[Federal Register Volume 78, Number 246 (Monday, December 23, 2013)]
[Notices]
[Page 77471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30430]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License for: Convection Enhanced 
Delivery of a Therapeutic Agent With a Surrogate Tracer for Treating 
Cancer and Urological Diseases

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
404.7, 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 inventions embodied in: HHS Ref. No 
E-202-2002/0 ``Method for Convection Enhanced Delivery of Therapeutic 
Agents'', U.S. Provisional Patent Application 60/413,673 (filed 
September 24, 2002; expired), International Patent Application No. PCT/
US2003/30155 (filed September 24, 2003; nationalized), U.S. Patent 
Application 7,371,225, European Patent Application 03756863.1, 
Australian Patent 2003299140, to Medicenna Therapeutics, Inc. having a 
principle place of business in 1075 West Georgia St., Vancouver, BC, 
Canada V6E 3C9.
    The United States of America is an assignee to the patent rights of 
these inventions.
    The contemplated exclusive license may be in a field of use 
directed to the treatment of cancers and urological disorders that 
express IL-4 receptor on their cell surface by administering cpIL4-
PE38KDEL by convection enhanced deliver along with a Gd-DTPA surrogate 
tracer.

DATES: Only written comments and/or applications for a license that are 
received by the NIH Office of Technology Transfer on or before January 
22, 2014 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, Esq, CLP, Senior Licensing 
and Patent Manager, 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; Email: 
[email protected]. A signed confidential disclosure agreement may 
be required to receive copies of the patent application assuming it has 
not already been published under either the publication rules of either 
the U.S. Patent and Trademark Office or the World Intellectual Property 
Organization.

SUPPLEMENTARY INFORMATION: 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 now expired NIH-owned U.S. Patent No. 
5,720,720 (HHS Ref. E-173-1992/0). 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 such as chelated Gd(III). 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.
    The prospective exclusive license will be royalty-bearing and 
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 30 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 17, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-30430 Filed 12-20-13; 8:45 am]
BILLING CODE 4140-01-P