Federal Register / Vol. 69, No. 190 / Friday, October 1, 2004 / Notices 58933

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: ‘‘Anthrax Toxin Fusion 

Proteins and Uses Thereof,’’ ‘‘Anthrax 

Toxin Fusion Proteins and Related 

Methods,’’ and ‘‘Targeting Agents to 

the MHC Class I Processing Pathway 

with an Anthrax Toxin Fusion Protein’’

AGENCY: National Institutes of Health, 

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This notice, in accordance 

with 35 U.S.C. 209(c)(1) and 37 CFR 

Part 404.7(a)(1)(i), that the Food and 

Drug Administration and the 

Department of Health and Human 

Services is contemplating the grant of an 

exclusive license to practice the 

inventions embodied in ‘‘Anthrax toxin 

fusion proteins and uses thereof’’, by 

Leppla et al., issued as U.S. patent 

5,591,631 on January 7, 1997; ‘‘Anthrax 

toxin fusion proteins and related 

methods’’ by Leppla et al., issued as 

U.S. patent 5,677,274 on October 14, 

1997; and ‘‘Targeting agents to the MHC 

class I processing pathway with an 

anthrax toxin fusion protein’’ by 

Klimpel et al. filed internationally as 

PCT/US97/16452, and claiming priority 

to U.S. provisional patent application 

60/025,270, filed September 17, 1996 to 

Avant Immunotherapeutics, Inc., which 

is located in Needham, MA. The patent 

rights in these inventions have been 

assigned to the United States of 

America. This technology is currently 

licensed to Avant Immunotherapeutics, 

Inc. on a non-exclusive basis in the area 

of immune diseases. 

The prospective exclusive license 

territory will be worldwide and the field 

of use may be limited to vaccines and 

immunotherapeutics for the prevention 

or treatment of the following human and 

animal diseases: Human 

immunodeficiency, hepatitis B virus 

and hepatitis C virus.

DATES: Only written comments and/or 

license applications that are received by 

the National Institutes of Health on or 

before November 30, 2004 will be 

considered.

ADDRESSES: Requests for copies of the 

patent, inquiries, comments and other 

materials relating to the contemplated 

exclusive license should be directed to: 

Brenda J. Hefti, 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; and e-mail: heftib@od.nih.gov.

SUPPLEMENTARY INFORMATION: In this 

technology, an anthrax binary toxin 

system provides antigen access to MHC 

Class I processing pathway. The 

Bacillus antracis binary toxin consists of 

two proteins, a protective antigen (PA) 

combines with lethal factor (LF) to make 

anthrax toxin. In this system PA binds 

to the protein receptor on the target cell, 

is cleaved to produce the PA63 

fragment, PA63 binds to LF and the 

binary anthrax toxin is endocytosed and 

transported into the cell to be processed 

by the MHC Class I processing pathway. 

Advantages of this system include its 

ability to accommodate large fusion 

proteins and the fact that anthrax toxin 

is not widely used for immunization. 

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 establish that the grant of 

the license would not be consistent with 

the requirements of 35 U.S.C. 209 and 

37 CFR 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: September 27, 2004. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health.

[FR Doc. 04–22146 Filed 9–30–04; 8:45 am] 

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Co-Exclusive 

License: Monoclonal Antibodies 

Against the IL–2 Receptor Alpha Chain 

as a Novel Treatment for Multiple 

Sclerosis

AGENCY: National Institutes of Health, 

Public Health Services, DHHS.

ACTION: Notice.

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, Department of 

Health and Human Services, is 

contemplating the grant of a coexclusive license to practice the 

inventions embodied in U.S. Provisional 

Patent Application No. 60/393,021, filed 

June 28, 2002, ‘‘Method of Treating 

Autoimmune Diseases with InterferonBeta and IL–2R Antagonist’’ (DHHS ref. 

no. E–143–2002/0–US–01), 

International Patent Application No. 

PCT/US2002/038290, filed November 

27, 2002, International Publication No. 

WO 2004/002500 A1, published January 

8, 2004, ‘‘Method of Treating 

Autoimmune Diseases with InterferonBeta and IL–2R Antagonist’’ (DHHS ref. 

no. E–143–2002/0–PCT–02), 

International Application No. PCT/

US2003/020428, filed June 27, 2003, 

International Publication No. WO 2004/

002421 A2, published January 8, 2004, 

‘‘Method For the Treatment of Multiple 

Sclerosis’’ (DHHS ref. no. E–143–2002/

0–PCT–04), and U.S. Patent Application 

No. 10/607,598, filed June 27, 2003, 

Publication No. U.S. 2004/0109859 A1, 

published June 10, 2004, ‘‘Method For 

the Treatment of Multiple Sclerosis’’

(DHHS ref. no. E–143–2002/0–US–03), 

and all corresponding foreign patent 

applications to Serono S.A., of Geneva, 

Switzerland. The patent rights in these 

inventions have been assigned to the 

United States of America. This notice is 

a correction of a notice published in the 

Federal Register in 69 FR 52515–52516, 

Aug. 26, 2004. 

The prospective co-exclusive license 

territory will be worldwide. The field of 

use may be limited to the treatment of 

multiple sclerosis using monoclonal 

antibodies against the interleukin-2 

receptor. Two co-exclusive licenses may 

be granted.

DATES: Only license applications which 

are received by the National Institutes of 

Health on or before October 25, 2004 

will be considered.

ADDRESSES: Requests for information, 

inquiries, comments, and other 

materials relating to the contemplated 

co-exclusive license should be directed 

to: Thomas P. Clouse, Office of 

Technology Transfer, National Institutes 

of Health, 6011 Executive Boulevard, 

Suite 325, Rockville, MD 20852–3804; 

Telephone: 301–435–4076; Facsimile: 

301–402–0220; E-mail: 

clouset@mail.nih.gov. Copies of the 

international publications can be 

obtained from http://ep.espacenet.com.

Copies of the U.S. publication can be 

obtained from http://www.uspto.gov.

SUPPLEMENTARY INFORMATION: The 

above-identified patent applications 

relate to the discovery that 

administration of an interleukin-2