[Federal Register: February 21, 2008 (Volume 73, Number 35)]
[Notices]
[Page 9582]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21fe08-78]
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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: shmilovm@mail.nih.gov. 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]
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