[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)]
[Notices]
[Pages 11926-11927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03823]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: The Development of 
an Anti-Mesothelin Recombinant Immunotoxin (RIT) for the Treatment of 
Human Cancers.

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
an Exclusive Patent License to Selecta Biosciences (``Selecta'') 
located in Watertown, Massachusetts to practice the inventions embodied 
in the patent applications listed in the Supplementary Information 
section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NCI Technology Transfer Center on or before March 
14, 2017 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: David A. Lambertson, Ph.D., Senior Licensing and 
Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center 
Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), 
Rockville, MD 20850-9702 Telephone: (240)-276-6467; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement:

U.S. Patent Application 61/535,668 (HHS Ref. E-263-2011/0-US-01), 
PCT Application PCT/US2012/055034 (HHS reference E-263-2011/0-PCT-
02), Australian Patent Application 2012308591 (HHS reference E-263-
2011/0-AU-03), Canadian Patent Application 2846608 (HHS reference E-
263-2011/0-CA-04), European Patent Application 12766780.6 (HHS 
reference E-263-2011/0-EP-05), US Patent 9,206,240 (HHS reference E-
263-2011/0-US-06), Hong Kong Patent Application 14111650.2 (HHS 
reference E-263-2011/0-HK-07), and US Patent Application 14/927,645 
(HHS reference E-263-2011/0-US-08);
U.S. Patent Application 61/495,085 (HHS Ref. E-174-2011/0-US-01), 
PCT Application PCT/US2012/041234 (HHS reference E-174-2011/0-PCT-
02), Australian Patent Application 2012268013 (HHS reference E-174-
2011/0-AU-03), Brazilian Patent Application 112013031262-9 (HHS 
reference E-174-2011/0-BR-04), Canadian Patent Application 2838013 
(HHS reference E-174-2011/0-CA-05), Chinese Patent Application 
201280039071.1 (HHS reference E-174-2011/0-CN-06), European Patent 
Application 12727074.2 (HHS reference E-174-2011/0-EP-07), Hong Kong 
Patent Application 14105911.9 (HHS reference E-174-2011/0-HK-08), 
Japanese Patent Application 2014-514616 (HHS reference E-174-2011/0-
JP-09), South Korean Patent Application 2013-7032402 (HHS reference 
E-174-2011/0-KR-10), Mexican Patent Application MX/a/2013/014388 
(HHS reference E-174-2011/0-MX-11), Russian Patent Application 
2013151655 (HHS reference E-174-2011/0-RU-12), US Patent 9,346,859 
(HHS reference E-174-2011/0-US-13), Hong Kong Patent Application 
14106689.7 (HHS reference E-174-2011/0-HK-14), and US Patent 
Application 15/095,470 (HHS reference E-174-2011/0-US-15);
U.S. Patent Application 61/483,531 (HHS Ref. E-117-2011/0-US-01), 
PCT Application PCT/US2012/036456 (HHS reference E-117-2011/0-PCT-
02), Australian Patent Application 2012253896 (HHS reference E-117-
2011/0-AU-03), Brazilian Patent Application 112013028537-0 (HHS 
reference E-117-2011/0-BR-04), Canadian Patent Application 2835070 
(HHS reference E-117-2011/0-CA-05), Chilean Patent Application 
03182-2013 (HHS reference E-117-2011/0-CL-06), Ecuadorian Patent 
Application SP-13-13067 (HHS reference E-117-2011/0-EC-07), Egyptian 
Patent Application PCT 1697/2013 (HHS reference E-117-2011/0-EG-08), 
European Patent Application 12722586.0 (HHS reference E-117-2011/0-
EP-09), Hong Kong Patent Application 14105586.3 (HHS reference E-
117-2011/0-HK-10), South Korean Patent Application 2013-7032247 (HHS 
reference E-117-2011/0-KR-11), Mexican Patent Application MX/a/2013/
012905 (HHS reference E-117-2011/0-MX-12), Malaysian Patent 
Application PI2013702094 (HHS reference E-117-2011/0-MY-13), New 
Zealand Patent Application 617386 (HHS reference E-117-2011/0-NZ-
14), Philippines Patent Application 1-2013-502264 (HHS reference E-
117-2011/0-PH-15), Russian Patent Application 2013148919 (HHS 
reference E-117-2011/0-RU-16), Singapore Patent Application 
201308179-9 (HHS reference E-117-2011/0-SG-17), Thailand Patent 
Application 1301006329 (HHS reference E-117-2011/0-TH-18), Ukrainian 
Patent Application 201313011 (HHS reference E-117-2011/0-UA-19), 
Vietnamese Patent Application 1-2013-03855 (HHS reference E-117-
2011/0-VN-20), South African Patent Application 2013/08270 (HHS 
reference E-117-2011/0-ZA-21), US Patent Application 14/115,131 (HHS 
reference E-117-2011/0-US-22), Japanese Patent Application 2014-
509467 (HHS reference E-117-2011/0-JP-23), Chinese Patent 
201280033583.7 (HHS reference E-117-2011/0-CN-24), Colombian Patent 
Application 13-274.153 (HHS reference E-117-2011/0-CO-25), Costa 
Rican Patent Application 2013-0571 (HHS reference E-117-2011/0-CR-
26), Indonesian Patent Application W-00201305198 (HHS reference E-
117-2011/0-ID-27), Israeli Patent Application 229198 (HHS reference 
E-117-2011/0-IL-28), Indian Patent Application 8854/CHENP/2013 (HHS 
reference E-117-2011/0-IN-29), Peruvian Patent Application 2456.13 
(HHS reference E-117-2011/0-PE-30), Algerian Patent Application 
130758 (HHS reference E-117-2011/0-DZ-31), Moroccan Patent 
Application 36534 (HHS reference E-117-2011/0-MA-32), and Hong Kong 
Patent Application 14108273.5 (HHS reference E-117-2011/0-HK-33);
U.S. Patent Application 61/241,620 (HHS Ref. E-269-2009/0-US-01), 
PCT Application PCT/US2010/048504 (HHS reference E-269-2009/0-PCT-
02), Australian Patent 2010292069 (HHS reference E-269-2009/0-AU-
03), Canadian Patent Application 2773665 (HHS reference E-269-2009/
0-CA-04), Chinese Patent 201080049559.3 (HHS reference E-269-2009/0-
CN-05), European Patent 2475398 (HHS reference E-269-2009/0-EP-06), 
as validated in France, Germany, Italy, Spain and the United 
Kingdom, Indian Patent Application 3197/CHENP/2012 (HHS reference E-
269-2009/0-IN-07), Japanese Patent 5795765 (HHS reference E-269-
2009/0-JP-08), Russian Patent Application 2012114005 (HHS

[[Page 11927]]

reference E-269-2009/0-RU-09), and US Patent 8,936,792 (HHS 
reference E-269-2009/0-US-10);
U.S. Patent Application 60/969,929 (HHS Ref. E-292-2007/0-US-01), 
PCT Application PCT/US2008/075296 (HHS reference E-292-2007/0-PCT-
02), Australian Patent 2008296194 (HHS reference E-292-2007/0-AU-
03), Canadian Patent Application 2698357 (HHS reference E-292-2007/
0-CA-04), European Patent 2197903 (HHS reference E-292-2007/0-EP-05) 
as validated in Austria, Belgium, Bulgaria, Switzerland, Cyprus, 
Germany, Denmark, Estonia, Spain, Finland, France, the United 
Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, 
Luxembourg, Latvia, Monaco, Malta, the Netherlands, Norway, Poland, 
Portugal, Romania, Slovenia, Slovakia, and Turkey, US Patent 
8,871,906 (HHS reference E-292-2007/0-US-06), European Patent 
Application 12184319.7 (HHS reference E-292-2007/0-EP-07), and Hong 
Kong Patent Application 13106628.2 (HHS reference E-292-2007/0-HK-
08);
U.S. Patent Application 60/703,798 (HHS Ref. E-262-2005/0-US-01), 
PCT Application PCT/US2006/028986 (HHS reference E-262-2005/0-PCT-
02), Australian Patent 2006275865 (HHS reference E-262-2005/0-AU-
03), Canadian Patent 2616987 (HHS reference E-262-2005/0-CA-04), 
European Patent 1910407 (HHS reference E-262-2005/0-EP-05) as 
validated in Switzerland, Germany, Spain, France, the United 
Kingdom, and Italy, US Patent 8,907,060 (HHS reference E-262-2005/0-
US-06), European Patent 2311854 (HHS reference E-262-2005/0-EP-07) 
as validated in Switzerland, Germany, Spain, France, the United 
Kingdom, and Italy, European Patent 2332970 (HHS reference E-262-
2005/0-EP-08) as validated in Germany, Spain, France, the United 
Kingdom, and Italy, Australian Patent 2012216642 (HHS reference E-
262-2005/0-AU-15), Australian Patent 2014208269 (HHS reference E-
262-2005/0-AU-22), European Patent Application 15191388.6 (HHS 
reference E-262-2005/0-EP-28), European Patent Application 
15191391.0 (HHS reference E-262-2005/0-EP-29), European Patent 
Application 15191395.1 (HHS reference E-262-2005/0-EP-30), 
Australian Patent Application (HHS reference E-262-2005/0-AU-31), 
and Canadian Patent Application (HHS reference E-262-2005/0-CA-32);
U.S. Patent Application 60/160,071 (HHS Ref. E-139-1999/0-US-01), 
PCT Application PCT/US00/14829 (HHS reference E-139-1999/0-PCT-02), 
Canadian Patent 2374398 (HHS reference E-139-1999/0-CA-03), European 
Patent 1180123 (HHS reference E-139-1999/0-EP-04) as validated in 
Belgium, Switzerland, Germany, Denmark, France, The United Kingdom, 
Italy, The Netherlands, and Sweden, Japanese Patent 5683766 (HHS 
reference E-139-1999/0-JP-05), Mexican Patent 270476 (HHS reference 
E-139-1999/0-MX-06); and U.S. Patent 7,081,518 (HHS reference E-139-
1999/0-US-07);
U.S. Patent Application 60/067,175 (HHS Ref. E-021-1998/0-US-01), 
PCT Application PCT/US98/25270 (HHS reference E-021-1998/0-PCT-02), 
Australian Patent 760120 (HHS reference E-021-1998/0-AU-03), 
Canadian Patent 2318576 (HHS reference E-021-1998/0-CA-04), European 
Patent 1025230 (HHS reference E-021-1998/0-EP-05) as validated in 
Switzerland, Germany, France, Italy, Spain and the United Kingdom, 
Israeli Patent 135775 (HHS reference E-021-1998/0-IL-06), US Patent 
6,809,184 (HHS reference E-021-1998/0-US-07), US Patent 7,368,110 
(HHS reference E-021-1998/0-US-08), and US Patent 7,709,252 (HHS 
reference E-021-1998/0-US-15),
U.S. Patent Application 60/010,166 (HHS Ref. E-002-1996/0-US-01), 
PCT Application PCT/US97/00224 (HHS Ref. E-002-1996/1-PCT-01), U.S. 
Patent 6,083,502 (HHS reference E-002-1996/1-US-02), Australian 
Patent 703769 (HHS reference E-002-1996/1-AU-03), Canadian Patent 
2241604 (HHS reference E-002-1996/1-CA-04), European Patent 0871492 
(HHS reference E-002-1996/1-EP-05) as validated in Switzerland, 
Germany, France, Italy Spain and the United Kingdom, U.S. Patent 
6,153,430 (HHS reference E-002-1996/1-US-14), and U.S. Patent 
7,375,183 (HHS reference E-002-1996/1-US-15);

and all continuing applications and foreign counterparts.
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, the patent rights in these inventions have been assigned to 
the Government of the United States of America.
    The prospective Exclusive Patent License territory may be worldwide 
for the following field of use:
    ``The use of anti-mesothelin targeted immunotoxins for the 
treatment of mesothelin-expressing cancers, wherein the immunotoxins 
have:
    (1) A targeting domain containing the complementary determining 
regions (CDRs) of the SS1 antibody; and
    (2) A Pseudomonas exotoxin A (PE) toxin domain that lacks at least 
one B cell or T cell epitope due to the alteration or deletion of one 
or more amino acids.
    For purposes of clarity, the immunotoxin may include additional 
alterations to B cell and T cell epitopes for the reduction of 
immunogenicity, a peptide linker sequence, and/or polyethylene glycol 
molecule(s). The immunotoxins may also be combined with the use of 
synthetic vaccine particle (SVP)-rapamycin.''
    The present inventions to be licensed concern RITs which are 
targeted to mesothelin-expressing cancer cells, and methods of using 
the immunotoxins for the treatment of mesothelin-expressing cancers 
(such as mesothelioma, ovarian cancer and pancreatic cancer). The 
specific immunotoxin will have an antibody targeting domain that 
contains the CDRs of the antibody identified as SS1, which was invented 
at the NIH. The specific immunotoxin will also have a toxin domain 
derived from PE that is resistant to lysosomal proteases due to the 
deletion of a large portion of the exotoxin, and which lacks at least 
one major B-cell epitope due to the alteration an amino acid. 
Ultimately, the PE used in the immunotoxin may lack multiple B-cell 
epitopes, as well as multiple T-cell epitopes, in an effort to minimize 
immunogenicity.
    Alterations to the toxin that reduce immunogenicity improve the 
therapeutic value of the immunotoxin while maintaining its ability to 
trigger cell death. Since mesothelin is preferentially expressed on 
certain types of cancer cells, the immunotoxins selectively bind and 
kill only those cancer cells, allowing healthy, essential cells to 
remain unharmed. This may result in an effective therapeutic strategy 
with fewer side effects, especially when combined with agents that can 
suppress the formation of neutralizing antibodies.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Exclusive Patent License will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the National Cancer Institute 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.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated Exclusive Patent 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 21, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-03823 Filed 2-24-17; 8:45 am]
 BILLING CODE 4140-01-P