[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33321-33322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13261]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Delivery of a 
Corrective Glucose-6-Phosphatase-Alpha Gene to Treat Glycogen Storage 
Disease Type 1a (GSD-Ia) in Humans

AGENCY: National Institutes of Health, DHHS.

ACTION: Notice.

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SUMMARY: The National Institute of Child Health and Human Development, 
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 U.S. and foreign 
Patents and Patent Applications listed in the Supplementary Information 
section of this notice to Panacea Opportunity, Ltd.

DATES: Only written comments and/or applications for a license which 
are received by the National Institute of Child Health and Human 
Development c/o National Cancer Institute's Technology Transfer Center 
on or before July 9, 2021 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Alan Hubbs, Ph.D., Senior Technology Transfer 
Manager at Telephone: (240)-276-5530 or Email: [email protected].

SUPPLEMENTARY INFORMATION:  The following represents the intellectual 
property to be licensed under the prospective agreement:

Intellectual Property

    1. Priority Application, U.S.P.T.O. No. 62/096,400, filed December 
23, 2014 [HHS Reference No. E-039-2015/0-US-01];
    2. PCT Patent Application No. PCT/US2015/067338, filed December 22, 
2015 [HHS Reference No. E-039-2015-0-PCT-02];
    3. Pending Canadian Patent Application No. 2972038, filed on 
December 22, 2015, [HHS Reference No. E-039-2015-0-CA-03];
    4. Issued China Patent No. ZL201580076462.4, filed on December 22, 
2015, Issued December 11, 2020 [HHS Reference No. E-039-2015-0-CN-04];
    5. Issued European Patent No. 2182936, filed December 22, 2015, 
Issued July 22, 2020 [HHS Reference No. E-039-2015-0-EP-05];
    6. Issued Israeli Patent No. 253103, filed on December 22, 2015, 
Issued April 1, 2020 [HHS Reference No. E-039-2015-0-IL-06];
    7. Issued Japan Patent No. 6824169, filed June 22, 2017, Issued 
January 14, 2021 [HHS Reference No. E-039-2015-0-JP-07];
    8. Issued United States Patent No. 10,415,044, filed September 17, 
2019, Issued September 17, 2019 [HHS Reference No. E-039-2015-0-US-08]
    9. Pending United States Patent Application No. 16/526,327, filed 
July 30, 2019, [HHS Reference No. E-039-2015-0-US-08]
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, the patent rights in these inventions have been assigned to 
the Government of the United States of America. The prospective 
exclusive license territory may be world-wide, and the field of use may 
be limited to the use of Licensed Patent Rights for the following: 
``Delivery of a corrective glucose-6-phosphatase-alpha gene to treat 
glycogen storage disease type 1a (GSD-Ia) in humans.''
    This technology discloses a gene therapy to treat glycogen storage 
disease type 1a (GSD-Ia) in humans using adeno-associated virus 
mediated delivery of a corrective glucose-6-phosphatase-alpha (G6Pase-
[alpha]) gene nucleic acid sequence that codes for a protein having an 
amino acid sequence that differs from the wildtype human amino acid 
sequence at amino acid position 293.
    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, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Institute of Child Health and Human Development 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.


[[Page 33322]]


    Dated: June 11, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-13261 Filed 6-23-21; 8:45 am]
BILLING CODE 4140-01-P