2753 Application Contents [R-01.2024]

37 CFR 1.740 sets forth the requirements for a formal application for extension of patent term. See MPEP § 2752 for a discussion of who may apply for a patent term extension. See 37 CFR 1.741 and MPEP § 2754 for a description of the information that must be submitted in the patent term extension application in order to be accorded a filing date.

37 CFR 1.740(a)(1) requires a complete identification of the approved product as by appropriate chemical and generic name, physical structure or characteristics so as to enable the Director to make a determination of whether the patent claims the approved product, or a method of using or manufacturing the approved product.

37 CFR 1.740(a)(2) requires a complete identification of the federal statute including the applicable provision(s) of law under which the regulatory review occurred. When the regulatory review of the product took place under more than one federal statute, each appropriate statute should be listed. This could apply to a situation where a human biological product is tested under an investigational new drug (IND) application pursuant to the Federal Food, Drug, and Cosmetic Act, but is approved under the Public Health Service Act; or to a situation where approval is sought for use of a particular medical device having a specific drug component which may require review under more than a single provision of law. The product that forms the basis of an application for patent term extension must be either a medical device or a drug product. Any extension granted from the application will be based on the review of the product as either a medical device or a drug product rather than as a combination of those separate products. See the file history of U.S. Patent No. 4,428,744 or U.S. Patent No. 5,891,086 for examples of the application of this principle.

The date that a product receives permission for commercial marketing or use (which must be identified pursuant to 37 CFR 1.740(a)(3)) is generally the mailing date of the letter from the regulatory agency indicating regulatory approval. For a food additive, the approval date is generally the effective date stated in the regulation and the date the regulation is published. With respect to drug products where the Secretary of Health and Human Services recommends controls under the Controlled Substances Act, the drug product cannot legally be marketed until such time as an interim final rule is published by the Drug Enforcement Agency (the agency which administers the Controlled Substances Act) in the Federal Register scheduling the drug product. This means that the date of approval for a drug product, where controls under the Controlled Substances Act have been recommended, will be the later of :

• (1)
  • (a) the approval date of an application submitted for approval of a human biological product under subsection (a) of section 351 of the Public Health Services Act;
  • (b) the approval date of an application submitted for approval of a human drug under section 505(b) of the Federal Food Drug and Cosmetic Act (FFDCA);
  • (c) the approval date of an application submitted for approval of an animal drug under section 512(c) of the FFDCA;
  • (d) the date of a conditional approval for an animal drug under section 571(b) of the FFDCA;
  • (e) the date a request for indexing is granted under section 572(d) of the FFDCA; or
• (2) the date of issuance of an interim final rule controlling the drug product under section 201(j) of the Controlled Substances Act.

37 CFR 1.740(a)(4) provides that for drug products, each active ingredient must be identified and there must be an indication of the use for which the product was approved. For each active ingredient, a statement must be made that either the active ingredient was not previously approved for commercial marketing or use under the Federal Food, Drug and Cosmetic Act, or that the active ingredient was approved for commercial marketing or use (either alone or in combination with other active ingredients) and the provision of law under which it was approved. The information is especially necessary for a determination of eligibility where, for example, the application is based on a second or subsequent approval of an active ingredient, but the first approval was for administration to a food-producing animal.

In accordance with 37 CFR 1.740(a)(5), the application must be submitted within the sixty day period permitted for submission pursuant to 37 CFR 1.720(f); see MPEP § 2754.01. If the sixty day period ends on a Saturday, Sunday or federal holiday, then the last day on which the application could be submitted will be considered to be the next business day following the Saturday, Sunday or federal holiday. See 37 CFR 1.7. The starting date of the sixty-day period as recited in 35 U.S.C. 156(d)(1) has been clarified by the America Invents Act where the Act provides that, “[f]or 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.” See Section 37 of the American Invents Act and 35 U.S.C. 156.

Under the November 25, 2015 amendments to 156(d)(1), the time period for submission for an application for patent term extension, where the regulatory review is of a drug product for which the Secretary of Health and Human Services intends to recommend controls under the Controlled Substances Act, is the sixty-day period beginning on the “covered date,” where the “covered date” is 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.

However, applicants are cautioned to avoid filing an application for patent term extension on the last day for filing to avoid the application being denied because the filing deadline was inadvertently missed.

The expiration date of the patent for which an extension is sought as identified pursuant to 37 CFR 1.740(a)(6) should be the expiration date according to the law (35 U.S.C. 154) at the time of filing of the application for patent term extension, and should take into account any patent term adjustment under 35 U.S.C. 154(b) as well as any terminal disclaimer. It is recommended that the application shows how the expiration date was calculated. For example, 20 years from filing of the parent non-provisional application (filing date of August 16, 2005), plus 240 days of patent term adjustment yields an expiration date of April 13, 2026, in the absence of any terminal disclaimer which would further limit the term.

Pursuant to 37 CFR 1.740(a)(9), the application for patent term extension need only explain how one product claim of the patent claims the approved product, if there is a claim to the product. In addition, the application need only explain how one method of use claim of the patent claims the method of use of the approved product, if there is a claim to the method of use of the product. Lastly, the application need only explain how one claim of the patent claims the method of manufacturing the approved product, if there is a claim to the method of manufacturing the approved product. At most, a showing explaining three claims is required. However, each claim that claims the approved product, the method of use of the approved product, or the method of manufacturing the approved product must be listed. See 35 U.S.C. 156(d)(1)(B).

The showing should clearly demonstrate how the product, method of use and/or method of manufacture claim reads on the approved product, should all three patent claim types be present in a patent for which term extension is being sought. For example, where a generic chemical structure is used in the claim to define the claimed invention, a listing of variables and substituents which correspond to the approved product is appropriate. Where a claim uses the “means for” language permitted by pre-AIA 35 U.S.C. 112, paragraph 6, or 35 U.S.C. 112(f) for patents granted on AIA applications, reference to the column and line number of the patent text and any drawing reference numbers, as well as a description of any relevant equivalents, is also appropriate. Another example that may be helpful for demonstrating that a patent claims a medical device is to use a claim chart to describe how, using an element by element approach, the patent claims the approved medical device or a component of the approved medical device.

Pursuant to 37 CFR 1.740(a)(10), the patent term extension applicant must provide a statement to enable the Secretary of Health and Human Services or the Secretary of Agriculture, as appropriate, to determine the applicable regulatory period. In cases where there is no regulatory event to reflect the commencement of the testing or approval phase of the regulatory review period, applicants should include in the application the dates that they claim initiate either the approval or the testing phases and an explanation of their reasonable bases for why they conclude that these dates are the relevant dates. For instance, when the clinical trials are conducted outside of the United States, the testing phase for a medical device begins on the date the clinical investigation involving the device began. An applicant should include an explanation as to why the date claimed is the date on which such clinical investigations commenced. If the applicant has any means of substantiating that date, that information should be included in the application.

37 CFR 1.740(a)(11) requires a brief description of the activities of the marketing applicant before the regulatory agency. This description should include an identification of significant communications of substance with the regulatory agency and the dates of such communications. For example, these activities would include the dates of the submissions of new data to the FDA, communications between FDA and the applicant with respect to the appropriate protocols for testing the product, and communications between FDA and the applicant that are attempts to define the particular requirements for premarketing approval for this particular product. The applicant is not required to establish the existence of due diligence during the regulatory review period in order to have a complete application.

As stated above in MPEP § 2752, the marketing applicant must have been an agent of the patent owner, if not the same entity as the patent owner. Accordingly, the Office will not assist the patent owner in obtaining information required in an application for patent term extension from the marketing applicant. It is sufficient that the description of the activities briefly identify those significant activities undertaken by the marketing applicant directed toward regulatory approval, and a submission of insignificant details or identification of non-substantive communications is not required.

37 CFR 1.740(a)(12) requires that the extension applicant state the length of extension claimed and show how the length of extension was calculated, including whether the 14-year limit of 35 U.S.C. 156(c)(3) or the five-year limit of 35 U.S.C. 156(g)(6)(A) applies.

37 CFR 1.740(a)(13) requires a statement by the applicant acknowledging a duty to disclose to the Director 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 the entitlement to the extension sought. See MPEP § 2001.06(e) regarding duty of disclosure related to regulatory review.

37 CFR 1.740(a)(14) requires payment of the prescribed fee (37 CFR 1.20(j)) for receiving and acting upon the application for extension. It is preferable that an authorization to charge a deposit account for the fee under 37 CFR 1.20(j) be included in the application. Alternatively, the fee can be paid via the Office’s online Financial Manager system.

37 CFR 1.740(a)(15) requires the patent term extension applicant to provide the name, address, telephone number, and email address of the person to whom inquiries and correspondence related to the patent term extension application are to be directed. The USPTO uses the information provided under 37 CFR 1.740(a)(15) strictly for inquiries and correspondence regarding the patent term extension application. If a patent term extension applicant subsequently wishes to change the 37 CFR 1.740(a)(15) correspondence address, or any of the other information provided under 37 CFR 1.740(a)(15), a document should be filed referencing 37 CFR 1.740(a)(15) and using the document description “Limited POA and/or Change of Address for a Patent Term Extension Application” (document code PTE.POA). A change of address 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 the correspondence address for the underlying patent. Patent term extension applicants are reminded to separately file a change of address with any relevant regulatory agency to timely receive copies of correspondence from that agency.

To change the address to be used only for correspondence in the patent file unrelated to the patent term extension application, including maintenance fee reminders, a change of address under 37 CFR 1.33 should be filed using, for example, the document description “Change of Address” (document code C.AD). In general, 37 CFR 1.33 requires a change of address to be signed by the patent applicant or a patent practitioner of record.

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