35 U.S.C. 156 Extension of patent term.
- (2) If the term of a patent for which an application has been submitted under subsection (d)(1) would expire before a certificate of extension is issued or denied under paragraph (1) respecting the application, the Director shall extend, until such determination is made, the term of the patent for periods of up to one year if he determines that the patent is eligible for extension.
37 CFR 1.760 Interim extension of patent term under 35 U.S.C. 156(e)(2).
An applicant who has filed a formal application for extension in compliance with § 1.740 may request one or more interim extensions for periods of up to one year each pending a final determination on the application pursuant to § 1.750. Any such request should be filed at least three months prior to the expiration date of the patent. The Director may issue interim extensions, without a request by the applicant, for periods of up to one year each until a final determination is made. The patent owner or agent will be notified when an interim extension is granted and notice of the extension will be published in the Official Gazette of the United States Patent and Trademark Office. The notice will be recorded in the official file of the patent and will be considered as part of the original patent. In no event will the interim extensions granted under this section be longer than the maximum period for extension to which the applicant would be eligible.
If the original term of the patent for which extension is sought will expire before a final decision to issue a certificate of extension can be made, and a determination is made that the patent is eligible for extension, 35 U.S.C. 156 provides that the Director may issue an interim extension of the patent term for up to one year pending a final decision on the application for extension. Should additional time be necessary, additional interim extensions of up to one year may be granted by the Director. The length of any interim extension is discretionary with the Director so long as it is for one year or less. Its length should be set to provide time for completion of any outstanding requirements. See In re Reckitt & Colman Products Ltd., 230 USPQ 369, 372 (Comm’r Pat. & Tm. 1986). The Director may issue an interim extension under 35 U.S.C. 156(e)(2) with or without a request from the applicant. However, it is best practice for the applicant for term extension to track the expiration dates of any patents for which extension has been sought and timely file a request for interim extension under 37 CFR 1.760 in order for the Office to timely grant an interim extension under 35 U.S.C. 156(e)(2).
Where a determination is made that the patent is not eligible for patent term extension, an interim extension of the patent term is not warranted under 35 U.S.C. 156(e)(2). See In re Alcon Laboratories Inc., 13 USPQ2d 1115, 1123 (Comm’r. Pat.& Tm. 1989).
Where an interim extension has been granted and it is subsequently determined that the patent is not eligible for patent term extension, the interim extension may be vacated ab initio as ineligible under 35 U.S.C. 156(e)(2). See In re Reckitt, 230 USPQ at 370.
While 37 CFR 1.760 provides that a request for an interim extension by the applicant “should” be filed three months prior to the expiration of the patent, this time frame is not mandatory. Any request filed within a shorter period of time will be considered, upon a proper showing, where it is not possible to make an earlier request. However, for an interim extension to be granted, the application for extension, in compliance with 37 CFR 1.741, must have been filed prior to the expiration date of the patent. In no event will an interim extension be granted for a period of patent term extension longer than the period of extension to which the patent would be eligible.
A notice of each interim extension granted will be issued to the applicant for patent term extension. The notice will be recorded in the official file of the patent and will be considered as part of the original patent.
In circumstances where extensions of multiple patents have been sought based on a single regulatory review period as per 37 CFR 1.785, where those patents expire on the same day, multiple interim extensions under 35 U.S.C. 156(e)(2) would be permitted. This is possible because 35 U.S.C. 156(c)(4) recites the prohibition that, “in no event shall more than one patent be extended under subsection (e)(1) for the same regulatory review period for any product.” The language “under subsection (e)(1)” refers to the certificate of extension only. This language was added in 1993 by section 5 of Public Law 103-179, which was the same time when the interim extension provisions of 35 U.S.C. 156(d)(5) were added, so as to distinguish a final certificate of extension from interim extensions granted under either 35 U.S.C. 156(e)(2) or 35 U.S.C. 156(d)(5).