Novartis AG et al. v. Michelle K. Lee (USPTO)


Docket No. 2013-1160, -1179

NEWMAN, DYK, TARANTO
January 15, 2014

Brief Summary: Under 35 § 154(b)(1)(B), the patent term adjustment time should be calculated by determining the length of time between application and patent issuance, then substracting any continued examination time, and determining the extent to which the result exceeds three years.

Summary: Novartis appealed DC dismissal of claims regarding the 35 U.S.C. § 154(b) extensions for fifteen of its patents as untimely asserted and determination that the PTO correctly calculated the extensions for three other patents. The FC panel affirmed the dismissals and found the PTO “partly correct and partly incorrect in its interpretation of § 154(b)(1)(B)” (“Guarantee of no more than 3-year application pendency”) under the Wyeth standard. The regulations are implemented in two steps: 1) patent term is adjusted if issuance was delayed due to the failure of the PTO to issue a patent within three years of filing not including any time consumed by continued examination; and, 2) “[t]he period of adjustment…is the number of days, if any, in the period beginning on the day after the date that is three years after the date that is three years after the date on which the application was filed…and ending on the date a patent was issued, but not including…(1) [t]he number of days, if any, in the period beginning on the date on which a request for continued examination…was filed and ending on the date the patent was issued….” 35 U.S.C. § 154(b)(3) and (4) provide the applicant with a 180-day period during which an applicant may file a civil action to challenge an extension determination. The FC panel agreed with the DC that this requirement was not met for fifteen of Novartis’ patents. The § 154(b)(1)(B) arguments turned on whether all time “consumed by continued examination…does not count toward depleting the allotment of three years” (“no adjustment of time is available for any time in continued examination, even if the continued examination was initiated more than three years after the application’s filing”). The FC panel found, however, that “that view runs counter to the textual fact that there is no time-of-initiation restriction on the processes identified in the exclusions, including continued examinations” (pointing to § 154(b)(1)(B) (i), (ii) and (iii)). “The better reading”, the panel wrote, “is that the patent term adjustment time should be calculated by determining the length of time between application and patent issuance, then substracting any continued examination time…and determining the extent to which the result exceeds three years.” Based on the facts presented in this case, the panel concluded that the calculations for three of Novartis’ patents must be recalculated.

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