(a) The patent will include notification of any patent term adjustment under 35 U.S.C. 154(b).
(b) Any request for reconsideration of the patent term adjustment indicated on the patent must be by way of an application for patent term adjustment filed no later than two months from the date the patent was granted. This two-month time period may be extended under the provisions of § 1.136(a). An application for patent term adjustment under this section must be accompanied by:
(1) The fee set forth in § 1.18(e); and
(2) A statement of the facts involved, specifying:
(i) The correct patent term adjustment and the basis or bases under § 1.702 for the adjustment;
(ii) The relevant dates as specified in §§ 1.703(a) through (e) for which an adjustment is sought and the adjustment as specified in § 1.703(f) to which the patent is entitled;
(iii) Whether the patent is subject to a terminal disclaimer and any expiration date specified in the terminal disclaimer; and
(iv)(A) Any circumstances during the prosecution of the application resulting in the patent that constitute a failure to engage in reasonable efforts to conclude processing or examination of such application as set forth in § 1.704; or
(B) That there were no circumstances constituting a failure to engage in reasonable efforts to conclude processing or examination of such application as set forth in § 1.704.
(c) Any request for reinstatement of all or part of the period of adjustment reduced pursuant to § 1.704(b) for failing to reply to a rejection, objection, argument, or other request within three months of the date of mailing of the Office communication notifying the applicant of the rejection, objection, argument, or other request must be filed prior to the issuance of the patent. This time period is not extendable. Any request for reinstatement of all or part of the period of adjustment reduced pursuant to § 1.704(b) under this paragraph must also be accompanied by:
(1) The fee set forth in § 1.18(f); and
(2) A showing to the satisfaction of the Director that, in spite of all due care, the applicant was unable to reply to the rejection, objection, argument, or other request within three months of the date of mailing of the Office communication notifying the applicant of the rejection, objection, argument, or other request. The Office shall not grant any request for reinstatement for more than three additional months for each reply beyond three months from the date of mailing of the Office communication notifying the applicant of the rejection, objection, argument, or other request.
(d) No submission or petition on behalf of a third party concerning patent term adjustment under 35 U.S.C. 154(b) will be considered by the Office. Any such submission or petition will be returned to the third party, or otherwise disposed of, at the convenience of the Office.
[65 FR 56394, Sept. 18, 2000, as amended at 69 FR 21711, Apr. 22, 2004; 78 FR 19420, Apr. 1, 2013]
Notes of Decisions
Nippon Shinyaku Co. v. Iancu, 369 F. Supp. 3d 226 (D.C. Cir. 2019).
· cites it 4× “§ 154 (b)(3)(B)(ii), "within two months of the date the patent issued," 37 C.F.R. § 1.705 (d) (2012) ("Rule 1.705(d)").”
Janssen Pharmaceutica, N v. v. Kappos, 928 F. Supp. 2d 102 (D.D.C. 2013).
· cites it 7× “§ 154 (b)(3)(B); accord 37 C.F.R. § 1.705 (a). Because the notice of allowance issues well before the patent is granted, the notice of patent term adjustment contains only the USPTO’s calculation of A *104 delay.”
Daiichi Sankyo Co. v. Lee, 791 F.3d 1373 (Fed. Cir. 2015).
· cites it 7× “See 37 C.F.R. § 1.705 (d) (2012). B. Review of Patent TERM Adjustments A patentee who is dissatisfied with the number of days restored to the term of the patent has a statutory right to both administrative and judicial review.”
Janssen Pharmaceutica, N.V. v. Kappos, 844 F. Supp. 2d 707 (E.D. Va. 2012).
· cites it 4× “” 37 C.F.R. § 1.705 (b). The request must be filed no later than the date when the applicant pays the issue fee, which is due no later than three months from the notice of allowance.”
Bristol-Myers Squibb Co. v. Doll, 891 F. Supp. 2d 135 (D.D.C. 2012).
· cites it 2× “37 C.F.R. § 1.705 (d). Section 154 permits the applicant to appeal the patent term adjustment to a United States District Court.”
Actelion Pharm. Ltd. v. Kappos, 972 F. Supp. 2d 51 (D.D.C. 2013).
· cites it 2× “§ 154 (b)(3)(B)(i); 37 C.F.R. § 1.705 (a) (2006). The applicant must pay an issue fee within three months; once payment occurs, USPTO issues the patent and determines the final PTA as of the date of the patent grant, noting this determination on the face of the patent.”
Daiichi Sankyo Co., Ltd. v. Kappos, 12 F. Supp. 3d 8 (D.D.C. 2013).
“§ 154(b)(3)(B)(ii), “within two months of the date the patent issued,” 37 C.F.R. § 1.705 (d) (2012). “[0]n petition of the interested party,” (“Rule 183 petition”) the two-month limitation “may be suspended or waived by the Director or the Director’s designee” “[i]n an…”
Novartis Ag v. Kappos, 904 F. Supp. 2d 58 (D.D.C. 2012).
“Within 180 days of the PTO’s denial of reconsideration (but more than 180 days after the issuance of the patent), Novartis filed suit in this court. Thus, Novartis argues that the 180-day limitation period should have been tolled by its filing of a petition for reconsideration,…”
Bristol-Myers Squibb Co. v. Doll, 841 F. Supp. 2d 238 (D.D.C. 2012).
“§ 154 (b)(3)(B)(ii) and 37 C.F.R. § 1.705 (d) within the requisite two month time period after the patent was granted.”
Abraxis Bioscience, LLC v. Kappos, 10 F. Supp. 3d 53 (D.D.C. 2014).
· cites it 2× “On June 3, 2010, the plaintiff paid the requisite issue fee and filed a petition, pursuant to 37 C.F.R. § 1.705 (b), seeking a patent term adjustment under Part A and Part B.”
Actelion Pharm. Ltd. v. Lee, 216 F. Supp. 3d 680 (E.D. Va. 2016).
“On November 25, 2014, Plaintiff submitted a Request for Reconsideration of Patent Term Adjustment Pursuant to 37 C.F.R. § 1.705 (“the First Reconsideration Request”).”
Actelion Pharm., Ltd. v. Matal, 881 F.3d 1339 (Fed. Cir. 2018).
“In November 2014, Actelion filed a petition for reconsideration under 37 C.F.R. § 1.705 , contending that the ’675 patent is entitled to 45 PTA days, or alternatively, at least 41 PTA days.”
— 37 C.F.R. § 1.705(d) — 2 cases
Nippon Shinyaku Co. v. Iancu, 369 F. Supp. 3d 226 (D.C. Cir. 2019).
“§ 154 (b)(3)(B)(ii), "within two months of the date the patent issued," 37 C.F.R. § 1.705 (d) (2012) ("Rule 1.705(d)").”
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