[Federal Register Volume 68, Number 244 (Friday, December 19, 2003)]
[Notices]
[Page 70827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31325]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: ``Methods of Making, 
Using and Pharmaceutical Formulations Comprising 7[alpha], 11[beta]-
dimethyl-17[beta]-hydroxyestra-4,14-dien-3-one and 17 Esters Thereof 
and 17 Esters of 7[alpha]-methyl-17[beta]-hydroxylestra-4,14-dien-3-
one''

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: 
USSN 60/193,530 and USSN 60/194,440, converted into combined PCT 
Application, PCT/US01/10293, and national stage filed in the U.S., 
Canada, Australia, Europe and Japan. A PCT-CIP was also filed and given 
a PCT Application Number of PCT/US02/09886, followed by national stage 
filings in the U.S., Canada, Australia, Europe, and Japan. The 
potential licensee is Torotech, LLC, having a place of business in the 
State of Maryland. The field of use may be limited to the therapeutic 
treatment of hypogonadism and human reproduction therapy. The United 
States of America is the assignee of the patent rights in this 
invention. This announcement is the first notice to grant an exclusive 
license to this technology.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before February 
17, 2004 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: Marlene Shinn-Astor, Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 435-4426; Facsimile: (301) 402-0220; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: This technology relates to compounds that 
possess potent androgenic activity. These compounds offer a potential 
therapeutic benefit in the treatment of hypogonadism, regardless of 
cause, as an adjuvant in hormone replacement therapy for both men and 
women and for androgen stimulation of anabolism in a broad spectrum of 
disease entities involving debilitation.
    These compounds are far more active and retain their potency after 
oral administration more than that achieved with the current oral 
androgen standard, methyltestosterone. An additional expected benefit 
is that liver toxicity, if any, should be minimal because 7[alpha], 
11[beta]-dimethyl-17[beta]-hydroxy-4-estren-3-one bucyclate is not 
alkylated at the C17 position.
    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.
    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: December 12, 2003.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 03-31325 Filed 12-18-03; 8:45 am]
BILLING CODE 4140-01-P