82 FR 58007 - Prospective Grant of Exclusive Patent License: N-Acetyl Mannosamine as a Therapeutic Agent

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 235 (December 8, 2017)

Page Range		58007-58008
FR Document		2017-26540

The National Human Genome Research 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 Leadiant Biosciences, Inc, located in Gaithersburg, Maryland, USA.

Federal Register, Volume 82 Issue 235 (Friday, December 8, 2017)

[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 58007-58008]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26540]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: N-Acetyl 
Mannosamine as a Therapeutic Agent

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Human Genome Research 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 
Leadiant Biosciences, Inc, located in Gaithersburg, Maryland, USA.

DATES: Only written comments and/or applications for a license which 
are received by the National Human Genome Research Institute's 
Technology Transfer Office on or before December 26, 2017 will be 
considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Eggerton Campbell, Ph.D., Senior 
Licensing and Patenting Manager, Technology Transfer Office (TTO), 
National Human Genome Research Institute (NHGRI), National Institutes 
of Health (NIH), 5635 Fishers Lane, Suite 3058, MSC 9307, Bethesda, MD 
20892-9307. Telephone: 301-402-1648. Fax: 301-402-9722. email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    U.S. Provisional Patent Application No.: 60/932,451, [HHS Ref. No.: 
E-217-2007/0-US-01], Filed May 31, 2007; PCT Patent Application No.: 
PCT/US2008/006895, [HHS Ref. No.: E-217-2007/0-PCT-02], Filed: May 30, 
2008; CA Patent Application 2680842, [HHS Ref. No.: E-217-2007/0-CA-
03], Filed: May 30, 2008; EP Patent Application No.: 08767999.9, [HHS 
Ref. No.: E-217-2007/0-EP-04], Filed: September 14, 2009; IL Patent 
Application No.: 200872, [HHS Ref. No.: E-217-2007/0-IL-05], Filed: May 
30, 2008; JP Patent Application No.: 2010-510363, [HHS Ref. No.: E-217-
2007/0-JP-06, Filed: May 30, 2008; U.S. Patent Application No.: 12/
530,433, [HHS Ref. No.: E-217-2007/0-US-07], Filed: Sept 8, 2009; U.S. 
Patent Application No.: 13/791,576, [HHS Ref. No.: E-217-2007/0-US-08], 
Filed: March 8, 2013; JP Patent Application No.: 2014-208695, [HHS Ref. 
No.: E-217-2007/0-JP-09], Filed: May 30, 2008; U.S. Patent Application 
No.: 14/754,304, [HHS Ref. No.: E-217-2007/0-US-10], Filed: June 29, 
2015; CA Patent Application No.: 2903133, [HHS Ref. No.: E-217-2007/0-
CA-11], Filed: May 30, 2008; IL Patent Application No.: 245026, [HHS 
Ref. No.: E-217-2007/0-IL-12], Filed: March 8, 2013; JP Patent 
Application No.: 2016-159061, [HHS Ref. No.: E-217-2007/0-JP-13], 
Filed: August 15, 2016; EP Patent Application No.: 16196935.7, [HHS 
Ref. No.: E-217-2007/0-EP-14], Filed: March 8, 2013; U.S. Patent 
Application No.: 15/702,529, [HHS Ref. No.: E-217-2007/0-US-08], Filed: 
September 12, 2017; and all continuing applications and foreign 
counterparts.

[[Page 58008]]

    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 use of Licensed Patent Rights 
for the following: ``Treating GNE Myopathy (also referred to as distal 
myopathy with rimmed vacuoles (DMRV), Nonaka myopathy, muscular 
dystrophy hereditary inclusion body myopathy (HIBM) or inclusion body 
myopathy type 2 (IBM2)) and kidney disorders due to hyposialylation of 
the glomerulae or sialic acid deficiency including but not limited to 
minimal change disease glomerulopathy, focal segmental 
glomerulosclerosis and membranous nephropathy, in humans with oral 
formulations of N-acetyl mannosamine (ManNAc) or derivative.''
    N-Acetyl Mannosamine is a precursor for the synthesis of sugar 
molecules known as sialic acids which play an important role in 
specific biological processes such as cellular adhesion, cellular 
communication and signal transduction. Lack of sialic acids also play 
an important role in disease processes such as cancer, inflammation and 
immunity.
    This invention relates to methods of administering ManNAc or its 
derivative (to produce sialic acid in patients who are deficient in the 
sugar molecule) to treat GNE Myopathy (also referred to as distal 
myopathy with rimmed vacuoles (DMRV), Nonaka myopathy, muscular 
dystrophy hereditary inclusion body myopathy (HIBM) or inclusion body 
myopathy type 2 (IBM2)), and kidney disorders due to hyposialylation of 
the glomerulae or sialic acid deficiency may be treated by this method 
as well.
    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 
Human Genome Research 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 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: November 30, 2017.
Claire T. Driscoll,
Director, NHGRI Technology Transfer Office.
[FR Doc. 2017-26540 Filed 12-7-17; 8:45 am]
 BILLING CODE 4140-01-P

58008 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices

The patent rights in these inventions confidential information and any release additional information, please visit
have been assigned and/or exclusively of information in these license www.cbp.gov/368.
licensed to the government of the applications will be made only as SUPPLEMENTARY INFORMATION:
United States of America. required and upon a request under the
The prospective exclusive license Freedom of Information Act, 5 U.S.C. Background
territory may be worldwide and the 552. U.S. Customs and Border Protection
field of use may be limited to the use Dated: November 30, 2017. (CBP) collects various maritime taxes
of Licensed Patent Rights for the and fees with regard to commercial
Claire T. Driscoll,
following: ‘‘Treating GNE Myopathy vessels that enter ports of entry, proceed
(also referred to as distal myopathy with Director, NHGRI Technology Transfer Office.
coast-wise, or utilize certain customs
rimmed vacuoles (DMRV), Nonaka [FR Doc. 2017–26540 Filed 12–7–17; 8:45 am]
services at a port. These maritime taxes
myopathy, muscular dystrophy BILLING CODE 4140–01–P
and fees include tonnage taxes and light
hereditary inclusion body myopathy money, Consolidated Omnibus Budget
(HIBM) or inclusion body myopathy Reconciliation Act (COBRA) user fees,
type 2 (IBM2)) and kidney disorders due Agriculture Quarantine and Inspection
to hyposialylation of the glomerulae or DEPARTMENT OF HOMELAND
SECURITY (AQI) user fees, and navigation fees.1
sialic acid deficiency including but not CBP regulations require payment of
limited to minimal change disease these taxes and fees by cash or check
U.S. Customs and Border Protection
glomerulopathy, focal segmental and specify a paper-based payment
glomerulosclerosis and membranous Revenue Modernization: Mobile process that occurs at the ports.
nephropathy, in humans with oral Collections & Receipt (MCR) Pilot
formulations of N-acetyl mannosamine Current Payment Methods
(ManNAc) or derivative.’’ AGENCY: U.S. Customs and Border CBP regulations require that most
N-Acetyl Mannosamine is a precursor Protection; DHS. customs duties, taxes, fees, interest, and
for the synthesis of sugar molecules ACTION: General notice. other charges be paid by cash or check.
known as sialic acids which play an See title 19 Code of Federal Regulations
important role in specific biological SUMMARY: This document announces section 24.1 (19 CFR 24.1). Accordingly,
processes such as cellular adhesion, that U.S. Customs and Border Protection a party responsible for the payment of
cellular communication and signal (CBP) will be conducting a pilot test commercial vessel maritime taxes and
transduction. Lack of sialic acids also program to allow for the electronic fees must pay all applicable tonnage
play an important role in disease payment of certain taxes and fees taxes, light money, COBRA user fees,
processes such as cancer, inflammation imposed on commercial vessels prior to AQI user fees, and navigation fees,
and immunity. or upon a vessel’s arrival at four including the prepayment of annual
This invention relates to methods of designated ports of entry. The pilot also COBRA user fees, by cash or check only.
administering ManNAc or its derivative introduces portable, electronic devices
(to produce sialic acid in patients who Maritime taxes and fees cannot be paid
that authorized CBP employees will use by credit card or through any other
are deficient in the sugar molecule) to to electronically process payments of
treat GNE Myopathy (also referred to as electronic method.
certain taxes and fees and to send
distal myopathy with rimmed vacuoles electronic receipts via email. The pilot Current Payment Process
(DMRV), Nonaka myopathy, muscular will not affect the amount of taxes and Pursuant to CBP regulations, maritime
dystrophy hereditary inclusion body fees due, the clearance process, or the taxes and fees are paid at the port to an
myopathy (HIBM) or inclusion body proof of documentation required to be authorized CBP employee either
myopathy type 2 (IBM2)), and kidney presented to CBP. This notice describes onboard the vessel or at the port office.
disorders due to hyposialylation of the the pilot, including its purpose, See 19 CFR 24.2. Specifically, all
glomerulae or sialic acid deficiency may procedures, locations, and how to applicable tonnage taxes, light money,
be treated by this method as well. participate, and invites public comment and COBRA user fees must be paid to
This notice is made in accordance on any aspect of the pilot. an authorized CBP employee on arrival
with 35 U.S.C. 209 and 37 CFR part 404. DATES: The pilot will begin no earlier at a port of entry. See 19 CFR 4.20
The prospective exclusive license will than January 8, 2018 and will continue (tonnage taxes and light money) and 19
be royalty bearing, and the prospective for 18 months at the designated ports of CFR 24.22(b) (COBRA user fee). Annual
exclusive license may be granted unless entry. Comments concerning this notice COBRA user fees may be prepaid. In
within fifteen (15) days from the date of and all aspects of the pilot may be such case, they must be paid at the port
this published notice, the National submitted at any time during the pilot office. See 19 CFR 24.22(b)(3).
Human Genome Research Institute to the address set forth below. Navigation fees and AQI user fees must
receives written evidence and argument
ADDRESSES: Written comments be paid at the time the applicable
that establishes that the grant of the
concerning any aspect of the pilot service is provided. See 19 CFR 4.98
license would not be consistent with the
should be submitted to the CBP (navigation fees) and 7 CFR 354.3(b)
requirements of 35 U.S.C. 209 and 37
Revenue Modernization (‘‘Rev Mod’’) (AQI user fee).
CFR part 404.
In response to this Notice, the public Office at revmod@cbp.dhs.gov. In the When a cash register is unavailable to
may file comments or objections. subject line of your email please process a payment, such as when
indicate ‘‘Comment on Mobile
sradovich on DSK3GMQ082PROD with NOTICES

Comments and objections, other than 1 See 46 U.S.C. 60301–60303 and 19 CFR 4.20–
those in the form of a license Collections & Receipt Pilot.’’
4.23 (tonnage tax and light money); 19 U.S.C. 58c
application, will not be treated FOR FURTHER INFORMATION CONTACT: and 19 CFR 24.22(b) (COBRA user fees); 19 U.S.C.
confidentially, and may be made Kathleen Druitt, Rev Mod Program 58a and 19 CFR 4.98 (navigation fees); and 21
publicly available. Manager, Office of Finance, U.S. U.S.C. 136a and 7 CFR 354.3(b) (AQI user fees). CBP
collects AQI user fees pursuant to an inter-agency
License applications submitted in Customs and Border Protection, via agreement with the U.S. Department of
response to this Notice will be email at kathleen.c.druitt@cbp.dhs.gov Agriculture’s Animal and Plant Health Inspection
presumed to contain business or by telephone at (202) 427–8448. For Service.

VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\08DEN1.SGM 08DEN1

Document Created: 2017-12-08 01:43:19
Document Modified: 2017-12-08 01:43:19

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Only written comments and/or applications for a license which are received by the National Human Genome Research Institute's Technology Transfer Office on or before December 26, 2017 will be considered.
FR Citation		82 FR 58007

82 FR 58007 - Prospective Grant of Exclusive Patent License: N-Acetyl Mannosamine as a Therapeutic Agent

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 235 (December 8, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health