Prospective Grant of an Exclusive Patent License: Concatenated L2 Peptide Based Human Papillomavirus Vaccines, 56621-56622 [2017-25744]

Download as PDF 56621 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices REPORTING REQUIREMENTS—Continued Regulatory/section requirements Number of respondents Responses per respondent Total annual responses Hours per response Total burden hours 57.311(a), Disability Cancellation ................................. 57.315(a)(1)(ii), Administrative Hearings ...................... 57.316(a), Administrative Hearings .............................. 16 0 0 1 0 0 16 0 0 1 0 0 16 0 0 NSL Subtotal ......................................................... ........................ ........................ ........................ ........................ 7,567 HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Amy McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2017–25750 Filed 11–28–17; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Concatenated L2 Peptide Based Human Papillomavirus Vaccines National Institutes of Health. Notice. AGENCY: ACTION: 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 pmangrum on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850– 9702 Telephone: (240)–276–6910; Facsimile: (240)–276–5504 Email: changke@mail.nih.gov. 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 Crossneutralizing 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 Crossneutralizing 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- PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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 Crossneutralizing 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 Crossneutralizing Antibodies’’ [HHS Ref. No. E–103–2005/3–EP–09]; German Patent No. 1853307 issued December 14, 2016 and entitled, ‘‘Papillomavirus L2 Nterminal 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 Crossneutralizing 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 Crossneutralizing 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 E:\FR\FM\29NON1.SGM 29NON1 56622 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices pmangrum on DSK3GDR082PROD with NOTICES1 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 VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI SPORE V Review. Date: February 5–6, 2018. Time: 4:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Gaithersburg Washingtonian Marriott, 9751 Washingtonian Boulevard, Gaithersburg, MD 20878. Contact Person: Mukesh Kumar, Ph.D., Scientific Review Officer, Research Program Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W618, Bethesda, MD 20892–9750, 240–276–6611, mukesh.kumar3@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Molecular and Cellular Analysis Technologies. Date: February 8, 2018. Time: 10:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W030, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Nadeem Khan, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W260, Bethesda, MD 20892– 9750, 240–276–5856, nadeem.khan@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI SPORE VI Review. Date: February 8–9, 2018. Time: 4:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Gaithersburg Washingtonian Marriott, 9751 Washingtonian Boulevard, Gaithersburg, MD 20878. Contact Person: Anita T. Tandle, Ph.D., Scientific Review Officer, Research Program Review Branch, Division of Extramural PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W248, Bethesda, MD 20892–9750, 240–276–5007, tandlea@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Quantitative Imaging. Date: February 14, 2018. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 4W030, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Eduardo E. Chufan, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W254, Bethesda, MD 20892– 9750, 240–276–7975, chufanee@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: November 22, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–25732 Filed 11–28–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: T-Cells Transduced with HLA A11 Restricted CT–RCC HERV–E Reactive T-Cell Receptors for the Treatment of Renal Cell Carcinoma National Institutes of Health. Notice. AGENCY: ACTION: The National Heart, Lung, and Blood Institute (‘‘NHLBI’’), an institute of the National Institutes of Health; an agency within the Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to commercialize the invention(s) embodied in the intellectual property estate stated in the Summary Information section of this notice to T-Cure Bioscience, Inc. located in Thousand Oaks, California and incorporated under the laws of Delaware. DATES: Only written comments and/or applications for a license which are received by the NHLBI Office of Technology Transfer and Development SUMMARY: E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56621-56622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 
changke@mail.nih.gov.

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