83_FR_26597 83 FR 26487 - Prospective Grant of an Exclusive Patent License: The Development of an Anti-BCMA Immunotoxin for the Treatment of Human Cancer

83 FR 26487 - Prospective Grant of an Exclusive Patent License: The Development of an Anti-BCMA Immunotoxin for the Treatment of Human Cancer

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 110 (June 7, 2018)

Page Range26487-26488
FR Document2018-12179

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.

Federal Register, Volume 83 Issue 110 (Thursday, June 7, 2018) 
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26487-26488]
From the Federal Register Online  [www.thefederalregister.org]
[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: david.lambertson@nih.gov.

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

Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26487 Dated: June 1, 2018. (HHS reference E–771–2013–1–US–01), reference E–174–2011–0–KR–10), Sylvia L. Neal, U.S. Patent Application 61/982,051 Mexican Patent Application MX/a/ Program Analyst, Office of Federal Advisory (HHS reference E–771–2013–2–US–01), 2013/014388 (HHS reference E–174– Committee Policy. U.S. Patent Application 61/052,665 2011–0–MX–11), Russian Patent [FR Doc. 2018–12175 Filed 6–6–18; 8:45 am] (HHS reference E–771–2013–3–US–01), 2627216 (HHS reference E–174–2011– BILLING CODE 4140–01–P PCT Application PCT/US2014/058941 0–RU–12), U.S. Patent 9,346,859 (HHS (HHS reference E–771–2013–4–PCT– reference E–174–2011–0–US–13), Hong 01), U.S. Patent 9,388,222 (HHS Kong Patent Application 14106689.7 DEPARTMENT OF HEALTH AND reference E–771–2013–4–US–02), (HHS reference E–174–2011–0–HK–14), HUMAN SERVICES Australian Patent Application U.S. Patent 9,765,123 (HHS reference E– 2014329437 (HHS reference E–771– 174–2011–0–US–15), Australian Patent National Institutes of Health 2013–4–AU–08), Canadian Patent Application 2017200541 (HHS reference Application 2926215 (HHS reference E– E–174–2011–0–AU–16), European Prospective Grant of an Exclusive 771–2013–4–CA–09), Chinese Patent Patent Application 17163568.3 (HHS Patent License: The Development of an Application 201480062185.7 (HHS reference E–174–2011–0–EP–17), Anti-BCMA Immunotoxin for the Reference E–771–2013–4–CN–10), Japanese Patent Application 2017– Treatment of Human Cancer European Patent Application 031283 (HHS reference E–174–2011–0– AGENCY: National Institutes of Health, 14789449.7 (HHS reference E–771– JP–18), and U.S. Patent Application 15/ Department of Health and Human 2013–4–EP–11), Indian Patent 693,705 (HHS reference E–174–2011/0– Services. Application 201647015226 (HHS US–24); reference E–771–2013–4–IN–12), U.S. Patent Application 61/241,620 ACTION: Notice. Russian Patent Application 2016114406 (HHS reference E–269–2009–0–US–01), SUMMARY: The National Cancer Institute, (HHS reference E–771–2013–4–RU–13), PCT Application PCT/US2010/048504 an institute of the National Institutes of Japanese Patent Application (HHS (HHS reference E–269–2009–0–PCT– Health, Department of Health and reference E–771–2013–4–JP–14), and 02), Australian Patent 2010292069 (HHS Human Services, is contemplating the U.S. Patent Application 15/191,392 reference E–269–2009–0–AU–03), grant of an Exclusive Patent License to (HHS reference E–771–2013–4–US–15); Canadian Patent 2773665 (HHS practice the inventions embodied in the U.S. Patent Application 61/535,668 reference E–269–2009–0–CA–04), Patents and Patent Applications listed (HHS reference E–263–2011–0–US–01), Chinese Patent 201080049559.3 (HHS in the SUPPLEMENTARY INFORMATION PCT Application PCT/US2012/055034 reference E–269–2009–0–CN–05), section of this notice to BEORO (HHS reference E–263–2011–0–PCT– European Patent 2475398 (HHS Therapeutics, GmbH. (‘‘Beoro’’) located 02), Australian Patent 2012308591 (HHS reference E–269–2009–0–EP–06), as in Seefeld, Germany. reference E–263–2011–0–AU–03), validated in France, Germany, Italy, Canadian Patent Application 2846608 Spain and the United Kingdom, Indian DATES: Only written comments and/or (HHS reference E–263–2011–0–CA–04), Patent Application 3197/CHENP/2012 complete applications for a license European Patent 2755993 (HHS (HHS reference E–269–2009–0–IN–07), which are received by the National reference E–263–2011–0–EP–05), U.S. Japanese Patent 5795765 (HHS reference Cancer Institute’s Technology Transfer Patent 9,206,240 (HHS reference E–263– E–269–2009–0–JP–08), Russian Patent Center on or before June 22, 2018 will 2011–0–US–06), Hong Kong Patent Application 2012114005 (HHS reference be considered. Application 14111650.2 (HHS reference E–269–2009–0–RU–09), and U.S. Patent ADDRESSES: Requests for copies of the E–263–2011–0–HK–07), U.S. Patent 8,936,792 (HHS reference E–269–2009– patent application, inquiries, and 9,657,066 (HHS reference E–263–2011– 0–US–10); comments relating to the contemplated 0–US–08), U.S. Patent Application 15/ U.S. Patent Application 60/969,929 an Exclusive Patent License should be 488,898 (HHS reference E–263–2011–0– (HHS reference E–292–2007–0–US–01), directed to: David A. Lambertson, Ph.D., US–09) and European Patent PCT Application PCT/US2008/075296 Senior Technology Transfer Manager, Application 14/927,645 (HHS reference (HHS reference E–292–2007–0–PCT– NCI Technology Transfer Center, 9609 E–263–2011–0–EP–18); 02), Australian Patent 2008296194 (HHS Medical Center Drive, RM 1E530 MSC U.S. Patent Application 61/495,085 reference E–292–2007–0–AU–03), 9702, Bethesda, MD 20892–9702 (for (HHS reference E–174–2011–0–US–01), Canadian Patent 2698357 (HHS business mail), Rockville, MD 20850– PCT Application PCT/US2012/041234 reference E–292–2007–0–CA–04), 9702 Telephone: (240)–276–5530; (HHS reference E–174–2011–0–PCT– European Patent 2197903 (HHS Facsimile: (240)–276–5504 Email: 02), Australian Patent 2012268013 (HHS reference E–292–2007–0–EP–05) as david.lambertson@nih.gov. reference E–174–2011–0–AU–03), validated in Austria, Belgium, Bulgaria, SUPPLEMENTARY INFORMATION: Brazilian Patent Application Switzerland, Cyprus, Germany, 112013031262–9 (HHS reference E– Denmark, Estonia, Spain, Finland, Intellectual Property 174–2011–0–BR–04), Canadian Patent France, the United Kingdom, Greece, The following represents the Application 2838013 (HHS reference E– Croatia, Hungary, Ireland, Italy, intellectual property to be licensed 174–2011–0–CA–05), Chinese Patent Lithuania, Luxembourg, Latvia, Monaco, under the prospective agreement: Application 201280039071.1 (HHS Malta, the Netherlands, Norway, U.S. Patent Application 62/255,255 reference E–174–2011–0–CN–06), Poland, Portugal, Romania, Slovenia, (HHS reference E–010–2016–0–US–01), European Patent 2718308 (HHS Slovakia, and Turkey, U.S. Patent sradovich on DSK3GMQ082PROD with NOTICES U.S. Patent Application 62/257,493 reference E–174–2011–0–EP–07) as 8,871,906 (HHS reference E–292–2007– (HHS reference E–010–2016–1–US–01), validated in Germany, Spain, France, 0–US–06), European Patent 2570425 and PCT Patent Application PCT/ the United Kingdom, and Italy, Hong (HHS reference E–292–2007–0–EP–07) US2016/061320 (HHS reference E–010– Kong Patent Application 14105911.9 as validated in France, Germany, the 2016–2–PCT–01); (HHS reference E–174–2011–0–HK–08), United Kingdom, Italy and Spain, and U.S. Patent Application 61/887,418 Japanese Patent 6100764 (HHS reference Hong Kong Patent Application (HHS reference E–771–2013–0–US–01), E–174–2011–0–JP–09), South Korean 13106628.2 (HHS reference E–292– U.S. Patent Application 61/908,464 Patent Application 2013–7032402 (HHS 2007–0–HK–08); VerDate Sep<11>2014 17:19 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1

26488 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices U.S. Patent Application 60/703,798 (2) a Pseudomonas Exotoxin A-based presumed to contain business (HHS reference E–262–2005–0–US–01), payload consisting of a PE25 variant with or confidential information and any release PCT Application PCT/US2006/028986 without alterations of one or more amino of information in these license acids in one or more B cell and/or T cell (HHS reference E–262–2005–0–PCT– applications will be made only as epitopes. 02), Australian Patent 2006275865 (HHS for the treatment of hematological required and upon a request under the reference E–262–2005–0–AU–03), malignancies.’’ Freedom of Information Act, 5 U.S.C. Canadian Patent 2616987 (HHS 552. reference E–262–2005–0–CA–04), The E–010–2016 technology discloses antibodies that recognize the BCMA (B Dated: June 1, 2018. European Patent 1910407 (HHS Cell Maturation Antigen) protein. Richard U. Rodriguez, reference E–262–2005–0–EP–05) as validated in Switzerland, Germany, BCMA is expressed on the cell surface Associate Director, Technology Transfer of several forms of cancer, most notably Center, National Cancer Institute. Spain, France, the United Kingdom, and Italy, U.S. Patent 8,907,060 (HHS multiple myeloma. Although these [FR Doc. 2018–12179 Filed 6–6–18; 8:45 am] reference E–262–2005–0–US–06), BCMA antibodies can potentially be BILLING CODE 4140–01–P European Patent 2311854 (HHS used in many therapeutic formats (e.g., reference E–262–2005–0–EP–07) as unconjugated antibodies, bispecific validated in Switzerland, Germany, antibodies (and variants thereof), DEPARTMENT OF HEALTH AND Spain, France, the United Kingdom, and antibody-drug conjugates (ADCs), HUMAN SERVICES Italy, European Patent 2332970 (HHS chimeric antigen receptors (CARs), etc., to target cancer cells for destruction, the National Institutes of Health reference E–262–2005–0–EP–08) as validated in Germany, Spain, France, contemplated field of use only concerns the development of one specific format National Institute of Nursing Research; the United Kingdom, and Italy, Notice to Close Meeting Australian Patent 2012216642 (HHS (recombinant immunotoxins) using one reference E–262–2005–0–AU–15), type of toxin variant (Pseudomonas Exotoxin A variants). Many other Pursuant to section 10(d) of the Australian Patent 2014208269 (HHS Federal Advisory Committee Act, as reference E–262–2005–0–AU–22), formats, and therefore fields of use, remain available for licensing and amended, notice is hereby given of the European Patent Application following meeting. 15191388.6 (HHS reference E–262– development. The E–263–2011–0, E–174–2011–0, The meeting will be closed to the 2005–0–EP–28), European Patent E–269–2009–0, E–292–2007, E–262– public in accordance with the 3006457 (HHS reference E–262–2005/0– 2005–0 and E–771–2013–0–5 provisions set forth in sections EP–29) as validated in Austria, Belgium, technologies (i.e., ‘‘non-E–010–2016–0 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Germany, Spain, France, the United technologies’’) all concern distinct as amended. The grant applications and Kingdom, Ireland, Italy, the variants of Pseudomonas Exotoxin A the discussions could disclose Netherlands, and Poland, European which can be used in the BCMA- confidential trade secrets or commercial Patent 3006458 (HHS reference E–262– targeted immunotoxin. The property such as patentable material, 2005–0–EP–30) as validated in Austria, Pseudomonas Exotoxin A variants and personal information concerning Belgium, Germany, Spain, France, the represent the ‘‘payload’’ portion of the individuals associated with the grant United Kingdom, Ireland, Italy, the immunotoxin, which is the portion that applications, the disclosure of which Netherlands, and Poland, Australian instigates the destruction of the cancer would constitute a clearly unwarranted Patent 2016202754 (HHS reference E– cells that are targeted by the invasion of personal privacy. 262–2005–0–AU–31), and Canadian aforementioned BCMA antibodies. Name of Committee: National Institute of Patent Application 2941466 (HHS The development of a new reference E–262–2005/0–CA–32); Nursing Research Special Emphasis Panel; therapeutic targeting BCMA will benefit Multicenter Clinical Grants. and all continuing applications and public health by offering up a treatment Date: June 6, 2018. foreign counterparts to the patents and for these cancers in instances when Time: 8:00 a.m. to 5:00 p.m. applications listed above for each conventional first line therapies are Agenda: To review and evaluate grant technology. ineffective. applications. With respect to persons who have an This notice is made in accordance Place: Bethesda Marriott Suites, 6711 with 35 U.S.C. 209 and 37 CFR part 404. Democracy Boulevard, Bethesda, MD 20817. obligation to assign their right, title and The prospective exclusive license will Contact Person: Tamizchelvi Thyagarajan, interest to the Government of the United Ph.D., Scientific Review Officer, National States of America, the patent rights in be royalty bearing, and the prospective Institute of Nursing Research, National these inventions have been assigned to exclusive license may be granted unless Institutes of Health, 6701 Democracy the Government of the United States of within fifteen (15) days from the date of Boulevard, Bethesda, MD 20892, (301) 594– America. this published notice, the National 0343, Tamizchelvi.thagarajan@nih.gov. The prospective exclusive license Cancer Institute receives written This notice is being published less than 15 territory may be worldwide and the evidence and argument that establishes days prior to the meeting due to the timing field of use may be limited to the that the grant of the license would not limitations imposed by the review and following: be consistent with the requirements of funding cycle. 35 U.S.C. 209 and 37 CFR part 404. (Catalogue of Federal Domestic Assistance ‘‘The development and commercialization In response to this Notice, the public Program Nos. 93.361, Nursing Research, of a monospecific BCMA-targeted sradovich on DSK3GMQ082PROD with NOTICES may file comments or objections. National Institutes of Health, HHS) immunotoxin, whereby the immunotoxin is Comments and objections, other than comprised of: Dated: June 1, 2018. (1) the complementary determining region those in the form of a completed license application, will not be treated Sylvia L. Neal, (CDR) sequences of either confidentially, and may be made Program Analyst, Office of Federal Advisory i. the anti-BCMA antibody known as publicly available. Committee Policy. BM24; or ii. the anti-BCMA antibody known as License applications submitted in [FR Doc. 2018–12178 Filed 6–6–18; 8:45 am] BM306; and response to this Notice will be BILLING CODE 4140–01–P VerDate Sep<11>2014 17:19 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00079 Fmt 4703 Sfmt 9990 E:\FR\FM\07JNN1.SGM 07JNN1


Document Created: 2018-06-07 00:49:39
Document Modified: 2018-06-07 00:49:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly 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.
FR Citation83 FR 26487 
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