[Federal Register Volume 61, Number 179 (Friday, September 13, 1996)]
[Notices]
[Page 48497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23424]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Prospective Grant of Exclusive License: Pharmaceuticals for the
Treatment of Autoimmune Disease and Transplant Rejection
AGENCY: National Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
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SUMMARY: This is notice in accordance with 15 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
a worldwide, limited field of use, exclusive license to practice the
inventions embodied in the patents and patent applications referred to
below to Sentron Medical, Inc. of Cincinnati, Ohio. The patent rights
in these inventions have been assigned to the Government of the United
States of America. The patents and patent applications to be licensed
are:
(1) Method of Treating Autoimmune Diseases and Transplantation
Rejection
U.S. Patent Application Serial No. 08/073,830
Filing Date: 6/07/93
(2) Method of Treating Autoimmune Diseases and Transplantation
Rejection
U.S. Patent Application Serial No. 08/480,525
Filing Date: 06/07/95
(3) Method of Treating Autoimmune Diseases and Transplantation
Rejection
U.S. Patent Application Serial No. 08/464,130
Filing Date: 06/05/95
(4) Method of Treating Autoimmune Diseases and Transplantation
Rejection
U.S. Patent Application Serial No. 08/462,165
Filing Date: 06/05/95
(5) Method of Treating Autoimmune Diseases and Transplantation
Rejection
U.S. Patent Application Serial No. 08/460,886
Filing Date: 06/05/95
(6) Methods for Assessing the Ability of a Candidate Drug To Suppress
MHC Class 1 Expression
U.S. Patent Application Serial No. 08/503,525
Filing Date: 08/21/95
The patents and patent applications to be licensed include those
noted above, and all continuation applications, divisional
applications, continuation-in-part applications, and foreign
counterpart applications of these patents and patent applications.
ADDRESSES: Requests for a copy of these patent applications, inquiries,
comments, and other materials relating to the contemplated license
should be directed to: Carol C. Lavrich, Technology Licensing
Specialist, Office of Technology Transfer, National Institutes of
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852;
Telephone: (301) 496-7056, ext. 287; Facsimile: (301) 402-0220.
Applications for a license filed in response to this notice will be
treated as objections to the grant of the contemplated license. Only
written comments and/or applications for a license which are received
by NIH on or before November 12, 1996, will be considered. 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. A signed Confidential Disclosure Agreement will be required to
receive a copy of any pending patent application.
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.
SUPPLEMENTARY INFORMATION: The subject technology provides methods for
treating autoimmune diseases in mammals and for preventing or treating
transplantation rejection in a transplant recipient. The methods of
treatment involve the use of drugs capable of suppressing expression of
MHC Class I molecules. In particular, the use of the drug methimazole
to suppress expression of MHC Class I molecules in the treatment of
autoimmune diseases and the prevention or treatment of rejection in a
transplant recipient is disclosed. In addition, in vivo and in vitro
assays are provided for the assessment and development of drugs capable
of suppressing MHC Class I molecules.
Although organ transplantation is an established therapy in the
United States, there remain major clinical and practical obstacles
which continue to limit the use of transplantation. The number of
transplants currently performed dramatically understates the size of
the opportunity for transplantation should these obstacles be overcome.
In addition to the over 15,000 organ transplants that were performed in
the U.S. in 1990, another 20,000-25,000 patients are on nationwide
organ specific waiting lists because of organ shortages. New
technologies which may enable the use of cells, organ segments, or non-
human donors will make transplants possible for more of the patients on
waiting lists.
Dated: September 4, 1996.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 96-23424 Filed 9-12-96; 8:45 am]
BILLING CODE 4140-01-M
