[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