[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Notices]
[Pages 20081-20082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09654]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Antibodies Against
TL1A, a TNF-Family Cytokine, for the Treatment and Diagnosis of Crohn's
Disease, Ulcerative Colitis, Asthma, Psoriasis and Biliary Cirrhosis
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Heart, Lung, and Blood Institute (``NHLBI''), an
institute of the National Institutes of Health; an agency within the
Department of Health and Human Services, is contemplating the grant of
an exclusive patent license to commercialize the invention(s) embodied
in the intellectual property estate stated in the Summary Information
section of this notice to Precision IBD, Inc., located in San Diego,
California, and incorporated under the laws of Delaware.
DATES: Only written comments and/or applications for a license which
are received by the NHLBI Office of Technology Transfer and Development
on or before May 22, 2018 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated exclusive license should be
directed to: Cristina Thalhammer-Reyero, Ph.D., MBA, Senior Licensing
and Patenting Manager, NHLBI Office of Technology Transfer and
Development, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-
2479; Telephone: +1-301-435-4507; Fax: +1-301-594-3080; Email:
[email protected].
SUPPLEMENTARY INFORMATION: The following represents the intellectual
property to be licensed under the prospective agreement:
U.S. Provisional Patent Application No. 61/488,671, filed May 20,
2011; PCT Application. No. PCT/US2012/028926, filed March 13, 2012;
U.S. Patent No. 9,068,003, issued June 30, 2015; U.S. Patent No.
9,896,511, issued February 20, 2018; and U.S. Patent Application No.
15/872,592, filed January 16, 2018, ``Antibodies Against TL1A, a TNF-
Family Cytokine, for the Treatment and Diagnosis of Autoimmune
Inflammatory Diseases'', NIH Reference No. E-073-2011/0,1,2.
With respect to persons who have an obligation to assign their
right, title and interest to the Government of the United States of
America, the patent rights in these inventions 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 Licensed Patent Rights
for the following: ``Development and commercialization of antibodies
against TL1A for the treatment and diagnosis of Crohn's Disease,
Ulcerative Colitis, Asthma, Psoriasis and Biliary Cirrhosis''
The subject technology is based on the use of antibodies against
TL1A, a TNF-Family cytokine, for the treatment and diagnosis of
autoimmune inflammatory diseases. Autoimmune inflammatory diseases
occur in greater than five percent of the U.S. population. Treatments
generally include immunosuppressants or anti-inflammatory drugs, which
can have serious side effects. Recently, more specific immunomodulatory
therapies such as TNF-alpha antagonists have been developed. In
experiments with
[[Page 20082]]
mice, NIAMS inventors have shown that the interaction between the TNF
family ligand TL1A with its receptor, DR3, is critical for development
of disease in asthma, inflammatory bowel disease and multiple
sclerosis. They have also developed anti-TL1A antibodies that prevent
disease in mouse models of rheumatoid arthritis and inflammatory bowel
disease. This invention describes anti-human TL1A monoclonal antibodies
that may be useful for the development of diagnostics and therapeutics
for autoimmune inflammatory diseases, as well as methods of treating
such diseases by blocking the interaction between TL1A and DR3 by the
described antibodies. This specific immunomodulatory effect provides
potential for potent therapy without inducing global immunosuppression.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective Exclusive Patent License will be royalty
bearing and may be granted unless within fifteen (15) days from the
date of this published notice, the NHLBI Office of Technology Transfer
and Development 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.
The public may file comments or objections in response to this
Notice. Comments and objections, other than those in the form of a
license application, will not be treated confidentially and may be made
publicly available.
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: April 27, 2018.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager, Office of Technology Transfer
and Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2018-09654 Filed 5-4-18; 8:45 am]
BILLING CODE 4140-01-P