[Federal Register Volume 66, Number 222 (Friday, November 16, 2001)]
[Notices]
[Pages 57722-57723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28706]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing: Method 
of Treating HIV With 2', 3'-Dideoxyinosine (ddI; didanosine)

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

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by agencies of the U.S. 
Government and are available for nonexclusive licensing in the U.S. in 
accordance with 35 U.S.C. 207 to achieve expeditious commercialization 
of results of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for non-exclusive licensing.

(1) U.S. Patent No. 4,861,759, issued August 29, 1989, entitled 
``Antiviral Compositions and Methods'' (PHS Reference No. E-081-87/1)
(2) U.S. Patent No. 5,254,539, issued October 19, 1993, entitled 
``Antiviral Compositions and Methods'' (PHS Reference No. E-081-87/4)

[[Page 57723]]

(3) U.S. Patent No. 5,616,566, issued April 01, 1997, entitled ``Method 
of Inhibiting HIV Replication with 2', 3'-Dideoxyadenosine'' (PHS 
Reference No. E-081-87/6)
(4) U.S. Patent Application No. 08/246,916, filed May 20, 1994, 
entitled ``Antiviral Compositions and Methods'' (PHS Reference No. E-
081-87/7)
(5) U.S. Patent No. 5,026,687, issued June 25, 1991, entitled 
``Treatment of Human Retroviral Infections with 2', 3'-Dideoxyinosine'' 
(PHS Reference No. E-051-90/0)
(6) U.S. Patent No. 5,376,642, issued December 27, 1994, entitled 
``Treatment of Human Retroviral Infections with 2', 3'-Dideoxyinosine'' 
(PHS Reference No. E-051-90/2)

ADDRESSES: Licensing information may be obtained by contacting Sally 
Hu, Ph.D., M.B.A., at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; Telephone: 301/496-7056 ext. 265; Fax: 301/402-
0220; E-mail: [email protected].

SUPPLEMENTARY INFORMATION: Human Immunodeficiency Virus (HIV) and other 
retroviruses need three viral enzymes for replication: reverse 
transcriptase (RT), protease and integrase. The current focus for 
treatment of acquired immune deficiency syndrome (AIDS) is the 
development of antiviral drugs that target the infection and 
replication of HIV. The patents and patent applications describe group 
novel compounds discovered by Dr. Hiroaki Mitsuya, Dr. Robert Yarchoan 
and Dr. Samuel Broder at the National Cancer Institute. It has been 
shown that the drugs 2', 3'-dideoxyinosine (ddI), 2', 3'-
dideoxyadenosine (ddA), and 2', 3'-dideoxyguanosine (ddG), and their 
triphosphate derivatives are useful for treatment of retroviral 
infections, particularly HIV-infection and AIDS. ddI, ddA, and ddG are 
metabolized in vivo to active triphosphate derivatives that inhibit HIV 
and retroviral reverse transcriptase, an enzyme required for retroviral 
replication. Liposomal encapsulated dideoxynucleosides, salts and 
esters are also claimed since triphosphates ordinarily do not penetrate 
cell membranes and the triphosphate derivatives of this invention are 
delivered by liposomes, small particles that serve as intracellular 
transport systems. ddI (didanosine) is licensed for human use in the 
U.S. and around the world as a treatment for HIV infections.

    Dated: November 6, 2001.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 01-28706 Filed 11-15-01; 8:45 am]
BILLING CODE 4140-01-P