[Federal Register Volume 74, Number 36 (Wednesday, February 25, 2009)]
[Notices]
[Pages 8558-8559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4053]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Diagnostic Tests for 
Predicting the Emergence of Suicidal Ideation Subsequent to Anti-
Depressant Treatment

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

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(l) and 37 CFR 
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 U.S. Patent 
Application 60/854,978 [HHS Ref. E-157-2006/0-US-01], PCT Patent 
Application PCT/US2007/082683 [HHS Ref. E-157-2006/1-PCT-01], U.S. 
Patent Application 11/925,334 [HHS Ref. E-157-2006/1-US-02], all 
entitled ``Methods to Identify Patients at Risk of Developing Adverse 
Events During Treatment With Antidepressant Medication'', and all 
continuing

[[Page 8559]]

applications and foreign counterparts, to NeuroMark, Inc., which has 
offices in Boulder, CO. 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, 
licensees will need to address the medical usefulness of multi-gene 
test formats should data be developed to support such approaches and 
the term of the agreement may be commensurate with commercial 
incentives and public health needs. The field of use may be limited to:

FDA approved diagnostic test kits for predicting the emergence of 
suicidal ideation subsequent to anti-depressant treatment and for 
screening patients to identify those patients more likely to exhibit 
an increased risk of treatment-emergent suicidal ideation by 
assaying for the presence of a genotype in the patients which is 
associated with an increased risk of treatment-emergent suicidal 
ideation.


DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
April 27, 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: 
<a href="/cdn-cgi/l/email-protection#26564948525c435448664b474f4a08484f4e08414950"><span class="__cf_email__" data-cfemail="02726d6c767867706c426f636b6e2c6c6b6a2c656d74">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Suicidal ideation is an uncommon symptom 
than can emerge during antidepressant treatment. The Food and Drug 
Administration (FDA) requires a black box warning of worsening 
depression and/or emergence of suicidality (i.e., development of 
suicidal thoughts or behavior) for both adult and pediatric patients 
taking antidepressant medications. While use of antidepressants fell 
after to the black box warning, studies suggest that pediatric suicides 
may actually be rising. This has led to concerns that the black box 
warning led to a decrease in treatment and resulted in an overall 
increase in suicides. The Sequenced Treatment Alternatives for 
Depression (STAR*D) trial at NIH found that versions of genes coding 
for components of the brain's chemical messenger system may be linked 
to suicidal thinking associated with antidepressant use. If links 
between genes and suicidal thinking are validated under a license, 
depressed individuals at higher risk for suicide could benefit from 
closer monitoring, alternative treatments, or specialty care while 
allowing more aggressive treatment in individuals without the increased 
risk.
    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 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 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.

    February 18, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E9-4053 Filed 2-24-09; 8:45 am]
BILLING CODE 4140-01-P


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