[Federal Register Volume 86, Number 84 (Tuesday, May 4, 2021)]
[Notices]
[Pages 23734-23735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09332]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Natural Product 
Based Nanoparticles as Dietary Management and/or Treatment of 
Inflammatory Related Diseases

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, 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 
inventions embodied in the Patents and Patent Applications listed in 
the Supplementary Information section of this notice to MaDu, LLC 
located at 2025 Broadway, Suite 23E, New York, NY 10023.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before May 19, 2021 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Michelle A. Favila, Ph.D., Technology Transfer 
Manager, National Institutes of Health, NCI Technology Transfer Center 
by email ([email protected]).

SUPPLEMENTARY INFORMATION: 

Intellectual Property

HHS Ref No. E-154-2018-0: Binary Lipid Bilayer-Containing Vesicles 
Comprising Embedded Cytotoxic Agents and Methods of Making and Using 
the Same

    1. United States Provisional Patent Application No. No. 62/697,287 
filed July 12, 2018. [HHS Ref No. E-154-2018-0-US-01]
    2. International Patent Application No. PCT/US2019/041464 filed 
July 11, 2019. [HHS Ref. No. E-154-2018-0-PCT-02]
    3. Canadian Patent Application No. 3106008 filed July 11, 2019. 
[HHS Ref No. E-154-2018-0-CA-03]
    4. European Patent Application 19746275.7 filed July 11, 2019. [HHS 
Ref No. E-154-2018-0-EP-04]
    5. Japanese Patent Application 2021-500734 filed July 11, 2019. 
[HHS Ref No. E-154-2018-0-JP-05] and
    6. United States Patent Application 17/259,499 filed January 11, 
2021 [HHS Ref No. E-154-2018-0-US-01]
    The patent and patent application 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 
will be less than the full patent term and the field of use may be 
limited to the following: Development and commercialization of the 
Binary Lipid Nanoparticle encapsulating known natural products 
curcumin, vitamin D, and/or L-serine that are Generally Recognized as 
Safe for use as medical foods, as defined by the FDA, or over-the-
counter products for the management of pain and inflammatory-related 
diseases. The prospective licensee plans to develop Medical Foods, 
which is defined by the FDA as

[[Page 23735]]

``food which is formulated to be consumed or administered enterally 
under the supervision of a physician and which is intended for the 
specific dietary management of a disease or condition for which 
distinctive nutritional requirements, based on recognized scientific 
principles, are established by medical evaluation.''
    This technology discloses formulation and methods of using novel 
stealth lipid nanoparticles that have a high stability and payload 
capacity. Combination of these nanoparticles with selected agents may 
have various medical applications for cancer and anti-inflammatory 
indications.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
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 Cancer 
Institute 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 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 from 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 16, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-09332 Filed 5-3-21; 8:45 am]
BILLING CODE 4140-01-P