E6-9767. Grant of Interim Extension of the Term of U.S. Patent No. 4,826,811; PolyHeme® (Acellular Red Blood Cell Substitute)

AGENCY:

United States Patent and Trademark Office, DOC.

ACTION:

Notice of interim patent term extension.

SUMMARY:

The United States Patent and Trademark Office has issued a certificate under 35 U.S.C. 156(d)(5) for a fourth one-year interim extension of the term of U.S. Patent No. 4,826,811.

FOR FURTHER INFORMATION CONTACT:

Mary C. Till by telephone at [phone]; by mail marked to her attention and addressed to the Commissioner for Patents, Mail Stop Patent Ext., P.O. Box 1450, Alexandria, VA 22313-1450; by fax marked to her attention at [phone], or by e-mail to [e-mail].

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 31, 2006, patent owner, Northfield Laboratories Inc., timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 4,826,811. The patent claims the human biological product PolyHeme® (acellular red blood cell substitute), a method of use of the biological product, and a method of manufacturing the biological product. The application indicates, and the Food and Drug Administration has confirmed, that an investigational new drug application for the human biological product PolyHeme® 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 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 (June 20, 2006), 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. 4,826,611 is granted for a period of one year from the extended expiration date of the patent, i.e., until June 20, 2007.

Dated: June 15, 2006.

Jon W. Dudas,

Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.