[Federal Register Volume 86, Number 122 (Tuesday, June 29, 2021)]
[Notices]
[Page 34246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 
[email protected].

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