37 C.F.R. 1.750 Determination of eligibility for extension of patent term.

A determination as to whether a patent is eligible for extension may be made by the Director solely on the basis of the representations contained in the application for extension filed in compliance with § 1.740 or § 1.790. This determination may be delegated to appropriate Patent and Trademark Office officials and may be made at any time before the certificate of extension is issued. The Director or other appropriate officials may require from applicant further information or make such independent inquiries as desired before a final determination is made on whether a patent is eligible for extension. In an application for extension filed in compliance with § 1.740, a notice will be mailed to applicant containing the determination as to the eligibility of the patent for extension and the period of time of the extension, if any. This notice shall constitute the final determination as to the eligibility and any period of extension of the patent. A single request for reconsideration of a final determination may be made if filed by the applicant within such time as may be set in the notice of final determination or, if no time is set, within one month from the date of the final determination. The time periods set forth herein are subject to the provisions of § 1.136.

The determination as to whether a patent is eligible for an extension may be made solely from the representations contained in the application for patent term extension. However, under 37 CFR 1.750, further information may be required or inquiry made of applicant before a final determination is made on whether a patent is eligible for extension. In circumstances where further information is required by the Office, the applicant will be given a time period within which to respond. The failure to provide a response within the time period provided may result in a final determination adverse to the granting of an extension of patent term unless the response period is extended. An extension of time to respond may be requested under the provisions of 37 CFR 1.136. The USPTO patent electronic filing system includes the document description "Response to request for information sent under 37 CFR 1.750" (document code TERM.INF.RES) which is to be used for responses to requests for information under 37 CFR 1.750. Under appropriate circumstances, e.g., if time is of the essence for a particular reason, a request for information may contain a statement that the provisions of 37 CFR 1.136(a) are not available. The intentional failure to provide the information requested may result in an adverse final determination.

A final determination may be made at any time after an application is filed. A single request for reconsideration of a final determination may be filed within one month or within such other time period set in the final determination. This period of time may be extended under the provisions of 37 CFR 1.136(a). A notice will be mailed to applicant containing the determination as to eligibility of the patent for extension and the period of time of the extension of the term, if any. This notice shall constitute the final determination as to eligibility and any period of extension of the patent term. If no request for reconsideration is filed within the time period set in the notice of final determination, the certificate of patent term extension will be issued in due course. See MPEP § 2758.

35 U.S.C. 156 Extension of patent term.

*****

1. (e)
   1. (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 C.F.R. 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 a 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 & Colman Products Ltd., 230 USPQ at 370.

While 37 CFR 1.760 provides that a request for an interim extension by the applicant under 35 U.S.C. 156(e)(2) "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, multiple interim extensions under 35 U.S.C. 156(e)(2) are 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).

35 U.S.C. 156 Extension of patent term.

*****

1. (d)
   1. (5)
      1. (A) If the owner of record of the patent or its agent reasonably expects that the applicable regulatory review period described in paragraph (1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii) of subsection (g) that began for a product that is the subject of such patent may extend beyond the expiration of the patent term in effect, the owner or its agent may submit an application to the Director for an interim extension during the period beginning 6 months, and ending 15 days before such term is due to expire. The application shall contain—
         1. (i) the identity of the product subject to regulatory review and the Federal statute under which such review is occurring;
         2. (ii) the identity of the patent for which interim extension is being sought and the identity of each claim of such patent which claims the product under regulatory review or a method of using or manufacturing the product;
         3. (iii) information to enable the Director to determine under subsection (a)(1), (2), and (3) the eligibility of a patent for extension;
         4. (iv) a brief description of the activities undertaken by the applicant during the applicable regulatory review period to date with respect to the product under review and the significant dates applicable to such activities; and
         5. (v) such patent or other information as the Director may require.
   2. 1. (B) If the Director determines that, except for permission to market or use the product commercially, the patent would be eligible for an extension of the patent term under this section, the Director shall publish in the Federal Register a notice of such determination, including the identity of the product under regulatory review, and shall issue to the applicant a certificate of interim extension for a period of not more than 1 year.
      2. (C) The owner of record of a patent, or its agent, for which an interim extension has been granted under subparagraph (B), may apply for not more than 4 subsequent interim extensions under this paragraph, except that, in the case of a patent subject to subsection (g)(6)(C), the owner of record of the patent, or its agent, may apply for only 1 subsequent interim extension under this paragraph. Each such subsequent application shall be made during the period beginning 60 days before, and ending 30 days before, the expiration of the preceding interim extension.
      3. (D) Each certificate of interim extension under this paragraph shall be recorded in the official file of the patent and shall be considered part of the original patent.
      4. (E) Any interim extension granted under this paragraph shall terminate at the end of the 60-day period beginning on the date on which the product involved receives permission for commercial marketing or use, except that, if within that 60-day period, the applicant notifies the Director of such permission and submits any additional information under paragraph (1) of this subsection not previously contained in the application for interim extension, the patent shall be further extended, in accordance with the provisions of this section—
         1. (i) for not to exceed 5 years from the date of expiration of the original patent term; or
         2. (ii) if the patent is subject to subsection (g)(6)(C), from the date on which the product involved receives approval for commercial marketing or use.
      5. (F) The rights derived from any patent the term of which is extended under this paragraph shall, during the period of interim extension—
         1. (i) in the case of a patent which claims a product, be limited to any use then under regulatory review;
         2. (ii) in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent then under regulatory review; and
         3. (iii) in the case of a patent which claims a method of manufacturing a product, be limited to the method of manufacturing as used to make the product then under regulatory review.

*****

37 C.F.R. 1.790 Interim extension of patent term under 35 U.S.C. 156(d)(5).

1. (a) An owner of record of a patent or its agent who reasonably expects that the applicable regulatory review period described in 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii) that began for a product that is the subject of such patent may extend beyond the expiration of the patent term in effect may submit one or more applications for interim extensions for periods of up to one year each. In no event will the interim extensions granted under this section be longer than the maximum period of extension to which the applicant would be entitled under 35 U.S.C. 156(c).
2. (b) Any application for interim extension under this section must be filed using the USPTO patent electronic filing system in accordance with the USPTO patent electronic filing system requirements.
3. (c) Complete initial applications for interim extension under this section must:
   1. (1) Be filed during the period beginning 6 months and ending 15 days before the patent term is due to expire, and include a statement that the initial application is being submitted within the period and an identification of the date of the last day on which the initial application could be submitted;
   2. (2) Include all of the information required for a formal application under § 1.740 and a complete application under § 1.741, except as follows:
      1. (i) Paragraphs (a)(1), (2), (4), and (6) through (15) of §§ 1.740 and 1.741 shall be read in the context of a product currently undergoing regulatory review; and
      2. (ii) Paragraphs (a)(3) and (5) of § 1.740 are not applicable to an application for interim extension under this section; and
   3. (3) Include a statement that the applicable regulatory review period, described in 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), has begun for the product that is the subject of the patent.
4. (d) Each subsequent application for interim extension:
   1. (1) Must be filed during the period beginning 60 days before and ending 30 days before the expiration of the preceding interim extension and include a statement that it is being submitted within the period and an identification of the date of the last day on which it could be submitted;
   2. (2) May be limited in content to a request for a subsequent interim extension along with any materials or information required under §§ 1.740 and 1.741 that are not present in the preceding interim extension application; and
   3. (3) Must include a statement that the applicable regulatory review period, described in 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), has not been completed.

37 C.F.R. 1.791 Termination of interim extension granted prior to regulatory approval of a product for commercial marketing or use.

Any interim extension granted under 35 U.S.C. 156(d)(5) terminates at the end of the 60-day period beginning on the date on which the product involved receives permission for commercial marketing or use. If within that 60-day period the patent owner or its agent files an application for extension under §§ 1.740 and 1.741 including any additional information required under 35 U.S.C. 156(d)(1) not contained in the application for interim extension, the patent shall be further extended in accordance with the provisions of 35 U.S.C. 156.

If a patent that claims a product which is undergoing the approval phase of regulatory review as defined by 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), and (5)(B)(ii) is expected to expire before approval is granted, interim patent term extension is available under 35 U.S.C. 156(d)(5). The application for patent term extension that must be submitted is generally the same as would be filed had the product been approved, except that the approval date is not required to be set forth. See 37 CFR 1.790 for the complete requirements of an interim patent term extension under 35 U.S.C. 156(d)(5). In addition, interim extensions under 35 U.S.C. 156(d)(5) of multiple patents based on a single ongoing regulatory review period are permitted, for the same reason that multiple interim extensions under 35 U.S.C. 156(e)(2) are permitted, i.e., 35 U.S.C. 156(c)(4) prohibits only multiple certificates of extension under 35 U.S.C. 156(e)(1), as discussed at MPEP § 2755.01.

Processing of an application for interim patent term extension under 35 U.S.C. 156(d)(5) is performed in the Office of Patent Legal Administration and is similar to other applications for patent term extension, except that the Office is not required to seek the advice of the relevant regulatory agency. The relevant agency, however, is normally consulted before an interim extension is granted or before the application is denied. The fee for an application for patent term extension under 35 U.S.C. 156(d)(5) is set forth in 37 CFR 1.20(j)(2), and the fee for a subsequent application is set forth in 37 CFR 1.20(j)(3). Copies of an application for interim extension are maintained in the same manner as applications for patent term extension. As required by 35 U.S.C. 156(d)(5)(B), a determination that a patent is eligible for extension under 35 U.S.C. 156, but for regulatory approval, is published in the Federal Register. A sample order granting a second interim extension follows:

UNITED STATES PATENT AND TRADEMARK OFFICE

In re___

Request for Patent Term Extension ORDER GRANTING U.S. Patent No.___ INTERIM EXTENSION

On __, patent owner __, filed an application under 35 U.S.C. 156(d)(5) for interim extension of the term of U.S. Patent No. __. The patent claims the active ingredient __ in the human drug product "___." The application indicates that the product is currently undergoing a regulatory review before the Food and Drug Administration for permission to market or use the product commercially. The original term of the patent expired on ___. On ___, the patent was granted an first interim extension under 35 U.S.C. 156(d)(5) for a period of one year.

Review of the application indicates that except for receipt of permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156 . Since it is apparent that the regulatory review period may extend beyond the date of expiration of the patent, as extended by the first interim extension, a second interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.

An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. __ is granted for a period of one year from the extended expiration date of the patent.

As seen from the example given, a series of one-year interim extensions may be granted if requested in a timely manner (in the window of time between thirty and sixty days before the extended expiration date).

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). 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).