Gilead Sciences, Inc., v. Michelle K. Lee, Deputy Director, USPTO, No. 2014-1159, 2015 U.S. App. LEXIS 2828 (Fed. Cir. Feb. 26, 2015)(Wallach, J.). Click Here for a copy of the opinion.
Gilead appealed from a decision granting summary judgment to the PTO on its calculation of the Patent Term Adjustment (PTA) period for U.S. Pat. No. 8,148,374. Gilead complained that the PTO improperly subtracted a period of applicant delay from the period of PTO delay when calculating the adjusted patent term. Specifically, the appeal asked whether "filing a supplemental IDS after submitting a reply to a restriction requirement constitutes a failure to engage in reasonable efforts to conclude prosecution of the application" under § 154(b)(2)(C). The statute states, in part:
The statute authorizes the Director to "prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application." The PTO promulgated C.F.R. 1.704(c)(8), which in turn defined a failure to engage in such "reasonable efforts" to include "[s]ubmission of a supplemental reply or other paper, other than a supplemental reply or other paper expressly requested by the examiner, after a reply has been filed." The district court concluded that, under Rule 1.704(c)(8), a supplemental Information Disclosure Statement (IDS), when filed after responding to a restriction requirement, was a supplemental paper not requested by the Examiner, and counted against the applicant for purposes of the PTA calculation.
On appeal, the Federal Circuit rejected Gilead's argument that the statute permits a reduction in PTA only "in instances where the applicant's conduct 'actually delays the conclusion of prosecution.'" The court applied a two-step analysis under ChevronU.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), and concluded (1) Congress did not directly address whether a failure to engage in reasonable efforts requires conduct that actually causes delay and (2) the PTO's construction of the statute was reasonable.
Consequently, Gilead's interpretation was neither supported by the plain language of the statute nor by evidence of legislative intent. By the broad language of the statute, "Congress intended the PTO to employ its expertise in identifying applicant conduct demonstrating a lack of 'reasonable efforts to conclude processing or examination of an application." Therefore, "a reasonable interpretation of the statute is that Congress intended to sanction not only applicant conduct or behavior that results in actual delay, but also those having the potential to result in delay irrespective of whether such delay actually occurred." Because the PTO's interpretation of the statute was reasonable, the court affirmed.
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