[Federal Register Volume 67, Number 178 (Friday, September 13, 2002)]
[Page 58067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23336]

[[Page 58067]]



National Institutes of Health

Prospective Grant of Exclusive License: ``Compositions and 
Methods for In Vitro Fertilization''

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

ACTION: Notice.


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 Application Serial No. 60/091,771, filed July 6, 1998, now 
converted into PCT application number PCT/US99/14841 filed June 30, 
1999 along with foreign filed patent applications in Europe, Canada, 
Japan, and Australia, entitled, ``Compositions and Methods for In Vitro 
Fertilization'' to Amrad Corporation Limited, having a place of 
business in the country of Australia. The field of use may be limited 
to the clinical treatment of infertility in humans. The United States 
of America is the 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 
November 12, 2002, 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, 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. 285; Facsimile: (301) 402-0220; e-mail: 

SUPPLEMENTARY INFORMATION: This technology relates to methods for 
utilizing Leukemia Inhibitory Factor (LIF) (a member of the IL-6 family 
of cytokines that functions through the gp130 receptor pathway) to 
enhance embryo implantation and LIF antagonists to block implantation 
in mammals. Previous studies have concentrated on the dependence on 
estrogen for embryo implantation. However, the identification of LIF as 
an absolute factor necessary for embryo implantation offers new routes 
to treatment. This invention portrays that a single dose injection of 
recombinant LIF in LIF deficient mice restores their ability to 
successfully implant an embryo. During In Vitro Fertilization (IVF) 
treatments, the majority of embryos are lost after transfer prior to 
implantation. Apparently the decreased receptivity of the uterus to 
implantation may be due to exposures of high concentrations of 
estradiol after recovery of the eggs prior to IVF. The current 
invention portrays that LIF may be substituted for estrogen in embryo 
transfer (during IVF) which can increase implantation frequencies and 
alleviate side effects associated with increased levels of estrogen in 
the uterine environment. Furthermore, the viability of subsequent 
embryonic development is not compromised with LIF.
    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: September 9, 2002.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 02-23336 Filed 9-12-02; 8:45 am]