[Federal Register Volume 77, Number 104 (Wednesday, May 30, 2012)]
[Notices]
[Pages 31864-31866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-13006]



[[Page 31864]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of 
PANVACTM and Tumor Associated Antigens as Colorectal Cancer 
Vaccine

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

Group I--Exclusive Licensed Patent Rights

    1. U.S. Patent Application No. 60/061,589 filed October 10, 1997 as 
well as all issued and pending foreign counterparts [HHS Ref. No. E-
099-1996/0-US-01];
    2. PCT Patent Application No. PCT/US1998/19794 filed September 22, 
1998 as well as all issued and pending foreign counterparts [HHS Ref. 
No. E-099-1996/0-PCT-02];
    3. 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];
    4. U.S. Patent No. 7,723,096 issued May 25, 2010 as well as 
continuation and divisional applications, and issued and pending 
foreign counterparts [HHS Ref. No. E-099-1996/0-US-08];
    5. European Patent No. lOI7810 [HHS Ref. No. E-099-1996/0-EP-05], 
and all European contracting states in which this patent is validated;
    6. European Patent Application No. 04011673.3 (now EP Patent No. 
1447414) [HHS Ref. No. E-099-1996/0-EP-17], and all European 
contracting states in which this patent is validated, Japan Patent 
Application No. 2000-516030 (now JP Patent No. 4291508) [HHS Ref. No. 
E-099-1996/0-JP-06], and all continuations and divisional applications 
claiming priority to this application;
    7. Australia Patent No. 745863 [HHS Ref. No. E-099-1996/0-AU-03], 
and all continuations and divisional applications claiming priority to 
this application;
    8. Canada Patent No. 2308127 [HHS Ref. No. E-099-1996/0-CA-04], and 
all continuations and divisional applications claiming priority to this 
application;
    9. PCT Patent Application No. PCT/US1992/03843 filed May 6, 1992 as 
well as all issued and pending foreign counterparts [HHS Ref. No. E-
200-1990/2-PCT-01];
    10. U.S. Patent No. 5,698,530 issued December 6, 1997 as well as 
issued and pending foreign counterparts [HHS Ref. No. E-200-1990/1-US-
02];
    11. Australian Patent No. 674492 issued April 22, 1997 [HHS Ref. 
No. E-200-1990/2-AU-02]; Europe Patent No. 0584266 issued September 3, 
2003 [HHS Ref. No. E-200-1990/2-EP-04]; Japan Patent No. 3399943 issued 
February 21, 2003 [HHS Ref. No. E-200-1990/2-JP-05]; and Canada Patent 
No. 2102623 issued April 22, 2003 [HHS Ref. No. E-200-1990/2-CA-03];
    12. 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];
    13. U.S. Patent Application No. 60/519,354 filed November 12, 2003 
as well as all issued and pending foreign counterparts [HHS Ref. No. E-
087-2005/0-US-01];
    14. 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-0872005/0-US-03];
    15. U.S. Patent Application No. 60/519,427 filed November 12, 2003 
as well as all issued and pending foreign counterparts [HHS Ref. No. E-
088-2005/0-US-01];
    16. 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 [HHS Ref. No. E-088-2005/0-US-03];
    17. U.S. Patent Application No. 60/038,253 filed February 24, 1997 
as well as all issued and pending foreign counterparts [HHS Ref. No. E-
154-1998/0-US-01];
    18. PCT Patent Application No. PCT/US1998/03693 filed February 24, 
1998 as well as all issued and pending foreign counterparts [HHS Ref. 
No. E-154-1998/0-PCT-02];
    19. 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];
    20. PCT Patent Application No. PCT/US1995/12638 filed October 2, 
1995 as well as all issued and pending foreign counterparts [HHS Ref. 
No. E-259-1994/2-PCT-01];
    21. PCT Patent Application No. PCT/US1997/12203 filed July 15, 1997 
as well as all issued and pending foreign counterparts [HHS Ref. No. E-
259-1994/3-PCT-02];
    22. U.S. Patent Application No. 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];
    23. 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];
    24. PCT Patent Application No. PCT/US1995/12624 filed October 2, 
1995 as well all issued and pending foreign counterparts [HHS Ref. No. 
E-260-1994/2-PCT-01];
    25. 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];
    26. 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 [HHS Ref. No. E-260-1994/2-AU-11]; Canada 
Patent No. 2201587 issued June 25, 2002 [HHS Ref. No. E-260-1994/2-CA-
12];
    27. U.S. Patent Application No. 60/211,717 filed June 15, 2000 as 
well as all continuation and divisional applications, and issued and 
pending foreign counterparts [HHS Ref. No. E-187-2000/0-US-01];
    28. PCT Patent Application No. PCT/US2001/19201 filed June 15, 2001 
as well all issued and pending foreign counterparts [HHS Ref. No. E-
187-2000/0-PCT-02];
    29. 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

[[Page 31865]]

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;
    30. U.S. Patent Application No. 60/776,506 filed February 24, 2006 
as well as all continuation and divisional applications, and issued and 
pending foreign counterparts [HHS Ref. No. E-104-2006/0-US-01];
    31. PCT Patent Application No. PCT/US2007/004603 filed February 27, 
2007 as well all issued and pending foreign counterparts [HHS Ref. No. 
E-104-2006/0-PCT-02];
    32. 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 applications.
    33. U.S. Patent Application No. 60/904,236 filed February 28, 2007 
as well as all continuation and divisional applications, and issued and 
pending foreign counterparts [HHS Ref. No. E-074-2007/0-US-01];
    34. PCT Patent Application No. PCT/US2008/055185 filed February 28, 
2008 as well all issued and pending foreign counterparts [HHS Ref. No. 
E-074-2007/0-PCT-02];
    35. 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 Application No. 60/111,582 filed December 9, 1998 as 
well as all continuation and divisional applications, and issued and 
pending foreign counterparts [HHS Ref. No. E-256-1998/0-US-01];
    2. PCT Patent Application No. PCT/US1999/26866 filed November 12, 
1999 as well all issued and pending foreign counterparts [HHS Ref. No. 
E-256-1998/0-PCT-02];
    3. 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];
    4. U.S. Patent Application No. 60/448,591 filed February 20, 2003 
as well as all continuation and divisional applications, and issued and 
pending foreign counterparts [HHS Ref. No. E-028-2007/0-US-01];
    5. PCT Patent Application No. PCT/US2004/005077 filed February 20, 
2004 as well all issued and pending foreign counterparts [HHS Ref. No. 
E-028-2007/0-PCT-02];
    6. 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];
    7. PCT Patent Application No. PCT/US1998/003032 filed September 2, 
1998 as well all issued and pending foreign counterparts [HHS Ref. No. 
E-134-2007/0-PCT-02];
    8. 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];
    9. PCT Patent Application No. PCT/US1989/03701 filed August 25, 
1989 as well all issued and pending foreign counterparts [HHS Ref. No. 
E-135-2007/0-PCT-02];
    10. U.S. Patent No. 5,093,258 issued March 3, 1992, as well as all 
continuation and divisional applications, and issued and pending 
foreign counterparts [HHS Ref. No. E-135-2007/0];
    11. PCT Patent Application No. PCT/US1989/02486 filed June 7, 1989 
as well all issued and pending foreign counterparts [HHS Ref. No. E-
136-2007/0-PCT-02];
    12. 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];
    13. 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-138-2007/0-US-01];
    14. PCT Patent Application No. PCT/US2005/040170 filed November 4, 
2005 as well all issued and pending foreign counterparts [HHS Ref. No. 
E-138-2007/0-PCT-02];
    15. 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];
    16. U.S. Patent Application No. 60/678,329 filed May 5, 2005 as 
well as all continuation and divisional applications, and issued and 
pending foreign counterparts [HHS Ref. No. E-139-2007/0-US-01];
    17. PCT Patent Application No. PCT/US2006/017765 filed May 5, 2006 
as well all issued and pending foreign counterparts [HHS Ref. No. E-
139-2007/0-PCT-02];
    18. U.S. Patent Application No. 60/678,329 filed May 5, 2005, as 
well as all continuation and divisional applications, and issued and 
pending foreign counterparts [HHS Ref. No. E-139-2007/0]; and
    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 limited to the use of Licensed Patent Rights 
for development of therapeutics for human colorectal cancer in all 
geographic territories.'' For the avoidance of doubt, delivery 
formulations shall specifically exclude canary poxvirus vectors, NYVAC, 
non-viral eukaryotic expression vectors and recombinant yeast 
vectors.''

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before June 
29, 2012 will be considered.

FOR FURTHER INFORMATION CONTACT: Requests for copies of the patent 
application, inquiries, and comments relating to the contemplated 
exclusive license should be directed to: Sabarni K. Chatterjee, Ph.D., 
M.B.A. Licensing and Patenting Manager, 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; Email: [email protected].

[[Page 31866]]


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 result 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. 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 
over-expression of these two (2) TAAs are associated with the presence 
of a variety of carcinomas; including colorectal cancer and therefore 
PANVAC can potentially be an effective cancer vaccine for colorectal 
cancer. Additionally, new tumor associated antigens can also be used 
with TRICOM to develop novel vaccines. For example, Brachyury, well 
known for its role in developmental cell biology and recently been 
implicated in tumor cell invasion and metastasis, has been shown to be 
aberrantly expressed in several tumors including colorectal tumors. As 
a result, Brachyury is being used as a tumor associated antigen along 
with TRICOM and has potential as a cancer immunotherapeutic vaccine for 
the treatment of several tumors including colorectal cancer.
    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 
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 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: May 23, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-13006 Filed 5-29-12; 8:45 am]
BILLING CODE 4140-01-P