81_FR_66233 81 FR 66047 - Prospective Grant of Exclusive Patent License: Development of Adeno-Associated Virus-Based Vectors for the Treatment of Menkes Disease and Related Copper Transport Disorders

81 FR 66047 - Prospective Grant of Exclusive Patent License: Development of Adeno-Associated Virus-Based Vectors for the Treatment of Menkes Disease and Related Copper Transport Disorders

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 186 (September 26, 2016)

Page Range66047-66048
FR Document2016-23134

The Eunice Kennedy Shriver National Institute of Child Health and Human Development, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to Cyprium Therapeutics, Inc. (``Cyprium'') located in New York, NY, USA.

Federal Register, Volume 81 Issue 186 (Monday, September 26, 2016) 
[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Notices]
[Pages 66047-66048]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23134]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Development of 
Adeno-Associated Virus-Based Vectors for the Treatment of Menkes 
Disease and Related Copper Transport Disorders

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The Eunice Kennedy Shriver National Institute of Child Health 
and Human Development, an institute of the National Institutes of 
Health, Department of Health and Human Services, is contemplating the 
grant of an Exclusive Commercialization Patent License to practice the 
inventions embodied in the U.S. Patents and Patent Applications listed 
in the Supplementary Information section of this notice to Cyprium 
Therapeutics, Inc. (``Cyprium'') located in New York, NY, USA.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before October 11, 2016 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Commercialization 
Patent License should be directed to: Surekha Vathyam, 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) 276-5530; 
Facsimile: (240) 276-5504; Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    United States Provisional Patent Application No. 62/244,594, filed 
October 21, 2015 and entitled ``Codon-optimized Reduced-size ATP7A cDNA 
and Uses for Treatment of Copper Transport Disorders'' [HHS Reference 
No. E-062-2015/0-US-01].
    The patent rights in these inventions have been assigned 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 Licensed Patent Rights 
for the following: ``Development and commercialization of adeno-
associated virus-based vectors for the treatment of Menkes Disease and 
related copper transport disorders.''
    This technology discloses a codon-optimized reduced-size Adenosine 
Triphosphate 7A (ATP7-alpha or ATP7A) cDNA, vectors, and recombinant 
adeno-associated viruses (AAVs) and uses thereof for treatment of 
copper transport disorders. Such uses, include the administration of 
copper in addition to ATP7A in order to maximize the advantage of the 
gene therapy.
    Human P-type ATPase copper-transporting ATPase 1 (ATP7A) transports 
copper from enterocytes (where it is taken up from dietary copper) into 
the blood. ATP7A also mediates passage of copper across the blood-
cerebrospinal fluid barrier and the blood-brain barrier. In Menkes 
disease and occipital horn syndrome (OHS), ATP7A activity is reduced or 
absent and copper export from the enterocytes is impaired. As a result, 
copper accumulates in intestinal cells and less copper is delivered to 
the blood, resulting in restricted copper supply to other tissues, 
particularly the brain. If successfully developed, this invention would 
be a first of its kind therapy for treating copper transport disorders, 
such as Menkes disease, OHS, or ATP7A-related distal motor neuropathy, 
by administering the disclosed nucleic acid, vector, or recombinant 
virus to a subject with a copper transport disorder.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Exclusive Commercialization 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

[[Page 66048]]

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 filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Commercialization Patent 
License Agreement. 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: September 21, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-23134 Filed 9-23-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 186 / Monday, September 26, 2016 / Notices 66047 Review Group; Macromolecular Structure Health, 6701 Rockledge Drive, Room 6210, Intellectual Property and Function A Study Section. MSC 7804, Bethesda, MD 20892, 301–435– Date: October 25–26, 2016. 1211, quadris@csr.nih.gov. United States Provisional Patent Time: 8:00 a.m. to 6:00 p.m. (Catalogue of Federal Domestic Assistance Application No. 62/244,594, filed Agenda: To review and evaluate grant Program Nos. 93.306, Comparative Medicine; October 21, 2015 and entitled ‘‘Codon- applications. optimized Reduced-size ATP7A cDNA 93.333, Clinical Research, 93.306, 93.333, Place: Hyatt Regency Bethesda, One and Uses for Treatment of Copper Bethesda Metro Center, 7400 Wisconsin 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Transport Disorders’’ [HHS Reference Avenue, Bethesda, MD 20814. Contact Person: Nitsa Rosenzweig, Ph.D., Institutes of Health, HHS) No. E–062–2015/0–US–01]. Scientific Review Officer, Center for Dated: September 21, 2016. The patent rights in these inventions Scientific Review, National Institutes of Natasha M. Copeland, have been assigned and/or exclusively Health, 6701 Rockledge Drive, Room 4152, licensed to the government of the MSC 7760, Bethesda, MD 20892, (301) 404– Program Analyst, Office of Federal Advisory United States of America. 7419, rosenzweign@csr.nih.gov. Committee Policy. [FR Doc. 2016–23135 Filed 9–23–16; 8:45 am] The prospective exclusive license Name of Committee: Cell Biology territory may be worldwide and the Integrated Review Group; Biology of the BILLING CODE 4140–01–P field of use may be limited to the use Visual System Study Section. Date: October 25–26, 2016. of Licensed Patent Rights for the Time: 8:00 a.m. to 3:00 p.m. DEPARTMENT OF HEALTH AND following: ‘‘Development and Agenda: To review and evaluate grant HUMAN SERVICES commercialization of adeno-associated applications. virus-based vectors for the treatment of Place: Hilton Washington/Rockville, 1750 National Institutes of Health Menkes Disease and related copper Rockville Pike, Rockville, MD 20852. transport disorders.’’ Contact Person: Michael H. Chaitin, Ph.D., Prospective Grant of Exclusive Patent This technology discloses a codon- Scientific Review Officer, Center for License: Development of Adeno- optimized reduced-size Adenosine Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5202, Associated Virus-Based Vectors for Triphosphate 7A (ATP7-alpha or MSC 7850, Bethesda, MD 20892, (301) 435– the Treatment of Menkes Disease and ATP7A) cDNA, vectors, and 0910, chaitinm@csr.nih.gov. Related Copper Transport Disorders recombinant adeno-associated viruses Name of Committee: Center for Scientific (AAVs) and uses thereof for treatment of Review Special Emphasis Panel; Member AGENCY: National Institutes of Health, copper transport disorders. Such uses, Conflict: Developing and Adult Neural HHS. include the administration of copper in Circuits. ACTION: Notice. addition to ATP7A in order to maximize Date: October 25, 2016. the advantage of the gene therapy. Time: 11:00 a.m. to 3:00 p.m. Human P-type ATPase copper- Agenda: To review and evaluate grant SUMMARY: The Eunice Kennedy Shriver applications. National Institute of Child Health and transporting ATPase 1 (ATP7A) Place: National Institutes of Health, 6701 Human Development, an institute of the transports copper from enterocytes Rockledge Drive, Bethesda, MD 20892 National Institutes of Health, (where it is taken up from dietary (Virtual Meeting). Department of Health and Human copper) into the blood. ATP7A also Contact Person: Jana Drgonova, Ph.D., Services, is contemplating the grant of mediates passage of copper across the Scientific Review Officer, Center for an Exclusive Commercialization Patent blood-cerebrospinal fluid barrier and Scientific Review, National Institutes of the blood-brain barrier. In Menkes Health, 6701 Rockledge Drive, Room 5213, License to practice the inventions embodied in the U.S. Patents and Patent disease and occipital horn syndrome Bethesda, MD 20892, jdrgonova@ (OHS), ATP7A activity is reduced or mail.nih.gov. Applications listed in the Supplementary Information section of absent and copper export from the Name of Committee: Center for Scientific enterocytes is impaired. As a result, Review Special Emphasis Panel; Research this notice to Cyprium Therapeutics, Resource: Advanced NMR Technology. Inc. (‘‘Cyprium’’) located in New York, copper accumulates in intestinal cells Date: October 25–27, 2016. NY, USA. and less copper is delivered to the Time: 7:00 p.m. to 1:00 p.m. blood, resulting in restricted copper Agenda: To review and evaluate grant DATES: Only written comments and/or supply to other tissues, particularly the applications. applications for a license which are brain. If successfully developed, this Place: Residence Inn Tallahassee received by the National Cancer invention would be a first of its kind Universities at Capitol, 600 W. Gaines St., Institute’s Technology Transfer Center therapy for treating copper transport Tallahassee, FL 32304. on or before October 11, 2016 will be disorders, such as Menkes disease, OHS, Contact Person: Marie-Jose Belanger, Ph.D., considered. or ATP7A-related distal motor Scientific Review Officer, Center for Scientific Review, National Institutes of neuropathy, by administering the ADDRESSES: Requests for copies of the disclosed nucleic acid, vector, or Health, 6701 Rockledge Drive, Room 5181, patent application, inquiries, and Bethesda, MD 20892, belangerm@csr.nih.gov. recombinant virus to a subject with a comments relating to the contemplated copper transport disorder. Name of Committee: Center for Scientific Exclusive Commercialization Patent Review Special Emphasis Panel; Member This notice is made in accordance License should be directed to: Surekha Conflict: Cancer Immunotherapy. with 35 U.S.C. 209 and 37 CFR part 404. Date: October 25, 2016. Vathyam, Ph.D., Senior Licensing and The prospective Exclusive Time: 12:00 p.m. to 2:00 p.m. Patenting Manager, NCI Technology Commercialization Patent License will mstockstill on DSK3G9T082PROD with NOTICES Agenda: To review and evaluate grant Transfer Center, 9609 Medical Center be royalty bearing and may be granted applications. Drive, RM 1E530 MSC 9702, Bethesda, unless within fifteen (15) days from the Place: National Institutes of Health, 6701 MD 20892–9702 (for business mail), Rockledge Drive, Bethesda, MD 20892 date of this published notice, the Rockville, MD 20850–9702; Telephone: (Telephone Conference Call). National Cancer Institute receives (240) 276–5530; Facsimile: (240) 276– Contact Person: Syed M. Quadri, Ph.D., written evidence and argument that 5504; Email: vathyams@mail.nih.gov. Scientific Review Officer, Center for establishes that the grant of the license Scientific Review, National Institutes of SUPPLEMENTARY INFORMATION: would not be consistent with the VerDate Sep<11>2014 19:40 Sep 23, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1

66048 Federal Register / Vol. 81, No. 186 / Monday, September 26, 2016 / Notices requirements of 35 U.S.C. 209 and 37 No. 61/771,251 filed March 1, 2013, inspection and, to the extent permitted CFR part 404. entitled ‘‘Methods of Producing by law, will not be released under the Complete applications for a license in Enriched Populations of Tumor Reactive Freedom of Information Act, 5 U.S.C. the prospective field of use that are filed T Cells from Peripheral Blood’’ [HHS 552. in response to this notice will be treated Reference No. E–085–2013/0–US–01]; Dated: September 20, 2016. as objections to the grant of the and PCT Application No. PCT/US2013/ Richard U. Rodriguez, contemplated Exclusive 038813 filed April 30, 2013 entitled Commercialization Patent License Associate Director, Technology Transfer ‘‘Methods of Producing Enriched Center, National Cancer Institute. Agreement. Comments and objections Populations of Tumor Reactive T Cells submitted to this notice will not be [FR Doc. 2016–23048 Filed 9–23–16; 8:45 am] from Peripheral Blood’’ [HHS Reference made available for public inspection No. E–085–2013/0–PCT–02] (and U.S. BILLING CODE 4140–01–P and, to the extent permitted by law, will and foreign patent applications claiming not be released under the Freedom of priority to the aforementioned Information Act, 5 U.S.C. 552. applications). DEPARTMENT OF HEALTH AND The patent rights in these inventions HUMAN SERVICES Dated: September 21, 2016. Richard U. Rodriguez, have been assigned to the government of National Institutes of Health the United States of America. Associate Director, Technology Transfer Center, National Cancer Institute. The prospective Start-up Exclusive National Institute of Neurological Evaluation Patent License territory may Disorders and Stroke [FR Doc. 2016–23134 Filed 9–23–16; 8:45 am] be worldwide and the field of use may BILLING CODE 4140–01–P Pursuant to section 10(a) of the be limited to the development, manufacture and commercialization of Federal Advisory Committee Act, as autologous tumor-reactive peripheral amended (5 U.S.C. App.), notice is DEPARTMENT OF HEALTH AND hereby given of an Interagency Pain blood T cell therapy products as set HUMAN SERVICES Research Coordinating Committee forth in the Licensed Patent Rights for National Institutes of Health the treatment of metastatic follicular (IPRCC) meeting. thyroid cancer and metastatic soft tissue The meeting will feature invited Prospective Grant of Start-Up sarcomas in humans. speakers and discussions of committee Exclusive Evaluation Patent License: The present invention describes a business items including a progress Development of Autologous Tumor- method of selecting highly tumor- report on implementation of the reactive T Cells Isolated From reactive T cells from autologous National Pain Strategy, updates on the Peripheral Blood for the Treatment of peripheral blood samples based on the Federal Pain Research Strategy and new Metastatic Follicular Thyroid Cancer expression of two specific T cell surface pain initiatives. and Metastatic Soft Tissue Sarcomas markers: Programmed cell death protein The meeting will be open to the 1 (PD–1; CD279) and/or T cell Ig- and public and accessible by live webcast AGENCY: National Institutes of Health. mucin-domain-containing molecule-3 and conference call. ACTION: Notice. (TIM–3). Following selection, isolated Name of Committee: Interagency Pain cells may be expanded and reinfused Research Coordinating Committee. SUMMARY: The National Cancer Institute, into the donor patient as part of an Type of meeting: Open Meeting. National Institutes of Health, adoptive cell transfer therapeutic Date: October 31, 2016. Department of Health and Human Time: 8:30 a.m. to 5:00 p.m. *Eastern regimen. The disclosed method may be Services, is contemplating the grant of a Time*—Approximate end time. advantageous over existing approaches Start-up Exclusive Evaluation Patent Agenda: The meeting will feature invited which rely on the isolation of T cells License to MedGene Therapeutics, Inc. speakers and discussions of Committee from tumor samples since it eliminates (‘‘MedGene’’) located in Bethesda, MD business items including a progress report on the cost and complications associated to practice the inventions embodied in implementation of the National Pain with tumor resection, as well as Strategy, updates on the Federal Pain the patent applications listed provides a T cell product for patients Research Strategy and new pain initiatives. Supplementary Information section of without resectable lesions. Place: National Institutes of Health, this notice. This notice is made in accordance Building 31C, 6th Floor, Room 10, 31 Center DATES: Only written comments and/or with 35 U.S.C. 209 and 37 CFR part 404. Drive, Bethesda, MD 20892. applications for a license which are The prospective Start-up Exclusive Cost: The meeting is free and open to the received by the NCI Technology Evaluation Patent License will be public. Transfer Center on or before October 11, royalty bearing and the may be granted Webcast Live: http://videocast.nih.gov/. 2016 will be considered. unless within fifteen (15) days from the Deadlines: Notification of intent to present ADDRESSES: Requests for copies of the oral comments: Monday, October 17, 2016, date of this published notice, the by 5:00 p.m. ET. patent applications, inquiries, and National Cancer Institute receives Submission of written/electronic statement comments relating to the contemplated written evidence and argument that for oral comments: Monday, October 24, Start-up Exclusive Evaluation Patent establishes that the grant of the license 2016, by 5:00 p.m. ET. License should be directed to: Andrew would not be consistent with the Submission of written comments: Monday, Burke, Ph.D., Licensing and Patenting requirements of 35 U.S.C. 209 and 37 October 24, 2016, by 5:00 p.m. ET. Manager, NCI Technology Transfer CFR part 404. Access: Medical Center Metro (Red Line). Center, 9609 Medical Center Drive, RM Complete applications for a license in Visitor Information: http://www.nih.gov/ mstockstill on DSK3G9T082PROD with NOTICES 1E530 MSC 9702, Bethesda, MD 20892– the prospective field of use that are about/visitor/index.htm. 9702 (for business mail), Rockville, MD timely filed in response to this notice Contact Person: Linda L. Porter, Ph.D., 20850–9702 Telephone: (240) 276–5530; Pain Policy Advisor, Office of Pain Policy, will be treated as objections to the grant Officer of the Director, National Institute of Facsimile: (240) 276–5504; Email: of the contemplated Start-up Exclusive Neurological Disorders and Stroke, NIH, 31 andy.burke@nih.gov. Evaluation Patent License. Comments Center Drive, Room 8A31, Bethesda, MD SUPPLEMENTARY INFORMATION: United and objections submitted to this notice 20892, Phone: (301) 451–4460, Email: States Provisional Patent Application will not be made available for public Linda.Porter@nih.gov. VerDate Sep<11>2014 19:40 Sep 23, 2016 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1


Document Created: 2018-02-09 13:22:44
Document Modified: 2018-02-09 13:22:44
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 applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before October 11, 2016 will be considered.
FR Citation81 FR 66047 
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