelevant. After considering the language of the statute, other statutes, and the legislative history, Federal Circuit first concluded that Congress had not directly addressed whether the “reasonable efforts” provision required actual delay. With respect to the second step, Federal Circuit found that “a reasonable interpretation of the statute is that Congress intended to sanction not only applicant conduct or behavior that result in actual delay, but also those having the potential to result in delay irrespective of whether such delay actually occurred.” Slip Op. at 14.