2752 Patent Term Extension Applicant [R-01.2024]
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, or in the case of a drug product described in subsection
(i), within the sixty-day period beginning on the covered date (as defined
in subsection (i)). 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 which claims the approved product or a method of using or manufacturing the approved product;
- (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.
For purposes of determining the date on which a product receives permission under the second sentence of this paragraph, 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 section 6103 of title 5.
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- (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, or in the case of a drug product described in subsection
(i), within the sixty-day period beginning on the covered date (as defined
in subsection (i)). The application shall contain—
- (i)
- (1) For purposes of this section, if the
Secretary of Health and Human Services provides notice to the sponsor of an
application or request for approval, conditional approval, or indexing of a
drug product for which the Secretary intends to recommend controls under the
Controlled Substances Act, beginning on the covered date, the drug product
shall be considered to—
- (A) have been approved or indexed under the relevant provision of the Public Health Service Act or Federal Food, Drug, and Cosmetic Act; and
- (B) have permission for commercial marketing or use.
- (2) In this subsection, the term “covered date”
means the later of—
- (A) the date an application is
approved—
- (i) under section 351(a)(2)(C) of the Public Health Service Act; or
- (ii) under section 505(b) or 512(c) of the Federal Food, Drug, and Cosmetic Act;
- (B) the date an application is conditionally approved under section 571(b) of the Federal Food, Drug, and Cosmetic Act;
- (C) the date a request for indexing is granted under section 572(d) of the Federal Food, Drug, and Cosmetic Act; or
- (D) the date of issuance of the interim final rule controlling the drug under section 201(j) of the Controlled Substances Act.
- (A) the date an application is
approved—
- (1) For purposes of this section, if the
Secretary of Health and Human Services provides notice to the sponsor of an
application or request for approval, conditional approval, or indexing of a
drug product for which the Secretary intends to recommend controls under the
Controlled Substances Act, beginning on the covered date, the drug product
shall be considered to—
37 CFR 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(s), the application papers should refer to the reel(s) and frame number(s) of the recorded assignment. A power of attorney from the patent owner to any registered practitioner submitting the patent term extension application papers should be filed, if the registered practitioner is not already of record in the patent (see 37 CFR 1.32 and 37 CFR 1.33). The power of attorney may be filed as a limited power of attorney specifying that the power is limited to prosecution of the application for patent term extension. The USPTO patent electronic filing system includes the document description “Limited POA and/or Change of Address for a Patent Term Extension Application” (document code PTE.POA) for limited powers of attorney that are filed specifically for patent term extension applications. A limited power of attorney filed using the document description “Limited POA and/or Change of Address for a Patent Term Extension Application” (document code PTE.POA) will not change an existing power for the underlying patent or establish power for the underlying patent. If an application for patent term extension is filed by a registered practitioner not of record, the Office will consider the registered practitioner to be acting in a representative capacity in accordance with 37 CFR 1.34.
If the applicant for patent term extension was not the marketing applicant before the regulatory agency, then there must have been 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.
