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.

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: pontzern@mail.nih.gov.

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.