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)

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.

[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