02-6417. Prospective Grant of Co-Exclusive License: “Cloning and Expression of cDNA for Human Dihydropyrimidine Dehydrogenase”

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, Department of Health and Human Services, is contemplating the grant of a co-exclusive license to practice the inventions embodied in the international patent application WO96/08568 (PCT/US95/12016) related to DHHS reference No. E-157-94/3, entitled “Cloning and expression of cDNA for human dihydropyrimidine dehydrogenase,” to Oncoscreen GmbH of Jena, Germany.

The prospective co-exclusive license territory may be limited to Europe and the field of use may be limited to in-vitro diagnostics.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before May 17, 2002, will be considered.

ADDRESSES:

Requests for copies of the patent, inquiries, comments and other materials relating to the contemplated co-exclusive license should be directed to: Matthew B. Kiser, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3821; Telephone: [phone], x224; Facsimile: [phone]; e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The technology relates to the DPD gene. Cancer patients having a DPD deficiency are at risk of a severe toxic reaction to the commonly used anticancer agent 5-fluorouracil (5-FU). Claimed are DPD genes from human and pig, methods for detecting the level of nucleic acids that encode DPD in patients, and nucleic acids that are useful as probes for this purpose. Also claimed are methods for expressing DPD in heterologous organisms. Expression vectors that employ a DPD nucleic acid as a selectable marker are also claimed.

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 sixty (60) days from the date of this published notice, the NIH receives written evidence and argument that establish 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 field of use filed in response to this notice will be treated as objections to the grant of the contemplated co-exclusive license. Comments and objections submitted 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 8, 2002.

Jack Spiegel,

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