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, 20081-20082 [2018-09654]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[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