[Federal Register Volume 74, Number 60 (Tuesday, March 31, 2009)]
[Notices]
[Page 14575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7210]



[[Page 14575]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Orally Active Synthetic 
Estrogens for Fertility Control, Hormone Replacement Therapy, and 
Endometriosis

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

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)(1), that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive patent license to practice the invention embodied in 
United States Patent No. 5,554,603, issued September 10, 1996, entitled 
``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. 
E-137-1993/0-US-01); PCT Application No. PCT/US94/10393, filed 
September 15, 1994, now expired, entitled ``Orally Active Derivatives 
of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-PCT-02); 
Australian Patent No. 700576, issued April 22, 1999, entitled ``Orally 
Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-
1993/0-AU-03); Canadian Patent No. 2171740, issued July 26, 2005, 
entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS 
Ref. No. E-137-1993/0-CA-04); European Patent No. 719276, issued 
November 26, 1997, entitled ``Orally Active Derivatives of 1, 3, 5(10)-
Estratriene'' (HHS Ref. No. E-137-1993/0-EP-05) and validated in 
Austria, Switzerland, Germany, Denmark, Spain, France, Greece, Ireland, 
Italy, Luxembourg, Monaco, the Netherlands, Portugal, Sweden, Belgium, 
and Great Britain; and Japanese Patent No. 3993228, issued August 3, 
2007, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' 
(HHS Ref. No. E-137-1993/0-JP-06) to Evestra, Inc., having a place of 
business in San Antonio, Texas. The patent rights in this invention 
have been assigned to the United States of America.
    The contemplated exclusive license territory may be worldwide, and 
the field of use may be limited to the use of CDB-3701 (11[beta], 
17[beta]-dinitratoestradiol 3-acetate) for all indications where 
estrogen is prescribed as a treatment, including fertility control, 
hormone replacement therapy (``HRT''), and endometriosis.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before June 1, 
2009 will be considered.

ADDRESSES: Requests for copies of the patents, inquiries, comments, and 
other materials relating to the contemplated license should be directed 
to: Tara L. Kirby, Ph.D., Licensing and Patenting Manager, 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: The utility of estrogenic substances in the 
practice of medicine is well documented. Estrogens may be used for the 
replacement of the natural hormone estradiol in hypogonadism, and 
following the removal of the ovaries or cessation of ovarian activity 
during menopause. They are also widely employed as a component of oral 
contraceptives. However, available orally-active synthetic estrogens 
are associated with a number of potential side effects, including 
cancer, blood clots, heart attack, elevated blood pressure, and reduced 
glucose tolerance.
    This technology relates to a family of novel, active estrogens that 
are nitrate esters of estradiol. These nitrate esters possess enhanced 
estrogenic activity following oral administration and lack a 17-ethynyl 
alcohol, which has been implicated in many side effects attributed to 
other synthetic estrogens. It is anticipated that these esters could be 
used in all instances where estrogen is prescribed as a treatment.
    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, the 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.
    Applications for a license in the prospective field of use filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive 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: March 24, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-7210 Filed 3-30-09; 8:45 am]
BILLING CODE 4140-01-P