Prospective Grant of Exclusive License: The Development of Human Anti-Mesothelin Monoclonal Antibodies for the Treatment of Human Cancers, 63317 [2011-26342]

Download as PDF Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices Dated: October 4, 2011. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2011–26343 Filed 10–11–11; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health Prospective Grant of Exclusive License: The Development of Human Anti-Mesothelin Monoclonal Antibodies for the Treatment of Human Cancers National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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 U.S. Patent Application 61/040,005 entitled ‘‘Human Monoclonal Antibodies Specific for Mesothelin’’ [HHS Ref. E–079–2008/0– US–01], PCT Application PCT/US2009/ 038228 entitled ‘‘Human Monoclonal Antibody Against Mesothelin’’ [HHS Ref. E–079–2008/0–PCT–02], Australian patent application AU 2009228361 entitled ‘‘Human Monoclonal Antibody Against Mesothelin’’ [HHS Ref. E–079– 2008/0–AU–03], Canadian patent application CA 2718321 entitled ‘‘Human Anti-Mesothelin Monoclonal Antibodies’’ [HHS Ref. E–079–2008/0– CA–04], European patent application EP 09726082.2 entitled ‘‘Human Monoclonal Antibody Against Mesothelin’’ [HHS Ref. E–079–2008/0– EP–05], U.S. patent application 12/934,060 entitled ‘‘Human AntiMesothelin Monoclonal Antibodies ’’ [HHS Ref. E–079–2008/0–US–06], and all related continuing and foreign patents/patent applications for the technology family, to Sanomab, Ltd. The patent rights in these inventions have been assigned to and/or exclusively licensed 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: jlentini on DSK4TPTVN1PROD with NOTICES The use of the monoclonal antibody m912 (SM–101) as an antibody therapy for the treatment of pancreatic cancer, ovarian cancer, lung cancer, mesothelioma, and stomach/gastric cancer. The Licensed Field of Use explicitly excludes the use of the Jkt 226001 Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: David A. Lambertson, Ph.D., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–4632; Facsimile: (301) 402– 0220; E-mail: lambertsond@od.nih.gov. This invention concerns a monoclonal antibody and methods of using the antibody for the treatment of mesothelin-expressing cancers, including mesothelioma, lung cancer, stomach/gastric cancer, ovarian cancer and pancreatic cancer. The specific antibody covered by this technology is designated m912 (SM–101), which is a fully human monoclonal antibody against mesothelin. Mesothelin is a cell surface antigen that is preferentially expressed on certain types of cancer cells. The m912 antibody can selectively bind to these cancer cells and induce cell death while leaving healthy, essential cells unharmed. This can result in an effective therapeutic strategy with fewer side effects due to less non-specific killing of cells.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 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 within thirty (30) days from the date of this published notice. Complete 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. SUPPLEMENTARY INFORMATION: SUMMARY: 17:43 Oct 11, 2011 Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before November 14, 2011 will be considered. DATES: Dated: October 4, 2011. Richard U. Rodriguez, Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2011–26342 Filed 10–11–11; 8:45 am] BILLING CODE 4140–01–P ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Mar<15>2010 antibody in the form of an immunoconjugate, including, but not limited to, immunotoxins. 63317 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA–4031– DR; Docket ID FEMA–2011–0001] New York; Major Disaster and Related Determinations Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: This is a notice of the Presidential declaration of a major disaster for the State of New York (FEMA–4031–DR), dated September 13, 2011, and related determinations. DATES: Effective Date: September 13, 2011. FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated September 13, 2011, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ‘‘Stafford Act’’), as follows: SUMMARY: I have determined that the damage in certain areas of the State of New York resulting from the Remnants of Tropical Storm Lee beginning on September 7, 2011, and continuing, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ‘‘Stafford Act’’). Therefore, I declare that such a major disaster exists in the State of New York. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Individual Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration for the approved E:\FR\FM\12OCN1.SGM 12OCN1

Agencies

[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Page 63317]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26342]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of Human 
Anti-Mesothelin Monoclonal Antibodies for the Treatment of Human 
Cancers

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 U.S. 
Patent Application 61/040,005 entitled ``Human Monoclonal Antibodies 
Specific for Mesothelin'' [HHS Ref. E-079-2008/0-US-01], PCT 
Application PCT/US2009/038228 entitled ``Human Monoclonal Antibody 
Against Mesothelin'' [HHS Ref. E-079-2008/0-PCT-02], Australian patent 
application AU 2009228361 entitled ``Human Monoclonal Antibody Against 
Mesothelin'' [HHS Ref. E-079-2008/0-AU-03], Canadian patent application 
CA 2718321 entitled ``Human Anti-Mesothelin Monoclonal Antibodies'' 
[HHS Ref. E-079-2008/0-CA-04], European patent application EP 
09726082.2 entitled ``Human Monoclonal Antibody Against Mesothelin'' 
[HHS Ref. E-079-2008/0-EP-05], U.S. patent application 12/934,060 
entitled ``Human Anti-Mesothelin Monoclonal Antibodies '' [HHS Ref. E-
079-2008/0-US-06], and all related continuing and foreign patents/
patent applications for the technology family, to Sanomab, Ltd. The 
patent rights in these inventions have been assigned to and/or 
exclusively licensed 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 use of the monoclonal antibody m912 (SM-101) as an antibody 
therapy for the treatment of pancreatic cancer, ovarian cancer, lung 
cancer, mesothelioma, and stomach/gastric cancer. The Licensed Field 
of Use explicitly excludes the use of the antibody in the form of an 
immunoconjugate, including, but not limited to, immunotoxins.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
November 14, 2011 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: David A. Lambertson, Ph.D., Senior 
Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 
402-0220; E-mail: lambertsond@od.nih.gov.

SUPPLEMENTARY INFORMATION: This invention concerns a monoclonal 
antibody and methods of using the antibody for the treatment of 
mesothelin-expressing cancers, including mesothelioma, lung cancer, 
stomach/gastric cancer, ovarian cancer and pancreatic cancer. The 
specific antibody covered by this technology is designated m912 (SM-
101), which is a fully human monoclonal antibody against mesothelin.
    Mesothelin is a cell surface antigen that is preferentially 
expressed on certain types of cancer cells. The m912 antibody can 
selectively bind to these cancer cells and induce cell death while 
leaving healthy, essential cells unharmed. This can result in an 
effective therapeutic strategy with fewer side effects due to less non-
specific killing of cells.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 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 within thirty 
(30) days from the date of this published notice.
    Complete 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: October 4, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-26342 Filed 10-11-11; 8:45 am]
BILLING CODE 4140-01-P
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