[Federal Register Volume 75, Number 62 (Thursday, April 1, 2010)]
[Notices]
[Pages 16490-16491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7341]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of PANVAC and 
Tumor Associated Antigens as Cancer Vaccines

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

ACTION: Notice.

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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, 
Department of Health and Human Services, is contemplating the grant of 
an exclusive patent license to practice the inventions embodied in the 
following U.S. Patents and Patent Applications to Bavarian Nordic 
Immunotherapeutics (``BNIT'') located in Mountain View, CA, USA.
    Intellectual Property:
    1. U.S. Patent No. 6,756,038 issued June 29, 2004 as well as issued 
and pending foreign counterparts [HHS Ref. No. E-099-1996/0-US-07];
    2. U.S. Patent Application No. 10/725,373 (recently allowed) filed 
December 3, 2003 as well as continuation and divisional applications, 
and issued and pending foreign counterparts [HHS Ref. No. E-099-1996/0-
US-08];
    3. U.S. Patent No. 6,001,349 issued 14 Dec. 1999 as well as issued 
and pending foreign counterparts [HHS Ref. No. E-200-1990/3-US-01];
    4. U.S. Patent Application No. 10/579,025 filed May 11, 2006 as 
well as all continuation and divisional applications, and issued and 
pending foreign counterparts [E-087-2005/0-US-03];
    5. U.S. Patent Application No. 10/579,007 filed May 11, 2006 as 
well as all continuation and divisional applications, and issued and 
pending foreign counterparts [E-088-2005/0-US-03];
    6. U.S. Patent No. 7,118,738 issued October 10, 2006 as well as all 
continuations and divisional applications, and issued and pending 
foreign counterparts [HHS Ref. No. E-154-1998/0-US-07];
    7. U.S. Patent Application Nos. 08/686,280 filed July 25, 1996 as 
well as all issued and pending foreign counterparts [HHS Ref. No. E-
259-1994/3-US-01];
    8. U.S. Patent No. 7,410,644 issued August 12, 2008 as well as all 
continuation and divisional applications, and issued and pending 
foreign counterparts [HHS Ref. No. E-259-1994/3-US-08];
    9. U.S. Patent Nos. 6,893,869, 6,548,068 and 6,045,802 issued May 
17, 2005, April 15, 2003 and April 4, 2000 respectively, as well as 
issued and pending foreign counterparts [HHS Ref. Nos. E-260-1994/1-US-
03, US-02, US-01]; U.S. Patent No. 7,368,116 issued May 6, 2008 and 
U.S. Patent Application No. 12/112,819, as well as all continuation and 
divisional applications [HHS Ref. Nos. E-260-1994/1-US-04 and US-05];
    10. Europe Patent Application No. 00102998.2 filed October 2, 1995, 
Europe Patent No. 0784483 issued November 29, 2001, Europe Patent 
Application No. 09013495.8 filed October 26, 2009, as well as all 
continuation, and divisional applications [HHS Ref. Nos. E-260-1994/2-
EP-15, EP-16 and EP-27]; Japan Patent Application No. 512100/96 filed 
October 2, 1995; Japan Patent No. 4078319 issued February 8, 2008 [HHS 
Ref. No. E-260-1994/2-JP-25]; and Japan Patent No. 4160612 issued July 
25, 2008, as well as all continuation and divisional applications; [HHS 
Ref. No. E-260-1994/2-JP-21, JP-25 and JP-26]; Australia Patent No. 
688606 issued July 2, 1998 [E-260-1994/2-AU-11]; Canada Patent No. 
2201587 issued June 25, 2002 [E-260-1994/2-CA-12];
    11. Canada Patent Application No. 2,412,050 filed June 15, 2001 
[HHS Ref. No. E-187-2000/0-CA-05]; Australia Patent No. 2001268452 
issued November 30, 2006 [HHS Ref. No. E-187-2000/0-AU-06]; Japan 
Patent Application No. 2002-510097 filed June 15, 2001 [HHS Ref. No. E-
187-2000/0-JP-07]; Hong Kong Patent Application No. 03105975.5 filed 
June 15, 2001 [HHS Ref. No. E-187-2000/0-HK-08]; as well as all 
continuation and divisional applications;
    12. U.S. Patent Application No. 12/280,534 filed February 21, 2007, 
[HHS Ref. No. E-104-2006/0-US-06]; Australia Patent Application No. 
2007221255 filed February 21, 2007 [HHS Ref. No. E-104-2006/0-AU-03]; 
Europe Patent Application No. 07751371.1 filed February 21, 2007, [HHS 
Ref. No. E-104-2006/0-US-06]; filed February 21, 2007, [HHS Ref. No. E-
104-2006/0-EP-05]; Canada Patent Application No. 2642994 filed February 
21, 2007 [HHS Ref. No. E-104-2006/0-CA-04]; as well as all continuation 
and divisional and applications;
    13. U.S. Patent Application No. 12/528,796 filed August 26, 2009 
[HHS Ref. No. E-074-2007/0-US-07]; Australia Patent Application No. 
2008221383 filed February 27, 2008 [HHS Ref. No. E-074-2007/0-AU-03]; 
Europe Patent Application No. 08743578.0 filed February 27, 2008 [HHS 
Ref. No. E-074-2007/0-EP-05]; Canada Patent Application No. 2,678,404 
filed February 27, 2008 [HHS Ref. No. E-074-2007/0-CA-04]; Japan Patent 
Application No. not yet assigned filed February 27, 2008 [HHS Ref. No. 
E-074-2007/0-JP-06] as well as all continuation, divisional and pending 
foreign counterpart applications;
    Group II--Nonexclusive Licensed Patent Rights:
    1. U.S. Patent No. 6,969,609 issued November 29, 2005; U.S. Patent 
No. 7,211,432 issued May 1, 2007; U.S. Patent Application No. 11/
723,666 filed March 21, 2007; as well as all continuation and 
divisional applications, and issued and pending foreign counterparts 
[HHS Ref. No. E-256-1998/0, 1];
    2. U.S. Patent Application Nos. 60/448,591 and 10/543,944 filed 
February 20, 2003 and February 20, 2004 respectively, as well as all 
continuation and divisional applications, and issued and pending 
foreign counterparts [HHS Ref. No. E-028-2007/0];
    3. U.S. Patent No. 6,699,475 issued March 2, 2004, as well as all 
continuation and divisional applications, and issued and pending 
foreign counterparts [HHS Ref. No. E-134-2007/0];
    4. U.S. Patent No. 5,093,258 issued March 3, 1992, as well as all 
continuation and divisional applications, and issued and pending

[[Page 16491]]

foreign counterparts [HHS Ref. No. E-135-2007/0];
    5. U.S. Patent Application No. 07/205,189 filed June 10, 1988, as 
well as all continuation and divisional applications, and issued and 
pending foreign counterparts [HHS Ref No. E-136-2007];
    6. U.S. Patent Application No. 60/625,321 filed November 5, 2004, 
as well as all continuation and divisional applications, and issued and 
pending foreign counterparts [HHS Ref. No. E-138-2007]; and
    7. U.S. Patent Application No. 07/340,052 filed April 18, 1989, as 
well as all continuation and divisional applications, and issued and 
pending foreign counterparts [HHS Ref. No. E-147-2007].
    The patent rights in these inventions have been assigned to the 
United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be use of Licensed Patent Rights for development 
of therapeutics for human cancers. The field of use will specifically 
exclude prostate cancer, melanoma and colorectal cancer. For the 
avoidance of doubt, delivery formulations shall specifically exclude 
canary poxvirus vectors, NYVAC, non-viral eukaryotic expression vectors 
and recombinant yeast vectors in all geographic territories.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before May 
3, 2010 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Sabarni K. Chatterjee, Ph.D. Licensing 
and Patenting Associate, Cancer Branch, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-5587; Facsimile: (301) 
435-4013; E-mail: [email protected].

SUPPLEMENTARY INFORMATION: Cancer immunotherapy is a recent approach 
where tumor associated antigens (TAAs), which are primarily expressed 
in human tumor cells, and not expressed or minimally expressed in 
normal tissues, are employed to generate a tumor-specific immune 
response. Specifically, these antigens serve as targets for the host 
immune system and elicit responses that results in tumor destruction. 
The initiation of an effective T-cell immune response to antigens 
requires two signals. The first one is antigen-specific via the 
peptide/major histocompatibility complex and the second or 
``costimulatory'' signal is required for cytokine production, 
proliferation, and other aspects of T-cell activation.
    The patents and patent applications describe a vaccine technology, 
TRICOM, in conjunction with tumor associated antigens (TAAs). The 
TRICOM technology employs avirulent poxviruses to present a combination 
of costimulatory signaling molecules with tumor-associated antigens 
(TAAs) to activate T-cells and break the immune systems tolerance 
towards cancer cells. This is achieved using recombinant poxvirus DNA 
vectors that encode both T-cell costimulatory molecules and TAAs. The 
combination of the three (3) costimulatory molecules B7.1, ICAM-1 and 
LFA-3, hence the name TRICOM, has been shown to have more than the 
additive effect of each costimulatory molecule when used individually 
to optimally activate both CD4+ and CD8+ T cells. When a TRICOM based 
vaccine expressing TAAs is administered it greatly enhances the immune 
response against the malignant cells expressing those TAAs. By changing 
the TAAs used for immunization with TRICOM vaccines, immune responses 
can be generated to diverse types of cancers. The versatility of the 
vector-based TRICOM based vaccine is that it allows, including several 
TAAs, to help maximize the effectiveness. Transgenes reflecting 
alterations of TAAs can also be inserted into TRICOM based vaccines to 
further enhance immunogenicity. The addition of the two well-known 
TAAs, carcinoembryonic antigen (CEA) and MUC-1 to the TRICOM vector 
results in the PANVAC vaccine, which is used in a prime and boost 
vaccine strategy. It is well established that the overexpression of 
these two (2) TAAs are associated with the presence of a variety of 
carcinomas; therefore PANVAC can potentially be effective against a 
range of tumor types.
    Additionally, new TAAs are being continually identified. One such 
example is the antigen Brachyury. Although Brachyury has been well 
known for its role in developmental cell biology, it has recently been 
implicated in tumor cell invasion and metastasis. Pre-clinical data 
indicates that Brachyury is aberrantly expressed on tumors of the lung, 
intestine, stomach, kidney, bladder, uterus, ovary, and testis, and in 
chronic lymphocytic leukemia. When used in combination with 
costimulatory molecules, it can effectively activate T-cells to kill 
tumors cells that originated from above mentioned tumors. Therefore, as 
one example, Brachyury combined with TRICOM also has potential as a 
cancer immunotherapy for the treatment of several tumors.
    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 thirty 
(30) 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 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: March 26, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-7341 Filed 3-31-10; 8:45 am]
BILLING CODE 4140-01-P