[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Page 23014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10155]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Manufacturing 
and Testing of PVSRIPO in the Treatment of Solid, Non-lymphoid Tumors 
Expressing Poliovirus Receptor CD155

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 Commercialization Patent 
License to practice the inventions embodied in the Patents and Patent 
Applications listed in the Supplementary Information section of this 
notice to Istari Oncology Incorporated located in North Carolina, 
U.S.A.

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 June 5, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Commercialization 
Patent License should be directed to: Lauren Nguyen-Antczak, Ph.D., 
J.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) 276-5530; Facsimile: (240) 276-5504, Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    United States Provisional Patent Application No. 62/173,777, filed 
June 10, 2015 and entitled ``Processes for Production and Purification 
of Nucleic Acid Containing Compositions'' [HHS Reference No. E-267-
2014/0-US-01];
    PCT Patent Application PCT/US2016/036888, filed E-267-2014/0-PCT-02 
and entitled ``Processes for Production and Purification of Nucleic 
Acid Containing Compositions'' [HHS Reference No. E-267-2014/0-PCT-02];
    United States Provisional Patent Application No. 62/199,663, filed 
July 31, 2015 and entitled ``Methods of Analyzing Virus-Derived 
Therapeutics'' [HHS Reference No. E-240-2015/0-US-01];
    PCT Patent Application PCT/US2016/044788, filed July 29, 2016 and 
entitled ``Methods of Analyzing Virus-Derived Therapeutics'' [HHS 
Reference No. E-240-2015/1-PCT-01]; 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 worldwide and 
the field of use may be limited to the use of Licensed Patent Rights 
for the following: ``Manufacturing and Testing of PVSRIPO in the 
Treatment of Solid, Non-lymphoid Tumors expressing Poliovirus Receptor 
CD155, wherein PVSRIPO is genetically recombinant, non-pathogenic 
poliovirus:rhinovirus chimera that consists of the genome of the live 
attenuated poliovirus serotype 1 (SABIN) vaccine (PV1S) with its 
cognate IRES element replaced with that of HRV2.''
    The E-267-2014 technology discloses improved methods for large 
scale production of highly purified, therapeutic grade, oncolytic 
polioviruses. Invention processes provide industrial scale, and cGMP 
compliant manufacturing of PVSRIPO. The E-240-2015 technology discloses 
improved methods for detecting genetic micro-heterogeneity in 
manufactured batches of RNA virus-derived therapeutics, such as 
PVSRIPO.
    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.
    Complete applications for a license in the prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Commercialization Patent 
License Agreement. 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 12, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-10155 Filed 5-18-17; 8:45 am]
 BILLING CODE 4140-01-P