By Sydney Kokjohn --
Fish & Richardson and its pharmaceutical client Japan Tobacco Inc. recently discovered another error in the U.S. Patent and Trademark Office's method of calculating patent term adjustment ("PTA"). On January 8, 2009, Fish & Richardson filed an Application for Patent Term Adjustment under 37 C.F.R. § 1.705(d) (see Application). In addition to arguing that additional patent term was due in light of Wyeth v. Dudas, 580 F. Supp. 2d 138 (D.D.C. 2008) (see Patent Docs post), Fish & Richardson argued that the Patent Office was incorrectly calculating "B-delay" (delay for failure to issue a patent within three years of the actual filing date of the application) for U.S. national stage applications. The Patent Office was using the date on which an international applications fulfilled the requirements of 35 U.S.C. § 371 as the filing date for calculation of B-delay. But 37 C.F.R. § 1.702(b) states that "the term of an original patent shall be adjusted if the issuance of the patent was delayed due to the failure of the Office to issue a patent within three years after the date on which the application was filed under 35 U.S.C. 111(a) or the national stage commenced under 35 U.S.C. 371(b) or (f) in an international application." Section 371(b) states that subject to § 371(f), "the national stage shall commence with the expiration of the applicable time limit under article 22 (1) or (2), or under article 39 (1)(a) of the [PCT]." Fish & Richardson pointed out that the time at which the national stage is commenced under section 371(b) and PCT Articles 22(1), 22(2), and 39(1)(a), and thus the "actual filing date" for purposes of calculating B-delay, is thirty months from the priority date of the international application.
While Fish was not successful with its Wyeth argument, the Patent Office did grant Japan Tobacco additional patent term for B-delay, indicating that B-delay should be calculated based on the date on which the national stage commenced, not the date on which the requirements of § 371 were fulfilled as it had previously determined (see Decision). But the PTO's new PTA calculation method is not always beneficial for the applicant. Fish & Richardson has indicated on its website that applicants may also be granted too much patent term adjustment if they fulfill the § 371 requirements, but do not expressly request early processing of the national stage application under § 371(f) (see Correct Method for Measuring "B Delay" for 371 National Stage Applications). Under this section, an applicant may expressly request that the national stage be commenced as long as the requirements of § 371(c) have been met. If the applicant does not expressly request commencement of the national stage, § 371(b)'s thirty month date will be the date used in B-delay calculations even if the applicant met the requirements of § 371(c) prior to that date. In this situation, the applicant will be granted less patent term under the new calculation.
Note also that "A-delay" for failure to mail a notification under 35 U.S.C. § 132 or a notice of allowance under 35 U.S.C. § 151 is still calculated from the date of fulfillment of the requirements of § 371 (see 35 U.S.C. § 154(b)(1)(A)(i)(II) and 37 C.F.R. § 1.702(a)(1)). Interestingly, however, A-delay is not affected by late submission of a fee and/or oath in a filing under 35 U.S.C. § 111(a). 37 C.F.R. § 1.702(a)(1) states that "the term of an original patent shall be adjusted if the issuance of the patent was delayed due to the failure of the Office to . . . [m]ail at least one of a notification under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151 not later than fourteen months after the date on which the application was filed under 35 U.S.C. 111(a) or fulfilled the requirements of 35 U.S.C. 371 in an international application." The filing date for purposes of § 111(a) and A-delay is "the date on which the specification and any required drawing are received in the [Patent Office]" (see 35 U.S.C. § 111(a)(4)). An applicant may lose patent term if he fails to respond to the notice of missing parts within three months, but the late filing of an oath or fee in an application filed under § 111(a) does not affect that calculation of A-delay for failure to issue an action or notice of allowance within fourteen months. The late filing of any of the requirements under § 371(c), however, does affect the calculation of A-delay. Thus, a discrepancy remains between the calculation of A-delay for applications under § 111(a) and the calculation for U.S. national stage applications.
Patent practitioners should remember that under 37 C.F.R. § 1.704(b), "an applicant shall be deemed to have failed to engage in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of three months that are taken to reply to any notice or action by the Office making any rejection, objection, argument, or other request." The three-month period applies to replies to all notices and actions, including those in which the shortened statutory period is less than three months, such as restriction requirements and notices of missing parts.
In sum, this decision provides another reason for patent practitioners to request additional patent term for many U.S. national stage filings and suggests that such petitions are likely to be more successful than petitions filed pursuant to the Wyeth decision. In addition, patent practitioners should carefully analyze all rules regarding patent term adjustment in order to maximize patent term.
Patent Docs thanks Fish & Richardson for alerting the patent community to this issue.