[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Notices]
[Page 53217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24917]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2009-0044]


Grant of Interim Extension of the Term of U.S. Patent No. 
4,919,140; Andara\TM\ OFS\TM\ System

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 a 
second certificate under 35 U.S.C. 156(d)(5) for a second one-year 
interim extension of the term of U.S. Patent No. 4,919,140.

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 one year if the regulatory review is anticipated to 
extend beyond the expiration date of the patent.
    On September 11, 2009, the patent owner, Purdue Research 
Foundation, timely filed an application under 35 U.S.C. 156(d)(5) for a 
second interim extension of the term of U.S. Patent No. 4,919,140. The 
patent claims the medical device Andara\TM\ OFS\TM\ System and a method 
of using the Andara\TM\ OFS\TM\ System. The application indicates that 
a Humanitarian Device Exemption, HDE 070002, for the medical device 
Andara\TM\ OFS\TM\ System 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 (October 14, 2009), interim extension of the patent 
term under 35 U.S.C. 156(d)(5) is appropriate.
    A second interim extension under 35 U.S.C. 156(d)(5) of the term of 
U.S. Patent No. 4,919,140 is granted for a period of one year from the 
extended expiration date of the patent, i.e., until October 14, 2010.

    Dated: October 9, 2009.
David J. Kappos,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. E9-24917 Filed 10-15-09; 8:45 am]
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