“[P]ost-interference examination period” was RCE time “attributable to Mayo” that reduced time of patent term adjustment (PTA)


Mayo Foundation v. Andrei Iancu (USPTO)

Docket No. 2018-2031
NEWMAN, LOURIE, DYK
September 16, 2019

Brief Summary: DC determination that “post-interference examination period” was “was RCE time ‘attributable to Mayo, and not the PTO’” and reduced Mayo’s PTA time.

Summary: Mayo appealed DC decision finding the PTO’s calculation of the patent term adjustment (PTA (section 154)) for US 8,981,063 relating to anti-HIV antibodies. The PTA provided under section 154 “compensates applicants for three broad classes of delay”: the “A Delay” for “when the PTO does not meet certain deadlines in the processing of patent applications”; the “B Delay” “for each day the application is pending beyond three years”; and, the “C Delay” “for each day the application is pending in an interference proceeding, a secrecy order, or a successful appeal” to the USPTO or a federal court. Section 154(b)(2) requires the PTA to be reduced “by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution”, including “RCE time” (Novartis, FC 2014; Supernus, FC 2019). The FC panel explained that “[t]his appeal concerns the calculation of [the] B Delay” (three year pendency) and that “the PTO calculated a PTA of 621 days, with no B Delay” and Mayo argued “it was due 685 days, because “[t]he examiner’s sua sponte reopening of prosecution after termination of the interference was not [RCE time under 35 U.S.C. [section] 154(b)(1)(B)(i)]”, calculating “the RCE time” (i.e., “the time between the filing of the RCE and the declaration of the interference”) as 148 days. The PTO calculated the RCE time as 342 days, “the 148 days identified by Mayo and the 194 days between the termination of the interference and mailing of the Notice of Allowance.” The DC agreed with the PTO, concluding “that the examination time after remand” (following termination of the interference) “was RCE time ‘attributable to Mayo, and not the PTO’”. The FC panel explained that “[p]atent term adjustments are reviewed in accordance with the Administrative Procedure Act (‘APA’)” and that PTO actions must be set aside…if it is, inter alia, ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law’ or ‘in excess of statutory jurisdiction, authority or limitations, or short of statutory right’” (5 USC section 706), and that here “[t]he only question is one of statutory interpretation” which is reviewed de novo (Power Int., FC 2019). Mayo argued “that examination ends once the claims are ‘deemed allowable’” (which occurred in this case before the interference was declared), but the FC panel concluded that this is not indicated by the PTO’s regulations (and “[n]either does Novartis” which held “that the time between the date of mailing of a Notice of Allowance and issuance is not RCE time”). Here, “[u]pon remand” following the interference proceeding, the examiner properly “updated her search” and “issued a rejection for obviousness-type double patenting”. Therefore, “examination clearly did not end under the date the Notice of Allowance was mailed.” The FC panel therefore affirmed the DC decision. Judge Newman’s dissent argued that the “post-interference examination period…plainly is examination delay to PTO procedures.”

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

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