35 U.S.C. 156 Extension of patent term.
- (1) A determination that a patent is eligible for extension may be made by the Director solely on the basis of the representations contained in the application for the extension. If the Director determines that a patent is eligible for extension under subsection (a) and that the requirements of paragraphs (1) through (4) of subsection (d) have been complied with, the Director shall issue to the applicant for the extension of the term of the patent a certificate of extension, under seal, for the period prescribed by subsection (c). Such certificate shall be recorded in the official file of the patent and shall be considered as part of the original patent.
37 CFR 1.780 Certificate or order of extension of patent term.
If a determination is made pursuant to § 1.750 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), 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), including the identity of the product currently under regulatory review, will be published in the Official Gazette of the United States Patent and TrademarkOffice 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 will indicate that no certificate or order will issue.
Once a determination is made pursuant to 37 CFR 1.750 that a patent is eligible for extension of its term, a certificate of extension, under seal, will be issued to the patent owner at the correspondence address specified in the application for patent term extension. Following the one-month period provided in the Notice of Final Determination, the Certificate of Extension is prepared and signed by the Director. The original certificate is mailed to the applicant and a copy is sent to the regulatory agency. A copy of the certificate is placed in the official patent file and the Office’s working file maintained for the patent term extension application in the Office of Patent Legal Administration.
Upon issuance of the certificate of extension, the Image File Wrapper available in PUBLIC PAIR will include an image of the certificate of extension.
All original papers from the application for patent term extension in the official file are transferred to the official patent file of the subject patent and become a part of the permanent record. A copy of the certificate of extension of patent term is added to the patent electronic database as part of the patent record in the same manner as is a certificate of correction or a terminal disclaimer. The patent is also added to the list of patents extended under 35 U.S.C. 156, a copy of which is posted on the USPTO website (www.uspto.gov) and updated as needed.