Grant of Interim Extension of the Term of U.S. Patent No. 4,977,138; ISTODAXTM, 32116 [E9-15863]

Download as PDF 32116 Federal Register / Vol. 74, No. 128 / Tuesday, July 7, 2009 / Notices recipient to submit additional environmental compliance information sufficient to enable NOAA to make an assessment on any impacts that a project may have on the environment. THE DEPARTMENT OF COMMERCE PRE–AWARD NOTIFICATION REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS: The Department of Commerce Pre– Award Notification Requirements for Grants and Cooperative Agreements contained in the Federal Register notice of February 11, 2008 (73 FR 7696), are applicable to this solicitation. Dated: June 29, 2009. Steven A. Murawski, Ph.D. NOAA Fisheries, Chief Scientific Advisor, Director of Scientific Programs. Dated: June 30, 2009. Phillip R. Taylor Section Head, Ocean Section, Division of Ocean Sciences, National Science Foundation. [FR Doc. E9–15960 Filed 7–6–09; 8:45 am] BILLING CODE 3510–22–S DEPARTMENT OF COMMERCE United States Patent and Trademark Office PAPERWORK REDUCTION ACT: [Docket No. PTO–P–2009–0027] This document contains collection– of–information requirements subject to the Paperwork Reduction Act (PRA). The use of Standard Forms 424, 424A, 424B, and SF–LLL and CD–346 has been approved by the Office of Management and Budget (OMB) under the respective control numbers 0348–0043, 0348–0044, 0348–0040, 0348–0046, and 0605–0001. Notwithstanding any other provision of law, no person is required to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA unless that collection of information displays a currently valid OMB control number. Grant of Interim Extension of the Term of U.S. Patent No. 4,977,138; ISTODAXTM EXECUTIVE ORDER 12866: This notice has been determined to be not significant for purposes of Executive Order 12866. EXECUTIVE ORDER 13132 (FEDERALISM): It has been determined that this notice does not contain policies with Federalism implications as that term is defined in Executive Order 13132. ADMINISTRATIVE PROCEDURE ACT/ REGULATORY FLEXIBILITY ACT: Prior notice and an opportunity for public comment are not required by the Administrative Procedure Act or any other law for rules concerning public property, loans, grants, benefits, and contracts (5 U.S.C. 553(a)(2)). Because notice and opportunity for comment are not required pursuant to 5 U.S.C. 553 or any other law, the analytical requirements for the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are inapplicable. Therefore, a regulatory flexibility analysis has not been prepared. VerDate Nov<24>2008 14:45 Jul 06, 2009 Jkt 217001 AGENCY: United States Patent and Trademark Office. ACTION: Notice of Interim Patent Term Extension. SUMMARY: The United States Patent and Trademark Office has issued an order granting interim extension under 35 U.S.C. 156(d)(5) for a one-year interim extension of the term of U.S. Patent No. 4,977,138. 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 Hatch-Waxman PTE, 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 June 12, 2009, Gloucester Pharmaceuticals, Inc., a licensee of Astellas Pharma Inc., the patent owner, timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 4,977,138. The patent claims the human drug product ISTODAXTM (romidepsin). The application indicates that a New Drug Application (NDA No. 22–393) for the human drug product ISTODAXTM (romidepsin) has been filed and is PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 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 one year as required by 35 U.S.C. 156(d)(5)(B). Because it is apparent that the regulatory review period will continue beyond the original expiration date of the patent (July 6, 2009), an 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. 4,977,138 is granted for a period of one year from the original expiration date of the patent, i.e., until July 6, 2010. June 30, 2009. John J. Doll, Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the United States Patent and Trademark Office. [FR Doc. E9–15863 Filed 7–6–09; 8:45 am] BILLING CODE 3510–16–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648–XQ12 Marine Mammals; File No. 540–1811 AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice; Issuance of permit amendment. SUMMARY: Notice is hereby given that Mr. John Calambokidis, Cascadia Research Collective, Waterstreet Building, 218 1/2 West Fourth Avenue, Olympia, WA 89501, has been issued an amendment to scientific research Permit No. 540–1811. ADDRESSES: The permit and related documents are available for review upon written request or by appointment (See SUPPLEMENTARY INFORMATION). FOR FURTHER INFORMATION CONTACT: Jennifer Skidmore or Carrie Hubard, (301)713–2289. SUPPLEMENTARY INFORMATION: On May 7, 2008, notice was published in the Federal Register (73 FR 25668) that a request for a scientific research permit amendment to take cetacean species had been submitted by the above-named E:\FR\FM\07JYN1.SGM 07JYN1

Agencies

[Federal Register Volume 74, Number 128 (Tuesday, July 7, 2009)]
[Notices]
[Page 32116]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-15863]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

[Docket No. PTO-P-2009-0027]


Grant of Interim Extension of the Term of U.S. Patent No. 
4,977,138; ISTODAX\TM\

AGENCY: United States Patent and Trademark Office.

ACTION: Notice of Interim Patent Term Extension.

-----------------------------------------------------------------------

SUMMARY: The United States Patent and Trademark Office has issued an 
order granting interim extension under 35 U.S.C. 156(d)(5) for a one-
year interim extension of the term of U.S. Patent No. 4,977,138.

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 Hatch-Waxman PTE, 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 June 12, 2009, Gloucester Pharmaceuticals, Inc., a licensee of 
Astellas Pharma Inc., the patent owner, timely filed an application 
under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. 
Patent No. 4,977,138. The patent claims the human drug product 
ISTODAXTM (romidepsin). The application indicates that a New 
Drug Application (NDA No. 22-393) for the human drug product 
ISTODAXTM (romidepsin) 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 one year as 
required by 35 U.S.C. 156(d)(5)(B). Because it is apparent that the 
regulatory review period will continue beyond the original expiration 
date of the patent (July 6, 2009), an 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. 4,977,138 is granted for a period of one year from the 
original expiration date of the patent, i.e., until July 6, 2010.

    June 30, 2009.
John J. Doll,
Acting Under Secretary of Commerce for Intellectual Property and Acting 
Director of the United States Patent and Trademark Office.
[FR Doc. E9-15863 Filed 7-6-09; 8:45 am]
BILLING CODE 3510-16-P