2024-18381. Prospective Grant of an Exclusive Patent License: Dimethyl Synaptamide for the Treatment of Autoimmune Disorders and Inflammatory Diseases

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Department of Health and Human Services

National Institutes of Health

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

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: [phone]; Email: [e-mail].

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 ( print 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.