Prospective Grant of an Exclusive Patent License: Engineered Tumor Infiltrating Lymphocytes for Cancer Therapy; Correction, 14331 [2021-05272]
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Federal Register / Vol. 86, No. 48 / Monday, March 15, 2021 / Notices
Dated: March 10, 2021.
Lynette Wilson,
Federal Register Liaison, Department of
Health and Human Services.
Dated: March 9, 2021.
Daniel R Hernandez,
Federal Register Officer, National Institutes
of Health.
[FR Doc. 2021–05322 Filed 3–12–21; 8:45 am]
[FR Doc. 2021–05272 Filed 3–12–21; 8:45 am]
BILLING CODE 4120–01–P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Engineered Tumor
Infiltrating Lymphocytes for Cancer
Therapy; Correction
Prospective Grant of an Exclusive
Patent License: Development,
Production, and Commercialization of
Ebola Neutralizing Single Monoclonal
Antibody for the Treatment of Ebola
Virus Disease in Humans
AGENCY:
National Institutes of Health,
HHS.
ACTION:
AGENCY:
Notice; correction.
The Department of Health and
Human Services, National Institutes of
Health published a Notice in the
Federal Register on February 25, 2021.
That Notice requires a correction in the
SUPPLEMENTARY INFORMATION section.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of February
25, 2021, in FR Doc. 2021–03873, on
page 11548, as found within the
SUPPLEMENTARY INFORMATION section,
correct to read:
khammond on DSKJM1Z7X2PROD with NOTICES
The use of the Licensed Patent Rights to
develop, manufacture, distribute, sell, and
use autologous tumor infiltrating lymphocyte
(TIL) adoptive cell therapy products for the
treatment of metastatic melanoma, lung,
breast, bladder, and HPV-positive cancers.
Specifically excluded from this Agreement
are cell therapy products involving TIL
genetically modified for reactivity against
cancer-specific mutations or TIL selected for
reactivity against cancer-specific mutations,
unless such cell therapy products are a
combination of unselected, unmodified TIL
therapy with the Licensee’s proprietary
technologies or the Licensee’s in-licensed
technologies.
The field of use described in the
Notice was found to be incorrect. The
correction addresses this discrepancy by
accurately stating the field of use which
the NIH intends to grant to Iovance
Biotherapeutics, Inc for the disclosed
federally owned invention.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Andrew Burke, Ph.D.,
Senior Technology Transfer Manager,
NCI Technology Transfer Center,
Telephone: (240)–276–5484; Email:
andy.burke@nih.gov.
VerDate Sep<11>2014
16:36 Mar 12, 2021
National Institutes of Health,
HHS.
Jkt 253001
ACTION:
Notice.
The National Institute of
Allergy and Infectious Diseases, 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 European Patents and Patent
Applications listed in the
Supplementary Information section of
this Notice to Ridgeback
Biotherapeutics, L.P., located in Miami,
Florida.
DATES: Only written comments and/or
applications for a license which are
received by the National Institute of
Allergy and Infectious Diseases’
Technology Transfer and Intellectual
Property Office on or before March 30,
2021 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: Daniel Lee, J.D., Technology
Transfer and Patent Specialist, National
Institute of Allergy and Infectious
Diseases Technology Transfer and
Intellectual Property Office by email
(daniel.lee5@nih.gov) or phone (301–
761–6327).
SUPPLEMENTARY INFORMATION:
SUMMARY:
Intellectual Property
E–045–2015: Neutralizing Antibodies to
Ebolavirus Glycoprotein and Their Use
1. United States Provisional Patent
Application No. 62/087,087, filed 3
December 2014 (HHS Reference No. E–
045–2015–0–US–01);
2. International Patent Application
No. PCT/US2015/060733, filed 13
November 2015 (HHS Reference No. E–
045–2015–0–PCT–02);
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
14331
3. European Patent Application No.
15797815.6, filed 13 November 2015
(HHS Reference No. E–045–2015–0–EP–
03); and
4. United States Patent No.
10,273,288, issued 30 April 2019 (HHS
Reference No. E–045–2015–0–US–05).
The patent and patent application
rights in these inventions have been
assigned and/or exclusively licensed to
the government of the United States of
America.
The prospective exclusive license
territory may be worldwide and the
fields of use may be limited to the
following: Development, production,
and commercialization of Ebola
neutralizing monoclonal antibody
mAb114, as a single antibody not in
combination with other monoclonal
antibodies, for the treatment of Ebola
virus disease in humans.
This technology discloses the
discovery, isolation, production, and
advancement in the development of
recombinant neutralizing antibodies
specific to the Ebola virus glycoprotein,
varying Ebola virus glycoprotein
recognition profiles, and increasing
neutralization potency for a therapeutic
in a patient diagnosed with Ebola virus.
This Notice is made in accordance
with 35 U.S.C. 209 and 37 CFR 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 Allergy and Infectious
Diseases 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 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
commercialization 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.
E:\FR\FM\15MRN1.SGM
15MRN1
]]>Agencies
[Federal Register Volume 86, Number 48 (Monday, March 15, 2021)]
[Notices]
[Page 14331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05272]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Engineered
Tumor Infiltrating Lymphocytes for Cancer Therapy; Correction
AGENCY: National Institutes of Health, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services, National
Institutes of Health published a Notice in the Federal Register on
February 25, 2021. That Notice requires a correction in the
SUPPLEMENTARY INFORMATION section.
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of February 25, 2021, in FR Doc. 2021-
03873, on page 11548, as found within the Supplementary Information
section, correct to read:
The use of the Licensed Patent Rights to develop, manufacture,
distribute, sell, and use autologous tumor infiltrating lymphocyte
(TIL) adoptive cell therapy products for the treatment of metastatic
melanoma, lung, breast, bladder, and HPV-positive cancers.
Specifically excluded from this Agreement are cell therapy products
involving TIL genetically modified for reactivity against cancer-
specific mutations or TIL selected for reactivity against cancer-
specific mutations, unless such cell therapy products are a
combination of unselected, unmodified TIL therapy with the
Licensee's proprietary technologies or the Licensee's in-licensed
technologies.
The field of use described in the Notice was found to be incorrect.
The correction addresses this discrepancy by accurately stating the
field of use which the NIH intends to grant to Iovance Biotherapeutics,
Inc for the disclosed federally owned invention.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated Exclusive Patent License
should be directed to: Andrew Burke, Ph.D., Senior Technology Transfer
Manager, NCI Technology Transfer Center, Telephone: (240)-276-5484;
Email: [email protected].
Dated: March 9, 2021.
Daniel R Hernandez,
Federal Register Officer, National Institutes of Health.
[FR Doc. 2021-05272 Filed 3-12-21; 8:45 am]
BILLING CODE 4140-01-P
