Prospective Grant of an Exclusive License: Development and Commercialization of Therapeutic Products for Breast Cancer, 9581-9582 [E8-3165]

Download as PDF Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / Notices amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Regulation of Adaptive Immunity by the Innate Immune System. Date: March 13, 2008. Time: 1:30 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6700B Rockledge Drive, MSC 3136, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Mercy R. Prabhudas, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, NIAID/NIH/DHHS, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892–7616, 301– 451–2615, mp457n@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: February 13, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08–773 Filed 2–20–08; 8:45 am] National Institutes of Health pwalker on PROD1PC71 with NOTICES National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which Jkt 214001 Dated: February 13, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08–774 Filed 2–20–08: 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive License: Development and Commercialization of Therapeutic Products for Breast Cancer National Institutes of Health, Public Health Service, HHS. ACTION: Notice. DEPARTMENT OF HEALTH AND HUMAN SERVICES 16:34 Feb 20, 2008 Name of Committee: National Institute on Aging Special Emphasis Panel; SWAN. Date: March 4, 2008. Time: 2 p.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20814 (Telephone Conference Call). Contact Person: Alicja L. Markowska, PhD, DSC, National Institute on Aging, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–496–9666, markowsa@nia.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) AGENCY: BILLING CODE: 4140–01–M VerDate Aug<31>2005 would constitute a clearly unwarranted invasion of personal privacy. SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent Application No. 09/693,600 filed October 20, 2000 entitled ‘‘Method and Composition for Enhancing Immune Response’’ [E–037–2001/1–US–01]; Japanese Patent Application No. 2002– 555834 filed October 22, 2001 entitled ‘‘Method and Composition for Enhancing Immune Response’’ [E–037– 2001/1–JP–03]; and European Patent Application No. 01989341.1 filed October 22, 2001 entitled ‘‘Method and Composition for Enhancing Immune Response’’ [E–037–2001/1–EP–04]; to ODC Therapy, Inc. The prospective exclusive license territory may be worldwide and the field of use may be limited to therapeutic applications for breast PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 9581 cancer patients expressing high levels of serum or plasma IgE. DATES: Only written comments and/or license applications which are received by the National Institutes of Health on or before April 21, 2008 will be considered. ADDRESSES: Requests for copies of the patent and/or patent applications, inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: Mojdeh Bahar, J.D., M.A., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD. 20852–3804. Telephone: (301) 435–2950; Facsimile: (301) 402– 0220; E-mail: baharm@od.nih.gov. SUPPLEMENTARY INFORMATION: The invention relates to a method of inhibiting tumor growth which comprises the administration of an IL– 13 inhibitor. Additionally, the invention relates to a method and composition for enhancing an immune response in a subject by administering to a subject an inhibitor of IL–13 or an inhibitor of an NK–T cell. The method can be used to prevent growth of a tumor in a subject, e.g., to inhibit tumor recurrence or metastasis. The method can also be used to enhance a response to a vaccine in a subject. IL–13 is an interleukin which has potent immunomodulatory effects. It is primarily secreted by TH2 lymphocytes. This invention relates to the discovery of a role for IL–13 in the down-regulation of tumor immunosurveillance. Using a mouse model in which tumors show a growthregression-recurrence pattern, the mechanisms for down-regulation of cytotoxic T lymphocyte-mediated tumor immunosurveillance was investigated. It was discovered that interleukin 4 receptor (IL–4R) knockout mice, and downstream signal transducer and activator of transcription 6 (STAT6) knockout mice, but not IL–4 knockout mice, resisted tumor recurrence. Thus, IL–13, the only other cytokine that uses the IL–4R–STAT6 pathway, was discovered to have a role in the downregulation of tumor immunosurveillance. 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 404.7. The prospective exclusive license may be granted unless within sixty (60) days from the date of this published notice, the NIH receives written evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. E:\FR\FM\21FEN1.SGM 21FEN1 9582 Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / Notices 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: February 11, 2008. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8–3165 Filed 2–20–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Regulatory Approved Clinical Diagnostics for Anti-HPV16 L1 Serum Antibody Detection in HPV Vaccine Recipients National Institutes of Health, Public Health Service, HHS. ACTION: Notice. pwalker on PROD1PC71 with NOTICES AGENCY: SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in HHS Ref. No. E– 253–1993/0 and certain foreign rights under HHS Ref. No. E–166–1992 including U.S. Patent 5,437,951, U.S. Patent 5,985,610, U.S. Patent 5,871,998, U.S. Patent 5,716,620, U.S. Patent 5,744,142, U.S. Patent 5,756,284, U.S. Patent 5,709,996, U.S. Patent Application 09/316,487, U.S. Patent Application 10/371,846, International Patent Application PCT/US93/08342, European Patent Application 93921353.4, European Patent Application 040104531.1, European Patent Application 040783235, Australian Patent 683220, Australian Patent Application 2004203609, Canadian Patent No. 2,143,845, Japanese Patent Applications 1994–507481, Japanese Patent Applications 2001– 101791 and continuation and divisional patents and patent applications thereof, entitled ‘‘Self-Assembling Recombinant Papillomavirus HPV16 Capsid Proteins,’’ to Biotrin International, Ltd., a limited liability company formed under the laws of the European Union and the Republic of Ireland. The United VerDate Aug<31>2005 16:34 Feb 20, 2008 Jkt 214001 States of America is the assignee of the patent rights of the above inventions. The contemplated exclusive license may be granted in the field of regulatory approved clinical diagnostics for serum anti-HPV16 L1 antibody detection in HPV vaccine recipients. DATE: Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before April 21, 2008 will be considered. ADDRESSES: Requests for a copy of the patent applications, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael A. Shmilovich, Esq., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–5019; Facsimile: (301) 402– 0220; E-mail: shmilovm@mail.nih.gov. A signed confidentiality nondisclosure agreement may be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: The patent applications intended for licensure disclose and/or cover the following: E–253–1993 and E–166–1992, ‘‘SelfAssembling Recombinant Papillomavirus Capsid Proteins of HPV16,’’ Lowy et al. Recombinant human papillomavirus 16 capsid proteins that are capable of self-assembly into capsomer structures and viral capsids that comprise conformational antigenic epitopes. The capsomer structures and viral capsids, consisting of the capsid proteins that are expression products of a bovine, monkey or human papillomavirus L1 conformational coding sequence proteins, can be prepared for use in ELISA or cell-based immunoassays for detecting the level of serum antibody in recipients of a vaccine against HPV16. The self-assembling capsid proteins can also be used as elements of diagnostic immunoassay procedures for papillomavirus infection. 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 404.7. The prospective exclusive license may be granted unless, within sixty (60) days from the date of this published notice, 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 404.7. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 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 14, 2008. David Sadowski, Deputy Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8–3162 Filed 2–20–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS–R9–MB–2008–N0031] Wildlife and Sport Fish Restoration Program Fish and Wildlife Service, Interior. ACTION: Notice of receipt of priority list. AGENCY: SUMMARY: We, the U.S. Fish and Wildlife Service (FWS), announce the FY 2008 priority list of wildlife and sport fish conservation projects from the Association of Fish and Wildlife Agencies (AFWA). As required by the Wildlife and Sport Fish Restoration Programs Improvement Act of 2000, AFWA submits a list of projects to us each year to consider for funding under the Multistate Conservation Grant program. We then review and award grants from this list. ADDRESSES: John C. Stremple, Multistate Conservation Grants Program Coordinator, Division of Federal Assistance, U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Mail Stop MBSP–4020, Arlington, Virginia 22203. FOR FURTHER INFORMATION CONTACT: John C. Stremple, (703) 358–2156 (phone) or John_Stremple@fws.gov (e-mail). SUPPLEMENTARY INFORMATION: The Wildlife and Sport Fish Restoration Programs Improvement Act of 2000 (Improvement Act, Pub. L. 106–408) amended the Pittman-Robertson Wildlife Restoration Act (16 U.S.C. 669 et seq.) and the Dingell-Johnson Sport Fish Restoration Act (16 U.S.C. 777 et seq.) and established the Multistate Conservation Grant Program. The Improvement Act authorizes us to award grants of up to $3 million annually from funds available under each of the Restoration Acts, for a total of up to $6 million annually. We may award grants from a list of priority projects recommended to us by AFWA. The FWS Director, exercising the E:\FR\FM\21FEN1.SGM 21FEN1

Agencies

[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Notices]
[Pages 9581-9582]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive License: Development and 
Commercialization of Therapeutic Products for Breast Cancer

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

ACTION: Notice.

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

SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 
Part 404.7(a)(1)(i), announces that the Department of Health and Human 
Services is contemplating the grant of an exclusive license to practice 
the inventions embodied in U.S. Patent Application No. 09/693,600 filed 
October 20, 2000 entitled ``Method and Composition for Enhancing Immune 
Response'' [E-037-2001/1-US-01]; Japanese Patent Application No. 2002-
555834 filed October 22, 2001 entitled ``Method and Composition for 
Enhancing Immune Response'' [E-037-2001/1-JP-03]; and European Patent 
Application No. 01989341.1 filed October 22, 2001 entitled ``Method and 
Composition for Enhancing Immune Response'' [E-037-2001/1-EP-04]; to 
ODC Therapy, Inc.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to therapeutic applications for breast 
cancer patients expressing high levels of serum or plasma IgE.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before April 21, 
2008 will be considered.

ADDRESSES: Requests for copies of the patent and/or patent 
applications, inquiries, comments and other materials relating to the 
contemplated exclusive license should be directed to: Mojdeh Bahar, 
J.D., M.A., Technology Licensing Specialist, Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD. 20852-3804. Telephone: (301) 435-2950; 
Facsimile: (301) 402-0220; E-mail: baharm@od.nih.gov.

SUPPLEMENTARY INFORMATION: The invention relates to a method of 
inhibiting tumor growth which comprises the administration of an IL-13 
inhibitor. Additionally, the invention relates to a method and 
composition for enhancing an immune response in a subject by 
administering to a subject an inhibitor of IL-13 or an inhibitor of an 
NK-T cell. The method can be used to prevent growth of a tumor in a 
subject, e.g., to inhibit tumor recurrence or metastasis. The method 
can also be used to enhance a response to a vaccine in a subject. IL-13 
is an interleukin which has potent immunomodulatory effects. It is 
primarily secreted by TH2 lymphocytes. This invention relates to the 
discovery of a role for IL-13 in the down-regulation of tumor 
immunosurveillance. Using a mouse model in which tumors show a growth-
regression-recurrence pattern, the mechanisms for down-regulation of 
cytotoxic T lymphocyte-mediated tumor immunosurveillance was 
investigated. It was discovered that interleukin 4 receptor (IL-4R) 
knockout mice, and downstream signal transducer and activator of 
transcription 6 (STAT6) knockout mice, but not IL-4 knockout mice, 
resisted tumor recurrence. Thus, IL-13, the only other cytokine that 
uses the IL-4R-STAT6 pathway, was discovered to have a role in the 
down-regulation of tumor immunosurveillance.
    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 404.7. 
The prospective exclusive license may be granted unless within sixty 
(60) days from the date of this published notice, the NIH receives 
written evidence and argument that establish that the grant of the 
license would not be consistent with the requirements of 35 U.S.C. 209 
and 37 CFR 404.7.

[[Page 9582]]

    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: February 11, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-3165 Filed 2-20-08; 8:45 am]
BILLING CODE 4140-01-P
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