[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Page 36567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14681]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: High ASS1 
Expressing Tumors Embody a Purine Rich Genomic Signature and 
Sensitivity to Purine Depletion

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute (NCI), an institute of the 
National Institutes of Health, Department of Health and Human Services, 
is contemplating the grant of an exclusive, sublicensable patent 
license to Yeda Research & Development Co, Ltd (``YEDA''), the 
technology transfer company of the Weizmann Institute of Science, a 
non-profit research institution located in Rehovot, Israel for NCI's 
rights to the patent applications listed in the Supplementary 
Information section of this 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 July 27, 2021 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive patent license 
should be directed to: Kevin W. Chang, Ph.D., Senior Licensing and 
Patenting Manager at Telephone: (240)-276-6910 or at Email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    The following and all continuing U.S. and foreign patents/patent 
applications thereof are the intellectual properties to be licensed 
under the prospective agreement to YEDA: PCT Patent Application PCT/
IL2020/050708, filed June 24, 2020 and entitled ``High ASS1 Expressing 
Tumors Embody A Purine Rich Genomic Signature And Sensitivity To Purine 
Depletion'' [HHS Reference No. E-210-2020-0-PCT-01].
    The patent rights in these inventions have been assigned to the 
Government of the United States of America and YEDA. The prospective 
license will be for the purpose of consolidating the patent rights to 
YEDA, one of the co-owners of said rights, for commercial development 
and marketing. Consolidation of these co-owned rights is intended to 
expedite development of the invention, consistent with the goals of the 
Bayh-Dole Act codified as 35 U.S.C. 200-212.
    The prospective patent license will be worldwide, exclusive, and 
may be limited to those fields of use commensurate in scope with the 
patent rights. It will be sublicensable, and any sublicenses granted by 
YEDA will be subject to the provisions of 37 CFR parts 401 and 404.
    This technology discloses methods of treating a high 
argininosuccinate synthase (ASS1) expressing solid tumor with a 
combination of a purine synthase inhibitor or an agent that increases 
the pyrimidine to purine ratio in a cell, and an immune-modulating 
drug, such as a checkpoint inhibitor.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will include terms for the 
sharing of royalty income with NCI from commercial sublicenses of the 
patent rights. 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 that are timely filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive patent license. 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: July 6, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-14681 Filed 7-9-21; 8:45 am]
BILLING CODE 4140-01-P