[Federal Register Volume 85, Number 100 (Friday, May 22, 2020)]
[Notices]
[Page 31193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11036]



[[Page 31193]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Antibody-Based 
Therapy for the Treatment of CD20 Expressing Lymphomas

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Heart, Lung, and Blood Institute, an institute of 
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 the Patents and Patent Applications 
listed in the Supplementary Information section of this notice to 
Retargeted Therapeutics, a corporation incorporated under the laws of 
the state of Delaware.

DATES: Only written comments and/or applications for a license which 
are received by the National Heart, Lung, and Blood on or before June 
8, 2020 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an exclusive patent license 
should be directed to: Vidita Choudhry, Ph.D. Technology Transfer 
Manager, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479, 
phone number (301)-594-4095, or [email protected].

SUPPLEMENTARY INFORMATION:

                                                                  Intellectual Property
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                Issued patent
           NIH ref No.                    Title           Patent application No.           Filing date               No.               Issue date
--------------------------------------------------------------------------------------------------------------------------------------------------------
E-758-2013-0-US-01...............  Antibody Targeting   61/924,967................  January 8, 2014..........  ..............  .........................
                                    Cell Surface
                                    Deposited
                                    Complement Protein
                                    C3d and Use
                                    Thereof.
E-758-2013-1-PCT-01..............  Antibody Targeting   PCT/US2015/010620.........  January 8, 2015..........  ..............  .........................
                                    Cell Surface
                                    Deposited
                                    Complement Protein
                                    C3d and Use
                                    Thereof.
E-758-2013-1-US-02...............  Antibody Targeting   15/110,577................  July 8, 2016.............      10,035,848  July 31, 2018.
                                    Cell Surface
                                    Deposited
                                    Complement Protein
                                    C3d and Use
                                    Thereof.
E-758-2013--1-CA-03..............  Antibody Targeting   2936346...................  January 8, 2015..........  ..............
                                    Cell Surface
                                    Deposited
                                    Complement Protein
                                    C3d and Use
                                    Thereof.
E-758-2013-1-EP-04...............  Antibody Targeting   15701442.4................  January 8, 2015..........         3092252  September 18, 2019.
                                    Cell Surface
                                    Deposited
                                    Complement Protein
                                    C3d and Use
                                    Thereof.
E-758-2013-1-US-05...............  Antibody Targeting   16/047,929................  July 27, 2018............  ..............
                                    Cell Surface
                                    Deposited
                                    Complement Protein
                                    C3d and Use
                                    Thereof.
E-025-2019-0-US-01...............  Antibody Targeting   62/945,569................  December 9, 2019.........  ..............  .........................
                                    Cell Surface
                                    Deposited
                                    Complement Protein
                                    C3d and Use
                                    Thereof.
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Intellectual property listed here includes all U.S. and foreign 
patents and applications claiming priority to any member of the 
aforementioned applications.
    The patent rights in these inventions have been assigned or 
exclusively licensed to the Government of the United States of America.
    The prospective exclusive license territory may be worldwide and in 
fields of use that may be limited to use of anti-C3d monoclonal 
antibodies (mAbs) to potentiate anti-tumor activity of anti-CD20 mAbs 
for the treatment of B-cell lymphomas.
    The aforementioned Patents and Patent applications cover technology 
directed to development of anti-C3d antibody or antibody fragments to 
re-target cells that have escaped from existing mAbs therapy and to 
potentiate the anti-tumor activity of therapeutic mAbs and eliminate 
antigen loss variants.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing. 
The prospective exclusive license may be granted unless within fifteen 
(15) days from the date of this published notice, the National Heart, 
Lung, and Blood Institute 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.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: May 14, 2020.
Bruce D. Goldstein,
Director, Office of Technology Transfer and Development, National 
Heart, Lung, and Blood Institute.
[FR Doc. 2020-11036 Filed 5-21-20; 8:45 am]
BILLING CODE 4140-01-P