E9-4053. 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.

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 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: [phone]; Facsimile: [phone]; E-mail: [e-mail].

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.