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Notice

Prospective Grant of Exclusive License: Pharmaceutical Methods of Delivering Folic Acid in a Hormonal Replacement or Contraceptive Composition

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AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a worldwide, limited field of use, exclusive license to practice the inventions embodied in the patent and patent applications referred to below to Johnson & Johnson Pharmaceutical Research & Development, L.L.C., having a place of business in Raritan, New Jersey. The patent rights in these inventions relate to the administration of folic acid in a contraceptive or hormonal replacement composition and have been assigned to Ortho-McNeil Pharmaceutical, Inc. (Raritan, New Jersey) and the government of the United States of America. The patent and patent applications to be licensed are:

Title: Pharmaceutical Methods of Delivering Folic Acid in a Hormonal Replacement or Contraceptive Composition,

U.S. Patent Application Serial No. 09/292,027.

Filing Date: 04/16/1999.

Domestic Status: Patent No.: 6,190,693.

Issue Date: 02/20/2001.

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 60 days from the date of this published Notice, CDC receives written evidence and argument that the grant of this license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Folic acid is a vitamin. It plays a crucial role in DNA synthesis, and in hematopoiesis (although the details of this role remain undefined). Folic acid is involved, for example, in single carbon transfers (such as those required for purine and pyrimidine metabolism), and in the re-methylation of homocysteine to methionine. Numerous disorders can result from insufficient intake of folic acid. Enhanced effects of risk factors for cervical dysplasia (e.g. HPV infection) have been linked to decreased folic acid levels. Sub-optimal body stores of folic acid, as measured by red cell folic acid concentrations, may amplify oncogenic risk. Administering folic acid can reduce the onset of disorders such as cardiovascular disease and cervical dysplasia. This invention provides a pharmaceutical composition comprising (a) an oral contraceptive for preventing pregnancy in a subject, and (b) folic acid in an amount sufficient to treat or prevent a disorder which (c) afflicts subjects for whom the oral contraceptive is indicated at a higher-than-normal incidence, and (d) is treatable or preventable by folic acid administration.

ADDRESSES:

Requests for a copy of this patent, inquiries, comments, and other materials relating to the contemplated license should be directed to Andrew Watkins, Director, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, Mailstop K-79, Atlanta, GA 30341, telephone: (770) 488-8610; facsimile: (770) 488-8615. Applications for a license filed in response to this notice will be treated as objections to the grant of the contemplated license. Only written comments and/or applications for a license which are received by CDC within sixty days of this notice will be considered. Comments and objections submitted in response 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. A signed Confidential Disclosure Agreement will be required to receive a copy of any pending patent application.

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Dated: October 26, 2002.

James D. Seligman,

Associate Director for Program Services, Centers for Disease Control and Prevention (CDC).

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[FR Doc. 02-27788 Filed 10-31-02; 8:45 am]

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