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Notice

Prospective Grant of Co-Exclusive License: Convection Enhanced Drug Delivery for Transforming Growth Factor Alpha (TGFα)

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Information about this document as published in the Federal Register.

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AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

This is a public 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 worldwide co-exclusive license with one other licensee to practice the inventions embodied in: U.S. Patent 5,720,720, issued February 24, 1998, entitled “Convection-enhanced drug delivery” (Laske, et al.) (U.S. Patent Application Serial No. 08/616,785, filed March 15, 1996) to Kaleidos Pharma, Inc. of Seattle, Washington.

The United States of America is the assignee to the patent rights of these inventions. The contemplated co-exclusive license may be restricted to the fields that include the use of the Convection Enhanced Delivery (CED) technique for therapeutic delivery of the Transforming Growth Factor Alpha (TGFα) family of growth factors, truncated TGFα family of growth factors, truncated TGFα polypeptides and modified TGFα, for treating Parkinson's disease.

DATES:

Only written comments and/or applications for a license that are received by the NIH Office of Technology Transfer on or before July 7, 2003 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: Michael Shmilovich, J.D.,A Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-5019; Facsimile: (301) 402-0220; E-mail: mish@codon.nih.gov.

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SUPPLEMENTARY INFORMATION:

The invention is a method for high-flow microinfusion of drug agents into the brain and other solid tissue structures. The method involves positioning the tip of an infusion catheter within a tissue structure and supplying an agent through the catheter while maintaining a pressure gradient from the tip of the catheter during infusion. Agent delivery Start Printed Page 24011rates of from 0.5 to 15.0 microliter/min have been used experimentally with infusion distances greater than 1 cm from the delivery source. The patent is limited to the method of delivery, and only U.S. rights for the invention were preserved.

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.

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Dated: April 24, 2003.

Steven M. Ferguson,

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

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[FR Doc. 03-11072 Filed 5-5-03; 8:45 am]

BILLING CODE 4140-01-P