[Federal Register Volume 72, Number 34 (Wednesday, February 21, 2007)]
[Notices]
[Page 7904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Use of Adenovirus 
Vectors for the Development of Vaccines Against Human Immunodeficiency 
Virus and Other Infectious Agents

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

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR Part 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services (HHS), is contemplating the 
grant of an exclusive patent license to practice the inventions 
embodied in Patent Cooperation Treaty Application No. PCT/US02/27592 
filed August 29, 2002 and United States National Stage Application 
Serial No. 10/487,974 filed February 27, 2004, entitled ``New 
Adenovirus Type 7 Vectors'' [HHS Reference No. E-236-2001/0], and 
United States Patent Application Serial No. 11/282,319 filed November 
17, 2005, entitled ``Improved Replication-Competent Adenovirus 
Vectors'' [HHS Reference No. E-203-2004/0], to PaxVax, Inc., which has 
offices in Menlo Park, CA. The patent rights in these inventions have 
been assigned and/or exclusively licensed to the Government of the 
United States of America.
    The prospective exclusive license territory may be the United 
States of America, and the field of use may be limited to the 
development of vaccines against human immunodeficiency virus, human 
papillomavirus, influenza, malaria, and tuberculosis.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
April 23, 2007 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Susan Ano, Ph.D., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 435-5515; Facsimile: (301) 402-0220; E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The subject application addresses two (2) 
technologies related to specific techniques for producing adenoviral 
vectors and application of such vectors for gene transfer, vaccine 
development and therapeutics. Use of the present technologies in the 
prevention and/or treatment of disease, especially human 
immunodeficiency virus (HIV), is the primary focus of the current 
subject inventions.
    The first technology (HHS Reference No. E-236-2001/0) describes a 
cosmid adenoviral serotype 7 (Ad7) vector for use in the prevention 
and/or treatment of HIV-1. This invention includes methods for 
producing and administering both replication-competent and incompetent 
Ad7. The cosmid Ad7 vector includes an Ad7 genome that can be modified 
to express specific nucleic acid sequences for production of a desired 
protein or epitope such as an HIV-1 gene product. This system may be 
used to generate proteins or epitopes of infectious agents for 
stimulation of desired immunogenic responses.
    The second invention (HHS Reference No. E-203-2004/0) discloses 
improvements upon replication-competent Ad vectors, which serve to 
produce high level expression of any gene of interest, i.e., a 
transgene. This system incorporates a novel hybrid gene regulatory unit 
comprising a CMV promoter and an adenovirus tripartite leader sequence 
for regulation of transgene expression. Additionally, the present 
disclosure provides methods of producing and administering the 
described adenoviral expression vectors, containing the nucleic acid 
sequence of significant HIV-1 proteins as transgenes for stimulation of 
an immune response to HIV-1.
    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 part 
404.7. The prospective exclusive license may be granted within ninety 
(90) days from the date of this published notice, unless the 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 part 404.7.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. Comments and objections submitted 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: February 12, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-2883 Filed 2-20-07; 8:45 am]
BILLING CODE 4140-01-P