[Federal Register Volume 77, Number 130 (Friday, July 6, 2012)]
[Notices]
[Pages 40076-40077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16499]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of the Citrus 
Flavanones Hesperetin, Hesperidin, and Naringenin in Nutrition for 
Endothelial Function, Vascular Health, Diabetes, and Insulin Resistance

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 part 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 BioActor B.V., a company having a place 
of business in Maastricht, Netherlands, to practice the inventions 
embodied in U.S. Provisional Patent Application No. 61/369,229, filed 
July 30, 2010 (HHS Ref. No. E-148-2010/0-US-01) and PCT Patent 
Application No. PCT/US2011/045898, filed July 29, 2011 (HHS Ref. No. E-
148-2010/0-PCT-02), both entitled ``Treatment of Metabolic Syndrome and 
Insulin Resistance with Citrus Flavanones.'' The patent rights in these 
inventions have been assigned to the United States of America. The 
prospective exclusive license territory may be ``worldwide'', and the 
field of use may be limited to ``hesperidin, naringenin, and any 
derivatives thereof for use in nutrition relating to endothelial 
function, vascular health, diabetes, and insulin resistance, wherein 
the Licensed Products are marketed under an approved Health Claim or 
GRAS designation from the FDA, under an approved Health Claim or Novel 
Food designation from the EFSA, or a foreign regulatory equivalent of 
the above.''

DATE:  Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
August 6, 2012 will be considered.

FOR FURTHER INFORMATION CONTACT: Requests for copies of the patent 
application(s), inquiries, and comments relating to the contemplated 
exclusive license should be directed to: Tara L. Kirby, Ph.D., Senior 
Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-4426; Facsimile: (301) 
402-0220; Email: [email protected].

SUPPLEMENTARY INFORMATION: Hesperidin is a flavonoid compound found in 
citrus fruits. Large epidemiological studies have linked increased 
consumption of flavonoid-rich foods, such as citrus, with reduced 
cardiovascular morbidity and mortality. Investigators from the National 
Center for Complementary and Alternative Medicine have demonstrated 
that administration of oral hesperidin to patients with metabolic 
syndrome attenuates biomarkers of inflammation and improves blood 
vessel relaxation, lipid cholesterol profiles, and insulin sensitivity 
when compared to controls. Thus, hesperidin and its active aglycone 
form, hesperetin, may be effective agents for the treatment of 
diabetes, obesity, metabolic syndrome, dyslipidemias, and their 
cardiovascular complications including hypertension, atherosclerosis, 
coronary heart disease, and stroke. This technology discloses methods 
for using a hesperetin or hesperidin composition to treat metabolic 
syndrome and insulin resistance. Also described is the use of the 
related citrus polyphenol, naringenin.
    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 thirty 
(30) 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.
    Only applications for a license in the field of use set forth in 
this notice and filed in response to this notice will be treated as 
objections to the grant of the

[[Page 40077]]

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 29, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-16499 Filed 7-5-12; 8:45 am]
BILLING CODE 4140-01-P