[Federal Register Volume 75, Number 137 (Monday, July 19, 2010)]
[Pages 41873-41874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17579]



National Institutes of Health

Prospective Grant of Exclusive License: The Development of Human 
Therapeutics for the Treatment of Cancer

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

ACTION: Notice.


SUMMARY: This is a notice, in accordance with 35 U.S.C. 209(c)(1) and 
37 CFR Part 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 US 
Patent Application 61/241,620 entitled ``Development of an Immunotoxin 
in Which All B-Cell Epitopes Have Been Removed and Which Has High 
Cytotoxic Activity'' [HHS Ref. E-269-2009/0-US-01], US Patent 
Application 60/969,929 entitled ``Deletions in Domain II of Pseudomonas 
Exotoxin A That Reduce Non-Specific Toxicity'' [HHS Ref. E-292-2007/0-
US-01], US Patent Application 60/703,798 entitled ``Mutated Pseudomonas 
Exotoxins with Reduced Antigenicity'' [HHS Ref. E-262-2005/0-US-01], 
and all continuing applications and foreign counterparts, to MedImmune, 
LLC. This license may also include non-exclusive rights to US Patent 
Application 60/525,371 entitled ``Mutated Anti-CD22 Antibodies and 
Immunoconjugates'' [HHS Ref. E-046-2004/0-US-01], US Patent Application 
60/325,360 entitled ``Mutated Anti-CD22 Antibodies with Increased 
Affinity to CD22 Expressing Leukemia Cells'' [HHS Ref. E-129-2001/0-US-
01], US Patent Application 60/041,437 entitled ``Recombinant 
Immunotoxins Targeted to CD22 Bearing Cells and Tumors'' [HHS Ref. E-
059-1997/0-US-01], US Patent 5,747,654 entitled ``Recombinant 
Disulfide-Stabilized Polypeptide Fragments Having Binding Specificity'' 
[HHS Ref. E-163-1993/0-US-01], PCT application PCT/US96/16327 entitled 
``Immunotoxin Containing A Disulfide-Stabilized Antibody Fragment'' 
[HHS Ref. E-163-1993/2-PCT-01], and all continuing applications and 
foreign counterparts. The patent rights in these inventions have been 
assigned to and/or exclusively licensed to the Government of 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 the HA22-LR, HA22-6X, HA22-8X, HA22-LR/6X and HA22-
LR/8X immunotoxins for the treatment of CD22-expressing 
hematological malignancies.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
August 3, 2010 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: David A. Lambertson, Ph.D., Senior 
Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 
402-0220; E-mail: [email protected].

SUPPLEMENTARY INFORMATION: These inventions concern immunotoxins and 
methods of using the immunotoxins for the treatment of hematological 
malignancies such as hairy cell leukemia (HCL), chronic lymphocytic 
leukemia (CLL), acute lymphocytic leukemia (ALL) and non-Hodgkin's 
lymphoma (NHL). Several specific immunotoxins are covered by this 
technology, including HA22-LR, HA22-6X, HA22-8X, HA22-LR/6X and HA22-
    Each of these immunotoxins comprises (1) a toxin moiety that is a 
modified version of the Pseudomonas exotoxin A (``PE'') and (2) an 
antibody fragment domain that is capable of binding to the CD22 cell 
surface receptor. The PE moieties have been modified in various manners 
in order reduce the immunogenicity of the molecule. The modifications 
improve the therapeutic value of PE while maintaining its ability to 
trigger cell death. Since CD22 is preferentially expressed on several 
types of hematological cancer cells, the anti-CD22 antibody binding 
fragment allows the immunotoxins to be targeted

[[Page 41874]]

selectively to cancer cells so that only the cancer cells are killed. 
This results in an effective therapeutic strategy with fewer side 
effects due to less non-specific killing of cells.
    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 Part 
404.7. The prospective exclusive license may be granted unless 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 Part 404.7 within fifteen (15) days from the date 
of this published notice.
    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: July 13, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-17579 Filed 7-16-10; 8:45 am]