[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

[[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