83 FR 11762 - Prospective Grant of an Exclusive Patent License: Anti-Marinobufagenin Antibodies and Methods for Diagnosis and Treatment of Cardiovascular Disease and Fibrotic Disease
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 52 (March 16, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 52 (March 16, 2018)
| Page Range | 11762-11763 | |
| FR Document | 2018-05310 |
[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)] [Notices] [Pages 11762-11763] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05310] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Anti- Marinobufagenin Antibodies and Methods for Diagnosis and Treatment of Cardiovascular Disease and Fibrotic Disease AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The National Institute on Aging, 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 U.S. and International Patents and Patent Applications listed in the Supplementary Information section of this notice to CTS Biopharma LLC, located in Sunnyvale, CA. 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 April 2, 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: Richard T. Girards, Jr., Esq., MBA, Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E508 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-9702 (for overnight courier services); Telephone: (240)-276-6825; Facsimile: (240)-276-5504; Email: [email protected]. SUPPLEMENTARY INFORMATION: Intellectual Property United States Provisional Patent Application No. 60/694,733 [HHS Ref No. E-092-2004/0-US-01], filed on June 27, 2005 and entitled ``Anti-marinobufagenin antibodies and methods for their use;'' Patent Cooperation Treaty Patent Application No. PCT/US2006/024918 [HHS Ref No. E-092-2004/0-PCT-02], filed on June 26, 2006 and entitled ``Anti- marinobufagenin antibodies and methods for their use;'' and U.S. and foreign patents and/or patent applications claiming priority to the aforementioned applications, including but not limited to United States Patent No. 8,038,997 [HHS Ref No. E-092-2004/0-US-03] entitled ``Anti- marinobufagenin antibodies and methods for their use.'' Certain rights in the patent and these applications 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 use of the Licensed Patent Rights for the following: (1) The use of anti-marinobufagenin antibodies for one or both of (a) the treatment of fibrotic disease and (b) the treatment of cardiovascular disease, including but not limited to preeclampsia and (2) companion diagnostics associated with the aforementioned treatments. The patents and applications potentially to be licensed disclose antibodies (mAbs) that specifically bind marinobufagenin. They also disclose use of these mAbs in the diagnosis and treatment of cardiovascular disease such as hypertension. Further, they disclose use of these mAbs in the diagnosis and treatment of fibrotic diseases. The patents and applications potentially to be licensed also disclose technologies useful with respect to companion diagnostics for both fibrotic and cardiovascular diseases. The public substantially will benefit from the clinical and commercial development of these mAbs for the treatment and of cardiovascular as well as fibrotic disorders. The public also will benefit from the clinical and commercial development of companion diagnostics relative to these conditions. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. [[Page 11763]] 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 must be complete and in acceptable form by the expiration date of this Notice to be considered for a license. 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: March 8, 2018. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2018-05310 Filed 3-15-18; 8:45 am] BILLING CODE 4140-01-P
![11762 Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices
guide new outcomes measurement. The consensus about dementia care 1E508 MSC 9702, Bethesda, MD 20892–
Council will hear speakers in two elements, and the second on models 9702 (for business mail), Rockville, MD
sessions, one focuses on developing that are informing outcomes 20850–9702 (for overnight courier
consensus about dementia care measurement. The meeting will also services); Telephone: (240)-276–6825;
elements, and the second on models include updates on work from the Facsimile: (240)-276–5504; Email:
that are informing outcomes previous meetings, a presentation on the richard.girards@nih.gov.
measurement. The meeting will also final report from the October 2017 Care SUPPLEMENTARY INFORMATION:
include updates on work from the Summit, and federal workgroup
previous meetings, a presentation on the updates. Intellectual Property
final report from the October 2017 Care Procedure and Agenda: This meeting United States Provisional Patent
Summit, and federal workgroup is open to the public. Please allow 30 Application No. 60/694,733 [HHS Ref
updates. minutes to go through security and walk No. E–092–2004/0–US–01], filed on
DATES: The meeting will be held on to the meeting room. The meeting will June 27, 2005 and entitled ‘‘Anti-
April 27, 2018 from 9:00 a.m. to 5:00 also be webcast at www.hhs.gov/live. marinobufagenin antibodies and
p.m. EDT. Authority: 42 U.S.C. 11225; Section methods for their use;’’ Patent
2(e)(3) of the National Alzheimer’s Cooperation Treaty Patent Application
ADDRESSES: The meeting will be held in
Project Act. The panel is governed by No. PCT/US2006/024918 [HHS Ref No.
Room 800 in the Hubert H. Humphrey
provisions of Public Law 92–463, as E–092–2004/0–PCT–02], filed on June
Building, 200 Independence Avenue
amended (5 U.S.C. Appendix 2), which 26, 2006 and entitled ‘‘Anti-
SW, Washington, DC 20201.
Comments: Time is allocated in the sets forth standards for the formation marinobufagenin antibodies and
afternoon on the agenda to hear public and use of advisory committees. methods for their use;’’ and U.S. and
comments. The time for oral comments Dated: March 12, 2018. foreign patents and/or patent
will be limited to two (2) minutes per John R. Graham,
applications claiming priority to the
individual. In lieu of oral comments, aforementioned applications, including
Acting Assistant Secretary for Planning and
formal written comments may be Evaluation.
but not limited to United States Patent
submitted for the record to Rohini No. 8,038,997 [HHS Ref No. E–092–
[FR Doc. 2018–05368 Filed 3–15–18; 8:45 am]
Khillan, OASPE, 200 Independence 2004/0–US–03] entitled ‘‘Anti-
BILLING CODE 4150–05–P
Avenue SW, Room 424E, Washington, marinobufagenin antibodies and
DC 20201. Comments may also be sent methods for their use.’’
Certain rights in the patent and these
to napa@hhs.gov. Those submitting DEPARTMENT OF HEALTH AND
applications have been assigned to the
written comments should identify HUMAN SERVICES government of the United States of
themselves and any relevant
National Institutes of Health America.
organizational affiliations. The prospective exclusive license
FOR FURTHER INFORMATION CONTACT: territory may be worldwide and the
Prospective Grant of an Exclusive
Rohini Khillan (202) 690–5932, field of use may be limited to the use
Patent License: Anti-Marinobufagenin
rohini.khillan@hhs.gov. Note: Seating of the Licensed Patent Rights for the
Antibodies and Methods for Diagnosis
may be limited. Those wishing to attend following: (1) The use of anti-
and Treatment of Cardiovascular
the meeting must send an email to marinobufagenin antibodies for one or
Disease and Fibrotic Disease
napa@hhs.gov and put ‘‘April 27 both of (a) the treatment of fibrotic
Meeting Attendance’’ in the Subject line AGENCY: National Institutes of Health, disease and (b) the treatment of
by Tuesday, April 17, so that their HHS. cardiovascular disease, including but
names may be put on a list of expected ACTION: Notice. not limited to preeclampsia and (2)
attendees and forwarded to the security companion diagnostics associated with
officers at the Department of Health and SUMMARY: The National Institute on the aforementioned treatments.
Human Services. Any interested Aging, an institute of the National The patents and applications
member of the public who is a non-U.S. Institutes of Health, Department of potentially to be licensed disclose
citizen should include this information Health and Human Services, is antibodies (mAbs) that specifically bind
at the time of registration to ensure that contemplating the grant of an Exclusive marinobufagenin. They also disclose use
the appropriate security procedure to Patent License to practice the inventions of these mAbs in the diagnosis and
gain entry to the building is carried out. embodied in the U.S. and International treatment of cardiovascular disease such
Although the meeting is open to the Patents and Patent Applications listed as hypertension. Further, they disclose
public, procedures governing security in the SUPPLEMENTARY INFORMATION use of these mAbs in the diagnosis and
and the entrance to Federal buildings section of this notice to CTS Biopharma treatment of fibrotic diseases. The
may change without notice. If you wish LLC, located in Sunnyvale, CA. patents and applications potentially to
to make a public comment, you must DATES: Only written comments and/or be licensed also disclose technologies
note that within your email. complete applications for a license useful with respect to companion
SUPPLEMENTARY INFORMATION: Notice of which are received by the National diagnostics for both fibrotic and
these meetings is given under the Cancer Institute’s Technology Transfer cardiovascular diseases. The public
Federal Advisory Committee Act (5 Center on or before April 2, 2018 will substantially will benefit from the
U.S.C. App. 2, section 10(a)(1) and be considered. clinical and commercial development of
(a)(2)). Topics of the Meeting: During ADDRESSES: Requests for copies of the these mAbs for the treatment and of
daltland on DSKBBV9HB2PROD with NOTICES
the April meeting, the Clinical Care patent application, inquiries, and cardiovascular as well as fibrotic
Subcommittee will be taking charge of comments relating to the contemplated disorders. The public also will benefit
the theme, focusing on advancing an Exclusive Patent License should be from the clinical and commercial
consensus on dementia care elements to directed to: Richard T. Girards, Jr., Esq., development of companion diagnostics
guide new outcomes measurement. The MBA, Senior Technology Transfer relative to these conditions.
Council will hear speakers in two Manager, NCI Technology Transfer This notice is made in accordance
sessions, one focuses on developing Center, 9609 Medical Center Drive, RM with 35 U.S.C. 209 and 37 CFR part 404.
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![Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices 11763
The prospective exclusive license will Agenda: To review and evaluate grant DEPARTMENT OF HEALTH AND
be royalty bearing, and the prospective applications. HUMAN SERVICES
exclusive license may be granted unless Place: National Institutes of Health, 6701
within fifteen (15) days from the date of Rockledge Drive, Bethesda, MD 20892 National Institutes of Health
this published notice, the National (Telephone Conference Call).
Contact Person: Shalanda A Bynum, Ph.D., Proposed Collection; 60-Day Comment
Cancer Institute receives written MPH, Scientific Review Officer, Center for
evidence and argument that establishes Request; Responsibility of Applicants
Scientific Review, National Institutes of for Promoting Objectivity in Research
that the grant of the license would not Health, 6701 Rockledge Drive, Room 3206,
be consistent with the requirements of for Which Public Health Service (PHS)
Bethesda, MD 20892, 301–755–4355,
35 U.S.C. 209 and 37 CFR part 404. bynumsa@csr.nih.gov.
Funding Is Sought and Responsible
Prospective Contractors, Office of
In response to this Notice, the public Name of Committee: Center for Scientific
Policy for Extramural Research
may file comments or objections. Review Special Emphasis Panel; Member
Conflict: AIDS and AIDS Related Research. Administration (OPERA), Office of
Comments and objections, other than
Date: April 6, 2018. Extramural Research (OER), Office of
those in the form of a completed license
Time: 10:00 a.m. to 5:00 p.m. the Director, (OD)
application, will not be treated
confidentially, and may be made Agenda: To review and evaluate grant
AGENCY: National Institutes of Health,
applications.
publicly available. HHS.
Place: National Institutes of Health, 6701
License applications submitted in Rockledge Drive, Bethesda, MD 20892 ACTION: Notice.
response to this Notice must be (Virtual Meeting).
complete and in acceptable form by the Contact Person: Robert Freund, Ph.D., SUMMARY: In compliance with the
expiration date of this Notice to be Scientific Review Officer, Center for requirement of the Paperwork
considered for a license. License Scientific Review, National Institutes of Reduction Act of 1995 to provide
applications submitted in response to Health, 6701 Rockledge Drive, Room 5216, opportunity for public comment on
this Notice will be presumed to contain MSC 7852, Bethesda, MD 20892, 301–435– proposed data collection projects, the
business confidential information and 1050, freundr@csr.nih.gov. National Institutes of Health, Office of
any release of information in these Name of Committee: Center for Scientific Policy and Extramural Research
license applications will be made only Review Special Emphasis Panel; Administration (OPERA), Office of
as required and upon a request under Fellowships: Endocrinology, Metabolism, Extramural Research (OER), Office of
Nutrition, and Reproductive Science. the Director (OD) will publish periodic
the Freedom of Information Act, 5
Date: April 6, 2018. summaries of propose projects to be
U.S.C. 552. Time: 10:00 a.m. to 6:00 p.m. submitted to the Office of Management
Dated: March 8, 2018. Agenda: To review and evaluate grant
and Budget (OMB) for review and
Richard U. Rodriguez, applications.
Place: National Institutes of Health, 6701
approval.
Associate Director, Technology Transfer
Center, National Cancer Institute. Rockledge Drive, Bethesda, MD 20892 DATES: Comments regarding this
(Virtual Meeting). information collection are best assured
[FR Doc. 2018–05310 Filed 3–15–18; 8:45 am]
Contact Person: Elaine Sierra-Rivera, Ph.D., of having their full effect if received
BILLING CODE 4140–01–P Scientific Review Officer, EMNR IRG, Center within 60 days of the date of this
for Scientific Review, National Institutes of publication.
Health, 6701 Rockledge Drive, Room 6182
DEPARTMENT OF HEALTH AND MSC 7892, Bethesda, MD 20892, 301 435– FOR FURTHER INFORMATION CONTACT: To
HUMAN SERVICES 2514, riverase@csr.nih.gov. obtain a copy of the data collection
Name of Committee: Center for Scientific plans and instruments, submit
National Institutes of Health Review Special Emphasis Panel; Member comments in writing, or request more
Conflict: AIDS and AIDS Related Research. information on the proposed project,
Center for Scientific Review; Notice of Date: April 6, 2018. contact: Kathy Hancock, Asst. Grants
Closed Meetings Time: 1:00 p.m. to 5:00 p.m. Compliance Officer, Division of Grants
Agenda: To review and evaluate grant Compliance and Oversight, Office of
Pursuant to section 10(d) of the applications.
Federal Advisory Committee Act, as Policy for Extramural Research
Place: National Institutes of Health, 6701 Administration, 6705 Rockledge Drive,
amended, notice is hereby given of the Rockledge Drive, Bethesda, MD 20892
following meetings. Suite 350, Bethesda, Maryland 20892 or
(Telephone Conference Call).
Contact Person: Jingsheng Tuo, Ph.D., call non-toll-free number 301–435–0949
The meetings will be closed to the
Scientific Review Officer, Center for or Email your request to
public in accordance with the
Scientific Review, National Institutes of FCOICompliance@mail.nih.gov. Formal
provisions set forth in sections
Health, 6701 Rockledge Drive, Room 5207, requests for additional plans and
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Bethesda, MD 20892, 301–451–8754, tuoj@ instruments must be requested in
as amended. The grant applications and
nei.nih.gov. writing.
the discussions could disclose
confidential trade secrets or commercial (Catalogue of Federal Domestic Assistance SUPPLEMENTARY INFORMATION: Section
Program Nos. 93.306, Comparative Medicine; 3506(c)(2)(A) of the Paperwork
property such as patentable material,
93.333, Clinical Research, 93.306, 93.333,
and personal information concerning Reduction Act of 1995 requires: Written
93.337, 93.393–93.396, 93.837–93.844,
individuals associated with the grant 93.846–93.878, 93.892, 93.893, National
comments and/or suggestions from the
applications, the disclosure of which Institutes of Health, HHS) public and affected agencies are invited
daltland on DSKBBV9HB2PROD with NOTICES
would constitute a clearly unwarranted to address one or more of the following
Dated: March 12, 2018. points: (1) Whether the proposed
invasion of personal privacy.
Melanie J. Pantoja, collection of information is necessary
Name of Committee: Center for Scientific
Program Analyst, Office of Federal Advisory for the proper performance of the
Review Special Emphasis Panel; Member
Committee Policy. function of the agency, including
Conflict: AIDS and AIDS Related Research.
Date: April 3, 2018. [FR Doc. 2018–05308 Filed 3–15–18; 8:45 am] whether the information will have
Time: 1:00 p.m. to 5:00 p.m. BILLING CODE 4140–01–P practical utility; (2) The accuracy of the
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Document Created: 2018-03-16 01:12:11
Document Modified: 2018-03-16 01:12:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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 April 2, 2018 will be considered. | |
| FR Citation | 83 FR 11762 |
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