[Federal Register Volume 68, Number 87 (Tuesday, May 6, 2003)]
[Notices]
[Pages 24010-24011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11072]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Co-Exclusive License: Convection Enhanced 
Drug Delivery for Transforming Growth Factor Alpha (TGF[alpha])

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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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 (TGF[alpha]) family of growth factors, 
truncated TGF[alpha] family of growth factors, truncated TGF[alpha] 
polypeptides and modified TGF[alpha], 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: 
[email protected].

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

[[Page 24011]]

rates 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.

    Dated: April 24, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer.
[FR Doc. 03-11072 Filed 5-5-03; 8:45 am]
BILLING CODE 4140-01-P