[Federal Register Volume 67, Number 212 (Friday, November 1, 2002)]
[Notices]
[Page 66642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27788]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


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

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

ACTION: Notice.

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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.

    Dated: October 26, 2002.
James D. Seligman,
Associate Director for Program Services, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 02-27788 Filed 10-31-02; 8:45 am]
BILLING CODE 4163-18-P