Prospective Grant of Exclusive License: The Development of Modified T-cells for the Treatment of Multiple Myeloma, 69429 [2013-27601]

Download as PDF 69429 Federal Register / Vol. 78, No. 223 / Tuesday, November 19, 2013 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Form name Type of respondent CTSU IBCSG Drug Accountability Form .............. CTSU IBCSG Transfer of Investigational Agent Form. Site Initiated Data Update Form ........................... Data Clarification Form ......................................... RTOG 0834 CTSU Data Transmittal Form .......... MC0845(8233) CTSU Data Transmittal ............... CTSU Generic Data Transmittal Form ................. CTSU Patient Enrollment Transmittal Form ......... CTSU P2C Enrollment Transmittal Form ............. CTSU Transfer Form ............................................ CTSU System Account Request Form ................. CTSU Request for Clinical Brochure .................... CTSU Supply Request Form ................................ CTSU Web Site Customer Satisfaction Survey ... CTSU Helpdesk Customer Satisfaction Survey ... CTSU OPEN Survey ............................................ PIO Customer Satisfaction Survey ....................... Concept Clinical Trial Survey ............................... Prospective Clinical Trial Survey .......................... Low Accrual Clinical Trial Survey ......................... Health Care Practitioner Health Care Practitioner Dated: November 7, 2013. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, National Institutes of Health. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: The Development of Modified T-cells for the Treatment of Multiple Myeloma National Institutes of Health, HHS. Notice. 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 to Thirsty Brook Bioscience, Inc., of an exclusive evaluation option license to practice the inventions embodied in the following US Patent Applications (and all continuing applications and foreign counterparts): Serial No. 61/622,6008 entitled, ‘‘Chimeric Antigen Receptors Targeting B-cell Maturation Antigen’’ [HHS Ref. E–040–2012/0–US–01]. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive evaluation option license territory may be TKELLEY on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:21 Nov 18, 2013 Jkt 232001 Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner 10/60 20/60 22 12 10 341 60 50 500 200 15 20 20 75 75 275 325 60 100 500 1,000 1,000 12 12 12 12 12 12 12 12 12 12 12 1 1 1 1 1 1 1 10/60 20/60 10/60 10/60 10/60 10/60 10/60 10/60 20/60 10/60 10/60 15/60 15/60 15/60 5/60 5/60 5/60 5/60 20 1,364 120 100 1,000 400 30 40 80 150 150 69 81 15 8 42 83 83 Upon the expiration or termination of the exclusive evaluation option license, Thirsty Brook Bioscience, Inc. will have the exclusive right to execute an exclusive commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the exclusive evaluation option license. DATES: Only written comments or applications for a license (or both) which are received by the NIH Office of Technology Transfer on or before December 4, 2013 will be considered. 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: 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) 435–5560; Facsimile: (301) 402–0220; Email: mccuepat@ mail.nih.gov. SUPPLEMENTARY INFORMATION: The invention concerns a series of CARs that specifically target BCMA (a.k.a. CD269), a protein that is highly expressed on the surface of multiple myeloma cells. The PO 00000 Frm 00068 Fmt 4703 Sfmt 9990 Total annual burden hour 12 12 ‘‘The research, development, and manufacture of chimeric antigen receptor (CAR)-expressing human T-cells directed against B-cell Maturation Antigen (BCMA) for the treatment of multiple myeloma.’’ BILLING CODE 4140–01–P ACTION: Care Care Care Care Care Care Care Care Care Care Care Care Care Care Care Care Care Care Average burden per response (in hours) 11 3 worldwide, and the field of use may be limited to: [FR Doc. 2013–27554 Filed 11–18–13; 8:45 am] AGENCY: Health Health Health Health Health Health Health Health Health Health Health Health Health Health Health Health Health Health Number of responses per respondent patent rights include claims to vectors incorporating the CARs, as well as methods of destroying multiple myeloma cells using T-cells engineered to express a CAR. The prospective exclusive evaluation option license is being considered under the small business initiative launched on 1 October 2011, and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive evaluation option license, and a subsequent exclusive commercialization 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 fifteen (15) days from the date of this published notice. 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: November 13, 2013. Richard U. Rodriguez, Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–27601 Filed 11–18–13; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\19NON1.SGM 19NON1

Agencies

[Federal Register Volume 78, Number 223 (Tuesday, November 19, 2013)]
[Notices]
[Page 69429]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27601]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of 
Modified T-cells for the Treatment of Multiple Myeloma

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 to Thirsty Brook 
Bioscience, Inc., of an exclusive evaluation option license to practice 
the inventions embodied in the following US Patent Applications (and 
all continuing applications and foreign counterparts): Serial No. 61/
622,6008 entitled, ``Chimeric Antigen Receptors Targeting B-cell 
Maturation Antigen'' [HHS Ref. E-040-2012/0-US-01]. The patent rights 
in these inventions 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 research, development, and manufacture of chimeric antigen 
receptor (CAR)-expressing human T-cells directed against B-cell 
Maturation Antigen (BCMA) for the treatment of multiple myeloma.''

    Upon the expiration or termination of the exclusive evaluation 
option license, Thirsty Brook Bioscience, Inc. will have the exclusive 
right to execute an exclusive commercialization license which will 
supersede and replace the exclusive evaluation option license with no 
greater field of use and territory than granted in the exclusive 
evaluation option license.

DATES: Only written comments or applications for a license (or both) 
which are received by the NIH Office of Technology Transfer on or 
before December 4, 2013 will be considered.

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: 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) 435-5560; Facsimile: (301) 
402-0220; Email: mccuepat@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The invention concerns a series of CARs that 
specifically target BCMA (a.k.a. CD269), a protein that is highly 
expressed on the surface of multiple myeloma cells. The patent rights 
include claims to vectors incorporating the CARs, as well as methods of 
destroying multiple myeloma cells using T-cells engineered to express a 
CAR.
    The prospective exclusive evaluation option license is being 
considered under the small business initiative launched on 1 October 
2011, and will comply with the terms and conditions of 35 U.S.C. 209 
and 37 CFR part 404. The prospective exclusive evaluation option 
license, and a subsequent exclusive commercialization 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 fifteen 
(15) days from the date of this published notice.
    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: November 13, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-27601 Filed 11-18-13; 8:45 am]
BILLING CODE 4140-01-P