[Federal Register Volume 74, Number 211 (Tuesday, November 3, 2009)]
[Notices]
[Pages 56857-56858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26309]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of a 
Companion Diagnostic Kit To Detect Asparagine Synthetase Expression 
Levels as a Method To Screen for the Drug Efficacy in Treatments for 
Pancreatic Cancer, Ovarian Cancer, and Multiple Myeloma

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)(1) and 37 
CFR 404.7(a)(1)(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 No. 12/281,589 and PCT Application No. PCT/US07/
05555 entitled ``Materials and Methods Directed to Asparagine 
Synthetase and Asparaginase Therapies'' (HHS Ref. No. E-132-2006/2), to 
the French-based ERYtech Pharma LLC which is located in Lyon, France 
(with an additional office in Philadelphia, Pennsylvania). The patent 
rights in this invention have been assigned to the United States of 
America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be for to the use of the Licensed Patent Rights 
limited to a FDA-approved companion diagnostic test predictive of L-
asparaginase therapeutic effect in the treatment of pancreatic cancer, 
ovarian cancer, and multiple myeloma as claimed in the Licensed Patent 
Rights.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
January 4, 2010 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: Samuel E. Bish, Ph.D., Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5282; Facsimile: (301) 402-0220; E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The technology describes methods and 
therapies involving asparagine synthetase (ASNS) and L-asparaginase

[[Page 56858]]

(L-asp). Included are methods to decrease cell proliferation, most 
notably in order to treat various cancers, by administrating to a 
subject a combination of an ASNS antagonist and a formulation of L-asp. 
The main ASNS antagonist utilized in these methods are small 
interfering RNAs (siRNAs) that reduce ASNS expression. Also included 
are methods of screening for the efficacy of L-asp in a subject by 
detecting the expression of the ASNS gene in a sample. The technology 
also describes a kit that probes to detect ASNS gene expression in a 
sample to identify the efficacy of L-asp treatment. ASNS serves as a 
key biomarker for acute lymphoblastic leukemia (ALL) and other 
malignancies because these cancer cells express little or no ASNS 
compared to normal cells. As a result, the cancerous cells must acquire 
asparagine from the bloodstream to survive and proliferate to form 
tumors. Over several decades, patients with ALL and other leukemias 
have been treated with L-asparaginase (L-asp) to break down asparagine 
in the body and starve leukemia cells of asparagine. L-asp treatment is 
usually more effective when ASNS expression in the patient is limited.
    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 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: October 26, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-26309 Filed 11-2-09; 8:45 am]
BILLING CODE 4140-01-P