[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2555-2556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01430]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Virus-Like 
Particles Vaccines Against Human Polyomaviruses, BK Virus (BKV) and JC 
Virus (JCV)

AGENCY: National Institutes of Health, HHS.

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 U.S. and foreign Patents and Patent 
Applications listed in the Supplementary Information section of this 
notice to BioE Holdings Inc. (parent company, Biological E Ltd.) 
located in Los Altos, California.

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 February 22, 2019 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent 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)-276-5530; Facsimile: (240)-
276-5504, Email: [email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    United States Provisional Patent Application No. 61/508,897 filed 
July 18, 2011 and entitled, ``Methods and Compositions for Inhibiting 
Polyomavirus-Associated Pathology'' [HHS Reference No. E-168-2011-0-US-
01]; PCT Patent Application No. PCT/US2012/047069 filed July 17, 2012, 
and entitled, ``Methods and Compositions for Inhibiting Polyomavirus-
Associated Pathology'' [HHS Reference No. E-168-2011-0-PCT-02]; 
Australian Patent No. 2012284122 issued September 14, 2017, and 
entitled, ``Methods and Compositions for Inhibiting Polyomavirus-
Associated Pathology'' [HHS Reference No. E-168-2011-0-AU-03]; Canadian 
Patent Application No. 2842180 filed July 17, 2012 and entitled, 
``Methods and Compositions for Inhibiting Polyomavirus-Associated 
Pathology'' [HHS Ref. No. E-168-2011-0-CA-04]; European Patent 
Application No. 12741191.6 filed July 17, 2012 and entitled, ``Methods 
and Compositions for Inhibiting Polyomavirus-Associated Pathology'' 
[HHS Ref. No. E-168-2011-0-EP-05]; Japanese Patent No. 6030650 issued 
October 28, 2016 and entitled, ``Methods and Compositions for 
Inhibiting Polyomavirus-Associated Pathology'' [HHS Ref. No. E-168-
2011-0-JP-06]; United States Patent No. 9,764,022 issued September 19, 
2017 and entitled, ``Methods and Compositions for Inhibiting 
Polyomavirus-Associated Pathology'' [HHS Ref. No. E-168-2011-0-US-07]; 
United States Patent Application No. 15/694,567 filed September 1, 2017 
and entitled, ``Methods and Compositions for Inhibiting Polyomavirus-
Associated Pathology'' [HHS Ref. No. E-168-2011-0-US-08]; United States 
Provisional Patent Application No. 61/919,043 filed December 20, 2013 
and entitled,

[[Page 2556]]

``Immunogenic JC Polyomavirus Compositions and Methods of Use'' [HHS 
Reference No. E-549-2013-0-US-01]; PCT Patent Application No. PCT/
US2014/071621 filed December 19, 2014, and entitled, ``Immunogenic JC 
Polyomavirus Compositions and Methods of Use'' [HHS Reference No. E-
549-2013-0-PCT-02]; United States Patent No. 9,931,393 issued April 3, 
2018, and entitled, ``Immunogenic JC Polyomavirus Compositions and 
Methods of Use'' [HHS Reference No. E-549-2013-0-US-03]; and U.S. and 
foreign patent applications claiming priority to the aforementioned 
applications.
    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 world-wide, and 
the field of use may be limited to the use of Licensed Patent Rights 
for the following: ``Virus-Like Particle (VLP) BKV and JCV polyomavirus 
vaccine(s) for the prevention and/or treatment of BKV and/or JCV 
associated diseases in organ/kidney transplantation, bone marrow 
transplantation, and progressive multifocal leukoencephalopathy 
(PML).''
    This technology discloses vaccine compositions and methods for 
eliciting immune responses to prevent or treat infections by two human 
polyomaviruses, BK virus (BKV) and JC virus (JCV), and their associated 
diseases using the vaccine compositions, which employ the capsid 
protein of certain serotypes of BKV and JCV as the immunogen. In 
particular, the vaccine is composed of virus-like particles that are 
formed from the capsid proteins of the viruses.
    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: January 31, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-01430 Filed 2-6-19; 8:45 am]
 BILLING CODE 4140-01-P