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2753 Application Contents [R-2] - 2700 Patent Terms and Extensions
2753 Application Contents [R-2]
37 CFR 1.740 Formal requirements for application for extension of patent term; correction of informalities.
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(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 § l.720(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) 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 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);<
(14) The prescribed fee for receiving and acting upon the application for extension (see § 1.20(j)); and
(15) The name, address, and telephone number of the person to whom inquiries and correspondence relating to the application for patent term extension are to be directed.
(b) The application under this section must be accompanied by two additional copies of such application (for a total of three copies).
(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.
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 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 with a specific drug product which may require approval 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; it cannot be a combination of those separate products. See the file history of U.S. Patent No. 4,428,744 for an example 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.
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 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). 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. 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 include any patent term adjustment under 35 U.S.C. 154(b).
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 explain how each listed claim reads on the approved product. 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 35 U.S.C. 112, paragraph 6, 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.
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 had 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 related to 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, 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 two or three limit of 35 U.S.C. 156(g)(6)(C) applies.
37 CFR 1.740(a)(15) requires the patent term extension applicant to provide a correspondence address. A fax number should also be provided. Normally only communications regarding the application for patent term extension will be sent to the address specified in the patent term extension application. If the address is changed after filing the application for patent term extension, the change of address should be sent to *>Mail Stop< Patent Extension, since changing the address for the patent file will not cause the address for the patent term extension application to also be changed.
In order to change the address of all correspondence, including maintenance fee reminders, a change of address should also be filed. A change of address must be signed by the patent applicant, the assignee of the entire interest, or an attorney or agent of record. 37 CFR 1.33(a). Accordingly, if the patent term extension application is signed by the marketing applicant, as an agent of the patent owner, a power of attorney from the patent owner to any attorney for the marketing applicant would be necessary for the attorney for the marketing applicant to be able to sign a change of address for the patent file.
Pursuant to 37 CFR 1.740(b), two additional copies of the application for patent term extension must be filed with the application. In addition, applicants are requested to file an additional two copies of the application, for a total of five copies. The original copy is placed into the patent application file after the Notice of Final Determination is mailed. Two copies of the application are forwarded to the regulatory agency, one copy is made available for public inspection in the Office of Patent Legal Administration, and the fifth copy is used by the Legal Advisor.
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