[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Notices]
[Pages 28048-28049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13426]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Prospective Grant of Exclusive License: Prophylactic Use of 
Pneumococcal Surface Adhesin A Protein as a Vaccine

AGENCY: Office of Technology Transfer, 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(c)(1) 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 Connaught 
Laboratories, Inc. (CLI), having a place of business in Swiftwater, 
Pennsylvania. The patent rights in these inventions have been assigned 
to the government of the United States of America. The patent and 
patent applications to the licensed are:

Title: Pneumococcal Fimbrial Protein A
U.S. Patent Application Serial No.: 07/791,377
Filing Date: 09/17/91
Domestic Status: Patent No.: 5,422,427
Issue Date: 06/06/95

    Title: Pneumococcal Fimbrial Protein A and Vaccines
U.S. Patent Application Serial No.: 08/222,179
Filing Date: 09/17/96

Title: Pneumococcal Fimbrial Protein A
U.S. Patent Application Serial No.: 08/356,106
Filing Date: 12/15/94

Title: Streptococcus Pneumoniae 37 kDa Surface Adhesin A Protein
U.S. Patent Application Serial No.: 08/715,131
Filing Date: 09/17/96

    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.

[[Page 28049]]

    Pneumococcal infections cause invasive disease (commonly known as 
``pneumonia''), meningitis and otitis media (commonly known as a 
``middle ear infection''). Invasive disease may occur at any age, but 
is particularly dangerous in elderly patients. Meningitis is a 
dangerous result of pneumococcal infection and can occur in persons of 
all ages. Otitis media is common in children under age two. It is 
estimated that between 33 percent and 50 percent of all otitis media 
cases are caused by pneumococcal infections. Otitis media may resolve 
within three to four days without medical intervention, while more 
serious cases require a course of antibiotics. Approximately forty-
seven million cases of otitis media require some form of medical 
intervention annually in the seven major markets for pharmaceutical 
products (U.S., France, Germany, Italy, Spain, U.K. and Japan).
    CDC scientists have discovered a particular surface protein of 
pneumococcus designated pneumococcal surface adhesin A protein 
(``PsaA''). Their discoveries include the amino acid sequence and the 
polypeptide formed by said sequence. CLI is proposing that through 
incorporation of PsaA it will be able to produce a vaccine which is 
immunogenic in children without the requirement of a conjugated toxoid.

ADDRESSES: Requests for a copy of these patent applications, inquiries, 
comments, and other materials relating to the contemplated license 
should be directed to Marjorie Hunter, Technology Licensing Specialist, 
Office of Technology Transfer, Centers for Disease Control and 
Prevention (CDC), 1600 Clifton Road, NE., Mailstop E-67, Atlanta, GA 
30333, telephone: (404) 639-6271; facsimile: (404)639-6266. 
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: May 16, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 97-13426 Filed 5-21-97; 8:45 am]
BILLING CODE 4163-18-P