01-4618. Prospective Grant of Co-Exclusive License: Homogeneous Tests for Sequentially Determining Lipoprotein Fractions

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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 a co-exclusive worldwide to practice the inventions embodied in US Patent Application Serial Number (60/136,709 (PCT/US00/14827) entitled “Homogeneous Tests for Sequentially Determining Lipoprotein Fractions”, provisionally filed May 28, 1999 and PCT filed May 26, 2000, to Genzyme Diagnostics, having a place of business in Cambridge, Massachusetts, and J&S Medical Associates, having a place of business in Framingham, Massachusetts. The United States of America is an assignee to the patent rights of this invention.

The contemplated co-exclusive license may be limited to the development of homogeneous sequential tests for determination of lipoprotein subfractions in biological fluids, with applications to clinical chemistry analyzers. The license may not include the use for Patient-Initiated Diagnostics (PID) in conjunction with the SerSite^TM remote-site mailable device or its equivalents, all covered by claims of US Patent Number 6,036,659.

DATES:

Only written comments and/or applications for a license which are received by he NIH Office of Technology Transfer on or before April 27, 2001 will be considered.

ADDRESSES:

Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Uri Reichman, Ph.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone], ext. 240; Facsimile: [phone]; E-mail: [e-mail]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent application.

SUPPLEMENTARY INFORMATION:

The measurement of the cholesterol content of the lipoproteins subfraction in blood has become the gold standard in the clinical assessment of the risk of coronary artery disease. Current commercial tests involve two or three separate determinations and some of them are rather cumbersome. The subject invention provides a new, homogeneous assay for the sequential determination of the HDL-C and of total cholesterol present in blood. The test can be performed in a single tube and can readily lend itself to automation. The method comprises complexing of the non-HDL-C fraction, performing a first measurement of the cholesterol content of the unbound fraction, disrupting the complex and performing a second measurement of total cholesterol. Subtraction of the first reading from the second provides the value of the cholesterol in the non-HDL subfractions. Optionally, a triglyceride assay can then also be performed on the sample in the same tube.

The prospective co-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 co-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: February 15, 2001.

Jack Spiegel,

Director, Division of Technology, Development and Transfer, Office of Technology Transfer.