2755.02 Interim Extension of Patent Term Before Product Approval [R-10.2019]

Created On
byChhabra Law Firm

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

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  • (d)
    • (5)
      • (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—
        • (i) the identity of the product subject to regulatory review and the Federal statute under which such review is occurring;
        • (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;
        • (iii) information to enable the Director to determine under subsection (a)(1), (2), and (3) the eligibility of a patent for extension;
        • (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
        • (v) such patent or other information as the Director may require.
      • (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.
      • (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.
      • (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.
      • (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—
        • (i) for not to exceed 5 years from the date of expiration of the original patent term; or
        • (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.
      • (F) The rights derived from any patent the term of which is extended under this paragraph shall, during the period of interim extension—
        • (i) in the case of a patent which claims a product, be limited to any use then under regulatory review;
        • (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
        • (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.

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

  • (a) An owner of record of a patent or its agent who 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 may submit one or more applications for interim extensions for periods of up to one year each. The initial application for interim extension must be filed during the period beginning 6 months and ending 15 days before the patent term is due to expire. Each subsequent application for interim extension must be filed during the period beginning 60 days before and ending 30 days before the expiration of the preceding interim extension. 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).
  • (b) A complete application for interim extension under this section shall include all of the information required for a formal application under § 1.740 and a complete application under § 1.741. Sections (a)(1), (a)(2), (a)(4), and (a)(6) – (a)(17) of § 1.740 and § 1.741 shall be read in the context of a product currently undergoing regulatory review. Sections (a)(3) and (a)(5) of § 1.740 are not applicable to an application for interim extension under this section.
  • (c) The content of each subsequent interim extension application may be limited to a request for a subsequent interim extension along with a statement that the regulatory review period has not been completed along with any materials or information required under §§ 1.740 and 1.741 that are not present in the preceding interim extension application.

37 CFR 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. Once the product is approved, the application must be converted to an application for patent term extension under 35 U.S.C. 156(d)(1) to obtain patent term extension under that subsection.

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) would be granted, provided 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).