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Notice

Prospective Grant of Exclusive License: Use of Human Papilloma Virus (HPV) Immunoreactive Peptides for the Development of Vaccines Against HPV Infections

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Information about this document as published in the Federal Register.

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AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the invention embodied in:

PCT/US02/09261 filed March 22, 2002, entitled “Human Papilloma Virus Immunoreactive Peptides” (E-126-2001/0-PCT-02), (Inventors: Samir N. Khleif and Jay Berzofsky) (NCI), prior U.S. provisional application 60/278,520, filed March 23, 2001, now abandoned. National stage filed March 22, 2002: In U.S. Patent Application No. 10/472,661; in Canada Patent Application No. 2,441,947; in EPO Patent Application No. 02728570.9; in Australia Patent Application No. 2002258614 to Panacea Biotec Ltd. (hereafter PBL), having a place of business in New Deli, India. The patent rights in these inventions have been assigned to the United States of America.

DATES:

Only written comments and/or application for a license, which are received by the NIH Office of Technology Transfer on or before July 5, 2005 will be considered.

ADDRESSES:

Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Sally Hu, Ph.D., M.B.A., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Email: hus@od.nih.gov; Telephone: (301) 435-5606; Facsimile: (301) 402-0220.

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SUPPLEMENTARY INFORMATION:

PCT/US02/09261 provides immunogenic peptides from the Human Papilloma Virus which are suitable for development of epitope-based vaccines directed towards HPV and discloses methods of administering these peptides to individuals, as well as a method for monitoring or evaluating an immune response to HPV with these peptides. This invention provides a potential prophylactic or therapeutic vaccine against cervical cancer caused by HPV16 and 18, and a targeted therapy for cervical cancer and other diseases that are caused by HPV including other genital cancers, head and neck cancers, and upper digestive tract cancers.

The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 60 days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

The field of use may be limited to the development of vaccines against HPV infections.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

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Dated: April 26, 2005.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 05-8960 Filed 5-4-05; 8:45 am]

BILLING CODE 4140-01-P