[Federal Register Volume 64, Number 14 (Friday, January 22, 1999)]
[Notices]
[Pages 3532-3533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1423]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Co-Exclusive License: erbB-2/HER2/neu Gene 
Segments, Probes, Recombinant DNA and Kits for Detection

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 (NIH), 
Department of Health and Human Services, is contemplating the grant of 
a co-exclusive license worldwide to practice the invention embodied in: 
U.S. Patent Application Serial Number 08/475,035, entitled ``erbB-2 
Gene Segments, Probes, Recombinant DNA and Kits for Detection'' filed 
June 7, 1995, and U.S. Patent Application Serial Number 07/110,791, 
entitled ``Human Gene Related To But Distinct From EGF Receptor'', 
filed October 21, 1987 to Ventana Medical Systems, Inc., Having a place 
of business in Tucson, AZ. This announcement supersedes the prior 
Notice of Intent to Grant published on October 19, 1998. The patent 
rights in this invention have been assigned to the United States 
America.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before March 
23, 1999 will be considered.

ADDRESSES: Requests for a copy of the patent applications, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Susan S. Rucker, J.D., Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; Telephone: (301) 496-7056, ext. 
245; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: In an effort to identify genes which are 
associated with cancer, the invention described in these patent 
applications includes a gene, related to the epidermal growth factor, 
now known as erbB-2/HER2/neu. Research related to this gene has 
indicated that the gene is implicated in breast and other cancers. 
While the amplification of this gene has been demonstrated to have 
prognostic value with respect to breast cancer additional development 
is needed to determine whether or not the gene has value as a 
prognostic indicator for other types of cancer or may serve as an 
indicator which can be sued to select the proper course of treatment 
for breast and other cancers.
    The prospective co-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, 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.
    The field of use may be limited to the development of nucleotide-
based diagnostic and prognostic uses, regulated by the Food and Drug 
Administration, of the invention for cancers other than breast cancer 
including, but not necessarily limited to, prostate, ovarian, and 
bladder cancers.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. 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

[[Page 3533]]

under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: January 13, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 99-1423 Filed 1-21-99; 8:45 am]
BILLING CODE 4140-01-M