Notice2021-13261
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 24, 2021
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 119 (Thursday, June 24, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33321-33322]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13261]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: <a href="/cdn-cgi/l/email-protection#2d45584f4f5e4c6d404c444103434445034a425b"><span class="__cf_email__" data-cfemail="f0988592928391b09d91999cde9e9998de979f86">[email protected]</span></a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 24, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.