[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Page 61659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26016]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Agonist/
Antagonist Compositions and Methods of Use

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 Bull Run 
Capital, Inc. located in Vancouver, BC, Canada.

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 17, 2018 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: Jaime M. Greene, 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

    U.S. Provisional Patent Application No. 61/340,063, filed March 12, 
2018, now abandoned, titled ``Agonist/Antagonist Compositions and 
Methods of Use'', HHS Ref. No.: E-048-2010-0-US-01;
    PCT Patent Application Serial No. PCT/US2011/028132, filed March 
11, 2011, now abandoned, HHS Reference Number E-048-2010-0-PCT-02 
titled ``Agonist/antagonist compositions and methods of use'';
    U.S. Patent 9,277,748 (Application No. 13/634,447) filed March 11, 
2011, issued March 8, 2016, titled ``Agonist/antagonist compositions 
and methods of use'', HHS Ref. No.: E-048-2010-0-US-04;
    Canada Patent Application Serial No. 2,792,878, filed March 11, 
2011, HHS Reference Number E-048-2010-0-CA-03 titled ``Agonist/
antagonist compositions and methods of use''; and
    U.S. Patent Application Serial No 15/010,830, filed January 29, 
2016, HHS Reference Number E-048-2010-0-US-05, titled ``Agonist/
antagonist compositions and methods of use''.
    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: ``Use of the TRVP1 antagonists 
BCTC, AMG9810, JYL-827, Capsazepine or IodoRTX combined with a TRVP1 
agonist in a composition for the temporary incapacitation of a 
subject.''
    This technology discloses novel compositions comprising a transient 
receptor potential cation channel subfamily V member 1 (TRPV1) receptor 
agonist and an antagonist in certain ratios which allow for the onset 
of agonist action followed by alleviation by antagonist action, and 
methods of use in personal defense and law enforcement.
    Non-lethal means of temporarily incapacitating a person are needed 
for law enforcement and for personal protection. A common approach 
currently is to use pepper spray. Although current pepper sprays are 
effective, and relatively safe, for most individuals, they can be life 
threatening for people who suffer from asthma and have hypersensitive 
airways.
    In order to reduce the length of time the pepper spray can cause 
the adverse effects that could result from extended exposure, inventors 
at NCI have created a composition comprising both an incapacitating 
pepper spray TRPV1 receptor agonist compound and a slower-acting TRPV1 
receptor antagonist compound that reverses the effects of the agonist. 
The agonist/antagonist composition is intended to be used as an aerosol 
or spray, that, when administered, causes a painful stimulation and 
incapacitates a person for only a short period of time. This technology 
may fill a public health need by improving safety over currently 
available pepper sprays.
    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 9, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2018-26016 Filed 11-29-18; 8:45 am]
 BILLING CODE 4140-01-P