(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 via the USPTO patent electronic filing system or filed pursuant to the procedure set forth in § 1.8(a)(1)(i)(C) and (a)(1)(ii). 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.

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 is 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.

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 is 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.

(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(f) 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.

(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(f) 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.

(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(f) 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.

An application for patent term extension under 35 U.S.C. 156 must be submitted using the USPTO patent electronic filing system in accordance with the USPTO patent electronic filing system requirements.

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 via the USPTO patent electronic filing system or filed pursuant to the certificate of transmission procedure set forth in § 1.8(a)(1)(i)(C) and (a)(1)(ii).

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 is 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.

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.

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.

Note that if the application satisfies the requirements of 37 CFR 1.741, the application filing date will have been established even if the application is held to be informal under 37 CFR 1.740.

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 is 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.