[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