[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Page 60510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25098]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Compositions and Method 
for Preventing Reactogenicity Associated with Administration of 
Immunogenic Live Rotavirus Compositions

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. 
Provisional Patent Application No. 60/178,689, filed January 28, 2000 
[HHS Ref. No. E-088-2000/0-US-01], now expired; PCT Patent Application 
No. PCT/US01/02686 [HHS Ref. No. E-088-2000/0-PCT-02] filed January 26, 
2001, which published as WO/2001/54718 on August 2, 2001, now expired; 
U.S. Patent No. 7,431,931 [HHS Ref. No. E-088-2000/0-US-06]; Australian 
Patent No. 784344 [HHS Ref. No. E-088-2000/0-AU-04]; German Patent No. 
60141681.308 [HHS Ref. No. E-088-2000/0-DE-08]; French Patent No. 
1251869 [HHS Ref. No. E-088-2000/0-FR-09]; United Kingdom Patent No. 
1251869 [HHS Ref. No. E-088-2000/0-GB-10]; and Canadian Patent 
Application No. 2398428 [HHS Ref. No. E-088-2000/0-CA-05], entitled 
``Compositions and Method for Preventing Reactogenicity Associated with 
Administration of Immunogenic Live Rotavirus Compositions,'' and all 
continuing applications to International Medica Foundation, having a 
place of business in Rochester, Minnesota. 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 ``rhesus-based rotavirus 
therapeutic and/or prophylactic vaccines.''

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
October 31, 2011 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: Kevin W. Chang, 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) 435-5018; Facsimile: (301) 402-0220; E-
mail: [email protected].

SUPPLEMENTARY INFORMATION: The present invention provides compositions 
for making a medicament and methods for the administration of vaccine 
compositions for protection against human rotaviral disease without 
significant reactogenicity. Human x rhesus reassortant rotavirus 
compositions were made which when administered during the first 7 to 
about 10 days of life, provided a composition which was non-reactogenic 
followed by booster immunizations at 16 to 18 weeks or 14 to 20 weeks, 
up to 1 year of age. The immune response induced by the initial 
neonatal administration of the live rotavirus vaccine composition 
protects the infant from the reactogenicity of the composition when 
administered as a second vaccine dose at or after 2 months of age. 
Administration of the immunogenic composition also is expected to 
ablate or significantly diminish the increase in the excess of 
intussusception observed 3 to 7 days following administration of the 
initial dose of rotavirus vaccine at about 2 to 4 months.
    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.
    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: September 22, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-25098 Filed 9-28-11; 8:45 am]
BILLING CODE 4140-01-P