[Federal Register Volume 74, Number 125 (Wednesday, July 1, 2009)]
[Notices]
[Page 31457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15576]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Pain Control by Selective 
Ablation of Pain-Sensing Neurons by Administration of Resiniferatoxin

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(l) and 37 
CFR Part 404.7(a)(l)(i), that 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 PCT 
Patent Application PCT/US2001/09425 [HHS Ref. E-109-2000/0-PCT-01], US 
Patent Application 10/472,874 [HHS Ref. E-109-2000/0-US-02], both 
entitled ``Molecular Neurochirurgerie for Pain Control Administering 
Locally Capsaicin or Resiniferatoxin'', and Canadian Patent Application 
2442049 [HHS Ref. E-109-2000/0-CA-03] entitled ``Selective Ablation of 
Pain-Sensing Neurons by Administration of a Vanilloid Receptor 
Agonist'', and all continuing applications and foreign counterparts, to 
Sherrington Pharmaceuticals, which has offices in New York, N.Y. The 
patent rights in these inventions have been assigned to 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:

    All fields of use, both human and veterinary, covered under the 
above listed patents, for the life of these patents; the selective 
ablation of pain-sensing neurons using vanilloid receptor agonists 
including resiniferatoxin and capsaicin using localized delivery, 
including intrathecal and intraganglionic injection.


DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
August 31, 2009 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Norbert Pontzer, Senior Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5502; Facsimile: (301) 402-0220; E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pain pathways, including those mediating 
severe pain associated with chronic and terminal diseases, have unique 
receptors (termed vanilloid or more recently TRPV1) that mediate the 
transmission of nociceptive sensory signals from the periphery through 
the spinal cord to the brain. Compounds such as capsaicin from hot 
peppers activate pain neurons by opening cation channels linked to 
TRPV1 receptors on nerve terminals and cell bodies. NIH inventors 
discovered that resiniferatoxin (RTX) is an extremely potent TRPV1 
receptor agonist that produces a calcium overload and selectively 
degeneration of pain neurons when cell body TRPV1 receptors are 
activated by RTX. Intrathecal or intraganglionic administration of RTX 
can thus cause the permanent and selective destruction of the pain 
neurons in the CNS displaying TRPV1 receptors. This invention allows 
pain control in human and other animals with intractable pain through 
selective ablation of pain pathway neurons.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR Part 
404.7. The prospective exclusive license may be granted unless within 
sixty (60) days from the date of this published notice, the NIH 
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 404.7.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. 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: June 19, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-15576 Filed 6-30-09; 8:45 am]
BILLING CODE 4140-01-P