Gilead Sciences, Inc. v. Michelle K. Lee, et al.


Docket No. 2014-1159

DYK, WALLACH, HUGHES
February 26, 2015

Brief Summary: PTO decision to reduce PTA due to the filing of a supplemental IDS after filed a response to a restriction requirement was reasonable.

Summary: Gilead appealed DC decision regarding the Patent Term Adjustment (PTA) for US 8,148,374. In 1999, Congress enacted 35 USC 154(b) “Adjustment of patent term”, providing for three general categories of delays: category A (“Guarantee of prompt Patent and Trademark Office responses” providing the PTO 14 months from filing to take action on an application); category B (“Guarantee of no more than 3-year application pendency”); and category C (Guarantee of adjustments for delays due to derivation proceedings, secrecy orders, and appeals”). The statute also provides for reduction of the adjustment for delays attributed to applicant conduct (“the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application”). The application on which the ‘374 patent was issued was filed on Feb. 22, 2008. On Nov. 18, 2009, the Examiner issued a restriction requirement to which Gilead responded on Feb. 18, 2010. Gilead then filed a supplemental IDS on April 16, 2010. A notice of allowance was issued on July 29, 2011 and issued on April 3, 2012. In calculating the PTA, the PTO reduced the number of days by 35 days (overlapping delay) and 57 days for the period between Gilead’s initial reply to the RR and its filing of the supplemental IDS. Gilead argued “its filing of the supplemental IDS did not cause any actual delay and therefore should not have been subtracted from its PTA.” The DC concluded the PTO’s interpretation of the rules was not unreasonable. The FC opinion explained “nothing in the plain language of the statute suggests reasonableness requires the applicant’s behavior to have an effect” on prosecution (“Absent a clearly expressed legislative intention to the contrary, [the statutue’s plain] language must ordinarily be regarded as conclusive.” Consumer Prod., US 1980). Gilead also pointed to Congress’ use of an example of a “failure to engage in reasonable efforts” in which an applicant does not respond to an office action within three months but the FC disagreed this indicates “Congress meant to restrict such conduct solely to applicant conduct causing delay.” It also found the House committee reports cited by Gilead did not support Gilead’s arguments (“it appears Congress’s primary intent was to penalize applicant conduct as opposed to the results of such conduct…Gilead’s interpretation of the statute necessarily leads to an illogical distinction between applicants whose conduct is intended to cause delay, but who nonetheless faily, from those whose conduct incidentally results in causing an actual delay. In such a scenario, egregious and obvious delay tactics would remain unsanctioned merely because they do not result in actual delay.”) The opinion also explained: “Although an applicant’s conduct may not actually result in delaying the issuance of that applicant’s patent, such conduct may have negative externalities for other patent applicants because it could result in delaying the issuance of their patents” (“…an Examiner is required to review a significant number of applications during a limited period of time.”) The opinion concluded that “the PTO’s construction of the statute [is] reasonable”.

This entry was posted in America Invents Act, Patent Prosecution, Patent Term Extension. Bookmark the permalink.

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