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) 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:
(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:
(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
(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
(A)
The date the authority to prepare an experimental biological product under the Virus-Serum-Toxin Act became effective;
(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
(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
(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.