[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Notices]
[Pages 18545-18546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07316]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: N-
butyldeoxynojirimycin To Treat Smith-Lemli Opitz Syndrome (SLOS) and 
Diseases That Exhibit a Similar NPC-Like Cellular Phenotype

AGENCY: National Institutes of Health, DHHS.

ACTION: Notice.

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SUMMARY: The National Institute of Child Health and Human Development, 
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 U.S. and foreign 
Patents and Patent Applications listed in the Supplementary Information 
section of this notice to SubRed Pty Ltd located in Australia, 
registered in Victoria.

DATES: Only written comments and/or applications for a license which 
are received by the National Institute of Child Health and Human 
Development c/o National Cancer Institute's Technology Transfer Center 
on or before April 26, 2021 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Alan Hubbs, Ph.D., Senior Technology Transfer 
Manager at Telephone (240)-276-5530 or at Email: [email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement:

Intellectually Property

    1. Great Britain Patent Application No. 712494.4, filed on June 27, 
2007 [HHS Reference No. E-206-2007-0-GB-01];
    2. PCT Patent Application No. PCT/GB2008/002207, filed June 26, 
2008 [HHS Reference No. E-206-2007-0-PCT-02];
    3. Issued Australian Patent No. 2008269585, filed on June 26, 2008, 
Issued July 2, 2015 [HHS Reference No. E-206-2007-0-AU-03];
    4. Issued Canadian Patent No. 2691937, filed on June 26, 2008, 
Issued January 23, 2018 [HHS Reference No. E-206-2007-0-CA-04];
    5. Issued European Patent No. 2182936, filed on June 26, 2008, 
Issued April 1, 2020 [HHS Reference No. E-206-2007-0-EP-05];
    6. Issued US Patent No. 8,557,844, filed January 19, 2010, Issued 
October 15, 2013 [HHS Reference No. E-206-2007/0-US-06];
    7. Issued United States Patent No. 9,428,541, filed on September 
13, 2013, Issued August 30, 2016 [HHS Reference No. E-206-2007-0-US-09]
    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 world-wide, and the field of use may 
be limited to the use of Licensed Patent Rights for the following: 
``The use of N-butyldeoxynojirimycin in humans to treat Smith-Lemli 
Opitz Syndrome (SLOS) and diseases that exhibit a similar NPC-like 
cellular phenotype.''

[[Page 18546]]

    This technology discloses pharmaceutical compositions and methods 
of use to treat SLOS and diseases having a secondary NPC like cellular 
phenotype or wherein the disease is an inborn error in cholesterol 
synthesis.
    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 Child Health and Human 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.

    Dated: March 22, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-07316 Filed 4-8-21; 8:45 am]
BILLING CODE 4140-01-P