[Federal Register Volume 63, Number 219 (Friday, November 13, 1998)]
[Notices]
[Page 63483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30432]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Long-Acting Testosterone 
Androgenic Compounds and Pharmaceutical Compositions Thereof

AGENCY: National Institutes of Health, Public Health Service, DHHS.

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 license worldwide to practice the invention embodied in: 
U.S. Patent 4,948,790, issued August 14, 1990 entitled, ``Long-Acting 
Androgenic Compounds, and Pharmaceutical Compositions Thereof'' to N.V. 
Organon, having a place of business in The Netherlands. The United 
States of America is an assignee of the patent rights in this 
invention.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before January 
12, 1999, 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: Dennis H. Penn, Pharm.D., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 496-7056, ext. 211; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: In an effort to develop an efficacious 
treatment for human reproductive disorders this invention describes 
testosterone bucyclate, which provides a means for prolonged androgenic 
activity when administered intramuscularly as an aqueous crystalline 
suspension. This compound may have utility as a therapeutic androgen 
for patients with androgen deficiency syndromes, male contraception, 
and as an androgen replacement in other methods of male contraception.

    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 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.
    The field of use may be limited to the use of the invention for the 
development of pharmaceutical compounds to treat human androgen 
deficiency syndromes and male contraception.
    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: November 5, 1998.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 98-30432 Filed 11-12-98; 8:45 am]
BILLING CODE 4140-01-M