2011-25098. 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.

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

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.