Supernus Pharm., Inc. et al. v. Andrei Iancu (USPTO)

Docket No. 2017-1357

January 23, 2019

Brief summary: DC grant of SJ to the USPTO regarding calculation of the PTA for Supernus’s patent reversed and remanded since Supernus could not have engaged in “reasonable efforts” to disclose a European opposition before the notice was issued by the EPO.

Summary: Supernus appealed the DC’s entry of SJ, based on Gilead (US 2015), with respect to the patent term adjustment for US 8,747,897. The FC panel opinion explains that 35 USC § 1.54(b)(2)(C) regulates the calculation for reduction of patent term adjustment (PTA) where an application failed “to engage in reasonable efforts to conclude” examination and 37 CFR § 1.704(c)(8) relates to the applicant’s submission of “a supplemental reply or other paper”. During prosecution of the ‘897 patent, Supernus filed an RCE on Feb. 22, 2011 in response to an Aug. 20, 2010 final rejection. On Sept. 11, 2012, Supernus’s European counsel notified it of an opposition against its corresponding European application, and an IDS regarding the same was filed on Nov. 29, 2012 (79 days after being notified by European counsel, and 100 days from EPO notification). On Sept. 10, 2013, the USPTO issued a first office action in response to the RCE and allowed the application on Feb. 4, 2014, with a 1,260-day PTA. The USPTO calculated the PTA by adding 1,656 days of Type A delays (for the USPTO’s failure to meet statutory deadlines) and 665 days for Type B delays (for the USPTO’s failure to issue the patent within three years of filing the application), and then subtracting 175 days of overlapping Type A and Type B delays as well as 886 days attributed to Supernus’s delay, including 646 days for the period between the filing of the RCE and the IDS. Supernus appealed the PTA calculation to the DC with respect to the 646 day subtraction (that “it was entitled to at least 546 of those days-i.e., the period between its filing of the RCE and the EPO notification”), but the DC granted SJ in favor of the USPTO under Gilead (“foreclosed, as a matter of law, Supernus’s statutory interpretation arguments”). In this appeal, the FC panel first explained “that Gilead does not foreclose Supernus’s statutory interpretation argument” as “the precise question addressed in Gilead” was “whether a failure to engage in reasonable efforts requires conduct that actually causes delay” (“as opposed to the potential to cause delay” (i.e., “what constitutes ‘reasonable efforts’”?) was not the question here, which was “whether efforts taken by Supernus, or those it could have taken, resulted in actual or potential delay”. Supernus and the USPTO agreed Supernus “could not have undertaken any efforts to conclude prosecution” before the EPO notified it of the opposition (i.e., the 546-day period). The FC panel reviewed the statute and concluded that “PTA cannot be reduced by a period of time during which there is no identifiable effort in which the application could have engaged to conclude prosecution” because such time would “exceed the time during which an applicant failed to engage in reasonable efforts” (“The ‘equal to’ limitation ensures that applications will be charged the full amount of time corresponding to their own delays…[t]o conclude otherwise renders the PTA statute’s ‘reasonable efforts’ language superfluous.”) Thus, the FC panel the 546-day reduction could not be included in the PTA calculation, and reversed and remanded the DC’s decision.

This entry was posted in America Invents Act, Patent Term Adjustment (PTA), Patent Term Extension. Bookmark the permalink.

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