82 FR 23013 - Prospective Grant of Exclusive Patent License: The Development of Monospecific and Bispecific Antibodies to GPC3 for the Treatment of Human Liver Cancers

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 96 (May 19, 2017)

Page Range		23013-23014
FR Document		2017-10154

The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to AbPro, located in Woburn, Massachusetts, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.

Federal Register, Volume 82 Issue 96 (Friday, May 19, 2017)

[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23013-23014]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: The Development of 
Monospecific and Bispecific Antibodies to GPC3 for the Treatment of 
Human Liver Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Cancer Institute, National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
an Exclusive Patent License to AbPro, located in Woburn, Massachusetts, 
to practice the inventions embodied in the patent applications listed 
in the SUPPLEMENTARY INFORMATION section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NCI Technology Transfer Center on or before June 5, 
2017 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: David A. Lambertson, Ph.D., Senior Licensing and 
Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center 
Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), 
Rockville, MD 20850-9702, Telephone: (240)-276-6467; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement: U.S. 
Provisional Patent Application 61/654,232 entitled ``High-affinity 
Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-
2012/0-US-01], PCT Patent Application PCT/US2013/043633 entitled 
``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' 
[HHS Ref. E-136-2012/0-PCT-02], Chinese Patent Application 
201380039993.7 entitled ``High-affinity Monoclonal Antibodies To 
Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-CN-03], Japanese 
Patent Application 2015-515243 entitled ``High-affinity Monoclonal 
Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-JP-
04], South Korean Patent Application 10-2014-7037046 entitled ``High-
affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS 
Ref. E-136-2012/0-KR-05], Singapore Patent Application 11201407972R 
entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use 
Thereof'' [HHS Ref. E-136-2012/0-SG-06], and United States Patent 
9,409,994 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 
And Use Thereof'' [HHS Ref. E-136-2012/0-US-07], and all continuing 
U.S. and foreign patents/patent applications for the technology family, 
to AbPro. The patent rights in these inventions have been assigned to 
and/or exclusively licensed to the Government of the United States of 
America.
    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 Patent License territory may be worldwide 
for the following field of use:

    The use of the YP7, YP8 and YP9.1 anti-GPC3 monoclonal 
antibodies as monospecific or bispecific antibodies for the 
treatment of liver cancer. The licensed field of use excludes any 
non-specified immunoconjugates, including, but not limited to, 
chimeric antigen receptors (CARs) and variants thereof, 
Immunotoxins, and antibody-drug conjugates (ADCs).

    The present inventions to be licensed concern monoclonal antibodies 
that are specific for the cell surface domain of GPC3: YP6, YP7, YP8, 
YP9 and YP9.1. These antibodies can potentially be used for the 
treatment of GPC3-expressing cancers such as HCC. By binding to and 
blocking GPC3 function, these antibodies can inhibit the growth of HCC 
cells, thereby decreasing the ability of tumors to grow and 
metastasize. Alternatively, the antibodies can be used to induce 
antibody-dependent anti-tumor activity by selectively killing cells 
which overexpress GPC3 while leaving healthy, normal cells unscathed. 
Finally, a secondary antibody capable of recruiting T cells to the 
tumor can be attached to the antibodies, thereby allowing for the 
localization of T cells or NK cells only to those cells which express 
GPC3, similarly leading to the selective killing of the cancer cells.
    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 National Cancer Institute 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.

[[Page 23014]]

    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: May 11, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-10154 Filed 5-18-17; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices 23013

Dated: May 11, 2017. DEPARTMENT OF HEALTH AND ‘‘High-affinity Monoclonal Antibodies
Richard U. Rodriguez, HUMAN SERVICES To Glypican-3 And Use Thereof’’ [HHS
Associate Director, Technology Transfer Ref. E–136–2012/0–SG–06], and United
Center, National Cancer Institute. National Institutes of Health States Patent 9,409,994 entitled ‘‘High-
[FR Doc. 2017–10153 Filed 5–18–17; 8:45 am] affinity Monoclonal Antibodies To
Prospective Grant of Exclusive Patent Glypican-3 And Use Thereof’’ [HHS Ref.
BILLING CODE 4140–01–P License: The Development of E–136–2012/0–US–07], and all
Monospecific and Bispecific continuing U.S. and foreign patents/
Antibodies to GPC3 for the Treatment patent applications for the technology
DEPARTMENT OF HEALTH AND of Human Liver Cancers
HUMAN SERVICES family, to AbPro. The patent rights in
AGENCY: National Institutes of Health, these inventions have been assigned to
National Institutes of Health HHS. and/or exclusively licensed to the
ACTION: Notice. Government of the United States of
National Institute on Alcohol Abuse America.
and Alcoholism; Notice of Closed SUMMARY: The National Cancer Institute, With respect to persons who have an
Meeting National Institutes of Health, obligation to assign their right, title and
Department of Health and Human interest to the Government of the United
Pursuant to section 10(d) of the Services, is contemplating the grant of States of America, the patent rights in
Federal Advisory Committee Act, as an Exclusive Patent License to AbPro, these inventions have been assigned to
amended (5 U.S.C. App.), notice is located in Woburn, Massachusetts, to the Government of the United States of
hereby given of the following meeting. practice the inventions embodied in the America.
patent applications listed in the The prospective Exclusive Patent
The meeting will be closed to the License territory may be worldwide for
public in accordance with the SUPPLEMENTARY INFORMATION section of
this notice. the following field of use:
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., DATES: Only written comments and/or The use of the YP7, YP8 and YP9.1 anti-
as amended. The grant applications and applications for a license which are GPC3 monoclonal antibodies as monospecific
received by the NCI Technology or bispecific antibodies for the treatment of
the discussions could disclose liver cancer. The licensed field of use
confidential trade secrets or commercial Transfer Center on or before June 5,
excludes any non-specified
property such as patentable material, 2017 will be considered. immunoconjugates, including, but not
and personal information concerning ADDRESSES: Requests for copies of the limited to, chimeric antigen receptors (CARs)
individuals associated with the grant patent applications, inquiries, and and variants thereof, Immunotoxins, and
applications, the disclosure of which comments relating to the contemplated antibody-drug conjugates (ADCs).
would constitute a clearly unwarranted Exclusive Patent License should be The present inventions to be licensed
invasion of personal privacy. directed to: David A. Lambertson, Ph.D., concern monoclonal antibodies that are
Senior Licensing and Patenting specific for the cell surface domain of
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Manager, NCI Technology Transfer GPC3: YP6, YP7, YP8, YP9 and YP9.1.
Emphasis Panel; NIAAA Fellowship Review. Center, 9609 Medical Center Drive, RM These antibodies can potentially be
Date: July 21, 2017. 1E530 MSC 9702, Bethesda, MD 20892– used for the treatment of GPC3-
Time: 8:00 a.m. to 5:00 p.m. 9702 (for business mail), Rockville, MD expressing cancers such as HCC. By
Agenda: To review and evaluate grant 20850–9702, Telephone: (240)–276– binding to and blocking GPC3 function,
applications. 6467; Email: david.lambertson@nih.gov. these antibodies can inhibit the growth
Place: National Institutes of Health, SUPPLEMENTARY INFORMATION: The of HCC cells, thereby decreasing the
National Institute on Alcohol Abuse and following represents the intellectual ability of tumors to grow and
Alcoholism, Terrace Level Conference Room, property to be licensed under the metastasize. Alternatively, the
5635 Fishers Lane, Bethesda, M.D 20892 prospective agreement: U.S. Provisional antibodies can be used to induce
Contact Person: Richard A. Rippe, Ph.D., Patent Application 61/654,232 entitled antibody-dependent anti-tumor activity
Scientific Review Officer , Extramural Project ‘‘High-affinity Monoclonal Antibodies by selectively killing cells which
Review Branch, Office of Extramural To Glypican-3 And Use Thereof’’ [HHS overexpress GPC3 while leaving
Activities, National Institute on Alcohol Ref. E–136–2012/0–US–01], PCT Patent healthy, normal cells unscathed.
Abuse and Alcoholism, 5635 Fishers Lane,
Application PCT/US2013/043633 Finally, a secondary antibody capable of
Room 2109, Rockville, MD 20852, 301–443–
entitled ‘‘High-affinity Monoclonal recruiting T cells to the tumor can be
8599, rippera@mail.nih.gov.
Antibodies To Glypican-3 And Use attached to the antibodies, thereby
(Catalogue of Federal Domestic Assistance Thereof’’ [HHS Ref. E–136–2012/0– allowing for the localization of T cells
Program Nos. 93.271, Alcohol Research
PCT–02], Chinese Patent Application or NK cells only to those cells which
Career Development Awards for Scientists
201380039993.7 entitled ‘‘High-affinity express GPC3, similarly leading to the
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Monoclonal Antibodies To Glypican-3 selective killing of the cancer cells.
Training; 93.273, Alcohol Research Programs; And Use Thereof’’ [HHS Ref. E–136– This notice is made in accordance
93.891, Alcohol Research Center Grants; 2012/0–CN–03], Japanese Patent with 35 U.S.C. 209 and 37 CFR part 404.
93.701, ARRA Related Biomedical Research Application 2015–515243 entitled The prospective Exclusive Patent
‘‘High-affinity Monoclonal Antibodies License will be royalty bearing and may
asabaliauskas on DSK3SPTVN1PROD with NOTICES

and Research Support Awards., National
Institutes of Health, HHS) To Glypican-3 And Use Thereof’’ [HHS be granted unless within fifteen (15)
Ref. E–136–2012/0–JP–04], South days from the date of this published
Dated: May 15, 2017.
Korean Patent Application 10–2014– notice, the National Cancer Institute
Melanie J. Pantoja, 7037046 entitled ‘‘High-affinity receives written evidence and argument
Program Analyst, Office of Federal Advisory Monoclonal Antibodies To Glypican-3 that establishes that the grant of the
Committee Policy. And Use Thereof’’ [HHS Ref. E–136– license would not be consistent with the
[FR Doc. 2017–10113 Filed 5–18–17; 8:45 am] 2012/0–KR–05], Singapore Patent requirements of 35 U.S.C. 209 and 37
BILLING CODE 4140–01–P Application 11201407972R entitled CFR part 404.

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23014 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices

Complete applications for a license in Intellectual Property be consistent with the requirements of
the prospective field of use that are United States Provisional Patent 35 U.S.C. 209 and 37 CFR part 404.
timely filed in response to this notice Application No. 62/173,777, filed June Complete applications for a license in
will be treated as objections to the grant 10, 2015 and entitled ‘‘Processes for the prospective field of use that are filed
of the contemplated Exclusive Patent Production and Purification of Nucleic in response to this notice will be treated
License. Comments and objections Acid Containing Compositions’’ [HHS as objections to the grant of the
submitted to this notice will not be Reference No. E–267–2014/0–US–01]; contemplated Exclusive
made available for public inspection PCT Patent Application PCT/US2016/ Commercialization Patent License
and, to the extent permitted by law, will 036888, filed E–267–2014/0–PCT–02 Agreement. Comments and objections
not be released under the Freedom of and entitled ‘‘Processes for Production submitted to this notice will not be
Information Act, 5 U.S.C. 552. and Purification of Nucleic Acid made available for public inspection
Dated: May 11, 2017. Containing Compositions’’ [HHS and, to the extent permitted by law, will
Richard U. Rodriguez, Reference No. E–267–2014/0–PCT–02]; not be released under the Freedom of
United States Provisional Patent Information Act, 5 U.S.C. 552.
Associate Director, Technology Transfer
Center, National Cancer Institute. Application No. 62/199,663, filed July Dated: May 12, 2017.
[FR Doc. 2017–10154 Filed 5–18–17; 8:45 am] 31, 2015 and entitled ‘‘Methods of Richard U. Rodriguez,
BILLING CODE 4140–01–P Analyzing Virus-Derived Therapeutics’’ Associate Director, Technology Transfer
[HHS Reference No. E–240–2015/0–US– Center, National Cancer Institute.
01]; [FR Doc. 2017–10155 Filed 5–18–17; 8:45 am]
DEPARTMENT OF HEALTH AND PCT Patent Application PCT/US2016/ BILLING CODE 4140–01–P
HUMAN SERVICES 044788, filed July 29, 2016 and entitled
‘‘Methods of Analyzing Virus-Derived
National Institutes of Health Therapeutics’’ [HHS Reference No. E– DEPARTMENT OF HEALTH AND
240–2015/1–PCT–01]; and U.S. and HUMAN SERVICES
Prospective Grant of an Exclusive foreign patent applications claiming
Patent License: Manufacturing and priority to the aforementioned National Institutes of Health
Testing of PVSRIPO in the Treatment applications.
of Solid, Non-lymphoid Tumors The patent rights in these inventions Government-Owned Inventions;
Expressing Poliovirus Receptor CD155 have been assigned and/or exclusively Availability for Licensing
licensed to the government of the AGENCY: National Institutes of Health,
AGENCY: National Institutes of Health,
United States of America. HHS.
HHS.
The prospective exclusive license
ACTION: Notice. ACTION: Notice.
territory may be worldwide and the
field of use may be limited to the use SUMMARY: The invention listed below is
SUMMARY: The National Cancer Institute, of Licensed Patent Rights for the owned by an agency of the U.S.
an institute of the National Institutes of following: ‘‘Manufacturing and Testing Government and is available for
Health, Department of Health and of PVSRIPO in the Treatment of Solid, licensing to achieve expeditious
Human Services, is contemplating the Non-lymphoid Tumors expressing commercialization of results of
grant of an Exclusive Commercialization Poliovirus Receptor CD155, wherein federally-funded research and
Patent License to practice the inventions PVSRIPO is genetically recombinant, development. Foreign patent
embodied in the Patents and Patent non-pathogenic poliovirus:rhinovirus applications are filed on selected
Applications listed in the chimera that consists of the genome of inventions to extend market coverage
Supplementary Information section of the live attenuated poliovirus serotype 1 for companies and may also be available
this notice to Istari Oncology (SABIN) vaccine (PV1S) with its cognate for licensing.
Incorporated located in North Carolina, IRES element replaced with that of
U.S.A. FOR FURTHER INFORMATION CONTACT: Dr.
HRV2.’’ Dianca Finch, 240–669–5503;
DATES: Only written comments and/or The E–267–2014 technology discloses dianca.finch@nih.gov. Licensing
applications for a license which are improved methods for large scale information and copies of the patent
received by the National Cancer production of highly purified, applications listed below may be
Institute’s Technology Transfer Center therapeutic grade, oncolytic obtained by communicating with the
on or before June 5, 2017 will be polioviruses. Invention processes indicated licensing contact at the
considered. provide industrial scale, and cGMP Technology Transfer and Intellectual
compliant manufacturing of PVSRIPO. Property Office, National Institute of
ADDRESSES: Requests for copies of the The E–240–2015 technology discloses
patent application, inquiries, and Allergy and Infectious Diseases, 5601
improved methods for detecting genetic Fishers Lane, Rockville, MD, 20852; tel.
comments relating to the contemplated micro-heterogeneity in manufactured
Exclusive Commercialization Patent 301–496–2644. A signed Confidential
batches of RNA virus-derived Disclosure Agreement will be required
License should be directed to: Lauren therapeutics, such as PVSRIPO.
Nguyen-Antczak, Ph.D., J.D., Senior to receive copies of unpublished patent
This notice is made in accordance applications.
Licensing and Patenting Manager, NCI with 35 U.S.C. 209 and 37 CFR part 404.
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Technology Transfer Center, 9609 SUPPLEMENTARY INFORMATION:
The prospective exclusive license will
Medical Center Drive, RM 1E530 MSC be royalty bearing, and the prospective Technology description follows.
9702, Bethesda, MD 20892–9702 (for exclusive license may be granted unless Products for Treatment and Prevention
business mail), Rockville, MD 20850– within fifteen (15) days from the date of of Ebola Zaire Disease
9702, Telephone: (240) 276–5530; this published notice, the National
Facsimile: (240) 276–5504, Email: Cancer Institute receives written Description of Technology
lauren.nguyen-antczak@nih.gov. evidence and argument that establishes Scientists at the NIAID Vaccine
SUPPLEMENTARY INFORMATION: that the grant of the license would not Research Center have developed human

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Document Created: 2018-11-08 08:47:55
Document Modified: 2018-11-08 08:47:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before June 5, 2017 will be considered.
FR Citation		82 FR 23013

82 FR 23013 - Prospective Grant of Exclusive Patent License: The Development of Monospecific and Bispecific Antibodies to GPC3 for the Treatment of Human Liver Cancers

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 96 (May 19, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health