Grant of Interim Extension of the Term of U.S. Patent No. 4,600,706; Natamycin

AGENCY:

United States Patent and Trademark Office.

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 one-year interim extension of the term of U.S. Patent No. 4,600,706.

FOR FURTHER INFORMATION CONTACT:

Karin Ferriter by telephone at (703) 306-3159; 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 (703) 872-9411, or by e-mail to Karin.Ferriter@uspto.gov.

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 November 3, 2003, patent owner Arkion Life Sciences timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 4,600,706. The patent claims the method of making the animal feed product NSURE® (natamycin). The application indicates that an amended Food Additive Petition for the animal feed product has been filed and was undergoing regulatory review before the Food and Drug Administration for permission to market or use the product commercially. The petition was granted by the Food and Drug Administration, and the regulations for food additives in feed and drinking water were amended to provide for the safe use of natamycin. See Food Additives Permitted in Feed and Drinking Water of Animals; Natamycin, 69 FR 19320 (April 13, 2004) (final rule).

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). Since regulatory review period continued beyond the expiration date of the patent (November 17, 2003, due to the terminal disclaimer disclaiming the term of the patent subsequent to the expiration date of U.S. Patent No. 4,536,494), 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. 4,600,706 is granted for a period of one year from the expiration date of the patent, i.e., until November 17, 2004.