[Federal Register Volume 89, Number 159 (Friday, August 16, 2024)]
[Notices]
[Pages 66730-66731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18381]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Dimethyl 
Synaptamide for the Treatment of Autoimmune Disorders and Inflammatory 
Diseases

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
and the National Center for Advancing Translational Sciences (NCATS), 
both institutes of the National Institutes of Health (NIH), Department 
of Health and Human Services (HHS), are contemplating the grant of an 
Exclusive Patent License to practice the inventions embodied in the 
Patents and Patent Applications listed in the Supplementary Information 
section of this notice to Autala Bio Inc., A Civala Company 
(``Autala''), incorporated in Delaware.

DATES: Only written comments and/or applications for a license that are 
received by the National Heart Lung and Blood Institute (NHLBI) Office 
of Technology Transfer And Development (OTTAD) on or before September 
3, 2024 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: Jillian Varonin, Ph.D., Technology Transfer 
Manager, NHLBI Office of Technology Transfer And Development, 
Telephone: (301) 496-0505; Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    1. United States Provisional Patent Application No. 61/624,741, 
filed April 16, 2012, entitled ``Derivatives Of Docosahexaenoylamide 
and Uses Thereof'' [HHS Reference No. E-070-2012-0-US-01];
    2. PCT Patent Application No. PCT/US2013/032333, filed March 15, 
2013, entitled ``Derivatives Of Docosahexaenoylamide and Uses Thereof'' 
[HHS Reference No. E-070-2012-0-PCT-02];
    3. European Patent No. 2847178, filed March 15, 2013, entitled 
``Derivatives Of Docosahexaenoylamide and Uses Thereof'' [HHS Reference 
No. E-070-2012-0-EP-03];
    4. United States Patent No. 9,422,308, filed September 23, 2014, 
entitled ``Derivatives Of Docosahexaenoylamide

[[Page 66731]]

and Uses Thereof'' [HHS Reference No. E-070-2012-0-US-04];
    5. Germany Patent No. 602013016154.2, filed October 30, 2014, 
entitled ``Derivatives Of Docosahexaenoylamide and Uses Thereof'' [HHS 
Reference No. E-070-2012-0-DE-05];
    6. France Patent No. 2847178, filed October 30, 2014, entitled 
``Derivatives Of Docosahexaenoylamide and Uses Thereof'' [HHS Reference 
No. E-070-2012-0-FR-06];
    7. Great Britain Patent No. 2847178, filed October 30, 2014, 
entitled ``Derivatives Of Docosahexaenoylamide and Uses Thereof'' [HHS 
Reference No. E-070-2012-0-GB-07].
    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 following:
    ``Use of a G-protein-coupled receptor 110 (``GPR110'') agonist 
named dimethyl synaptamide (``DMS'') (also known as Compound 
NCGC00248435; (4Z,7Z,10Z,13Z,16Z,19Z)-N-(2-hydroxy-2-methylpropyl) 
docosa-4,7,10,13,16,19-hexaenamide; or ``A8'') to treat multiple 
sclerosis (``MS''), chronic inflammatory demyelinating 
polyradiculoneuropathy (``CIDP''), psoriasis, inflammatory bowel 
disease (``IBD''), Crohn's disease, ulcerative colitis (``UC''), 
sclerosing cholangitis, ankylosing spondylitis, rheumatoid arthritis 
(``RA''), psoriatic arthritis, systemic lupus erythematosus (``SLE''), 
lupus nephritis, sarcoidosis, and Behcet's disease.''
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. 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 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.
    In response to this Notice, the public may file comments or 
objections. 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.

Bruce D. Goldstein,
Director, Office of Technology Transfer and Development, National 
Heart, Lung, and Blood Institute.
[FR Doc. 2024-18381 Filed 8-15-24; 8:45 am]
BILLING CODE 4140-01-P