Prospective Grant of Exclusive Patent License: Capsid-Free AAV Vectors, Compositions, and Methods for Vector Production and Gene Delivery, 51171 [2019-20992]
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Federal Register / Vol. 84, No. 188 / Friday, September 27, 2019 / Notices
onset of airway diseases. Such
inhibition blocks the development of
airway inflammation and airway
hyperresponsiveness (AHR), two of the
components associated with airway
diseases, and thus may be useful in the
treatment of such diseases. The
invention discloses two antagonists of
HA, i.e. heparosan, and Hyaluronan
oligosaccharides (oHAs). Their
administration to a human subject in
need can be accomplished via the use of
an inhaler or nebulizer.
Potential Commercial Applications:
• Treatment of Airway Diseases
Development Stage:
• In Vitro data available
Inventors: Stavros Garantziotis
(NIEHS), John Hollingsworth (Duke),
Brian P. Toole (UMSC), Jian Liu (UNC)
Intellectual Property: HHS Reference
E–080–2012: Issued Patents: US Patent
No. 9,717,752 issued 08/01/2017;
European Patent No. 2827877 issued 05/
08/2019 and validated in Germany,
France, and the United Kingdom.
Pending application: Canadian Patent
Application No. 2872569 filed 03/08/
2013.
Licensing Contact: Uri Reichman,
Ph.D., MBA, 301–435–4616;
uri.reichman@nih.gov.
Dated: September 17, 2019.
Uri Reichman Sr.,
Senior Licensing and Patenting Manager,
National Heart, Lung, and Blood Institute,
Office of Technology Transfer and
Development.
[FR Doc. 2019–20993 Filed 9–26–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Capsid-Free AAV Vectors,
Compositions, and Methods for Vector
Production and Gene Delivery
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Heart, Lung and
Blood Institute (NHLBI), National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license to Generation Bio Co.
(‘‘Generation Bio’’), a company based in
Cambridge, Massachusetts (in the
exclusive field specified below), and a
co-exclusive license to Generation Bio
and Spark Therapeutics, a company
based in Philadelphia, Pennsylvania (in
the co-exclusive field specified below),
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:29 Sep 26, 2019
Jkt 247001
to practice the inventions embodied in
the patent application listed in the
Supplementary Information section of
this notice.
DATES: Only written comments and/or
applications for a license which are
received by the NHLBI Office of
Technology Transfer and Development
within 15 days from the date of
publication of this notice in the Federal
Register will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
exclusive patent license should be
directed to: Uri Reichman, Ph.D., MBA,
Senior Licensing and Patenting
Manager, 31 Center Drive, Room 4A29,
MSC2479, Bethesda, MD 20892–2479,
phone number 301–435–4616, or
uri.reichman@nih.gov.
SUPPLEMENTARY INFORMATION: The
following and all continuing U.S. and
foreign patents/patent applications
thereof are included in the intellectual
property to be licensed under the
prospective agreements to Generation
Bio and Spark Therapeutics: NIH
reference #E–241–2010.
U.S. patent 9,598,703 issued March
03, 2017; Israeli patent 228328 issued
December 01, 2018; Australian patent
2012228376 issued October 05, 2017,
and pending applications in Brazil (BR
11 2013 023185 8 A2), Canada
(application 2829518), China
(application 201280022523.5), Europe
(application 12 708035.6), India
(application 8000/DELNP/2013), Japan
(application 2013–557138), and S. Korea
(application10–2013–7026982).
The invention is jointly owned by the
Government of the United States and by
the following French institutions:
Association Institut De Myologie,
Sorbonne University, INSERM, and
CNRS. The patent rights in these
inventions have been assigned to the
Government of the United States of
America, and to the French institutions
by their respective employees who are
the inventors of the subject matter
claimed in the patent rights. The
prospective patent license will be
granted worldwide and in fields of use
not broader than the following:
Exclusive field: Electroporationmediated delivery of DNA-based vectors
to express therapeutic molecules for the
treatment or prevention of human
diseases.
Co-exclusive field: The treatment or
prevention of cancer by administration
of DNA-based vectors (with the
exception of electroporation mediation)
to express therapeutic molecules.
All Fields of Use with the exception
of the aforementioned fields are
PO 00000
Frm 00065
Fmt 4703
Sfmt 9990
51171
available for licensing by other parties
on nonexclusive terms.
The subject technology provides
DNA-based constructs for human
therapeutics or preventative therapies.
Such DNA-based constructs may be
useful in gene therapy for treating
genetic disorders, or other diseases by
expressing therapeutic molecules. These
constructs are AAV genome-based,
where the gene of interest (therapeutic
payload) is inserted between two ITRs
(Inverted Terminal Repeats). The
resulting constructs are devoid of the
AAV capsid, and thus nonviral. They
are advantageous over conventionally
used AAV vectors, as they are nonimmunogenic. They are also
advantageous over plasmid-based
expression constructs since they are of
eukaryotic origin and thus devoid of the
bacterial-type DNA methylation as
typically present in plasmids.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 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 NHLBI 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.
Complete applications for a license in
the prospective field of use that are
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive patent
license. Comments and objections
submitted to this notice will not be
made available for public inspection
and, to the extent permitted by law, will
not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: September 17, 2019.
Uri Reichman Sr.,
Senior Licensing and Patenting Manager,
National Heart, Lung, and Blood Institute,
Office of Technology Transfer and
Development.
[FR Doc. 2019–20992 Filed 9–26–19; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\27SEN1.SGM
27SEN1
]]>Agencies
[Federal Register Volume 84, Number 188 (Friday, September 27, 2019)]
[Notices]
[Page 51171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20992]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Capsid-Free AAV
Vectors, Compositions, and Methods for Vector Production and Gene
Delivery
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National
Institutes of Health, Department of Health and Human Services, is
contemplating the grant of an exclusive patent license to Generation
Bio Co. (``Generation Bio''), a company based in Cambridge,
Massachusetts (in the exclusive field specified below), and a co-
exclusive license to Generation Bio and Spark Therapeutics, a company
based in Philadelphia, Pennsylvania (in the co-exclusive field
specified below), to practice the inventions embodied in the patent
application listed in the Supplementary Information section of this
notice.
DATES: Only written comments and/or applications for a license which
are received by the NHLBI Office of Technology Transfer and Development
within 15 days from the date of publication of this notice in the
Federal Register will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated exclusive patent license
should be directed to: Uri Reichman, Ph.D., MBA, Senior Licensing and
Patenting Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD
20892-2479, phone number 301-435-4616, or [email protected].
SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and
foreign patents/patent applications thereof are included in the
intellectual property to be licensed under the prospective agreements
to Generation Bio and Spark Therapeutics: NIH reference #E-241-2010.
U.S. patent 9,598,703 issued March 03, 2017; Israeli patent 228328
issued December 01, 2018; Australian patent 2012228376 issued October
05, 2017, and pending applications in Brazil (BR 11 2013 023185 8 A2),
Canada (application 2829518), China (application 201280022523.5),
Europe (application 12 708035.6), India (application 8000/DELNP/2013),
Japan (application 2013-557138), and S. Korea (application10-2013-
7026982).
The invention is jointly owned by the Government of the United
States and by the following French institutions: Association Institut
De Myologie, Sorbonne University, INSERM, and CNRS. The patent rights
in these inventions have been assigned to the Government of the United
States of America, and to the French institutions by their respective
employees who are the inventors of the subject matter claimed in the
patent rights. The prospective patent license will be granted worldwide
and in fields of use not broader than the following:
Exclusive field: Electroporation-mediated delivery of DNA-based
vectors to express therapeutic molecules for the treatment or
prevention of human diseases.
Co-exclusive field: The treatment or prevention of cancer by
administration of DNA-based vectors (with the exception of
electroporation mediation) to express therapeutic molecules.
All Fields of Use with the exception of the aforementioned fields
are available for licensing by other parties on nonexclusive terms.
The subject technology provides DNA-based constructs for human
therapeutics or preventative therapies. Such DNA-based constructs may
be useful in gene therapy for treating genetic disorders, or other
diseases by expressing therapeutic molecules. These constructs are AAV
genome-based, where the gene of interest (therapeutic payload) is
inserted between two ITRs (Inverted Terminal Repeats). The resulting
constructs are devoid of the AAV capsid, and thus nonviral. They are
advantageous over conventionally used AAV vectors, as they are non-
immunogenic. They are also advantageous over plasmid-based expression
constructs since they are of eukaryotic origin and thus devoid of the
bacterial-type DNA methylation as typically present in plasmids.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 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 NHLBI 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.
Complete applications for a license in the prospective field of use
that are timely filed in response to this notice will be treated as
objections to the grant of the contemplated exclusive patent license.
Comments and objections submitted to this notice will not be made
available for public inspection and, to the extent permitted by law,
will not be released under the Freedom of Information Act, 5 U.S.C.
552.
Dated: September 17, 2019.
Uri Reichman Sr.,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood
Institute, Office of Technology Transfer and Development.
[FR Doc. 2019-20992 Filed 9-26-19; 8:45 am]
BILLING CODE 4140-01-P
