MPEP § 2753
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; any extension will be granted based upon the review of the product as either a medical device or a drug productit 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. 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. 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, 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.
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 five-year limit of 35 U.S.C. 156(g)(6)(A) 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 Hatch-Waxman PTE, 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. The original copy, along with the patent file (if not already scanned into the Image File Wrapper system), is scanned into the Image File Wrapper system so that all patent prosecution and patent term extension documents are available in PUBLIC PAIR. One copy of the application is forwarded to the regulatory agency and the second copy is used by the Legal Advisor in the Office of Patent Legal Administration.