[Federal Register Volume 84, Number 228 (Tuesday, November 26, 2019)]
[Notices]
[Pages 65169-65170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25685]


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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, 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 OcQuila Therapeutics Ltd., a C 
corporation incorporated under the laws of the state of Delaware and a 
limited company incorporated under the laws of the United Kingdom, to 
practice the inventions covered by the patent estate listed in the 
Supplementary Information section of this notice.

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


[[Page 65170]]

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 thirty ( 
) 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: November 21, 2019.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute.
[FR Doc. 2019-25685 Filed 11-25-19; 8:45 am]
 BILLING CODE 4140-01-P