[Federal Register Volume 79, Number 137 (Thursday, July 17, 2014)]
[Notices]
[Pages 41700-41701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16764]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of 
Chimeric Antigen Receptors Targeting B-Cell Maturation Antigen To Treat 
or Prevent Cancer and Autoimmune Disease

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 
Part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an exclusive patent 
license to Bluebird Bio to practice the inventions embodied in US 
Provisional Patent Application Serial No. 61/622,600, entitled 
``Chimeric Antigen Receptors Targeting B-cell Maturation Antigen'' [HHS 
Ref. E-040-2012/0-US-01], and International (PCT) Application No. PCT/
US13/32029, entitled ``Chimeric Antigen Receptors Targeting B-cell 
Maturation Antigen'' [HHS Ref. E-040-2012/0-PCT-02], and all continuing 
applications and foreign counterparts. The patent rights in these 
inventions have been assigned 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:

    Use of the Patent Rights to make and have made, to sell, to 
offer for sale, to import, and to use in humans, human autologous 
peripheral blood T-cells modified by recombinant human 
immunodeficiency virus (``HIV'')-based lentiviral vectors or murine 
leukemia virus (``MLV'')-based gamma-retroviral vectors to express 
chimeric antigen receptors that recognize B-cell Maturation Antigen 
(``BCMA'') for the treatment or prevention of cancer and autoimmune 
diseases.


DATES: Only written comments or applications for a license (or both) 
which are received by the NIH Office of Technology Transfer on or 
before August 18, 2014 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: Patrick McCue, Ph.D., 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; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: These inventions concern a series of 
chimeric antigen receptors (CARs) that specifically target BCMA, a 
protein that is highly expressed on the surface of

[[Page 41701]]

multiple myeloma cells. The pending patent application includes claims 
to compositions and vectors incorporating the CARs, as well as methods 
of destroying multiple myeloma cells using T-cells engineered to 
express a CAR.
    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. 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 within thirty (30) days from the date of 
this published notice.
    Applications for a license in the field of use that are 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 14, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-16764 Filed 7-16-14; 8:45 am]
BILLING CODE 4140-01-P