[Federal Register Volume 72, Number 100 (Thursday, May 24, 2007)]
[Notices]
[Page 29137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10084]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2007-0021]


Grant of Interim Extension of the Term of U.S. Patent No. 
4,927,855; NUVIGIL\(TM)\ (armodafinil)

AGENCY: United States Patent and Trademark Office, Commerce.

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 one-
year interim extension of the term of U.S. Patent No. 4,927,855.

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 May 7, 2007, Cephalon, Inc., an agent of Laboratoire L. Lafon, 
the owner of record in the United States Patent and Trademark Office of 
U.S. Patent No. 4,927,855, timely filed an application under 35 U.S.C. 
156(d)(5) for an interim extension of the term of U.S. Patent No. 
4,927,855. The patent claims the human drug product 
NUVIGIL(TM) (armodafinil) and a method of said product. The 
application indicates, and the Food and Drug Administration has 
confirmed, that a new drug application (NDA 21-875) for the human drug 
product NUVIGIL(TM) (armodafinil) 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 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 original expiration date of the patent 
(May 22, 2007), interim extension of the patent term under 35 U.S.C. 
156(d)(5) is appropriate.
    An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. 
Patent No. 4,927,855 is granted for a period of one year from the 
expiration date of the patent, i.e., until May 22, 2008.

    Dated: May 18, 2007.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
 [FR Doc. E7-10084 Filed 5-23-07; 8:45 am]
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