[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26487-26488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12179]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: The Development 
of an Anti-BCMA Immunotoxin for the Treatment of Human Cancer

AGENCY: National Institutes of Health, Department of Health and Human 
Services.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, an institute of 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 Patents and Patent Applications listed in 
the Supplementary Information section of this notice to BEORO 
Therapeutics, GmbH. (``Beoro'') located in Seefeld, Germany.

DATES: Only written comments and/or complete applications for a license 
which are received by the National Cancer Institute's Technology 
Transfer Center on or before June 22, 2018 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: David A. Lambertson, Ph.D., Senior Technology 
Transfer 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)-276-5530; Facsimile: (240)-
276-5504 Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    The following represents the intellectual property to be licensed 
under the prospective agreement:
    U.S. Patent Application 62/255,255 (HHS reference E-010-2016-0-US-
01), U.S. Patent Application 62/257,493 (HHS reference E-010-2016-1-US-
01), and PCT Patent Application PCT/US2016/061320 (HHS reference E-010-
2016-2-PCT-01);
    U.S. Patent Application 61/887,418 (HHS reference E-771-2013-0-US-
01), U.S. Patent Application 61/908,464 (HHS reference E-771-2013-1-US-
01), U.S. Patent Application 61/982,051 (HHS reference E-771-2013-2-US-
01), U.S. Patent Application 61/052,665 (HHS reference E-771-2013-3-US-
01), PCT Application PCT/US2014/058941 (HHS reference E-771-2013-4-PCT-
01), U.S. Patent 9,388,222 (HHS reference E-771-2013-4-US-02), 
Australian Patent Application 2014329437 (HHS reference E-771-2013-4-
AU-08), Canadian Patent Application 2926215 (HHS reference E-771-2013-
4-CA-09), Chinese Patent Application 201480062185.7 (HHS Reference E-
771-2013-4-CN-10), European Patent Application 14789449.7 (HHS 
reference E-771-2013-4-EP-11), Indian Patent Application 201647015226 
(HHS reference E-771-2013-4-IN-12), Russian Patent Application 
2016114406 (HHS reference E-771-2013-4-RU-13), Japanese Patent 
Application (HHS reference E-771-2013-4-JP-14), and U.S. Patent 
Application 15/191,392 (HHS reference E-771-2013-4-US-15);
    U.S. Patent Application 61/535,668 (HHS reference E-263-2011-0-US-
01), PCT Application PCT/US2012/055034 (HHS reference E-263-2011-0-PCT-
02), Australian Patent 2012308591 (HHS reference E-263-2011-0-AU-03), 
Canadian Patent Application 2846608 (HHS reference E-263-2011-0-CA-04), 
European Patent 2755993 (HHS reference E-263-2011-0-EP-05), U.S. 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), U.S. Patent 
9,657,066 (HHS reference E-263-2011-0-US-08), U.S. Patent Application 
15/488,898 (HHS reference E-263-2011-0-US-09) and European Patent 
Application 14/927,645 (HHS reference E-263-2011-0-EP-18);
    U.S. Patent Application 61/495,085 (HHS reference E-174-2011-0-US-
01), PCT Application PCT/US2012/041234 (HHS reference E-174-2011-0-PCT-
02), Australian Patent 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 2718308 (HHS reference E-174-2011-
0-EP-07) as validated in Germany, Spain, France, the United Kingdom, 
and Italy, Hong Kong Patent Application 14105911.9 (HHS reference E-
174-2011-0-HK-08), Japanese Patent 6100764 (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 2627216 (HHS reference E-
174-2011-0-RU-12), U.S. 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), U.S. Patent 9,765,123 (HHS reference E-174-2011-0-US-
15), Australian Patent Application 2017200541 (HHS reference E-174-
2011-0-AU-16), European Patent Application 17163568.3 (HHS reference E-
174-2011-0-EP-17), Japanese Patent Application 2017-031283 (HHS 
reference E-174-2011-0-JP-18), and U.S. Patent Application 15/693,705 
(HHS reference E-174-2011/0-US-24);
    U.S. Patent Application 61/241,620 (HHS reference 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 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 reference E-269-2009-0-RU-09), and 
U.S. Patent 8,936,792 (HHS reference E-269-2009-0-US-10);
    U.S. Patent Application 60/969,929 (HHS reference 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 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, U.S. Patent 8,871,906 (HHS reference E-292-2007-0-US-06), 
European Patent 2570425 (HHS reference E-292-2007-0-EP-07) as validated 
in France, Germany, the United Kingdom, Italy and Spain, and Hong Kong 
Patent Application 13106628.2 (HHS reference E-292-2007-0-HK-08);

[[Page 26488]]

    U.S. Patent Application 60/703,798 (HHS reference 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, 
U.S. 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 3006457 (HHS reference E-262-2005/0-EP-29) as validated in 
Austria, Belgium, Germany, Spain, France, the United Kingdom, Ireland, 
Italy, the Netherlands, and Poland, European Patent 3006458 (HHS 
reference E-262-2005-0-EP-30) as validated in Austria, Belgium, 
Germany, Spain, France, the United Kingdom, Ireland, Italy, the 
Netherlands, and Poland, Australian Patent 2016202754 (HHS reference E-
262-2005-0-AU-31), and Canadian Patent Application 2941466 (HHS 
reference E-262-2005/0-CA-32);

and all continuing applications and foreign counterparts to the patents 
and applications listed above for each technology.
    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 license territory may be worldwide and 
the field of use may be limited to the following:

    ``The development and commercialization of a monospecific BCMA-
targeted immunotoxin, whereby the immunotoxin is comprised of:
    (1) the complementary determining region (CDR) sequences of 
either
    i. the anti-BCMA antibody known as BM24; or
    ii. the anti-BCMA antibody known as BM306; and
    (2) a Pseudomonas Exotoxin A-based payload consisting of a PE25 
variant with or without alterations of one or more amino acids in 
one or more B cell and/or T cell epitopes.
for the treatment of hematological malignancies.''

    The E-010-2016 technology discloses antibodies that recognize the 
BCMA (B Cell Maturation Antigen) protein. BCMA is expressed on the cell 
surface of several forms of cancer, most notably multiple myeloma. 
Although these BCMA antibodies can potentially be used in many 
therapeutic formats (e.g., unconjugated antibodies, bispecific 
antibodies (and variants thereof), antibody-drug conjugates (ADCs), 
chimeric antigen receptors (CARs), etc., to target cancer cells for 
destruction, the contemplated field of use only concerns the 
development of one specific format (recombinant immunotoxins) using one 
type of toxin variant (Pseudomonas Exotoxin A variants). Many other 
formats, and therefore fields of use, remain available for licensing 
and development.
    The E-263-2011-0, E-174-2011-0, E-269-2009-0, E-292-2007, E-262-
2005-0 and E-771-2013-0-5 technologies (i.e., ``non-E-010-2016-0 
technologies'') all concern distinct variants of Pseudomonas Exotoxin A 
which can be used in the BCMA-targeted immunotoxin. The Pseudomonas 
Exotoxin A variants represent the ``payload'' portion of the 
immunotoxin, which is the portion that instigates the destruction of 
the cancer cells that are targeted by the aforementioned BCMA 
antibodies.
    The development of a new therapeutic targeting BCMA will benefit 
public health by offering up a treatment for these cancers in instances 
when conventional first line therapies are ineffective.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license 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.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
completed license application, will not be treated confidentially, and 
may be made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: June 1, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2018-12179 Filed 6-6-18; 8:45 am]
BILLING CODE 4140-01-P