[Federal Register Volume 85, Number 137 (Thursday, July 16, 2020)]
[Notices]
[Pages 43246-43247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15340]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Gene Therapy 
for Ocular Disease

AGENCY: National Institutes of Health, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The National Eye Institute, the National Institute on Deafness 
and Other Communication Disorders, and the National Heart, Lung, and 
Blood Institute, institutes of the National Institutes of Health, 
Department of Health and Human Services, are contemplating the grant of 
an exclusive patent license to VegaVect, Inc., a start-up company spun-
off from the University of Pittsburgh Medical Center Enterprises and 
incorporated as a C corporation under the laws of the state of 
Delaware, to practice the inventions covered by the patent estate 
listed in the SUPPLEMENTARY INFORMATION section of this notice. This is 
a second notice intended to apprise the public of a change in 
prospective licensee of the subject intellectual property rights in the 
stated field of use from a first notice: Prospective Grant of An 
Exclusive Patent License: Gene Therapy for Ocular Disease, published in 
the Federal Register on November 26, 2019.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center (representing the National Eye Institute and the National Heart, 
Lung, and Blood Institute (representing the National Institute on 
Deafness and Other Communication Disorders) on or before July 31, 2020 
will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and

[[Page 43247]]

comments relating to the contemplated an exclusive patent license 
should be directed to: Michael Shmilovich, Esq., Senior Licensing and 
Patent Manager, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-
2479, phone number 301-435-5019, or [email protected].

SUPPLEMENTARY INFORMATION: 

                                              Intellectual Property
----------------------------------------------------------------------------------------------------------------
                                                    Patent                        Issued patent
         NIH ref No.               Title       application No.    Filing date          No.          Issue date
----------------------------------------------------------------------------------------------------------------
E-284-2012-0-US-01..........  Methods And      61/765,654.....  February 15,
                               Compositions                      2013.
                               For Treating
                               Genetically
                               Linked
                               Diseases Of
                               The Eye.
E-284-2012-1-US-01..........  Methods And      61/815,636.....  April 24, 2013.
                               Compositions
                               For Treating
                               Genetically
                               Linked
                               Diseases Of
                               The Eye.
E-284-2012-2-PCT-01.........  Methods And      PCT/US2014/      February 14,
                               Compositions     16389.           2014.
                               For Treating
                               Genetically
                               Linked
                               Diseases Of
                               The Eye.
E-284-2012-2-AU-02..........  AAV8             2014216160.....  February 14,         2014216160  July 13, 2017.
                               retinoschisin                     2014.
                               expression
                               vector for
                               treating X-
                               linked
                               retinoschisis.
E-284-2012-2-CA-03..........  AAV8             2900231........  February 14,            2900231  July 30, 2019.
                               retinoschisin                     2014.
                               expression
                               vector for
                               treating X-
                               linked
                               retinoschisis.
E-284-2012-2-JP-04..........  Methods And      2015-558144....  February 14,            6449175  December 14,
                               Compositions                      2014.                            2018.
                               For Treating
                               Genetically
                               Linked
                               Diseases Of
                               The Eye.
E-284-2012-2-US-05..........  Methods And      14/766,842.....  February 14,          9,873,893  January 23,
                               Compositions                      2014.                            2018.
                               For Treating
                               Genetically
                               Linked
                               Diseases Of
                               The Eye.
E-284-2012-2-US-07..........  Methods And      15/876,821.....  February 14,         10,350,306  July 16, 2019.
                               Compositions                      2014.
                               For Treating
                               Genetically
                               Linked
                               Diseases Of
                               The Eye.
E-284-2012-2-EP-06..........  Methods And      14708176.4.....  February 14,
                               Compositions                      2014.
                               For Treating
                               Genetically
                               Linked
                               Diseases Of
                               The Eye.
E-284-2012-2-PCT-08.........  Methods And      PCT/US2019/      January 21,
                               Compositions     14418.           2019.
                               For Treating
                               Genetically
                               Linked
                               Diseases Of
                               The Eye.
E-164-2018-0-US-01..........  Intraocular      62/701,267.....  July 20, 2018..
                               Delivery Of
                               Gene Therapy
                               Expression
                               Vectors.
E-164-2018-1-US-01..........  Intraocular      62/724,480.....  August 29, 2018
                               Delivery Of
                               Gene Therapy
                               Expression
                               Vectors.
E-164-2018-2-US-01..........  Intraocular      62/768,590.....  November 16,
                               Delivery Of                       2019.
                               Gene Therapy
                               Expression
                               Vectors.
E-164-2018-3-PCT-01.........  Intraocular      PCT/US2019/      July 18, 2019..
                               Delivery Of      042365.
                               Gene Therapy
                               Expression
                               Vectors.
----------------------------------------------------------------------------------------------------------------

    All U.S. and foreign patents and applications claiming priority to 
any member of the above.
    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 human therapeutics for (1) X-
linked juvenile retinoschisis and (2) schisis cavity associated ocular 
disease or injury.
    The aforementioned patent estates cover inventions directed to gene 
therapy and specifically, expression vectors and therapeutic methods of 
using such vectors in the treatment of ocular diseases resulting from 
failure to produce or the defective production of an ocular protein. 
This invention is also directed to methods of administering expression 
vectors capable of modulating a target gene or gene product for the 
treatment of ocular disease.
    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: July 2, 2020.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute.
[FR Doc. 2020-15340 Filed 7-15-20; 8:45 am]
BILLING CODE 4140-01-P