By Donald Zuhn --
On Friday, the U.S. Patent and Trademark Office published a notice of proposed rulemaking in the Federal Register (84 Fed. Reg. 53090), in which the Office proposes certain revisions to the rules of practice concerning Patent Term Adjustment (PTA) in view of the Federal Circuit's decision in Supernus Pharm., Inc. v. Iancu. In particular, the Office proposes revising the period of reduction of PTA in the following provisions of 37 C.F.R. § 1.704:
• Deferral of issuance of a patent (37 C.F.R. § 1.704(c)(2));
• Abandonment of an application (37 C.F.R. § 1.704(c)(3));
• Submission of a preliminary amendment (37 C.F.R. § 1.704(c)(6));
ª Submission of papers after a decision by the Patent Trial and Appeal Board or by a Federal court (37 C.F.R. § 1.704(c)(9)); and
• Submission of papers after a notice of allowance under 35 U.S.C. § 151 (37 C.F.R. § 1.704(c)(10)).
According to the Office's notice, the proposed changes will specify a period of reduction corresponding to "the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution" as opposed to the consequences to the Office of applicant's failure to engage in reasonable efforts to conclude prosecution.
In Supernus Pharmaceuticals, Inc. v. Iancu, the Federal Circuit reversed the entry of summary judgment by the District Court for the Eastern District of Virginia, which concluded that the U.S. Patent and Trademark Office had not erred in calculating the PTA for U.S. Patent No. 8,747,897. During prosecution of U.S. Application No. 11/412,100, which issued as the '897 patent, the Examiner issued a final Office Action, and Supernus responded by filing a Request for Continued Examination (RCE). After filing the RCE, Supernus was notified that an opposition had been filed in related European Patent No. EP 2 010 189 (which had issued from a European application corresponding to an International application that claimed priority from the '100 application). One hundred days after the European Patent Office's notification of the opposition, Supernus filed a supplemental Information Disclosure Statement (IDS) citing the Notice of Opposition and other documents concerning the opposition. The USPTO ultimately issued the '100 application as the '897 patent, determining that the '897 patent was entitled to 1,260 days of PTA. The Office's PTA determination included an assessment of 886 days of applicant delay, of which 646 days were assessed for the time between the filing of the RCE and the submission of the supplemental IDS. Supernus filed a request for Reconsideration of Patent Term Adjustment, but the Office rejected Supernus' request, concluding that the 646-day reduction in PTA was proper.
Supernus challenged the Office's PTA determination in the Eastern District of Virginia, contending that it was entitled to at least 546 of the 646 days of PTA reduction (i.e., the period of time between the filing of the RCE and the EPO notification of opposition). The District Court granted summary judgment in favor of the USPTO, finding that the USPTO did not err in the PTA calculation for the '897 patent.
In January, the Federal Circuit reversed the District Court's grant of summary judgment in favor of the USPTO, finding that because there were "no identifiable efforts" that Supernus could have undertaken in the time period between the filing of an RCE during prosecution of the application that issued as the '897 patent and the mailing of an EPO notification of opposition for a European counterpart patent (which resulted in Supernus filing a supplemental Information Disclosure Statement during prosecution of the '897 patent), Supernus had not failed to engage in reasonable efforts to conclude prosecution during that time period. The Federal Circuit noted in Supernus that "Congress expressly granted the USPTO authority to determine what constitutes reasonable efforts [under 35 U.S.C. § 154(b)(2)(C)(i)], but the USPTO lacks any authority to exceed the statutory 'equal to' limitation by including the 546-day time period during which it does not contend that Supernus failed to undertake reasonable efforts to conclude prosecution." The Court therefore found the USPTO's PTA reduction for the '897 patent to be inconsistent with the PTA statute, accorded no deference to the USPTO's application of the regulations at issue in the circumstances of this case, and reversed and remanded the District Court's summary judgment order.
In May, the USPTO issued a Federal Register notice notifying stakeholders of the impact of the Supernus decision on its PTA determinations (see "USPTO Issues Notice on Impact of Federal Circuit's Supernus Decision on PTA Procedures"). In its earlier notice, the Office indicated that it was "modifying its patent term adjustment procedures in view of the decision." However, that notice stated that "the USPTO will continue to make the patent term adjustment determinations indicated in patents under the existing regulations using information recorded in its PALM [Patent Application Locating and Monitoring] system," and that a patentee who believes there were no identifiable efforts it could have undertaken to conclude prosecution of an application (as Supernus argued with respect to the '897 patent) "may raise the issue in a timely request for reconsideration of the patent term adjustment, providing any relevant information that is not recorded in the USPTO's PALM system."
In the Office's latest notice regarding the impact of the Federal Circuit's Supernus decision, the Office points out that "[t]he Federal Circuit in Supernus held that a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C) must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application." As a result, the Office is now proposing revisions to certain provisions of 37 C.F.R § 1.704 for consistency with the Federal Circuit's decision in Supernus. The Office's notice explains that the Federal Circuit's decision in Supernus involved a reduction in PTA under the provisions of 37 C.F.R. § 1.704(c)(8), which specifies a period of reduction of PTA equal to "the number of days, if any, beginning on the day after the date the initial reply was filed and ending on the date that the supplemental reply or other such paper was filed," which "corresponds to 'the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution,' except in the rare situation in which such period includes 'a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.'" The Office notes that "[w]hile the Federal Circuit decision in Supernus involved 37 CFR 1.704(c)(8), there are several provisions in 37 CFR 1.704(c)(1) through (c)(14) whose period of reduction corresponds to or includes the consequences to the Office of applicant's failure to engage in reasonable efforts to conclude prosecution, rather than 'the period from the beginning to the end of the applicant's failure to engage in reasonable efforts to conclude prosecution.'"
Marked-up versions of the rules that the Office has proposed revising are as follows:
1.704 Reduction of period of adjustment of patent term.
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(c) * * *
(2) Deferral of issuance of a patent under § 1.314, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under § 1.314 was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued;
(3) Abandonment of the application or late payment of the issue fee, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date of abandonment or the date after the date the issue fee was due and ending on the earlier of:
(i) The date of mailing of the decision reviving the application or accepting late payment of the issue fee; or
(ii) The date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed;
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(6) Submission of a preliminary amendment or other preliminary paper less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or notice of allowance, in which case the period of adjustment set forth in § 1.703 shall be reduced by the lesser of:
(i) The number of days, if any, beginning on the day after the mailing date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the original Office action or notice of allowance national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date of mailing of the supplemental Office action or notice of allowance; the preliminary amendment or
(ii) Four months other preliminary paper was filed;
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(9) Submission of an amendment or other paper after a decision by the Board of Patent Appeals Trial and Interferences Appeal Board, other than a decision designated as containing a new ground of rejection under § 1.19641.50(b) of this title or statement under § 1.19641.50(c) of this title, or a decision by a Federal court, less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or supplemental notice of allowance, in which case the period of adjustment set forth in § 1.703 shall be reduced by the lesser of:
(i) The number of days, if any, beginning on the day after the mailing date of the original Office action decision by the Patent Trial and Appeal Board or notice of allowance by a Federal court and ending on the mailing date of the supplemental Office action or notice of allowance; amendment or
(ii) Four months other paper was filed;
(10) Submission of an amendment under § 1.312 or other paper, other than a request for continued examination in compliance with § 1.114, after a notice of allowance has been given or mailed, in which case the period of adjustment set forth in § 1.703 shall be reduced by the lesser of:
(i) The number of days, if any, beginning on the day after the mailing date of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under § 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under § 1.312 or such other paper; or
(ii) Four months;
While the Office notes that "prior notice and opportunity for public comment for the changes proposed by this rulemaking are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law," the Office has issued the notice of proposed rulemaking in order "to benefit from the public's input." Those interested in submitting comments regarding the proposed revisions to §§ 1.704(c)(2), (c)(3), (c)(6), (c)(9), and (c)(10), must do so by December 3, 2019. Comments may be submitted by e-mail to: [email protected]; by regular mail addressed to: Mail Stop Comments-Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Kery Fries, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal.
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