02-23336. 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: [phone], ext. 285; Facsimile: [phone]; e-mail: [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.