[Federal Register Volume 71, Number 64 (Tuesday, April 4, 2006)]
[Notices]
[Page 16765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4831]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2006-0020]


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

AGENCY: United States Patent and Trademark Office, DOC.

ACTION: Notice of interim patent term extension.

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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 [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 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[reg]. The application 
indicates that an Investigational New Animal Drug Application for the 
animal drug product, Zilmax[reg] (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.

    Dated: March 29, 2006.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
 [FR Doc. E6-4831 Filed 4-3-06; 8:45 am]
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