Grant of Interim Extension of the Term of U.S. Patent No. 4,585,770; ZILMAX® (Zilpaterol Hydrochloride)

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 certificates under 35 U.S.C. 156(d)(5) for three one-year interim extensions of the term of U.S. Patent No. 4,585,770.

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 Patent Ext., P.O. Box 1450, Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273-7755, or by e-mail to Mary.Till@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 March 26, 2003, patent owner, Hoechst Roussel Vet S.A., timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 4,585,770. On March 31, 2004, patent owner, Hoechst Roussel Vet S.A., timely filed a second application under 35 U.S.C. 156(d)(5) for a second interim extension of the term of U.S. Patent No. 4,585,770. On March 29, 2005, patent owner, Hoechst Roussel Vet S.A., timely filed a third application under 35 U.S.C. 156(d)(5) for a third interim extension of the term of U.S. Patent No. 4,585,770. The patent claims the active ingredient, zilpaterol hydrochloride, in the animal drug product Zilmax®. The application indicates that an Investigational New Animal Drug Application for the animal drug product, Zilmax® (zilpaterol hydrochloride), 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). Since it is apparent that the regulatory review period has continued beyond the original expiration date of the patent (October 12, 2003), 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. 4,585,770, is granted for a period of one year from the original expiration date of the patent, i.e., until October 12, 2004; a second interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 4,585,770, is granted for an additional period of one year from the extended expiration date of the patent, i.e., until October 12, 2005; and a third interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 4,585,770, is granted for an additional period of one year from the extended expiration date of the patent, i.e., until October 12, 2006.