[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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