Grant of Interim Extension of the Term of U.S. Patent No. 4,567,264; Ranolazine, 32761 [05-11176]

Download as PDF Federal Register / Vol. 70, No. 107 / Monday, June 6, 2005 / Notices Patent Ext., P.O. Box 1450, Alexandria, VA 22313–1450; by fax marked to her attention at (571) 273–7744; or by e-mail to Karin.Ferriter@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 May 4, 2005, Intarcia Therapeutics, Inc., on behalf of patent owner Schering Aktiengesellschaft, timely filed an application under 35 U.S.C. 156(d)(5) for a second interim extension of the term of U.S. Patent No. 4,591,585. The patent claims the product atamestane. The application indicates that a New Drug Application for the human drug product atamestane 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 period of one year as required by 35 U.S.C. 156(d)(5)(C). Since it is apparent that the regulatory review period will continue beyond the extended expiration date of the patent (June 18, 2005), 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. 4,591,585 is granted for a period of one year from the expiration date of the patent, i.e., until June 18, 2006. SUPPLEMENTARY INFORMATION: Dated: May 26, 2005. Jon W. Dudas, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. [FR Doc. 05–11175 Filed 6–3–05; 8:45 am] BILLING CODE 3510–16–P VerDate jul<14>2003 14:25 Jun 03, 2005 Jkt 205001 DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. 2005–P–064] Grant of Interim Extension of the Term of U.S. Patent No. 4,567,264; Ranolazine United States Patent and Trademark Office. ACTION: Notice of interim patent term extension. AGENCY: SUMMARY: The United States Patent and Trademark Office has issued a certificate under 35 U.S.C. 156(d)(5) for a third one-year interim extension of the term of U.S. Patent No. 4,567,264. FOR FURTHER INFORMATION CONTACT: Karin Ferriter by telephone at (571)272– 7744; by mail marked to her attention and addressed to Mail Stop Patent Ext., Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450; by fax marked to her attention at (571)273– 7744; or by e-mail to Karin.Ferriter@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 25, 2005, patent owner Roche Palo Alto LLC, timely filed an application under 35 U.S.C. 156(d)(5) for a third interim extension of the term of U.S. Patent No. 4,567,264. The patent claims the active ingredient ranolazine (RanexaTM). The application indicates, and the Food and Drug Administration (FDA) has confirmed, that a New Drug Application for the human drug product ranolazine has been filed and is currently undergoing regulatory review before the FDA 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 period of one year as required by 35 U.S.C. 156(d)(5)(C). Since it is apparent that the regulatory review period will continue beyond the extended expiration date of the patent (May 18, 2005), the term of the patent will be SUPPLEMENTARY INFORMATION: PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 32761 extended under 35 U.S.C. 156(d)(5) for an additional year. An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 4,567,264 is granted for an additional period of one year from the extended expiration date of the patent, i.e., until May 18, 2006. Dated: May 26, 2005. Jon W. Dudas, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. [FR Doc. 05–11176 Filed 6–3–05; 8:45 am] BILLING CODE 3510–16–P DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No.: 2003–P–018] Notice of Availability of and Request for Comments on Green Paper Concerning Restriction Practice United States Patent and Trademark Office, Commerce. ACTION: Request for comments. AGENCY: SUMMARY: The United States Patent and Trademark Office (USPTO) has established a 21st Century Strategic Plan to transform the USPTO into a quality focused, highly productive, responsive organization supporting a market-driven intellectual property system. As a part of this plan, the USPTO is conducting a study of its restriction practice. As part of this study, the Office requested public comments to help guide the study. After careful consideration of the public comments and an internal review, the USPTO has prepared a ‘‘Green Paper’’ describing and evaluating four options to reform restriction practice suggested by various members of the public. Prior to considering the desirability of drafting proposed legislation in a ‘‘White Paper’’ on reforming restriction practice, the USPTO is seeking public comment on the Green Paper. DATES: Comment Deadline Date: To be ensured of consideration, written comments must be received on or before August 5, 2005. No public hearing will be held. ADDRESSES: Comments should be sent by electronic mail message over the Internet addressed to: unity.comments@uspto.gov. Comments may also be submitted by mail addressed to: Mail Stop Comments— Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, or by facsimile to (571) 273–7735, marked to the attention of Robert A. E:\FR\FM\06JNN1.SGM 06JNN1

Agencies

[Federal Register Volume 70, Number 107 (Monday, June 6, 2005)]
[Notices]
[Page 32761]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11176]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. 2005-P-064]


Grant of Interim Extension of the Term of U.S. Patent No. 
4,567,264; Ranolazine

AGENCY: United States Patent and Trademark Office.

ACTION: Notice of interim patent term extension.

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SUMMARY: The United States Patent and Trademark Office has issued a 
certificate under 35 U.S.C. 156(d)(5) for a third one-year interim 
extension of the term of U.S. Patent No. 4,567,264.

FOR FURTHER INFORMATION CONTACT: Karin Ferriter by telephone at 
(571)272-7744; by mail marked to her attention and addressed to Mail 
Stop Patent Ext., Commissioner for Patents, P.O. Box 1450, Alexandria, 
VA 22313-1450; by fax marked to her attention at (571)273-7744; 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 March 25, 2005, patent owner Roche Palo Alto LLC, timely filed 
an application under 35 U.S.C. 156(d)(5) for a third interim extension 
of the term of U.S. Patent No. 4,567,264. The patent claims the active 
ingredient ranolazine (RanexaTM). The application indicates, 
and the Food and Drug Administration (FDA) has confirmed, that a New 
Drug Application for the human drug product ranolazine has been filed 
and is currently undergoing regulatory review before the FDA 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 period of one year 
as required by 35 U.S.C. 156(d)(5)(C). Since it is apparent that the 
regulatory review period will continue beyond the extended expiration 
date of the patent (May 18, 2005), the term of the patent will be 
extended under 35 U.S.C. 156(d)(5) for an additional year.
    An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. 
Patent No. 4,567,264 is granted for an additional period of one year 
from the extended expiration date of the patent, i.e., until May 18, 
2006.

    Dated: May 26, 2005.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 05-11176 Filed 6-3-05; 8:45 am]
BILLING CODE 3510-16-P
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