82 FR 56621 - Prospective Grant of an Exclusive Patent License: Concatenated L2 Peptide Based Human Papillomavirus Vaccines

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 228 (November 29, 2017)

Page Range		56621-56622
FR Document		2017-25744

The National Cancer Institute, 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 Patents and Patent Applications listed in the Supplementary Information section of this notice to BravoVax Co., Ltd located in Wuhan, China.

Federal Register, Volume 82 Issue 228 (Wednesday, November 29, 2017)

[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56621-56622]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25744]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Concatenated L2 
Peptide Based Human Papillomavirus Vaccines

AGENCY: National Institutes of Health.

ACTION: Notice.

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

SUMMARY: The National Cancer Institute, 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 Patents and Patent Applications listed in 
the Supplementary Information section of this notice to BravoVax Co., 
Ltd located in Wuhan, China.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before December 14, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Kevin W. Chang, Ph.D., Senior Technology Transfer 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)-276-6910; Facsimile: (240)-276-5504 Email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    United States Provisional Patent Application No. 60/649,249 filed 
February 1, 2005 and entitled, ``Papillomavirus L2 N-terminal Peptides 
For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS 
Reference No. E-103-2005/0-US-01]; United States Provisional Patent 
Application No. 60/697,655 filed July 7, 2005 and entitled, 
``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly 
Cross-neutralizing Antibodies'' [HHS Reference No. E-103-2005/1-US-01]; 
United States Provisional Patent Application No. 60/752,268 filed 
December 21, 2005 and entitled, ``Papillomavirus L2 N-terminal Peptides 
For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS 
Reference No. E-103-2005/2-US-01]; International PCT Application No. 
PCT/US2006/003601 filed February 1, 2006, and entitled, 
``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly 
Cross-neutralizing Antibodies'' [HHS Reference No. E-103-2005/3-PCT-
01]; United States Patent No. 8,404,244, issued March 26, 2013 and 
entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of 
Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-US-
02]; United States Patent No. 9,388,221 issued July 12, 2016 and 
entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of 
Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-US-
10]; Canadian Patent No. 2,596,698 issued May 16, 2017 and entitled, 
``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly 
Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-CA-03]; 
Australian Patent No. 2006210792 issued November 8, 2012 and entitled, 
``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly 
Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-AU-04]; 
Japanese Patent No. 5224821 issued March 22, 2013 and entitled, 
``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly 
Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-JP-05]; 
Brazilian Patent Application No. PI0607097-3 filed February 1, 2006 and 
entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of 
Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-BR-
06]; Chinese Patent No. 200680011079.1 issued March 27, 2013 and 
entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of 
Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-CN-
07]; Indian Patent No. 263255 issued October 16, 2014 and entitled, 
``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly 
Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-IN-08]; 
European Patent No. 1853307 issued December 14, 2016 and entitled, 
``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly 
Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-EP-09]; 
German Patent No. 1853307 issued December 14, 2016 and entitled, 
``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly 
Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-DE-11]; 
French Patent No. 1853307 issued December 14, 2016 and entitled, 
``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly 
Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-FR-12]; and 
United Kingdom Patent No. 1853307 issued December 14, 2016 and 
entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of 
Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-GB-
13]. The patent 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 field of use may be limited to the use of Licensed Patent Rights 
for the following: ``Development and use of

[[Page 56622]]

concatenated L2 peptides for the prevention of Human Papillomavirus 
(HPV) infection and associated diseases. Specifically excluded from the 
field of use are L2 based virus-like particles (VLPs), L1/L2 chimeric 
peptides, and L1/L2 chimeric peptide/protein based VLPs.''
    The subject technologies are papillomavirus L2 capsid protein based 
vaccines against HPV. The L2 protein is the minor papillomavirus capsid 
protein for papillomaviruses. It is known that antibodies to this 
protein can neutralize homologous infection. Furthermore, L2 proteins 
can induce cross-neutralizing antibodies. Specifically, epitopes at the 
N-terminus of L2 shared by cutaneous and mucosal types of 
papillomavirus types and by types that infect divergent species are 
broadly cross-neutralizing. These epitopes at the N-terminus of L2 can 
be used to elicit cross-neutralizing antibodies against different types 
of HPV.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 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 
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.
    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 in 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: November 14, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-25744 Filed 11-28-17; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices 56621

REPORTING REQUIREMENTS—Continued
Responses
Regulatory/section Number of Total annual Hours per Total burden
per
requirements respondents responses response hours
respondent

57.311(a), Disability Cancellation ................................. 16 1 16 1 16
57.315(a)(1)(ii), Administrative Hearings ...................... 0 0 0 0 0
57.316(a), Administrative Hearings .............................. 0 0 0 0 0

NSL Subtotal ......................................................... ........................ ........................ ........................ ........................ 7,567

HRSA specifically requests comments 9702, Bethesda, MD 20892–9702 (for neutralizing Antibodies’’ [HHS Ref. No.
on (1) the necessity and utility of the business mail), Rockville, MD 20850– E–103–2005/3–AU–04]; Japanese Patent
proposed information collection for the 9702 Telephone: (240)–276–6910; No. 5224821 issued March 22, 2013 and
proper performance of the agency’s Facsimile: (240)–276–5504 Email: entitled, ‘‘Papillomavirus L2 N-terminal
functions, (2) the accuracy of the changke@mail.nih.gov. Peptides For The Induction Of Broadly
estimated burden, (3) ways to enhance SUPPLEMENTARY INFORMATION: Cross-neutralizing Antibodies’’ [HHS
the quality, utility, and clarity of the Ref. No. E–103–2005/3–JP–05];
information to be collected, and (4) the Intellectual Property Brazilian Patent Application No.
use of automated collection techniques United States Provisional Patent PI0607097–3 filed February 1, 2006 and
or other forms of information Application No. 60/649,249 filed entitled, ‘‘Papillomavirus L2 N-terminal
technology to minimize the information February 1, 2005 and entitled, Peptides For The Induction Of Broadly
collection burden. ‘‘Papillomavirus L2 N-terminal Peptides Cross-neutralizing Antibodies’’ [HHS
For The Induction Of Broadly Cross- Ref. No. E–103–2005/3–BR–06]; Chinese
Amy McNulty,
neutralizing Antibodies’’ [HHS Patent No. 200680011079.1 issued
Acting Director, Division of the Executive March 27, 2013 and entitled,
Reference No. E–103–2005/0–US–01];
Secretariat.
United States Provisional Patent ‘‘Papillomavirus L2 N-terminal Peptides
[FR Doc. 2017–25750 Filed 11–28–17; 8:45 am]
Application No. 60/697,655 filed July 7, For The Induction Of Broadly Cross-
BILLING CODE 4165–15–P neutralizing Antibodies’’ [HHS Ref. No.
2005 and entitled, ‘‘Papillomavirus L2
N-terminal Peptides For The Induction E–103–2005/3–CN–07]; Indian Patent
Of Broadly Cross-neutralizing No. 263255 issued October 16, 2014 and
DEPARTMENT OF HEALTH AND
Antibodies’’ [HHS Reference No. entitled, ‘‘Papillomavirus L2 N-terminal
HUMAN SERVICES
E–103–2005/1–US–01]; United States Peptides For The Induction Of Broadly
National Institutes of Health Provisional Patent Application No. 60/ Cross-neutralizing Antibodies’’ [HHS
752,268 filed December 21, 2005 and Ref. No. E–103–2005/3–IN–08];
Prospective Grant of an Exclusive entitled, ‘‘Papillomavirus L2 N-terminal European Patent No. 1853307 issued
Patent License: Concatenated L2 Peptides For The Induction Of Broadly December 14, 2016 and entitled,
Peptide Based Human Papillomavirus Cross-neutralizing Antibodies’’ [HHS ‘‘Papillomavirus L2 N-terminal Peptides
Vaccines Reference No. E–103–2005/2–US–01]; For The Induction Of Broadly Cross-
International PCT Application No. PCT/ neutralizing Antibodies’’ [HHS Ref. No.
AGENCY: National Institutes of Health. US2006/003601 filed February 1, 2006, E–103–2005/3–EP–09]; German Patent
ACTION: Notice. and entitled, ‘‘Papillomavirus L2 No. 1853307 issued December 14, 2016
N-terminal Peptides For The Induction and entitled, ‘‘Papillomavirus L2 N-
SUMMARY: The National Cancer Institute, Of Broadly Cross-neutralizing terminal Peptides For The Induction Of
an institute of the National Institutes of Antibodies’’ [HHS Reference No. E– Broadly Cross-neutralizing Antibodies’’
Health, Department of Health and 103–2005/3–PCT–01]; United States [HHS Ref. No. E–103–2005/3–DE–11];
Human Services, is contemplating the Patent No. 8,404,244, issued March 26, French Patent No. 1853307 issued
grant of an exclusive patent license to 2013 and entitled, ‘‘Papillomavirus L2 December 14, 2016 and entitled,
practice the inventions embodied in the N-terminal Peptides For The Induction ‘‘Papillomavirus L2 N-terminal Peptides
Patents and Patent Applications listed Of Broadly Cross-neutralizing For The Induction Of Broadly Cross-
in the Supplementary Information Antibodies’’ [HHS Ref. No. E–103–2005/ neutralizing Antibodies’’ [HHS Ref. No.
section of this notice to BravoVax Co., 3–US–02]; United States Patent No. E–103–2005/3–FR–12]; and United
Ltd located in Wuhan, China. 9,388,221 issued July 12, 2016 and Kingdom Patent No. 1853307 issued
DATES: Only written comments and/or entitled, ‘‘Papillomavirus L2 N-terminal December 14, 2016 and entitled,
applications for a license which are Peptides For The Induction Of Broadly ‘‘Papillomavirus L2 N-terminal Peptides
received by the National Cancer Cross-neutralizing Antibodies’’ [HHS For The Induction Of Broadly Cross-
Institute’s Technology Transfer Center Ref. No. E–103–2005/3–US–10]; neutralizing Antibodies’’ [HHS Ref. No.
on or before December 14, 2017 will be Canadian Patent No. 2,596,698 issued E–103–2005/3–GB–13]. The patent
considered. May 16, 2017 and entitled, rights in these inventions have been
pmangrum on DSK3GDR082PROD with NOTICES1

ADDRESSES: Requests for copies of the ‘‘Papillomavirus L2 N-terminal Peptides assigned and/or exclusively licensed to
patent application, inquiries, and For The Induction Of Broadly Cross- the government of the United States of
comments relating to the contemplated neutralizing Antibodies’’ [HHS Ref. No. America.
exclusive license should be directed to: E–103–2005/3–CA–03]; Australian The prospective exclusive license
Kevin W. Chang, Ph.D., Senior Patent No. 2006210792 issued territory may be worldwide and the
Technology Transfer Manager, NCI November 8, 2012 and entitled, field of use may be limited to the use
Technology Transfer Center, 9609 ‘‘Papillomavirus L2 N-terminal Peptides of Licensed Patent Rights for the
Medical Center Drive, RM 1E530 MSC For The Induction Of Broadly Cross- following: ‘‘Development and use of

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56622 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices

concatenated L2 peptides for the DEPARTMENT OF HEALTH AND Activities, National Cancer Institute, NIH,
prevention of Human Papillomavirus HUMAN SERVICES 9609 Medical Center Drive, Room 7W248,
Bethesda, MD 20892–9750, 240–276–5007,
(HPV) infection and associated diseases.
National Institutes of Health tandlea@mail.nih.gov.
Specifically excluded from the field of
Name of Committee: National Cancer
use are L2 based virus-like particles Institute Special Emphasis Panel;
National Cancer Institute; Notice of
(VLPs), L1/L2 chimeric peptides, and Quantitative Imaging.
Closed Meetings
L1/L2 chimeric peptide/protein based Date: February 14, 2018.
VLPs.’’ Pursuant to section 10(d) of the Time: 10:00 a.m. to 5:00 p.m.
Federal Advisory Committee Act, as Agenda: To review and evaluate grant
The subject technologies are applications.
papillomavirus L2 capsid protein based amended, notice is hereby given of the
Place: National Cancer Institute, Shady
vaccines against HPV. The L2 protein is following meetings. Grove, 9609 Medical Center Drive, Room
The meetings will be closed to the 4W030, Rockville, MD 20850 (Telephone
the minor papillomavirus capsid protein
public in accordance with the Conference Call).
for papillomaviruses. It is known that provisions set forth in sections Contact Person: Eduardo E. Chufan, Ph.D.,
antibodies to this protein can neutralize 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Scientific Review Officer, Research
homologous infection. Furthermore, L2 as amended. The grant applications and Technology and Contract Review Branch,
proteins can induce cross-neutralizing the discussions could disclose Division of Extramural Activities, National
antibodies. Specifically, epitopes at the confidential trade secrets or commercial Cancer Institute, NIH, 9609 Medical Center
N-terminus of L2 shared by cutaneous Drive, Room 7W254, Bethesda, MD 20892–
property such as patentable material, 9750, 240–276–7975, chufanee@mail.nih.gov.
and mucosal types of papillomavirus and personal information concerning
types and by types that infect divergent (Catalogue of Federal Domestic Assistance
individuals associated with the grant Program Nos. 93.392, Cancer Construction;
species are broadly cross-neutralizing. applications, the disclosure of which 93.393, Cancer Cause and Prevention
These epitopes at the N-terminus of L2 would constitute a clearly unwarranted Research; 93.394, Cancer Detection and
can be used to elicit cross-neutralizing invasion of personal privacy. Diagnosis Research; 93.395, Cancer
antibodies against different types of Treatment Research; 93.396, Cancer Biology
Name of Committee: National Cancer
HPV. Research; 93.397, Cancer Centers Support;
Institute Special Emphasis Panel; NCI SPORE
93.398, Cancer Research Manpower; 93.399,
This notice is made in accordance V Review.
Cancer Control, National Institutes of Health,
Date: February 5–6, 2018.
with 35 U.S.C. 209 and 37 CFR part 404. HHS)
Time: 4:00 p.m. to 5:00 p.m.
The prospective exclusive license will Agenda: To review and evaluate grant Dated: November 22, 2017.
be royalty bearing, and the prospective applications. Melanie J. Pantoja,
exclusive license may be granted unless Place: Gaithersburg Washingtonian Program Analyst, Office of Federal Advisory
within fifteen (15) days from the date of Marriott, 9751 Washingtonian Boulevard, Committee Policy.
this published notice, the National Gaithersburg, MD 20878.
[FR Doc. 2017–25732 Filed 11–28–17; 8:45 am]
Cancer Institute receives written Contact Person: Mukesh Kumar, Ph.D.,
Scientific Review Officer, Research Program BILLING CODE 4140–01–P
evidence and argument that establishes Review Branch, Division of Extramural
that the grant of the license would not Activities, National Cancer Institute, NIH,
be consistent with the requirements of 9609 Medical Center Drive, Room 7W618, DEPARTMENT OF HEALTH AND
35 U.S.C. 209 and 37 CFR part 404. Bethesda, MD 20892–9750, 240–276–6611, HUMAN SERVICES
mukesh.kumar3@nih.gov.
In response to this Notice, the public
Name of Committee: National Cancer National Institutes of Health
may file comments or objections.
Institute Special Emphasis Panel; Molecular
Comments and objections, other than and Cellular Analysis Technologies. Prospective Grant of Exclusive Patent
those in the form of a license Date: February 8, 2018. License: T-Cells Transduced with HLA
application, will not be treated Time: 10:00 a.m. to 4:00 p.m. A11 Restricted CT–RCC HERV–E
confidentially, and may be made Agenda: To review and evaluate grant Reactive T-Cell Receptors for the
publicly available. applications. Treatment of Renal Cell Carcinoma
Place: National Cancer Institute, Shady
License applications submitted in Grove, 9609 Medical Center Drive, Room AGENCY: National Institutes of Health.
response to this Notice will be 7W030, Rockville, MD 20850 (Telephone ACTION: Notice.
presumed to contain business Conference Call).
confidential information and any release Contact Person: Nadeem Khan, Ph.D., SUMMARY: The National Heart, Lung, and
of information in these license Scientific Review Officer, Research Blood Institute (‘‘NHLBI’’), an institute
applications will be made only as Technology and Contract Review Branch, of the National Institutes of Health; an
Division of Extramural Activities, National agency within the Department of Health
required and upon a request under the Cancer Institute, NIH, 9609 Medical Center
Freedom of Information Act, 5 U.S.C. and Human Services, is contemplating
Drive, Room 7W260, Bethesda, MD 20892–
552. 9750, 240–276–5856, nadeem.khan@nih.gov.
the grant of an Exclusive Patent License
to commercialize the invention(s)
Dated: November 14, 2017. Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI SPORE
embodied in the intellectual property
Richard U. Rodriguez, estate stated in the Summary
VI Review.
Associate Director, Technology Transfer Date: February 8–9, 2018. Information section of this notice to
pmangrum on DSK3GDR082PROD with NOTICES1

Center, National Cancer Institute. Time: 4:00 p.m. to 5:00 p.m. T-Cure Bioscience, Inc. located in
[FR Doc. 2017–25744 Filed 11–28–17; 8:45 am] Agenda: To review and evaluate grant Thousand Oaks, California and
BILLING CODE 4140–01–P
applications. incorporated under the laws of
Place: Gaithersburg Washingtonian Delaware.
Marriott, 9751 Washingtonian Boulevard,
Gaithersburg, MD 20878. DATES: Only written comments and/or
Contact Person: Anita T. Tandle, Ph.D., applications for a license which are
Scientific Review Officer, Research Program received by the NHLBI Office of
Review Branch, Division of Extramural Technology Transfer and Development

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Document Created: 2017-11-29 01:26:14
Document Modified: 2017-11-29 01:26:14

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 National Cancer Institute's Technology Transfer Center on or before December 14, 2017 will be considered.
FR Citation		82 FR 56621

82 FR 56621 - Prospective Grant of an Exclusive Patent License: Concatenated L2 Peptide Based Human Papillomavirus Vaccines

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 228 (November 29, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health