[Federal Register Volume 71, Number 249 (Thursday, December 28, 2006)]
[Notices]
[Pages 78217-78218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-22187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Convection Enhanced 
Delivery and Tracking of Gadolinium Conjugated Therapeutic Agents to 
the Central Nervous System

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

ACTION: Notice.

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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 worldwide license to practice the invention embodied in: 
HHS. Ref. No. E-202-2002 ``Method for Convection Enhanced Delivery of 
Therapeutic Agents,'' Provisional Patent Application, 60/413,673; 
International Patent Application PCT/US03/30155, U.S. Patent 
Application Serial No. 10/528,310; European Patent Application Serial 
No. 03756863.1; Australian Patent Application No. 2003299140; Canadian 
Patent Application No. 2,499,573; and HHS Ref. No. E-206-2000/0 and /1 
``Method for Increasing the Distribution of Therapeutic Agents;'' and 
``Method for Increasing the Distribution of Nucleic Acids;'' 
Provisional Patent Application 60/250,286; Provisional Patent 
Application No. 60/286,308; U.S. Patent Application No. 09/999,203; 
U.S. Patent Application No. 10/132,681; and Canadian Patent Application 
No. 2327208, to Medtronic Neurological, a Division of the Medtronic 
Corporation, having its headquarters in Minneapolis, Minnesota. The 
United States of America is the assignee of the patent rights of the 
above invention. The contemplated exclusive license may be granted in a 
field of use limited to the development and sales of a clinical grade 
surrogate tracer for tracking the distribution of convection enhanced 
delivered central nervous system therapeutics, excluding lipid based 
systems.

DATES: Only written comments and/or applications for a license received 
by the NIH Office of Technology Transfer on or before February 26, 2007 
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 A. Shmilovich, Esq., 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]. A 
signed confidentiality nondisclosure agreement will be required to 
receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: The patent applications intended for 
licensure disclose and/or cover the following:

E-202-2002 ``Method for Convection Enhanced Delivery of Therapeutic 
Agents''

    The invention is a method for monitoring the spatial distribution 
of therapeutic substances by MRI or CT that have been administered to 
tissue using convection enhanced delivery, a technique that is the 
subject of NIH-owned U.S. Patent No. 5,720,720. In one embodiment, the 
tracer is a molecule, detectable by MRI or CT, which functions as a 
surrogate for the motion of the therapeutic agent through the solid 
tissue. In other particular embodiments, the tracer is the therapeutic 
agent conjugated to an imaging moiety. The method of this invention 
uses non-toxic macromolecular MRI contrast agents comprised of chelated 
Gd(III). In particular, the surrogate tracer used in this invention is 
a serum albumin conjugated with either a gadolinium chelate of 2-(p-
isothiocyanotobenzyl)-6-methyldiethylenetriamine pentaacetic acid or 
with iopanoic acid. These macromolecular imaging agents have clearance 
properties that mimic the pharmacokinetic properties of co-
administrated drugs, so as to be useful in quantifying the range and 
dosage level of therapeutic drugs using MR imaging.

E-206-2000 ``Method for increasing the distribution of therapeutic 
agents;'' ``Method for increasing the distribution of nucleic acids''

    The invention pertains to the reliance of therapies on the local 
parenchymal delivery of macromolecules or nucleic acids for success. 
However, the volume of distribution of many of these potential 
therapeutic agents is restricted by their interactions with the 
extracellular matrix and cellular receptors. Heparin-sulfate 
proteoglycans

[[Page 78218]]

are cell surface components which bind to an array of molecules such as 
growth factors, cytokines and chemokines and viruses such as 
cytomegalovirus, herpes simplex virus and HIV. The invention provides a 
method of dramatically increasing the volume of distribution and 
effectiveness of certain therapeutic agents after local delivery by the 
use of facilitating agents as described in Neuroreport. 2001 Jul 
3;12(9):1961-4 entitled ``Convection enhanced delivery of AAV-2 
combined with heparin increases TK gene transfer in the rat brain'' and 
in Exp Neurol. 2001 Mar;168(1):155-61 entitled ``Heparin coinfusion 
during convection-enhanced delivery (CED) increases the distribution of 
the glial-derived neurotrophic factor (GDNF) ligand family in rat 
striatum and enhances the pharmacological activity of neurturin.'' 
These methods are especially useful when used in conjunction with 
technology described and claimed in the convection enhanced delivery 
technology claimed in U.S. Patent 5,720,720.
    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 sixty 
(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: December 20, 2006.
Steven M. Ferguson
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-22187 Filed 12-27-06; 8:45 am]
BILLING CODE 4140-01-P