[Federal Register Volume 69, Number 225 (Tuesday, November 23, 2004)]
[Notices]
[Pages 68153-68154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25956]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Conformationally Locked 
Nucleoside Analogs

AGENCY: National Institutes of Health, Public Health Service, DHHS.

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 
an exclusive license to practice the following invention as embodied in 
the following patent applications: DHHS Ref. No. E-231-1993; U.S. 
Serial Number 08/126,796, filed on September 24, 1993; 08/311,425, 
filed on September 23, 1994, U.S. Patent No. 5,629,454; 08/818,563, 
filed on March 14, 1997, U.S. Patent No. 5,869,666; PCT (PCT/US94/
10794) filed on September 23, 1994, and National Stage filed in 
Singapore (9607728-4), Australia (78420/94), Canada (2172534), Europe 
(94929321.1), Japan (07-506691), Greece (3026166); DHHS Ref. No. E-100-
1996; U.S. Provisional 60/023,565, filed on August 7, 1996; U.S. Serial 
Number 08/908,724, filed on August 7, 1997, U.S. Patent No. 5,840,728; 
PCT (PCT/US96/12800) filed on August 15, 1996; DHHS Ref. No. E-249-
2000; U.S. Provisional 60/220,934, filed on July 26, 2000; U.S. Serial 
Number 10/346,762, filed on January 15, 2003; PCT (PCT/US01/23246) 
filed on July 24, 2001, and National Stage filed in Australia 
(2001278993), Canada (2417251), Europe (01951228.8) to N&N Scientific, 
having a place of business in Maryland but incorporated in Illinois. 
The patent rights in these inventions have been assigned to the United 
States of America.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before January 
24, 2005 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Robert M. Joynes, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Email: [email protected]; Telephone: (301) 
594-6565; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: The prospective exclusive license will be

[[Page 68154]]

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 compounds of the present invention represent the first examples 
of carbocyclic dideoxynucleosides that in solution exist locked in a 
defined N-geometry (C3'-endo) conformation typical of conventional 
nucleosides. These analogues exhibit increased stability due to the 
substitution of carbon for oxygen in the ribose ring. The invention 
includes 4'-6'-cyclopropane fused carbocyclic dideoxynucleosides, 2'-
deoxynucleosides and ribonucleosides as well as oligonucleotides 
derived from these analogues; the preferred embodiment of the invention 
is carbocyclic-4'-6'-cyclopropane-fused analogues of dideoxypurines, 
dideoxypyrimidines, deoxypurines, deoxypyrimidines, purine 
ribonucleosides and pyrimidine ribonucleosides. In addition, 
oligonucleotides derived from one or more of the nucleosides in 
combination with the naturally occurring nucleosides are within the 
scope of the present invention.
    The invention also includes a method for the treatment of herpes 
virus infections by the administration of cyclopropanated carbocyclic 
2'-deoxynucleosides to an affected individual. This invention is a 
method of administration of the compounds described above. The 
compounds of this invention are particularly efficacious against herpes 
simplex viruses 1 and 2 (HSV-1 and HSV-2), Epstein-Barr Virus (EBV) and 
human cytomegalovirus (CMV), although the nucleoside analogues of the 
invention may be used to treat any condition caused by a herpes virus. 
Specifically, the N-methanocarba-T (Thymidine) analogue (hereafter (N)-
MCT) has been shown to exhibit strong activity against HSV-1 and HSV-2, 
and moderate to strong activity against EBV. Significantly, the anti-
HSV activity of the Thymidine analogue is thirty times more potent than 
Acyclovir (shown in a plaque reduction assay), a widely used anti-HSV 
therapeutic. Furthermore, the Thymidine analogue is also non-toxic 
against stationary cells and is potent against rapidly dividing cells. 
Dosage amounts for the compounds are similar to those of Acyclovir.
    The field of use may be limited to development of antiviral 
therapeutics.
    The licensed territory will be exclusive worldwide.
    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 under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: November 15, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-25956 Filed 11-22-04; 8:45 am]
BILLING CODE 4140-01-P