[Federal Register Volume 74, Number 76 (Wednesday, April 22, 2009)]
[Notices]
[Page 18352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9145]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2009-0016]


Grant of Interim Extension of the Term of U.S. Patent No. 
4,650,787; Sanvar[reg]

AGENCY: United States Patent and Trademark Office.

ACTION: Notice of interim patent term extension.

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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 fifth 
one-year interim extension of the term of U.S. Patent No. 4,650,787.

FOR FURTHER INFORMATION CONTACT: Mary C. Till by telephone at (571) 
272-7755; by mail marked to her attention and addressed to the 
Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, 
Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273-
7755, or by e-mail to [email protected].

SUPPLEMENTARY INFORMATION: Section 156 of Title 35, United States Code, 
generally provides that the term of a patent may be extended for a 
period of 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 19, 2009, 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 fifth interim extension of 
the term of U.S. Patent No. 4,650,787. The patent claims the human drug 
product Sanvar[reg] (vapreotide acetate). The application 
indicates that a New Drug Application for the human drug product 
Sanvar[reg] (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) and 35 U.S.C. 156(d)(5)(C). Because 
it is apparent that the regulatory review period will continue beyond 
the extended expiration date of the patent (April 25, 2009), a fifth 
interim extension of the patent term under 35 U.S.C. 156(d)(5) is 
appropriate.
    A fifth 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, 2010.

    April 15, 2009.
John J. Doll,
Acting Under Secretary of Commerce for Intellectual Property and 
Director of the United States Patent and Trademark Office.
[FR Doc. E9-9145 Filed 4-21-09; 8:45 am]
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