2754 Filing Date [R-11.2013]
37 C.F.R. 1.741 Complete application given a filing date; petition procedure.
- (a) The filing date of an application for extension of a patent term is the date on which a complete application is received in the Office or filed pursuant to the procedures set forth in § 1.8 or § 1.10. A complete application must include:
- (1) An identification of the approved product;
- (2) An identification of each Federal statute under which regulatory review occurred;
- (3) An identification of the patent for which an extension is being sought;
- (4) An identification of each claim of the patent which claims the approved product or a method of using or manufacturing the approved product;
- (5) Sufficient information to enable the Director to determine under subsections (a) and (b) of 35 U.S.C. 156 the eligibility of a patent for extension, and the rights that will be derived from the extension, and information to enable the Director and the Secretary of Health and Human Services or the Secretary of Agriculture to determine the length of the regulatory review period; and
- (6) A brief description of the activities undertaken by the marketing applicant during the applicable regulatory review period with respect to the approved product and the significant dates applicable to such activities.
- (b) If an application for extension of patent term is incomplete under this section, the Office will so notify the applicant. If applicant requests review of a notice that an application is incomplete, or review of the filing date accorded an application under this section, applicant must file a petition pursuant to this paragraph accompanied by the fee set forth in § 1.17(h) within two months of the mail date of the notice that the application is incomplete, or the notice according the filing date complained of. Unless the notice indicates otherwise, this time period may be extended under the provisions of § 1.136.
I. FILING DATE ACCORDED
An application for patent term extension under 35 U.S.C. 156 may be filed by mail addressed to Mail Stop Hatch-Waxman PTE, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450 or may be hand carried to the Office of Patent Legal Administration. Applicants are encouraged to use the post card receipt practice described in MPEP § 502.
As set forth in 37 CFR 1.741(a), the filing date of an application for patent term extension is the date on which a complete application is received in the USPTO or filed pursuant to the certificate of mailing provisions of 37 CFR 1.8 (see MPEP § 512 for suggested formats for a certificate of mailing) or the Priority Mail Express® provisions of 37 CFR 1.10. Patent term extension applications must not be filed by facsimile or the Office’s electronic filing system (EFS-Web). However correspondence setting forth a change of address and other papers relating to a patent term extension may be sent by facsimile to the Office of Patent Legal Administration or via EFS-Web.
II. COMPLETE APPLICATION
The term "complete application" is defined in 37 CFR 1.741(a) and is an application meeting the requirements set forth in 35 U.S.C. 156(d)(1). For the establishment of a filing date, the distinction between the requirements of 37 CFR 1.740 and the requirements of 37 CFR 1.741 are important. While the requirements of 37 CFR 1.740 may be satisfied outside the 60-day filing period, the requirements of 37 CFR 1.741 are mandated by 35 U.S.C. 156 and must be satisfied within the 60-day filing period for the establishment of the filing date. The Office will consider each of these statutory requirements to be satisfied in an application which provides sufficient information, directed to each requirement, to act on the application, even though further information may be desired by the USPTO or the regulatory agency before a final determination of eligibility and length of patent term extension is made.
III. INFORMAL APPLICATION
37 C.F.R. 1.740 Formal requirements for application for extension of patent term; correction of informalities.
- (c) If an application for extension of patent term is informal under this section, the Office will so notify the applicant. The applicant has two months from the mail date of the notice, or such time as is set in the notice, within which to correct the informality. Unless the notice indicates otherwise, this time period may be extended under the provisions of § 1.136.
If the application does not meet all the formal requirements of 37 CFR 1.740(a) (see MPEP § 2753), the applicant will be notified of the informalities and may seek to have that holding reviewed under 37 CFR 1.740(c) or to correct the informality. The time periods set forth therein are subject to the provisions of 37 CFR 1.136, unless otherwise stated in the notice.