Grant of Interim Extension of the Term of U.S. Patent No. 4,585,770; ZILMAX® (Zilpaterol Hydrochloride), 16765 [E6-4831]

Download as PDF sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 71, No. 64 / Tuesday, April 4, 2006 / Notices alternatives to allocate halibut between the charter and commercial sectors. One alternative would be a percentage allocation to the charter sector. Elements to be considered include, but are not limited to: (1) A percentage based allocation that would float up and down with halibut abundance; (2) Subdivision of Area 2C and 3A into smaller geographic sub-districts; (3) Management measures that will be used to enforce the allocation, including: (a) the current suite of measures to reduce harvests under the Guideline Harvest Level (GHL) (i.e., one trip per vessel per day, no harvest by skipper and crew, and annual limit of 5 or 6 fish per person (for Area 2C only); (b) Limits on the number of lines fished to the number of clients; (c) Other annual bag limits; (d) Limits on days fished (either total number of days or by excluding specific days of the week); (e) Reduced daily limits including size limitations for the second fish caught; (f) Subtraction of any allocation overage from the following year’s allocation; (g) Federal limited entry program with delayed transferability; (h) Mechanisms which, if the charter harvest continues to grow, would allow for an orderly and compensated allocation shift from the longline sector to the charter sector, including the use of a charter stamp or other funding mechanisms to generate funds to buy commercial quota shares to convert commercial allocation to the charter sector and to pay for management of the charter fishery. A second alternative would be an Individual Fishing Quota (IFQ) program, including, but not be limited to: (1) Elements of the previously proposed (2001) charter IFQ program; (2) A modified IFQ program, including, but not be limited to, including recent participants who were not included in the 2001 plan. Such approaches might include a ‘‘leveling’’ plan, other effort based mechanisms to update 1998 and 1999 history, new history approaches, an effort based transferable seat program, or other options; (3) Subdivision of Area 2C and 3A into smaller geographic sub-districts; and (4) Other elements to be identified by the committee. Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been VerDate Aug<31>2005 18:55 Apr 03, 2006 Jkt 208001 notified of the Council’s intent to take final action to address the emergency. Special Accommodations These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Gail Bendixen at (907) 271–2809 at least 7 working days prior to the meeting date. Dated: March 30, 2006 Tracey L. Thompson, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. E6–4802 Filed 4–3–06; 8:45 am] BILLING CODE 3510–22–S 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 (Zilpaterol Hydrochloride) United States Patent and Trademark Office, DOC. ACTION: Notice of interim patent term extension. AGENCY: SUMMARY: The United States Patent and Trademark Office has issued certificates under 35 U.S.C. 156(d)(5) for three oneyear 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. 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) SUPPLEMENTARY INFORMATION: PO 00000 Frm 00010 Fmt 4703 Sfmt 4703 16765 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. 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] BILLING CODE 3510–16–P E:\FR\FM\04APN1.SGM 04APN1

Agencies

[Federal Register Volume 71, Number 64 (Tuesday, April 4, 2006)]
[Notices]
[Page 16765]
From the Federal Register Online via the Government Printing 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 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[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]
BILLING CODE 3510-16-P