[Federal Register Volume 70, Number 250 (Friday, December 30, 2005)]
[Notices]
[Page 77421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-8131]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Fusion Proteins 
Comprising Circularly Permuted Ligands

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, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive patent license to practice the inventions embodied in United 
States Patent No. 4,892,827, issued on January 9, 1990, entitled 
``Recombinant Pseudomonas Exotoxin: Construction Of An Active 
Immunotoxin With Low Side Effects'' [E-385-1986/0-US-01]; U.S. Patent 
No. 5,635,599, issued on June 3, 1997, entitled ``Fusion Proteins 
Comprising Circularly Permuted Ligands'' [E-047-1994/0-US-01]; PCT 
Patent Application No. PCT/US95/04468, filed April 6, 1995, entitled 
``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/
0-PCT-02]; Switzerland Patent No. 0754192, issued on January 29, 2003, 
entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-
047-1994/0-CH-03]; Spain Patent No. 0754192, issued on January 29, 
2003, entitled ``Fusion Proteins Comprising Circularly Permuted 
Ligands'' [E-047-1994/0-ES-04]; United Kingdom Patent No. 0754192, 
issued on January 29, 2003, entitled ``Fusion Proteins Comprising 
Circularly Permuted Ligands'' [E-047-1994/0-GB-05]; Italy Patent No. 
0754192, issued on January 29, 2003, entitled ``Fusion Proteins 
Comprising Circularly Permuted Ligands'' [E-047-1994/0-IT-06]; 
Luxembourg Patent No. 0754192, issued on January 29, 2003, entitled 
``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/
0-LU-07]; Netherlands Patent No. 0754192, issued on January 29, 2003, 
entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-
047-1994/0-NL-09]; German Patent No. 0754192, issued on January 29, 
2003, entitled ``Fusion Proteins Comprising Circularly Permuted 
Ligands'' [E-047-1994/0-DE-10]; Austria Patent No. 0754192, issued on 
January 29, 2003, entitled ``Fusion Proteins Comprising Circularly 
Permuted Ligands'' [E-047-1994/0-AT-11]; Australia Patent No. 694211, 
issued on November 5, 1998, entitled ``Fusion Proteins Comprising 
Circularly Permuted Ligands'' [E-047-1994/0-AU-12]; Belgium Patent No. 
0754192, issued on January 29, 2003, entitled ``Fusion Proteins 
Comprising Circularly Permuted Ligands'' [E-047-1994/0-BE-13]; Canada 
Patent No. 2187283, filed on April 6, 1995, entitled ``Fusion Proteins 
Comprising Circularly Permuted Ligands'' [E-047-1994/0-CA-14]; European 
Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion 
Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-EP-15]; 
France Patent No. 0754192, issued on January 29, 2003, entitled 
``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/
0-FR-16]; Ireland Patent No. 0754192, issued on January 29, 2003, 
entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-
047-1994/0-IE-17]; Liechtenstein Patent No. 0754192, issued on January 
29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted 
Ligands'' [E-047-1994/0-LI-18]; and U.S. Patent No. 6,011,002, issued 
on January 4, 2000, entitled ``Circularly Permutated Ligands And 
Circularly Permuted Chimeric Molecules'' [E-047-1994/1-US-01] to Protox 
Therapeutics, Inc., which has offices in Vancouver, British Columbia, 
Canada. The patent rights in these inventions have been assigned to the 
United States of America.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to the use of Interleukin-4/cytotoxin 
fusion proteins for the treatment of cancer.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
February 28, 2006 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Jesse S. Kindra, J.D., M.S., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 435-5559; Facsimile: (301) 402-0220; E-
mail: [email protected].

SUPPLEMENTARY INFORMATION: The technology relates to circularly 
permuted ligands having the ability to change the conformation of 
certain proteins so that they can be more effectively used as 
therapeutics. Specifically, growth factors such as IL-4 can be used in 
fusion proteins to target cell surface receptors. Accordingly, these 
growth factors can be used, when linked with cytotoxic moieties (i.e., 
Pseudomonas Exotoxin), to target and then kill desired cells. These 
circularly permuted molecules are advantageous over prior molecules in 
that they allow greater binding specificity of an immunotoxin to the 
targeted cell. This change in conformation is a result of the 
production of new carboxyl and amino termini. The new termini are 
located away from the active binding site and hence cause less steric 
hindrance between the active site and the fused protein. Hence, the 
targeting moiety is closer to its native conformation. Without such a 
conformational change, binding specificity for the immunotoxin is 
greatly reduced. Therefore, these circularly permuted molecules allow 
for greater binding specificity without retarding the cytotoxicity of 
the toxin to which they are bound.
    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, the 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.
    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 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: December 14, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.5
 [FR Doc. E5-8131 Filed 12-29-05; 8:45 am]
BILLING CODE 4140-01-P