2754 Filing Date [R-01.2024]
37 CFR 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 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.
- (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).
II. COMPLETE APPLICATIONThe 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.
III. INFORMAL APPLICATION37 CFR 1.740 Formal requirements for application for extension of patent term; correction of informalities.
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- (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.
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.
2754.01 Deadline for Filing an Application Under 35 U.S.C. 156(d)(1) [R-01.2024]
An application for patent term extension under 35 U.S.C. 156(d)(1) may only be filed within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use. The statutory time period is not extendable and cannot be waived or excused. See U.S. Patent No. 4,486,425 (application for patent term extension was filed after the end of the 60-day period and was therefore denied). In a 2008 final agency action, the USPTO clarified its understanding that in view of the “beginning on” language of the statute, the first day of the sixty-day period is the day that the marketing applicant received approval from the regulatory agency. In other words, day one of the sixty-day period is the approval date, not the day after approval. In re: Pat. Term Extension Application for U.S. Pat. No. 5,817,338, 2008 WL 5477176, at *8 (Comm’r Pat. 2008). This understanding is grounded in the Federal Circuit’s explanation of the statutory language: “[S]ection 156(d)(1) admits of no other meaning than that the sixty-day period begins on the FDA approval date.” Unimed, Inc. v. Quigg, 888 F.2d 826, 828, 12 USPQ2d 1644, 1646 (Fed. Cir. 1989). Thus, for example, if a marketing applicant receives approval from the regulatory agency prior to 4:30 P.M., Eastern Time, on the business day July 10, 2023 (day one of the count of sixty days), the application for patent term extension must be filed by September 7, 2023, in order to meet the timeliness requirement of 35 U.S.C. 156(d)(1).
For purposes of determining the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use, if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on a day that is not a business day, the product shall be deemed to have received such permission on the next business day. The term “business day” in this context means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under 5 U.S.C. 6103.
For drug products the approval date is the date of a letter by the Food and Drug Administration indicating that the application has been approved, even if the letter requires further action before the drug can be marketed. Mead Johnson Pharmaceutical Group v. Bowen, 838 F.2d 1332, 1336; 6 USPQ2d 1565, 1568 (D.C. Cir. 1988). For food or color additives, the relevant date is the effective date of the regulation or order, which is set forth in the regulation or order, and generally is the date that the regulation or order is published, e.g., in the Federal Register. See 21 U.S.C. 348(e). This date will generally be later than the date the approval is communicated to the marketing applicant. However, in the case of drug products for which the Secretary of Health and Human Services intends to recommend controls under the Controlled Substances Act, the time period is as described below.
Where the regulatory review is of a drug product for which the Secretary of Health and Human Services intends to recommend controls under the Controlled Substances Act, the sixty-day period of 35 U.S.C. 156(d)(1) begins on the “covered date,” where the “covered date” (defined in 35 U.S.C. 156(i)(2)) is the later of:
- (A) the date an application is approved—
- (i) under section 351(a)(2)(C) of the Public Health Service Act; or
- (ii) under section 505(b) or 512(c) of the Federal Food, Drug, and Cosmetic Act;
- (B) the date an application is conditionally approved under section 571(b) of the Federal Food, Drug, and Cosmetic Act;
- (C) the date a request for indexing is granted under section 572(d) of the Federal Food, Drug, and Cosmetic Act; or
- (D) the date of issuance of the interim final rule controlling the drug under section 201(j) of the Controlled Substances Act.
2754.02 Filing Window for an Application Under 35 U.S.C. 156(d)(5) [R-01.2024]
A first application for interim extension under 35 U.S.C. 156(d)(5) (to extend the patent term before product approval) must be filed using the USPTO patent electronic filing system (Patent Center) within the period beginning six months and ending fifteen days before the patent is due to expire. Each subsequent application for interim extension must be filed using the USPTO patent electronic filing system during the period beginning sixty days before and ending thirty days before the expiration of the preceding interim extension. 35 U.S.C. 156(d)(5)(C). An interim extension granted under 35 U.S.C. 156(d)(5) terminates sixty days after permission for commercial marketing or use of the product is granted. However, if within the sixty-day period any additional information needed for an application for patent term extension under 35 U.S.C. 156(d)(1) is submitted, the patent may be further extended. See 35 U.S.C. 156(d)(5)(E) and 37 CFR 1.791. The additional information required to be submitted includes the fee for an application for patent term extension under 35 U.S.C. 156(d)(1), identification of the date the product received permission for commercial marketing or use, a statement that the application is being submitted within sixty days of such date, and identification of the last date that the application could be submitted.
When the interim extension lapses under 35 U.S.C. 156(d)(5) because the product has received permission for commercial marketing or use, an interim extension pursuant to the provisions of 35 U.S.C. 156(e)(2) can be granted provided that the patent owner or its agent promptly files an application under 35 U.S.C. 156(d)(1) with sufficient time to permit the Office to grant an interim extension under 35 U.S.C. 156(e)(2). See 37 CFR 1.740(a)(3) and (5). However, if the product is not approved within the period of interim extension under 35 U.S.C. 156(d)(5), a new request for interim extension under 35 U.S.C. 156(d)(5) must be filed and another interim extension granted to keep the patent in force. An applicant is generally limited to four one-year interim extensions.
See MPEP § 2755.02 for additional information pertaining to the interim extension of patent term under 35 U.S.C. 156(d)(5).
