[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.

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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