[Federal Register Volume 71, Number 43 (Monday, March 6, 2006)]
[Notices]
[Page 11213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-2096]



[[Page 11213]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Use of IL13-PE38 for 
the Treatment of Asthma and Pulmonary Fibrosis

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR part 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services (HHS), is contemplating the 
grant of an exclusive patent license to practice the inventions 
embodied in U.S. Patent Application No. 60/337,179 filed December 4, 
2001, entitled ``IL-13 Receptor-Targeted Immunotoxins Ameliorates 
Symptoms of Asthma and of Allergy'' [HHS Reference No. E-296-2001/0-US-
01], PCT Application No. PCT/US02/00616 filed February 28, 2002, 
entitled ``Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders 
by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' 
[HHS Reference No. E-296-2001/0-PCT-02], U.S. Patent Application No. 
10/497,804 filed June 4, 2004, entitled ``Alleviating Symptoms of TH2-
Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing 
Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-US-
03], Australian Patent Application No. 2002258011 filed June 8, 2004, 
entitled ``Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders 
by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract'' 
[HHS Reference No. E-296-2001/0-AU-04], Canadian Patent Application No. 
2469082 filed February 28, 2002, entitled ``Chimeric Molecule for the 
Treatment of TH2-Like Cytokine Mediated Disorders'' [HHS Reference No. 
E-296-2001/0-CA-05], and European Patent Application No. 02727815.9 
filed June 29, 2004 entitled ``Alleviating Symptoms of TH2-Like 
Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells 
in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-EP-06], 
including background patent rights to U.S. Patent No. 4,892,827, issued 
on January 9, 1990, entitled ``Recombinant Pseudomonas Exotoxins: 
Construction of an Active Immunotoxin with Low Side Effects'' [HHS 
Reference No. E-385-1986/0-US-01], U.S. Patent No. 5,919,456, issued on 
July 6, 1999, entitled ``IL-13 Receptor Specific Chimeric Proteins'' 
[HHS Reference No. E-266-1994/0-US-07], U.S. Patent 6,518,061, issued 
on February 11, 2003, entitled ``IL-13 Receptor Specific Chimeric 
Proteins and Uses Thereof'' [HHS Reference No. E-266-1994/0-US-08], to 
NeoPharm, Inc., which has offices in Waukegan, Illinois. The patent 
rights in these inventions have been assigned and/or exclusively 
licensed to the Government of the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to the treatment of asthma and 
pulmonary fibrosis with IL13-PE38.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: David A. Lambertson, Ph.D., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 402-0220; E-
mail: [email protected].

SUPPLEMENTARY INFORMATION: The technology relates to the treatment of 
asthma and pulmonary fibrosis. When airway inflammation occurs (e.g., 
during an asthmatic attack or a response to an allergen), the number of 
cells that produce the receptor for IL-13 increases in the lungs. When 
IL-13 interacts with the receptor, an inflammatory response is induced; 
when this occurs in the lungs, it leads to the symptom of constricted 
breathing. Blocking the interaction between IL-13 and its receptors on 
the cells has been shown to reduce the inflammatory response.
    A chimeric molecule was developed that comprised both an IL-13 
domain (capable of interacting with its cognate receptor) and a toxin 
domain. This molecule has the capacity to interact with and kill IL-13 
receptor expressing cells. The invention relates to a method of 
treating asthma or pulmonary fibrosis by administering a chimeric 
molecule comprising a toxin linked to an IL-13 targeting moiety (e.g., 
IL13-PE38). By administering the toxin in this form, cells involved in 
airway inflammation can be selectively targeted and killed, thereby 
alleviating the symptom of constricted breathing.
    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 part 
404.7. The prospective exclusive license may be granted unless within 
sixty (60) days from the date of this published notice, the 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 part 404.7.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. Comments and objections submitted 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: February 27, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 06-2096 Filed 3-3-06; 8:45 am]
BILLING CODE 4140-01-P