E6-1277. Prospective Grant of Exclusive License: FDA Approvable Human DNA Diagnostic Test for Endometriosis

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 Number 60/654,331 filed February 18, 2005, entitled “Identification of Molecular Markers for Endometriosis in Blood Lymphocytes Using DNA Microarrays,” to Ortho-Clinical Diagnostics, having a place of business in Raritan, NJ 08869. The contemplated exclusive license may be limited to an FDA approvable human DNA diagnostic test for endometriosis. 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 National Institutes of Health on or before April 3, 2006 will be considered.

ADDRESSES:

Requests for a copy of the patent, inquires, comments, and other materials relating to the contemplated license should be directed to: Marlene Astor, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: 301-402-0220; e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Endometriosis is a common, non-malignant gynecological disease that affects up to twenty percent (20%) of women during their reproductive years. Endometriosis is characterized by the growth of endometrial tissue outside the uterus. This growth of tissue causes recurring severe pain and can lead to infertility. As the current procedure used for diagnosis is invasive and not entirely accurate, there is a need for a fast, accurate, and minimally invasive test to test for endometriosis.

Using DNA microarray analysis of blood lymphocytes, the inventors have identified two gene markers expressed in blood that are able to discriminate between those women who have endometriosis and those that don't. This new technology would be minimally invasive and quick using a blood sample from a patient.

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.

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: January 23, 2006.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.