---
kind: "range"
citation: "37 C.F.R. §§ 1.710–1.791"
title: "37"
from: "1.710"
to: "1.791"
count: 18
url: "https://uscodex.org/cfr/37/1.710..1.791"
---

# §1.710. Patents subject to extension of the patent term.

- (a) A patent is eligible for extension of the patent term if the patent claims a product as defined in [paragraph (b)](#b) of this section, either alone or in combination with other ingredients that read on a composition that received permission for commercial marketing or use, or a method of using such a product, or a method of manufacturing such a product, and meets all other conditions and requirements of this subpart.
- (b) **The term <I>product</I> referred to in paragraph (a) of this section means—**
  - (1) The active ingredient of a new human drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act) including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient; or
  - (2) The active ingredient of a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Virus-Serum-Toxin Act) that is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes including site specific genetic manipulation techniques, including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient; or
  - (3) Any medical device, food additive, or color additive subject to regulation under the Federal Food, Drug, and Cosmetic Act.

# §1.720. Conditions for extension of patent term.


The term of a patent may be extended if:

- (a) The patent claims a product or a method of using or manufacturing a product as defined in [§ 1.710](/cfr/37/1.710.md);
- (b) The term of the patent has never been previously extended, except for extensions issued pursuant to §§ [1.701](/cfr/37/1.701.md), [1.760](/cfr/37/1.760.md), or [§ 1.790](/cfr/37/1.790.md);
- (c) An application for extension is submitted in compliance with [§ 1.740](/cfr/37/1.740.md);
- (d) The product has been subject to a regulatory review period as defined in [35 U.S.C. 156(g)](/usc/35/156.md?p=g) before its commercial marketing or use;
- (e) **The product has received permission for commercial marketing or use and—**
  - (1) The permission for the commercial marketing or use of the product is the first received permission for commercial marketing or use under the provision of law under which the applicable regulatory review occurred, or
  - (2) In the case of a patent other than one directed to subject matter within [§ 1.710(b)(2)](/cfr/37/1.710.md?p=b-2) claiming a method of manufacturing the product that primarily uses recombinant DNA technology in the manufacture of the product, the permission for the commercial marketing or use is the first received permission for the commercial marketing or use of a product manufactured under the process claimed in the patent, or
  - (3) In the case of a patent claiming a new animal drug or a veterinary biological product that is not covered by the claims in any other patent that has been extended, and has received permission for the commercial marketing or use in non-food-producing animals and in food-producing animals, and was not extended on the basis of the regulatory review period for use in non-food-producing animals, the permission for the commercial marketing or use of the drug or product after the regulatory review period for use in food-producing animals is the first permitted commercial marketing or use of the drug or product for administration to a food-producing animal.
- (f) The application is submitted within the sixty-day period beginning on the date the product first received permission for commercial marketing or use under the provisions of law under which the applicable regulatory review period occurred; or in the case of a patent claiming a method of manufacturing the product which primarily uses recombinant DNA technology in the manufacture of the product, the application for extension is submitted within the sixty-day period beginning on the date of the first permitted commercial marketing or use of a product manufactured under the process claimed in the patent; or in the case of a patent that claims a new animal drug or a veterinary biological product that is not covered by the claims in any other patent that has been extended, and said drug or product has received permission for the commercial marketing or use in non-food-producing animals, the application for extension is submitted within the sixty-day period beginning on the date of the first permitted commercial marketing or use of the drug or product for administration to a food-producing animal;
- (g) The term of the patent, including any interim extension issued pursuant to [§ 1.790](/cfr/37/1.790.md), has not expired before the submission of an application in compliance with [§ 1.741](/cfr/37/1.741.md); and
- (h) **No other patent term has been extended for the same regulatory review period for the product.**

# §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](/cfr/37/1.740.md).
- (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(c)](/cfr/37/3.73.md?p=c) 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.

# §1.740. Formal requirements for application for extension of patent term; correction of informalities.

- (a) An application for extension of patent term must be made in writing to the Director. A formal application for the extension of patent term must include:
  - (1) A complete identification of the approved product as by appropriate chemical and generic name, physical structure or characteristics;
  - (2) A complete identification of the Federal statute including the applicable provision of law under which the regulatory review occurred;
  - (3) An identification of the date on which the product received permission for commercial marketing or use under the provision of law under which the applicable regulatory review period occurred;
  - (4) In the case of a drug product, an identification of each active ingredient in the product and as to each active ingredient, a statement that it has not been previously approved for commercial marketing or use under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Virus-Serum-Toxin Act, or a statement of when the active ingredient was approved for commercial marketing or use (either alone or in combination with other active ingredients), the use for which it was approved, and the provision of law under which it was approved.
  - (5) A statement that the application is being submitted within the sixty day period permitted for submission pursuant to [§ 1.720(f)](/cfr/37/1.720.md?p=f) and an identification of the date of the last day on which the application could be submitted;
  - (6) A complete identification of the patent for which an extension is being sought by the name of the inventor, the patent number, the date of issue, and the date of expiration;
  - (7) A copy of the patent for which an extension is being sought, including the entire specification (including claims) and drawings;
  - (8) A copy of any disclaimer, certificate of correction, receipt of maintenance fee payment, or reexamination certificate issued in the patent;
  - (9) A statement that the patent claims the approved product, or a method of using or manufacturing the approved product, and a showing which lists each applicable patent claim and demonstrates the manner in which at least one such patent claim reads on:
    - (i) The approved product, if the listed claims include any claim to the approved product;
    - (ii) The method of using the approved product, if the listed claims include any claim to the method of using the approved product; and
    - (iii) The method of manufacturing the approved product, if the listed claims include any claim to the method of manufacturing the approved product;
  - (10) A statement beginning on a new page of the relevant dates and information pursuant to [35 U.S.C. 156(g)](/usc/35/156.md?p=g) in order to enable the Secretary of Health and Human Services or the Secretary of Agriculture, as appropriate, to determine the applicable regulatory review period as follows:
    - (i) **For a patent claiming a human drug, antibiotic, or human biological product—**
      - (A) The effective date of the investigational new drug (IND) application and the IND number;
      - (B) The date on which a new drug application (NDA) or a Product License Application (PLA) was initially submitted and the NDA or PLA number; and
      - (C) The date on which the NDA was approved or the Product License issued;
    - (ii) **For a patent claiming a new animal drug—**
      - (A) The date a major health or environmental effects test on the drug was initiated, and any available substantiation of that date, or the date of an exemption under subsection (j) of Section 512 of the Federal Food, Drug, and Cosmetic Act became effective for such animal drug;
      - (B) The date on which a new animal drug application (NADA) was initially submitted and the NADA number; and
      - (C) The date on which the NADA was approved;
    - (iii) **For a patent claiming a veterinary biological product—**
      - (A) The date the authority to prepare an experimental biological product under the Virus-Serum-Toxin Act became effective;
      - (B) The date an application for a license was submitted under the Virus-Serum-Toxin Act; and
      - (C) The date the license issued;
    - (iv) **For a patent claiming a food or color additive—**
      - (A) The date a major health or environmental effects test on the additive was initiated and any available substantiation of that date;
      - (B) The date on which a petition for product approval under the Federal Food, Drug and Cosmetic Act was initially submitted and the petition number; and
      - (C) The date on which the FDA published a Federal Register notice listing the additive for use;
    - (v) **For a patent claiming a medical device—**
      - (A) The effective date of the investigational device exemption (IDE) and the IDE number, if applicable, or the date on which the applicant began the first clinical investigation involving the device, if no IDE was submitted, and any available substantiation of that date;
      - (B) The date on which the application for product approval or notice of completion of a product development protocol under [Section 515](/cfr/37/515.md) of the Federal Food, Drug and Cosmetic Act was initially submitted and the number of the application; and
      - (C) The date on which the application was approved or the protocol declared to be completed;
  - (11) A brief description beginning on a new page of the significant activities undertaken by the marketing applicant during the applicable regulatory review period with respect to the approved product and the significant dates applicable to such activities;
  - (12) A statement beginning on a new page that in the opinion of the applicant the patent is eligible for the extension and a statement as to the length of extension claimed, including how the length of extension was determined;
  - (13) A statement that applicant acknowledges a duty to disclose to the Director of the United States Patent and Trademark Office and the Secretary of Health and Human Services or the Secretary of Agriculture any information which is material to the determination of entitlement to the extension sought (see [§ 1.765](/cfr/37/1.765.md));
  - (14) The prescribed fee for receiving and acting upon the application for extension (see [§ 1.20(j)](/cfr/37/1.20.md?p=j)); and
  - (15) The name, address, telephone number, and email address of the person to whom inquiries and correspondence related to the application for patent term extension are to be directed.
- (b) The application under this section, and any related submissions to the Office, must be submitted using the USPTO patent electronic filing system in accordance with the USPTO patent electronic filing system requirements.
- (c) If an application for extension of patent term is informal under this section, the Office will so notify the applicant. The applicant has two months from the mail date of the notice, or such time as is set in the notice, within which to correct the informality. Unless the notice indicates otherwise, this time period may be extended under the provisions of [§ 1.136](/cfr/37/1.136.md).

# §1.741. Complete application given a filing date; petition procedure.

- (a) The filing date of an application for extension of a patent term is the date on which a complete application is received in the Office via the USPTO patent electronic filing system or filed pursuant to the procedure set forth in § [1.8(a)(1)(i)(C)](/cfr/37/1.8.md?p=a-1-i-C) and [(a)(1)(ii)](/cfr/37/1.8.md?p=a-a-1-ii). A complete application must include:
  - (1) An identification of the approved product;
  - (2) An identification of each Federal statute under which regulatory review occurred;
  - (3) An identification of the patent for which an extension is being sought;
  - (4) An identification of each claim of the patent which claims the approved product or a method of using or manufacturing the approved product;
  - (5) Sufficient information to enable the Director to determine under subsections [(a)](#a) and [(b)](#b) of [35 U.S.C. 156](/usc/35/156.md) 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 length of the regulatory review period; and
  - (6) A brief description of the activities undertaken by the marketing applicant during the applicable regulatory review period with respect to the approved product and the significant dates applicable to such activities.
- (b) If an application for extension of patent term is incomplete under this section, the Office will so notify the applicant. If applicant requests review of a notice that an application is incomplete, or review of the filing date accorded an application under this section, applicant must file a petition pursuant to this paragraph accompanied by the fee set forth in [§ 1.17(f)](/cfr/37/1.17.md?p=f) within two months of the mail date of the notice that the application is incomplete, or the notice according the filing date complained of. Unless the notice indicates otherwise, this time period may be extended under the provisions of [§ 1.136](/cfr/37/1.136.md).

# §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](/cfr/37/1.740.md) or [§ 1.790](/cfr/37/1.790.md). 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](/cfr/37/1.740.md), 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](/cfr/37/1.136.md).


# §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](/cfr/37/1.740.md) 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](/cfr/37/1.750.md). 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.


# §1.765. Duty of disclosure in patent term extension proceedings.

- (a) A duty of candor and good faith toward the Patent and Trademark Office and the Secretary of Health and Human Services or the Secretary of Agriculture rests on the patent owner or its agent, on each attorney or agent who represents the patent owner and on every other individual who is substantively involved on behalf of the patent owner in a patent term extension proceeding. All such individuals who are aware, or become aware, of material information adverse to a determination of entitlement to the extension sought, which has not been previously made of record in the patent term extension proceeding must bring such information to the attention of the Office or the Secretary, as appropriate, in accordance with [paragraph (b)](#b) of this section, as soon as it is practical to do so after the individual becomes aware of the information. Information is material where there is a substantial likelihood that the Office or the Secretary would consider it important in determinations to be made in the patent term extension proceeding.
- (b) Disclosures pursuant to this section must be accompanied by a copy of each written document which is being disclosed. The disclosure must be made to the Office or the Secretary, as appropriate, unless the disclosure is material to determinations to be made by both the Office and the Secretary, in which case duplicate copies, certified as such, must be filed in the Office and with the Secretary. Disclosures pursuant to this section may be made to the Office or the Secretary, as appropriate, through an attorney or agent having responsibility on behalf of the patent owner or its agent for the patent term extension proceeding or through a patent owner acting on his or her own behalf. Disclosure to such an attorney, agent or patent owner shall satisfy the duty of any other individual. Such an attorney, agent or patent owner has no duty to transmit information which is not material to the determination of entitlement to the extension sought.
- (c) No patent will be determined eligible for extension and no extension will be issued if it is determined that fraud on the Office or the Secretary was practiced or attempted or the duty of disclosure was violated through bad faith or gross negligence in connection with the patent term extension proceeding. If it is established by clear and convincing evidence that any fraud was practiced or attempted on the Office or the Secretary in connection with the patent term extension proceeding or that there was any violation of the duty of disclosure through bad faith or gross negligence in connection with the patent term extension proceeding, a final determination will be made pursuant to [§ 1.750](/cfr/37/1.750.md) that the patent is not eligible for extension.
- (d) The duty of disclosure pursuant to this section rests on the individuals identified in [paragraph (a)](#a) of this section and no submission on behalf of third parties, in the form of protests or otherwise, will be considered by the Office. Any such submissions by third parties to the Office will be returned to the party making the submission, or otherwise disposed of, without consideration by the Office.

# §1.770. Express withdrawal of application for extension of patent term.


An application for extension of patent term may be expressly withdrawn before a determination is made pursuant to [§ 1.750](/cfr/37/1.750.md) by filing in the Office a written declaration of withdrawal signed by the owner of record of the patent or its agent. An application may not be expressly withdrawn after the date permitted for reply to the final determination on the application. An express withdrawal pursuant to this section is effective when acknowledged in writing by the Office. The filing of an express withdrawal pursuant to this section and its acceptance by the Office does not entitle applicant to a refund of the filing fee ([§ 1.20(j)](/cfr/37/1.20.md?p=j)) or any portion thereof.


# §1.775. Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

- (a) If a determination is made pursuant to [§ 1.750](/cfr/37/1.750.md) that a patent for a human drug, antibiotic drug or human biological product is eligible for extension, the term shall be extended by the time as calculated in days in the manner indicated by this section. The patent term extension will run from the original expiration date of the patent or any earlier date set by terminal disclaimer ([§ 1.321](/cfr/37/1.321.md)).
- (b) The term of the patent for a human drug, antibiotic drug or human biological product will be extended by the length of the regulatory review period for the product as determined by the Secretary of Health and Human Services, reduced as appropriate pursuant to [paragraphs (d)(1) through (d)(6)](#d-1..d-6) of this section.
- (c) The length of the regulatory review period for a human drug, antibiotic drug or human biological product will be determined by the Secretary of Health and Human Services. Under [35 U.S.C. 156(g)(1)(B)](/usc/35/156.md?p=g-1-B), it is the sum of—
  - (1) The number of days in the period beginning on the date an exemption under subsection (i) of section 505 or subsection (d) of section 507 of the Federal Food, Drug, and Cosmetic Act became effective for the approved product and ending on the date the application was initially submitted for such product under those sections or under section 351 of the Public Health Service Act; and
  - (2) The number of days in the period beginning on the date the application was initially submitted for the approved product under section 351 of the Public Health Service Act, subsection (b) of section 505 or [section 507](/cfr/37/507.md) of the Federal Food, Drug, and Cosmetic Act and ending on the date such application was approved under such section.
- (d) The term of the patent as extended for a human drug, antibiotic drug or human biological product will be determined by—
  - (1) Subtracting from the number of days determined by the Secretary of Health and Human Services to be in the regulatory review period:
    - (i) The number of days in the periods of paragraphs [(c)(1)](#c-1) and [(c)(2)](#c-2) of this section which were on and before the date on which the patent issued;
    - (ii) The number of days in the periods of paragraphs [(c)(1)](#c-1) and [(c)(2)](#c-2) of this section during which it is determined under [35 U.S.C. 156(d)(2)(B)](/usc/35/156.md?p=d-2-B) by the Secretary of Health and Human Services that applicant did not act with due diligence;
    - (iii) One-half the number of days remaining in the period defined by [paragraph (c)(1)](#c-1) of this section after that period is reduced in accordance with [paragraphs (d)(1)](#d-1) (i) and (ii) of this section; half days will be ignored for purposes of subtraction;
  - (2) By adding the number of days determined in [paragraph (d)(1)](#d-1) of this section to the original term of the patent as shortened by any terminal disclaimer;
  - (3) By adding 14 years to the date of approval of the application under section 351 of the Public Health Service Act, or subsection (b) of section 505 or [section 507](/cfr/37/507.md) of the Federal Food, Drug, and Cosmetic Act;
  - (4) By comparing the dates for the ends of the periods obtained pursuant to paragraphs [(d)(2)](#d-2) and [(d)(3)](#d-3) of this section with each other and selecting the earlier date;
  - (5) If the original patent was issued after September 24, 1984,
    - (i) By adding 5 years to the original expiration date of the patent or any earlier date set by terminal disclaimer; and
    - (ii) By comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(5)(i)](#d-5-i) of this section with each other and selecting the earlier date;
  - (6) If the original patent was issued before September 24, 1984, and
    - (i) If no request was submitted for an exemption under subsection (i) of section 505 or subsection (d) of section 507 of the Federal Food, Drug, and Cosmetic Act before September 24, 1984, by—
      - (A) Adding 5 years to the original expiration date of the patent or earlier date set by terminal disclaimer; and
      - (B) By comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(6)(i)(A)](#d-6-i-A) of this section with each other and selecting the earlier date; or
    - (ii) If a request was submitted for an exemption under subsection (i) of section 505 or subsection (d) of section 507 of the Federal Food, Drug, or Cosmetic Act before September 24, 1984 and the commercial marketing or use of the product was not approved before September 24, 1984, by—
      - (A) Adding 2 years to the original expiration date of the patent or earlier date set by terminal disclaimer, and
      - (B) By comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(6)(ii)(A)](#d-6-ii-A) of this section with each other and selecting the earlier date.

# §1.776. Calculation of patent term extension for a food additive or color additive.

- (a) If a determination is made pursuant to [§ 1.750](/cfr/37/1.750.md) that a patent for a food additive or color additive is eligible for extension, the term shall be extended by the time as calculated in days in the manner indicated by this section. The patent term extension will run from the original expiration date of the patent or earlier date set by terminal disclaimer ([§ 1.321](/cfr/37/1.321.md)).
- (b) The term of the patent for a food additive or color additive will be extended by the length of the regulatory review period for the product as determined by the Secretary of Health and Human Services, reduced as appropriate pursuant to [paragraphs (d)(1) through (d)(6)](#d-1..d-6) of this section.
- (c) The length of the regulatory review period for a food additive or color additive will be determined by the Secretary of Health and Human Services. Under [35 U.S.C. 156(g)(2)(B)](/usc/35/156.md?p=g-2-B), it is the sum of—
  - (1) The number of days in the period beginning on the date a major health or environmental effects test on the additive was initiated and ending on the date a petition was initially submitted with respect to the approved product under the Federal Food, Drug, and Cosmetic Act requesting the issuance of a regulation for use of the product; and
  - (2) The number of days in the period beginning on the date a petition was initially submitted with respect to the approved product under the Federal Food, Drug, and Cosmetic Act requesting the issuance of a regulation for use of the product, and ending on the date such regulation became effective or, if objections were filed to such regulation, ending on the date such objections were resolved and commercial marketing was permitted or, if commercial marketing was permitted and later revoked pending further proceedings as a result of such objections, ending on the date such proceedings were finally resolved and commercial marketing was permitted.
- (d) The term of the patent as extended for a food additive or color additive will be determined by
  - (1) Subtracting from the number of days determined by the Secretary of Health and Human Services to be in the regulatory review period:
    - (i) The number of days in the periods of paragraphs [(c)(1)](#c-1) and [(c)(2)](#c-2) of this section which were on and before the date on which the patent issued;
    - (ii) The number of days in the periods of paragraphs [(c)(1)](#c-1) and [(c)(2)](#c-2) of this section during which it is determined under [35 U.S.C. 156(d)(2)(B)](/usc/35/156.md?p=d-2-B) by the Secretary of Health and Human Services that applicant did not act with due diligence;
    - (iii) The number of days equal to one-half the number of days remaining in the period defined by [paragraph (c)(1)](#c-1) of this section after that period is reduced in accordance with [paragraphs (d)(1)](#d-1) (i) and (ii) of this section; half days will be ignored for purposes of subtraction;
  - (2) By adding the number of days determined in [paragraph (d)(1)](#d-1) of this section to the original term of the patent as shortened by any terminal disclaimer;
  - (3) By adding 14 years to the date a regulation for use of the product became effective or, if objections were filed to such regulation, to the date such objections were resolved and commercial marketing was permitted or, if commercial marketing was permitted and later revoked pending further proceedings as a result of such objections, to the date such proceedings were finally resolved and commercial marketing was permitted;
  - (4) By comparing the dates for the ends of the periods obtained pursuant to paragraphs [(d)(2)](#d-2) and [(d)(3)](#d-3) of this section with each other and selecting the earlier date;
  - (5) If the original patent was issued after September 24, 1984,
    - (i) By adding 5 years to the original expiration date of the patent or earlier date set by terminal disclaimer; and
    - (ii) By comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(5)(i)](#d-5-i) of this section with each other and selecting the earlier date;
  - (6) If the original patent was issued before September 24, 1984, and
    - (i) If no major health or environmental effects test was initiated and no petition for a regulation or application for registration was submitted before September 24, 1984, by—
      - (A) Adding 5 years to the original expiration date of the patent or earlier date set by terminal disclaimer, and
      - (B) By comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(6)(i)(A)](#d-6-i-A) of this section with each other and selecting the earlier date; or
    - (ii) If a major health or environmental effects test was initiated or a petition for a regulation or application for registration was submitted by September 24, 1984, and the commercial marketing or use of the product was not approved before September 24, 1984, by—
      - (A) Adding 2 years to the original expiration date of the patent or earlier date set by terminal disclaimer, and
      - (B) By comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(6)(ii)(A)](#d-6-ii-A) of this section with each other and selecting the earlier date.

# §1.777. Calculation of patent term extension for a medical device.

- (a) If a determination is made pursuant to [§ 1.750](/cfr/37/1.750.md) that a patent for a medical device is eligible for extension, the term shall be extended by the time as calculated in days in the manner indicated by this section. The patent term extension will run from the original expiration date of the patent or earlier date as set by terminal disclaimer ([§ 1.321](/cfr/37/1.321.md)).
- (b) The term of the patent for a medical device will be extended by the length of the regulatory review period for the product as determined by the Secretary of Health and Human Services, reduced as appropriate pursuant to [paragraphs (d)(1) through (d)(6)](#d-1..d-6) of this section.
- (c) The length of the regulatory review period for a medical device will be determined by the Secretary of Health and Human Services. Under [35 U.S.C. 156(g)(3)(B)](/usc/35/156.md?p=g-3-B), it is the sum of
  - (1) The number of days in the period beginning on the date a clinical investigation on humans involving the device was begun and ending on the date an application was initially submitted with respect to the device under [section 515](/cfr/37/515.md) of the Federal Food, Drug, and Cosmetic Act; and
  - (2) The number of days in the period beginning on the date the application was initially submitted with respect to the device under [section 515](/cfr/37/515.md) of the Federal Food, Drug, and Cosmetic Act, and ending on the date such application was approved under such Act or the period beginning on the date a notice of completion of a product development protocol was initially submitted under section 515(f)(5) of the Act and ending on the date the protocol was declared completed under [section 515(f)(6)](/cfr/37/515.md?p=f-6) of the Act.
- (d) The term of the patent as extended for a medical device will be determined by—
  - (1) Substracting from the number of days determined by the Secretary of Health and Human Services to be in the regulatory review period pursuant to [paragraph (c)](#c) of this section:
    - (i) The number of days in the periods of paragraphs [(c)(1)](#c-1) and [(c)(2)](#c-2) of this section which were on and before the date on which the patent issued;
    - (ii) The number of days in the periods of paragraphs [(c)(1)](#c-1) and [(c)(2)](#c-2) of this section during which it is determined under [35 U.S.C. 156(d)(2)(B)](/usc/35/156.md?p=d-2-B) by the Secretary of Health and Human Services that applicant did not act with due diligence;
    - (iii) One-half the number of days remaining in the period defined by [paragraph (c)(1)](#c-1) of this section after that period is reduced in accordance with [paragraphs (d)(1)](#d-1) (i) and (ii) of this section; half days will be ignored for purposes of subtraction;
  - (2) By adding the number of days determined in [paragraph (d)(1)](#d-1) of this section to the original term of the patent as shortened by any terminal disclaimer;
  - (3) By adding 14 years to the date of approval of the application under [section 515](/cfr/37/515.md) of the Federal Food, Drug, and Cosmetic Act or the date a product development protocol was declared completed under section 515(f)(6) of the Act;
  - (4) By comparing the dates for the ends of the periods obtained pursuant to paragraphs [(d)(2)](#d-2) and [(d)(3)](#d-3) of this section with each other and selecting the earlier date;
  - (5) If the original patent was issued after September 24, 1984,
    - (i) By adding 5 years to the original expiration date of the patent or earlier date set by terminal disclaimer; and
    - (ii) By comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(5)(i)](#d-5-i) of this section with each other and selecting the earlier date;
  - (6) If the original patent was issued before September 24, 1984, and
    - (i) If no clinical investigation on humans involving the device was begun or no product development protocol was submitted under [section 515(f)(5)](/cfr/37/515.md?p=f-5) of the Federal Food, Drug, and Cosmetic Act before September 24, 1984, by—
      - (A) Adding 5 years to the original expiration date of the patent or earlier date set by terminal disclaimer and
      - (B) By comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(6)(i)(A)](#d-6-i-A) of this section with each other and selecting the earlier date; or
    - (ii) If a clinical investigation on humans involving the device was begun or a product development protocol was submitted under [section 515(f)(5)](/cfr/37/515.md?p=f-5) of the Federal Food, Drug, and Cosmetic Act before September 24, 1984 and the commercial marketing or use of the product was not approved before September 24, 1984, by
      - (A) Adding 2 years to the original expiration date of the patent or earlier date set by terminal disclaimer, and
      - (B) By comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(6)(ii)(A)](#d-6-ii-A) of this section with each other and selecting the earlier date.

# §1.778. Calculation of patent term extension for an animal drug product.

- (a) If a determination is made pursuant to [§ 1.750](/cfr/37/1.750.md) that a patent for an animal drug is eligible for extension, the term shall be extended by the time as calculated in days in the manner indicated by this section. The patent term extension will run from the original expiration date of the patent or any earlier date set by terminal disclaimer ([§ 1.321](/cfr/37/1.321.md)).
- (b) The term of the patent for an animal drug will be extended by the length of the regulatory review period for the drug as determined by the Secretary of Health and Human Services, reduced as appropriate pursuant to [paragraphs (d)(1) through (d)(6)](#d-1..d-6) of this section.
- (c) The length of the regulatory review period for an animal drug will be determined by the Secretary of Health and Human Services. Under [35 U.S.C. 156(g)(4)(B)](/usc/35/156.md?p=g-4-B), it is the sum of—
  - (1) The number of days in the period beginning on the earlier of the date a major health or environmental effects test on the drug was initiated or the date an exemption under subsection (j) of section 512 of the Federal Food, Drug, and Cosmetic Act became effective for the approved animal drug and ending on the date an application was initially submitted for such animal drug under [section 512](/cfr/37/512.md) of the Federal Food, Drug, and Cosmetic Act; and
  - (2) The number of days in the period beginning on the date the application was initially submitted for the approved animal drug under subsection (b) of section 512 of the Federal Food, Drug, and Cosmetic Act and ending on the date such application was approved under such section.
- (d) The term of the patent as extended for an animal drug will be determined by—
  - (1) Subtracting from the number of days determined by the Secretary of Health and Human Services to be in the regulatory review period:
    - (i) The number of days in the periods of paragraphs [(c)(1)](#c-1) and [(c)(2)](#c-2) of this section that were on and before the date on which the patent issued;
    - (ii) The number of days in the periods of paragraphs [(c)(1)](#c-1) and [(c)(2)](#c-2) of this section during which it is determined under [35 U.S.C. 156(d)(2)(B)](/usc/35/156.md?p=d-2-B) by the Secretary of Health and Human Services that applicant did not act with due diligence;
    - (iii) One-half the number of days remaining in the period defined by [paragraph (c)(1)](#c-1) of this section after that period is reduced in accordance with [paragraphs (d)(1)](#d-1) (i) and (ii) of this section; half days will be ignored for purposes of subtraction;
  - (2) By adding the number of days determined in [paragraph (d)(1)](#d-1) of this section to the original term of the patent as shortened by any terminal disclaimer;
  - (3) By adding 14 years to the date of approval of the application under [section 512](/cfr/37/512.md) of the Federal Food, Drug, and Cosmetic Act;
  - (4) By comparing the dates for the ends of the periods obtained pursuant to paragraphs [(d)(2)](#d-2) and [(d)(3)](#d-3) of this section with each other and selecting the earlier date;
  - (5) If the original patent was issued after November 16, 1988, by—
    - (i) Adding 5 years to the original expiration date of the patent or any earlier date set by terminal disclaimer; and
    - (ii) Comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(5)(i)](#d-5-i) of this section with each other and selecting the earlier date;
  - (6) If the original patent was issued before November 16, 1988, and
    - (i) If no major health or environmental effects test on the drug was initiated and no request was submitted for an exemption under subsection (j) of section 512 of the Federal Food, Drug, and Cosmetic Act before November 16, 1988, by—
      - (A) Adding 5 years to the original expiration date of the patent or earlier date set by terminal disclaimer; and
      - (B) Comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(6)(i)(A)](#d-6-i-A) of this section with each other and selecting the earlier date; or
    - (ii) If a major health or environmental effects test was initiated or a request for an exemption under subsection (j) of section 512 of the Federal Food, Drug, and Cosmetic Act was submitted before November 16, 1988, and the application for commercial marketing or use of the animal drug was not approved before November 16, 1988, by—
      - (A) Adding 3 years to the original expiration date of the patent or earlier date set by terminal disclaimer, and
      - (B) Comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(6)(ii)(A)](#d-6-ii-A) of this section with each other and selecting the earlier date.

# §1.779. Calculation of patent term extension for a veterinary biological product.

- (a) If a determination is made pursuant to [§ 1.750](/cfr/37/1.750.md) that a patent for a veterinary biological product is eligible for extension, the term shall be extended by the time as calculated in days in the manner indicated by this section. The patent term extension will run from the original expiration date of the patent or any earlier date set by terminal disclaimer ([§ 1.321](/cfr/37/1.321.md)).
- (b) The term of the patent for a veterinary biological product will be extended by the length of the regulatory review period for the product as determined by the Secretary of Agriculture, reduced as appropriate pursuant to [paragraphs (d)(1) through (d)(6)](#d-1..d-6) of this section.
- (c) The length of the regulatory review period for a veterinary biological product will be determined by the Secretary of Agriculture. Under [35 U.S.C. 156(g)(5)(B)](/usc/35/156.md?p=g-5-B), it is the sum of—
  - (1) The number of days in the period beginning on the date the authority to prepare an experimental biological product under the Virus-Serum-Toxin Act became effective and ending on the date an application for a license was submitted under the Virus-Serum-Toxin Act; and
  - (2) The number of days in the period beginning on the date an application for a license was initially submitted for approval under the Virus-Serum-Toxin Act and ending on the date such license was issued.
- (d) The term of the patent as extended for a veterinary biological product will be determined by—
  - (1) Subtracting from the number of days determined by the Secretary of Agriculture to be in the regulatory review period:
    - (i) The number of days in the periods of paragraphs [(c)(1)](#c-1) and [(c)(2)](#c-2) of this section that were on and before the date on which the patent issued;
    - (ii) The number of days in the periods of paragraphs [(c)(1)](#c-1) and [(c)(2)](#c-2) of this section during which it is determined under [35 U.S.C. 156(d)(2)(B)](/usc/35/156.md?p=d-2-B) by the Secretary of Agriculture that applicant did not act with due diligence;
    - (iii) One-half the number of days remaining in the period defined by [paragraph (c)(1)](#c-1) of this section after that period is reduced in accordance with [paragraphs (d)(1)](#d-1) (i) and (ii) of this section; half days will be ignored for purposes of subtraction;
  - (2) By adding the number of days determined in [paragraph (d)(1)](#d-1) of this section to the original term of the patent as shortened by any terminal disclaimer;
  - (3) By adding 14 years to the date of the issuance of a license under the Virus-Serum-Toxin Act;
  - (4) By comparing the dates for the ends of the periods obtained pursuant to paragraphs [(d)(2)](#d-2) and [(d)(3)](#d-3) of this section with each other and selecting the earlier date;
  - (5) If the original patent was issued after November 16, 1988, by—
    - (i) Adding 5 years to the original expiration date of the patent or any earlier date set by terminal disclaimer; and
    - (ii) Comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(5)(i)](#d-5-i) of this section with each other and selecting the earlier date;
  - (6) If the original patent was issued before November 16, 1988, and
    - (i) If no request for the authority to prepare an experimental biological product under the Virus-Serum-Toxin Act was submitted before November 16, 1988, by—
      - (A) Adding 5 years to the original expiration date of the patent or earlier date set by terminal disclaimer; and
      - (B) Comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(6)(i)(A)](#d-6-i-A) of this section with each other and selecting the earlier date; or
    - (ii) If a request for the authority to prepare an experimental biological product under the Virus-Serum-Toxin Act was submitted before November 16, 1988, and the commercial marketing or use of the product was not approved before November 16, 1988, by—
      - (A) Adding 3 years to the original expiration date of the patent or earlier date set by terminal disclaimer; and
      - (B) Comparing the dates obtained pursuant to paragraphs [(d)(4)](#d-4) and [(d)(6)(ii)(A)](#d-6-ii-A) of this section with each other and selecting the earlier date.

# §1.780. Certificate or order of extension of patent term.


If a determination is made pursuant to [§ 1.750](/cfr/37/1.750.md) that a patent is eligible for extension and that the term of the patent is to be extended, a certificate of extension, under seal, or an order granting interim extension under [35 U.S.C. 156(d)(5)](/usc/35/156.md?p=d-5), will be issued to the applicant for the extension of the patent term. Such certificate or order will be recorded in the official file of the patent and will be considered as part of the original patent. Notification of the issuance of the certificate or order of extension will be published in the Official Gazette of the United States Patent and Trademark Office. Notification of the issuance of the order granting an interim extension under [35 U.S.C. 156(d)(5)](/usc/35/156.md?p=d-5), including the identity of the product currently under regulatory review, will be published in the Official Gazette of the United States Patent and Trademark Office and in the Federal Register. No certificate of, or order granting, an extension will be issued if the term of the patent cannot be extended, even though the patent is otherwise determined to be eligible for extension. In such situations, the final determination made pursuant to [§ 1.750](/cfr/37/1.750.md) will indicate that no certificate or order will issue.


# §1.785. Multiple applications for extension of term of the same patent or of different patents for the same regulatory review period for a product.

- (a) Only one patent may be extended for a regulatory review period for any product ([§ 1.720(h)](/cfr/37/1.720.md?p=h)). If more than one application for extension of the same patent is filed, the certificate of extension of patent term, if appropriate, will be issued based upon the first filed application for extension.
- (b) If more than one application for extension is filed by a single applicant which seeks the extension of the term of two or more patents based upon the same regulatory review period, and the patents are otherwise eligible for extension pursuant to the requirements of this subpart, in the absence of an election by the applicant, the certificate of extension of patent term, if appropriate, will be issued upon the application for extension of the patent term having the earliest date of issuance of those patents for which extension is sought.
- (c) If an application for extension is filed which seeks the extension of the term of a patent based upon the same regulatory review period as that relied upon in one or more applications for extension pursuant to the requirements of this subpart, the certificate of extension of patent term will be issued on the application only if the patent owner or its agent is the holder of the regulatory approval granted with respect to the regulatory review period.
- (d) An application for extension shall be considered complete and formal regardless of whether it contains the identification of the holder of the regulatory approval granted with respect to the regulatory review period. When an application contains such information, or is amended to contain such information, it will be considered in determining whether an application is eligible for an extension under this section. A request may be made of any applicant to supply such information within a non-extendable period of not less than one month whenever multiple applications for extension of more than one patent are received and rely upon the same regulatory review period. Failure to provide such information within the period for reply set shall be regarded as conclusively establishing that the applicant is not the holder of the regulatory approval.
- (e) Determinations made under this section shall be included in the notice of final determination of eligibility for extension of the patent term pursuant to [§ 1.750](/cfr/37/1.750.md) and shall be regarded as part of that determination.

# §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 35 U.S.C. [156(g)(1)(B)(ii)](/usc/35/156.md?p=g-1-B-ii), [(2)(B)(ii)](/usc/35/156.md?p=g-2-B-ii), [(3)(B)(ii)](/usc/35/156.md?p=g-3-B-ii), [(4)(B)(ii)](/usc/35/156.md?p=g-4-B-ii), or [(5)(B)(ii)](/usc/35/156.md?p=g-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)](/usc/35/156.md?p=c).
- (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.
- (c) **Complete initial applications for interim extension under this section must—**
  - (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) Include all of the information required for a formal application under [§ 1.740](/cfr/37/1.740.md) and a complete application under [§ 1.741](/cfr/37/1.741.md), except as follows:
    - (i) Paragraphs [(a)(1)](/cfr/37/1.740.md?p=a-1), [(2)](/cfr/37/1.740.md?p=a-2), [(4)](/cfr/37/1.740.md?p=a-4), and [(6) through (15)](/cfr/37/1.740.md?p=a-6..a-15) of §§ 1.740 and 1.741 shall be read in the context of a product currently undergoing regulatory review; and
    - (ii) Paragraphs [(a)(3)](/cfr/37/1.740.md?p=a-3) and [(5)](/cfr/37/1.740.md?p=a-5) of § 1.740 are not applicable to an application for interim extension under this section; and
  - (3) Include a statement that the applicable regulatory review period, described in 35 U.S.C. [156(g)(1)(B)(ii)](/usc/35/156.md?p=g-1-B-ii), [(2)(B)(ii)](/usc/35/156.md?p=g-2-B-ii), [(3)(B)(ii)](/usc/35/156.md?p=g-3-B-ii), [(4)(B)(ii)](/usc/35/156.md?p=g-4-B-ii), or [(5)(B)(ii)](/usc/35/156.md?p=g-5-B-ii), has begun for the product that is the subject of the patent.
- (d) **Each subsequent application for interim extension—**
  - (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) May be limited in content to a request for a subsequent interim extension along with any materials or information required under §§ [1.740](/cfr/37/1.740.md) and [1.741](/cfr/37/1.741.md) that are not present in the preceding interim extension application; and
  - (3) Must include a statement that the applicable regulatory review period, described in 35 U.S.C. [156(g)(1)(B)(ii)](/usc/35/156.md?p=g-1-B-ii), [(2)(B)(ii)](/usc/35/156.md?p=g-2-B-ii), [(3)(B)(ii)](/usc/35/156.md?p=g-3-B-ii), [(4)(B)(ii)](/usc/35/156.md?p=g-4-B-ii), or [(5)(B)(ii)](/usc/35/156.md?p=g-5-B-ii), has not been completed.

# §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)](/usc/35/156.md?p=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](/cfr/37/1.740.md) and [1.741](/cfr/37/1.741.md) including any additional information required under [35 U.S.C. 156(d)(1)](/usc/35/156.md?p=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](/usc/35/156.md).