[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Notices]
[Page 9582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Regulatory Approved 
Clinical Diagnostics for Anti-HPV16 L1 Serum Antibody Detection in HPV 
Vaccine Recipients

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 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 worldwide license to practice the invention embodied in 
HHS Ref. No. E-253-1993/0 and certain foreign rights under HHS Ref. No. 
E-166-1992 including U.S. Patent 5,437,951, U.S. Patent 5,985,610, U.S. 
Patent 5,871,998, U.S. Patent 5,716,620, U.S. Patent 5,744,142, U.S. 
Patent 5,756,284, U.S. Patent 5,709,996, U.S. Patent Application 09/
316,487, U.S. Patent Application 10/371,846, International Patent 
Application PCT/US93/08342, European Patent Application 93921353.4, 
European Patent Application 040104531.1, European Patent Application 
040783235, Australian Patent 683220, Australian Patent Application 
2004203609, Canadian Patent No. 2,143,845, Japanese Patent Applications 
1994-507481, Japanese Patent Applications 2001-101791 and continuation 
and divisional patents and patent applications thereof, entitled 
``Self-Assembling Recombinant Papillomavirus HPV16 Capsid Proteins,'' 
to Biotrin International, Ltd., a limited liability company formed 
under the laws of the European Union and the Republic of Ireland. The 
United States of America is the assignee of the patent rights of the 
above inventions.
    The contemplated exclusive license may be granted in the field of 
regulatory approved clinical diagnostics for serum anti-HPV16 L1 
antibody detection in HPV vaccine recipients.

DATE: Only written comments and/or applications for a license received 
by the NIH Office of Technology Transfer on or before April 21, 2008 
will be considered.

ADDRESSES: Requests for a copy of the patent applications, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Michael A. Shmilovich, Esq., Office of 
Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-
5019; Facsimile: (301) 402-0220; E-mail: [email protected]. A 
signed confidentiality nondisclosure agreement may be required to 
receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: The patent applications intended for 
licensure disclose and/or cover the following:
    E-253-1993 and E-166-1992, ``Self-Assembling Recombinant 
Papillomavirus Capsid Proteins of HPV16,'' Lowy et al.
    Recombinant human papillomavirus 16 capsid proteins that are 
capable of self-assembly into capsomer structures and viral capsids 
that comprise conformational antigenic epitopes. The capsomer 
structures and viral capsids, consisting of the capsid proteins that 
are expression products of a bovine, monkey or human papillomavirus L1 
conformational coding sequence proteins, can be prepared for use in 
ELISA or cell-based immunoassays for detecting the level of serum 
antibody in recipients of a vaccine against HPV16. The self-assembling 
capsid proteins can also be used as elements of diagnostic immunoassay 
procedures for papillomavirus infection.
    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 sixty 
(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.
    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: February 14, 2008.
David Sadowski,
Deputy Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
 [FR Doc. E8-3162 Filed 2-20-08; 8:45 am]
BILLING CODE 4140-01-P