[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] ----------------------------------------------------------------------- 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