FEDERAL CIRCUIT AFFIRMS Patent term adjustment due to filing of supplemental IDS after reply to restriction
Federal Circuit affirmed district court's grant of motion for summary judgment on PTO's calculation of Patent Term Adjustment as proper. Gilead Sciences, Inc. v. Lee, No. 2014-1159 (Fed. Cir. Feb. 26, 2015). Gilead owns USP 8,148,374 relating to compounds and pharma compositions which improve the pharmacokinetics of a co-administered drug. Gilead filed its application for the '374 patent on Feb. 22, 2008 and the examiner issued a restriction requirement on Nov. 18, 2009. On Feb. 18, 2010, Gilead responded to the restriction requirement and while waiting for the PTO to issue a first office action, Gilead filed a supplemental information disclosure statement on April 16, 2010, disclosing two co-pending Gilead patent applications. PTO issued a notice of allowance on July 29, 2011 and calculated the PTA as 651 days, from which 57 days were reduced due to applicant delay for the period between Gilead's reply to restriction and filing of supplemental IDS. Gilead argued that its filing of supplemental IDS didn't cause actual delay but PTO rejected the argument under 35 USC 132 and 37 CFR1.704(c)(8). On appeal to the district court, the court granted PTO's motion for summary judgment on the grounds that Gilead failed to show PTO's interpretation of 35 USC 154(b) was unreasonable. In affirming the district court's judgment, the Federal Circuit concluded, applying the two-step framework of Chevron, that 35 USC 154(b)(2)(C)(iii) expressly delegated authority to the PTO 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." Full text of the opinion is available here.
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