[Federal Register Volume 60, Number 209 (Monday, October 30, 1995)]
[Notices]
[Pages 55276-55277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26800]
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[[Page 55277]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Prospective Grant of Exclusive License: Biomedical Uses of CPX
(8-Cyclopentyl-1,3-Dipropylxanthine) and Related Compounds for Cystic
Fibrosis and Other Human Diseases
AGENCY: National Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
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SUMMARY: This is notice in accordance with 15 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 worldwide, limited field of use, exclusive license to practice the
inventions embodied in the patents and patent applications referred to
below to SciClone Pharmaceuticals, Inc. of San Mateo, California. The
patent rights in these inventions have been assigned to the government
of the United States of America. The patents and patent applications to
be licensed are: ``Method of Treating Cystic Fibrosis Using 8-
Cyclopentyl-1,3-Dipropylxanthine or Xanthine Amino Congeners,'' U.S.
Patent Application Serial No. 07/952,965 filed 29 Sep 92 (U.S. Patent
No. 5,366,977 issued 22 Nov 94); ``A Method of Identifying CFTR-Binding
Compounds Useful for Activating Chloride Conductance in Animal Cells,''
U.S. Patent Application Serial No. 08/343,714 filed 22 Nov 94; and all
continuations, divisionals, continuations-in-part, and foreign
counterparts of these two patent applications.
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 sixty
(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.
ADDRESSES: Requests for a copy of these patent applications, inquiries,
comments, and other materials relating to the contemplated license
should be directed to: J. Peter Kim, Technology Licensing Specialist,
Office of Technology Transfer, National Institutes of Health, 6011
Executive Boulevard, Suite 325, Rockville, Maryland 20852. Telephone:
301/496-7056, ext. 264; Facsimile: 301/402-0220. 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 NIH on or before
December 29, 1995, 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.
SUPPLEMENTARY INFORMATION: Cystic fibrosis is caused by mutations in
the cystic fibrosis transmembrane regulator (CFTR) gene. Chloride (Cl-)
and sodium transport across epithelial membranes of an individual
afflicted with cystic fibrosis is abnormal. CPX activates impaired Cl-
conductance channels and exhibits high potency, low toxicity, and
little or no specificity for adenosine receptors.
Many of the present efforts to combat the disease have focused on
drugs that are capable of either activating the mutant CFTR gene
product or otherwise causing additional secretion of Cl- from
affected cells. Antagonism of the A1 adenosine receptor has been
shown to result in stimulating Cl- efflux from cystic fibrosis
cells. Many of the drugs currently in use or under development function
by antagonizing the A1 adenosine receptor, but lack specificity
for the receptor. As a result, they can produce undesirable side
effects. Similarly, antagonism of A1 adenosine receptors will
likely have an additional impact on an animal that is unrelated to the
cystic fibrosis affliction. Since CPX has little or no specificity for
adenosine receptors, it should be effective while minimizing side
effects.
Dated: October 20, 1995.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 95-26800 Filed 10-27-95; 8:45 am]
BILLING CODE 4140-01-P
