[Federal Register Volume 77, Number 210 (Tuesday, October 30, 2012)]
[Notices]
[Pages 65698-65699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26601]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Evaluation Option License: Pre-
clinical Evaluation of Human Therapeutics Utilizing Ubiquitin Based 
Fusion Proteins With Apoptosis Modifying Proteins Such as BCL-XL

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 evaluation option license to practice the inventions covered 
under the scope of United States Patent No. 6,737,511 issued May 18, 
2004 entitled ``Receptor-mediated Uptake of an Extracellular BCL-
xL Fusion Protein Inhibits Apoptosis'' (HHS Ref. No. E-073-
1999/0-US-02; Inventors Richard Youle et al.) and International Patent 
Application No. PCT/US2012/032762 filed April 9, 2012 entitled 
``Ubiquitin Fusions for Improving the Efficacy of Cytosolic Acting 
Targeted Toxins'' (HHS Ref. No. E-150-2011/0-PCT-02; Inventors 
Christopher Bachran et al.) to Medicenna Therapeutics, (``MEDICENNA'') 
a Canada based company. The patent rights in this invention have been 
assigned to the government of the United States of America.
    The prospective exclusive evaluation option license territory may 
be worldwide and the field of use may be limited to the pre-clinical 
evaluation of lead therapeutic candidates for the development of human 
therapeutics within the field of cancer and neurological diseases. Upon 
expiration or termination of the exclusive evaluation option license, 
MEDICENNA will have the right to execute an exclusive patent 
commercialization license which will supersede and replace the 
exclusive evaluation option license with no broader territory than 
granted in the exclusive evaluation option license and the field of use 
will be commensurate with the commercial development plan at the time 
of conversion.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
November 14, 2012 will be considered.

[[Page 65699]]


ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
evaluation option license should be directed to: Sabarni K. Chatterjee, 
Ph.D., M.B.A. Licensing and Patenting Manager, Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-5587; 
Facsimile: (301) 402-0220; Email: [email protected].

SUPPLEMENTARY INFORMATION: The technologies covered under the present 
inventions relate to (1) apoptosis-modifying fusion proteins with at 
least two domains, one of which targets the fusion proteins to a target 
cell, and another of which modifies an apoptotic response of the target 
cell. For example, fusing various cell-binding domains to Bcl-
XL and Bad allows targeting to specific subsets of cells in 
vivo, permitting treatment and/or prevention of cell-death related 
consequences of various diseases and injuries. This technology could be 
used to minimize or prevent apoptotic damage that can be caused by 
neurodegenerative disorders, e.g., Alzheimer's disease, Huntington's 
disease or spinal-muscular atrophy, stroke episodes or transient 
ischemic neuronal injury, e.g., spinal cord injuries. Additionally, 
apoptotic-enhancing fusion proteins of the current invention could be 
used to inhibit cell growth, e.g., uncontrolled cellular proliferation 
and (2) a platform technology using ubiquitin to improve the delivery 
and efficacy of cytosolic targeted toxins. This invention describes 
generation of fusion proteins via the introduction of the protein 
ubiquitin, a small protein in eukaryotic cells that plays a role in 
protein recycling, in between a targeting moiety and a catalytic 
moiety. Ubiquitin contains a cleavable motif at its C-terminus, which 
can help in the decoupling of the two moieties. Decoupling of the two 
moieties would increase the cytotoxicity of the treatment, since the 
catalytic domain of a Targeted Toxin (TT) remains longer in the 
cytosol. This method of generating fusion proteins would be highly 
useful for all TT and immunotoxins that access the cytosol to either 
affect cytosolic targets or traffic to further sites of action.
    The prospective exclusive evaluation option license is being 
considered under the small business initiative launched on October 1, 
2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 
37 CFR Part 404.7. The prospective exclusive evaluation option license, 
and a subsequent exclusive patent commercialization license, may be 
granted unless within fifteen (15) 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 Part 404.7.
    Any additional, properly filed, and complete 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 
evaluation option 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: October 23, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-26601 Filed 10-29-12; 8:45 am]
BILLING CODE 4140-01-P