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
- (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 Express Mail provisions of 37 CFR 1.10. Patent term extension applications must not be filed by facsimileor 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.
2754.01 Deadline for Filing an Application Under 35 U.S.C. 156(d)(1) [R-11.2013]
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 filed after the end of the 60-day period and was therefore denied). 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.
The statute takes into account only the regulatory review carried out by the Food and Drug Administration or the Department of Agriculture and no other government obstacles to marketing or use. See Unimed, Inc. v. Quigg, 888 F2d 826, 828; 12 USPQ2d 1644, 1646 (Fed. Cir. 1989). 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 F2d 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.
2754.02 Filing Window for an Application Under 35 U.S.C. 156(d)(5) [R-8.2012]
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 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 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, except, 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. 35 U.S.C. 156(d)(5)(E). 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. See 37 CFR 1.740(a)(3) and (5). However, if the product is not approved within the period of interim extension, a new request for interim extension 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.
2754.03 Filing of a Request for an Extension Under 35 U.S.C. 156(e)(2) [R-8.2012]
A request for an interim extension under 35 U.S.C. 156(e)(2) (to extend the patent term during the processing of the patent term extension application) should be made at least three months before the patent is due to expire. See MPEP § 2755.01 for information pertaining to the interim extension of patent term under 35 U.S.C. 156(e)(2).