Notice2026-17991
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Mifepristone and Analogues To Treat Hypercortisolism-Related Insulin Resistance Disorders
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 2, 2026
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Institute of Diabetes and Digestive and Kidney Diseases, 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 invention embodied in the patents and patent applications listed in the Supplementary Information section of this notice to Nulyn Science ("Nulyn"), a company located in Paris, France.
Full Text
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<title>Federal Register, Volume 91 Issue 169 (Wednesday, September 2, 2026)</title>
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[Federal Register Volume 91, Number 169 (Wednesday, September 2, 2026)]
[Notices]
[Page 56458]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17991]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of Mifepristone and Analogues To Treat
Hypercortisolism-Related Insulin Resistance Disorders
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Institute of Diabetes and Digestive and Kidney
Diseases, 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 invention embodied in the
patents and patent applications listed in the Supplementary Information
section of this notice to Nulyn Science (``Nulyn''), a company located
in Paris, France.
DATES: Only written comments and/or applications for a license which
are received by the National Institute of Diabetes and Digestive and
Kidney Diseases' Technology Advancement Office on or before September
17, 2026 will be considered.
ADDRESSES: Inquiries and comments relating to the contemplated
Exclusive Patent License should be directed to: Betty B. Tong, Ph.D.,
Senior Licensing and Patenting Manager, NIDDK Technology Advancement
Office, Telephone: (301)-451-7836; Email: <a href="/cdn-cgi/l/email-protection#d0a4bfbeb7b290bdb1b9bcfebeb9b8feb7bfa6"><span class="__cf_email__" data-cfemail="097d66676e6b496468606527676061276e667f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. Australian Patent Application No. 2020239920 filed March 9,
2020, entitled ``Method for Improving Insulin Sensitivity'' [HHS
Reference No. E-081-2019-0-AU-01];
2. South Korean Patent Application No. 10-2021-7033113 filed March
9, 2020, entitled ``Method for Improving Insulin Sensitivity'' [HHS
Reference No. E-81-2019-0-KR-01];
3. New Zealand Patent Application No. 781109 filed October 7, 2020,
entitled ``Method for Improving Insulin Sensitivity'' [HHS Reference
No. E-081-2019-0-NZ-01];
4. United States Patent Application No. 17/438, 580 filed September
13, 2021, entitled ``Method for Improving Insulin Sensitivity'' [HHS
Reference No. E-081-2019-0-US-02];
5. United States Patent Application No. 18/831,326 filed November
19, 2024, entitled ``Method for Improving Insulin Sensitivity'' [HHS
Reference No. E-081-2019-0-US-03];
6. European Patent 3941460, issued October 15, 2025, entitled
``Method for Improving Insulin Sensitivity'' [HHS Reference No. E-81-
2019-0-EP-01].
The patent rights in the invention 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 following:
``Commercial development of mifepristone and analogues for
treatment of hypercortisolism-related insulin resistance disorders in
humans''
The subject technology describes a method of treating or
ameliorating insulin sensitivity disorders using glucocorticoid
receptor antagonist (GRA), like mifepristone, to block the metabolic
side effects of cortisol, which is a key driver of hepatic and adipose
insulin resistance. The invention relates to a specific dosing approach
that restricts dosage to avoid over-activating the hypothalamic-
pituitary-adrenal (HPA) axis and ensure cortisol safety levels.
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 National
Institute of Diabetes and Digestive and Kidney Diseases 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.
Complete applications for a license that are timely filed in
response to this notice will be treated as objections to the grant of
the contemplated exclusive patent license. 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 confidential business 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: August 28, 2026.
Charles D. Niebylski,
Director, Technology Advancement Office, National Institute of Diabetes
and Digestive and Kidney Diseases.
[FR Doc. 2026-17991 Filed 9-1-26; 8:45 am]
BILLING CODE 4167-05-P
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