Notice2021-13826
Prospective Grant of an Exclusive Patent License: Adeno-Associated Virus Polynucleotides, Polypeptides and Virions
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 29, 2021
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Heart, Lung, and Blood Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive, Sublicensable Patent License to consolidate co-owned rights to the inventions and the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to The Children's Medical Research Institute, having a place of business in Westmead NSW, Australia.
Full Text
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<title>Federal Register, Volume 86 Issue 122 (Tuesday, June 29, 2021)</title>
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[Federal Register Volume 86, Number 122 (Tuesday, June 29, 2021)]
[Notices]
[Page 34246]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13826]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Adeno-
Associated Virus Polynucleotides, Polypeptides and Virions
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Heart, Lung, and Blood Institute, an institute of
the National Institutes of Health, Department of Health and Human
Services, is contemplating the grant of an Exclusive, Sublicensable
Patent License to consolidate co-owned rights to the inventions and the
Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION
section of this notice to The Children's Medical Research Institute,
having a place of business in Westmead NSW, Australia.
DATES: Only written comments and/or applications for a license that are
received by the National Heart, Lung, and Blood Institute Office of
Technology and Development on or before July 14, 2021 will be
considered.
ADDRESSES: Requests for a copy of the patent application(s), inquiries,
and comments relating to the contemplated license should be directed
to: John R. DeVany, Technology Transfer Analyst, NHLBI Office of
Technology Transfer and Development, Telephone: 301-594-2436; email:
<a href="/cdn-cgi/l/email-protection#8ee4e1e6e0a0eaebf8efe0f7cee0e7e6a0e9e1f8"><span class="__cf_email__" data-cfemail="442e2b2c2a6a202132252a3d042a2d2c6a232b32">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
The following and all continuing U.S. and foreign patents/patent
applications thereof are the intellectual properties to be licensed
under the prospective agreement:
1. U.S. Provisional Patent Application No. 62/331,188, filed May
3, 2016, entitled ``Adeno-Associated Virus Polynucleotides and
Virions'' [HHS Ref. No. E-156-2016-0-US-01].
2. Patent Cooperation Treaty Patent Application No. PCT/US2017/
030808, filed May 3, 2017, entitled ``Adeno-Associated Virus
Polynucleotides and Virions'' [HHS Ref. No. E-156-2016-0-PCT-02].
3. Australian National Phase Patent Application No. 2017261249,
filed October 30, 2018, entitled ``Adeno-Associated Virus
Polynucleotides and Virions'' [HHS Ref. No. E-156-2016-0-AU-03].
4. U.S. Patent No. 10,882,886 issued January 5, 2021, entitled
``Adeno-Associated Virus Polynucleotides and Virions'' [HHS Ref. No.
E-156-2016-0-US-04].
5. European National Phase Patent Application No. 17793239.9
filed December 3, 2018, entitled ``Adeno-Associated Virus
Polynucleotides and Virions'' [HHS Ref. No. E-156-2016-0-EP-05].
The patent rights in these inventions have been assigned to the
Government of the United States of America, Sydney Children's Hospital
Network, and the Children's Medical Research Institute (CMRI), a co-
owner of said rights, for commercial development and marketing. The
prospective patent license will be for the purpose of consolidating the
patent rights to CMRI. Consolidation of these co-owned rights is
intended to expedite development of the invention, consistent with the
goals of the Bayh-Dole Act codified as 35 U.S.C. 200-212. The
prospective patent license will be worldwide, exclusive, may be limited
to those fields of use commensurate in scope with the patent rights,
and will be sublicensable.
The subject technology pertains to a ``fossilized'' AAV-derived
endogenous viral element (referred to as mAAV-EVE) within the germline
of an ancient lineage of Australian marsupials. This novel AAV coat
protein sequence of mAAV-EVE may provide the basis for recombinant AAV
vectors with unique biological properties.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
404. The prospective Exclusive Patent License will be royalty bearing
and may be granted unless, within fifteen (15) days from the date of
this published notice, the National Heart, Lung, and Blood Institute
Office of Technology Transfer and 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 404.
Complete applications for a license that are timely filed in
response to this notice will be treated as objections to this to the
grant of the contemplated exclusive patent license.
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 from 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: June 22, 2021.
Bruce D. Goldstein,
Director, Office of Technology Transfer and Development, National
Heart, Lung, and Blood Institute.
[FR Doc. 2021-13826 Filed 6-28-21; 8:45 am]
BILLING CODE 4140-01-P
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