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2752    Patent Term Extension Applicant [R-11.2013]

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

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  • (d)
    • (1) To obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application to the Director. Except as provided in paragraph (5), such an application may only be submitted 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 application shall contain—
      • (A) the identity of the approved product and the Federal statute under which regulatory review occurred;
      • (B) the identity of the patent for which an extension is being sought and the identity of each claim of such patent;
      • (C) information to enable the Director to determine under subsections (a) and (b) 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 period of the extension under subsection (g);
      • (D) a brief description of the activities undertaken by the applicant during the applicable regulatory review period with respect to the approved product and the significant dates applicable to such activities; and
      • (E) such patent or other information as the Director may require.

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For purposes of determining the date on which a product receives permission under the second sentence of 35 U.S.C. 156(d)(1), 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 receive such permission on the next business day. For purposes of the preceding sentence, the term “business day” means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under 5 U.S.C. 6103.

37 C.F.R. 1.730   Applicant for extension of patent term; signature requirements.

  • (a) Any application for extension of a patent term must be submitted by the owner of record of the patent or its agent and must comply with the requirements of § 1.740.
  • (b) If the application is submitted by the patent owner, the application must be signed either by:
    • (1) The patent owner in compliance with § 3.73(b) of this chapter; or
    • (2) A registered practitioner on behalf of the patent owner.
  • (c) If the application is submitted on behalf of the patent owner by an agent of the patent owner (e.g., a licensee of the patent owner), the application must be signed by a registered practitioner on behalf of the agent. The Office may require proof that the agent is authorized to act on behalf of the patent owner.
  • (d) If the application is signed by a registered practitioner, the Office may require proof that the practitioner is authorized to act on behalf of the patent owner or agent of the patent owner.

35 U.S.C. 156(d)(1) requires that the application for extension of the patent term must be submitted by the owner of record of the patent or its agent. If the application is filed by an assignee, the application papers should refer to the reel and frame number of the recorded assignment. A power of attorney from the patent owner to any patent attorney or agent submitting the patent term extension application papers should be filed, if the attorney or agent is not already of record in the patent (see 37 CFR 1.34(b)).

If the applicant for patent term extension was not the marketing applicant before the regulatory agency, then there must be an agency relationship between the patent owner and the marketing applicant during the regulatory review period. To show that such an applicant is authorized to rely upon the activities of the marketing applicant before the Food and Drug Administration or the Department of Agriculture, it is advisable for the applicant for patent term extension to obtain a letter from the marketing applicant specifically authorizing such reliance.

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Last Modified: 03/27/2014 10:10:35