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DEPARTMENT OF COMMERCE

Patent and Trademark Office

Docket ID: [Docket No. PTO-P-2008-0015]

NOTICE: NOTICES

DOCUMENT ACTION: Notice of Interim Patent Term Extension.

SUBJECT CATEGORY: Grant of Interim Extension of the Term of U.S. Patent No. 4,650,787; Sanvar[supreg]

DOCUMENT SUMMARY: The United States Patent and Trademark Office has issued an order granting interim extension under 35 U.S.C. 156(d)(5) for a fourth oneyear interim extension of the term of U.S. Patent No. 4,650,787.

SUMMARY: Grant of Interim Extension of the Term of U.S. Patent No. 4,650,787; Sanvar,

SUPPLEMENTAL INFORMATION

Section 156 of Title 35, United States Code, generally provides that the term of a patent may be extended for a period of
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up to five years if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review, and that the patent may be extended for interim periods of up to a year if the regulatory review is anticipated to extend beyond the expiration date of the patent.

On March 24, 2008, Debiovision Inc., the exclusive agent of Debiopharm S.A. and Debio Recherche Pharmaceutique S.A., who is the exclusive licensee of the Administrators of the Tulane Educational Fund of New Orleans, Louisiana, the patent owner, timely filed an application under 35 U.S.C. 156(d)(5) for a fourth interim extension of the term of U.S. Patent No. 4,650,787. The patent claims the human drug product Sanvar[supreg] (vapreotide acetate). The application indicates that a New Drug Application for the human drug product Sanvar[supreg] (vapreotide acetate) has been filed and is currently undergoing regulatory review before the Food and Drug Administration for permission to market or use the product commercially.

Review of the application indicates that except for permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for an additional one year as required by 35 U.S.C. 156(d)(5)(B). Because it is apparent that the regulatory review period will continue beyond the extended expiration date of the patent (April 25, 2008), a fourth interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.

A fourth interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 4,650,787 is granted for a period of one year from the extended expiration date of the patent, i.e., until April 25, 2009.

Dated: April 9, 2008.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.
[FR Doc. E88058 Filed 41408; 8:45 am]
BILLING CODE 351016P

FOR FURTHER INFORMATION CONTACT Mary C. Till by telephone at (571) 2727755; by mail marked to her attention and addressed to the Commissioner for Patents, Mail Stop HatchWaxman PTE, P.O. Box 1450, Alexandria, VA 223131450; by fax marked to her attention at (571) 273 7755, or by email to Mary.Till@uspto.gov.