[Federal Register Volume 70, Number 86 (Thursday, May 5, 2005)]
[Notices]
[Page 23881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8960]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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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: [email protected]; Telephone: 
(301) 435-5606; Facsimile: (301) 402-0220.

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.

    Dated: April 26, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-8960 Filed 5-4-05; 8:45 am]
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