[Federal Register Volume 85, Number 120 (Monday, June 22, 2020)]
[Notices]
[Page 37461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13315]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Ointment for 
the Topical Administration to Ischemic Treat and/or Neuropathic Ulcers 
in Humans

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 Patents and Patent Applications listed in 
the Supplementary Information section of this notice to Emmaus Medical 
Inc. located in 21250 Hawthorne Boulevard, Suite 800, Torrance, CA, 
90503.

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 7, 2020 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: Edward Fenn, Senior Licensing and Patenting 
Manager, NCI Technology Transfer Center, Telephone: 240-276-6833 or 
Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    I. United States Provisional Patent Application No. 62/077,622 
filed Nov. 10, 2014, ``Topical Sodium Nitrite Formulations'', [HHS 
Ref. No. E-149-2014-0-US-01];
    II. International Patent Application No. PCT/US2015/060015 filed 
Nov. 10, 2015, ``Topical Sodium Nitrite Formulations'', [HHS 
Reference No. E-149-2014-0-PCT-02];
    III. European National Stage Patent Application No. 15798623.3, 
filed Nov. 10, 2015, ``Topical Sodium Nitrite Formulations'', [HHS 
Ref. No. E-149-2014-0-EP-03];
    IV. U.S. National Stage Patent Application No. 15/525,557 filed 
May 9, 2017, ``Topical Sodium Nitrite Formulations'', [HHS Ref. No. 
E-149-2014-0-US-04];

    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 the United 
States only and the field of use may be limited to the following:
    ``Treatment of neuropathic and/or ischemic skin ulcers in humans''.
    This technology discloses a topical ointment formulation comprising 
about .5% to 3.0% by weight non-acidified sodium nitrite dispersed in 
white petrolatum, mineral oil and bisabolol for topical administration. 
Nitrite anions may act as a vasodilator in vivo by generating nitric 
oxide (NO) in tissues with lower oxygen tension and pH. Therapeutic 
application of sodium nitrite through this specific topical formulation 
may provide selective vasodilation to hypoxemic tissue that treat 
ulcers associated with chronic ischemic and neuropathic ulcer 
conditions associated with several diseases.
    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: June 12, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2020-13315 Filed 6-19-20; 8:45 am]
BILLING CODE 4140-01-P