[Federal Register Volume 81, Number 100 (Tuesday, May 24, 2016)]
[Notices]
[Pages 32762-32763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12168]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Development of
Adeno-Associated Virus Vectors for the Treatment of Glycogen Storage
Disease Type Ia
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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[[Page 32763]]
SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7(a)(1)(i), that the National Institutes of Health, Department
of Health and Human Services (HHS), is contemplating the grant of an
exclusive license to practice the inventions embodied in the following
Patent Applications to Dimension Therapeutics, Inc. (``Dimension'')
located in Cambridge, Massachusetts, USA:
Intellectual Property
United States Provisional Patent Application No. 62/096,400, filed
December 23, 2014, titled ``Adeno-Associated Virus Vectors Encoding
G6PC and Uses Thereof'' [HHS Reference No. E-039-2015/0-US-01];
International Patent Application No. PCT/US2015/067338 filed December
22, 2015 titled ``Adeno-Associated Virus Vectors Encoding G6PC and Uses
Thereof'' [HHS Reference No. E-039-2015/0-PCT-02]; and all continuation
applications, divisional applications and foreign counterpart
applications claiming priority to the U.S. provisional application No.
62/096,400.
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 licensed territory may be worldwide and
the field of use may be limited to: ``Development and commercialization
of gene therapy using adeno-associated viral vectors for the treatment
of Glycogen Storage Disease Type Ia.''
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before June
8, 2016 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: Surekha Vathyam, Ph.D., Senior Licensing
and Patenting Manager, National Cancer Institute Technology Transfer
Center, 9609 Medical Center Drive, Rm 1E-530 MSC9702, Rockville, MD
20850-9702, Email: [email protected].
SUPPLEMENTARY INFORMATION: The subject technology discloses novel
adeno-associated virus (AAV) vectors expressing human G6Pase-alpha (or
G6PC) for the treatment of glycogen storage disease, particularly GSD-
Ia. GSD-Ia is an inherited disorder of metabolism associated with life-
threatening hypoglycemia, hepatic malignancy, and renal failure caused
by the deficiency of G6Pase-alpha, a key enzyme in maintaining blood
glucose homeostasis between meals. These new recombinant AAV vectors
that express human G6Pase-alpha directed by the tissue-specific human
G6PC promoter/enhancer at nucleotides -2864 to -1 incorporate the
following improvements: (1) One expresses a variant of G6Pase-alpha
with enhanced enzymatic activity; (2) the other expresses a codon-
optimized variant of G6Pase-alpha with higher enzyme expression levels
and enhanced enzymatic activity.
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part
404.7. The prospective exclusive license may be granted unless within
fifteen (15) days from the date of this published notice, the NIH
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 404.7.
Complete applications for a license in the prospective field of use
that are filed in response to this notice will be treated as objections
to the grant of the contemplated Exclusive Patent License Agreement.
Comments and objections submitted to this notice will not be made
available for public inspection and, to the extent permitted by law,
will not be released under the Freedom of Information Act, 5 U.S.C.
552.
Date: May 19, 2016.
Richard U. Rodriguez,
Associate Director, NCI, National Institutes of Health.
[FR Doc. 2016-12168 Filed 5-23-16; 8:45 am]
BILLING CODE 4140-01-P