81 FR 32762 - Prospective Grant of Exclusive Patent License: Development of Adeno-Associated Virus Vectors for the Treatment of Glycogen Storage Disease Type Ia

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 100 (May 24, 2016)

Page Range		32762-32763
FR Document		2016-12168

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:

Federal Register, Volume 81 Issue 100 (Tuesday, May 24, 2016)

[Federal Register Volume 81, Number 100 (Tuesday, May 24, 2016)]
[Notices]
[Pages 32762-32763]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Notices 32763

SUMMARY: This notice, in accordance enzyme in maintaining blood glucose would constitute a clearly unwarranted
with 35 U.S.C. 209(c)(1) and 37 CFR homeostasis between meals. These new invasion of personal privacy.
part 404.7(a)(1)(i), that the National recombinant AAV vectors that express Name of Committee: National Heart, Lung,
Institutes of Health, Department of human G6Pase-alpha directed by the and Blood Institute Special Emphasis Panel;
Health and Human Services (HHS), is tissue-specific human G6PC promoter/ Stem Cell-Derived Blood Products (SBIR).
contemplating the grant of an exclusive enhancer at nucleotides -2864 to -1 Date: June 16, 2016.
license to practice the inventions incorporate the following Time: 1:30 p.m. to 5:00 p.m.
embodied in the following Patent improvements: (1) One expresses a Agenda: To review and evaluate grant
applications.
Applications to Dimension variant of G6Pase-alpha with enhanced Place: National Institutes of Health, 6701
Therapeutics, Inc. (‘‘Dimension’’) enzymatic activity; (2) the other Rockledge Drive, Room 7180, Bethesda, MD
located in Cambridge, Massachusetts, expresses a codon-optimized variant of 20892 (Telephone Conference Call).
USA: G6Pase-alpha with higher enzyme Contact Person: Tony L. Creazzo, Ph.D.,
expression levels and enhanced Scientific Review Officer, Office of Scientific
Intellectual Property Review/DERA, National Heart, Lung, and
enzymatic activity.
United States Provisional Patent Blood Institute, 6701 Rockledge Drive, Room
The prospective exclusive license will
Application No. 62/096,400, filed 7180, Bethesda, MD 20892–7924, 301–435–
be royalty bearing and will comply with 0725, creazzotl@mail.nih.gov.
December 23, 2014, titled ‘‘Adeno- the terms and conditions of 35 U.S.C.
Associated Virus Vectors Encoding (Catalogue of Federal Domestic Assistance
209 and 37 CFR part 404.7. The Program Nos. 93.233, National Center for
G6PC and Uses Thereof’’ [HHS prospective exclusive license may be Sleep Disorders Research; 93.837, Heart and
Reference No. E–039–2015/0–US–01]; granted unless within fifteen (15) days Vascular Diseases Research; 93.838, Lung
International Patent Application No. from the date of this published notice, Diseases Research; 93.839, Blood Diseases
PCT/US2015/067338 filed December 22, the NIH receives written evidence and and Resources Research, National Institutes
2015 titled ‘‘Adeno-Associated Virus argument that establishes that the grant of Health, HHS).
Vectors Encoding G6PC and Uses of the license would not be consistent Dated: May 18, 2016.
Thereof’’ [HHS Reference No. E–039– with the requirements of 35 U.S.C. 209 Michelle Trout,
2015/0–PCT–02]; and all continuation and 37 CFR part 404.7. Program Analyst, Office of Federal Advisory
applications, divisional applications Complete applications for a license in Committee Policy.
and foreign counterpart applications the prospective field of use that are filed [FR Doc. 2016–12140 Filed 5–23–16; 8:45 am]
claiming priority to the U.S. provisional in response to this notice will be treated BILLING CODE 4140–01–P
application No. 62/096,400. as objections to the grant of the
The patent rights in these inventions
contemplated Exclusive Patent License
have been assigned and/or exclusively
Agreement. Comments and objections DEPARTMENT OF HEALTH AND
licensed to the Government of the
submitted to this notice will not be HUMAN SERVICES
United States of America.
made available for public inspection
The prospective exclusive licensed National Institutes of Health
and, to the extent permitted by law, will
territory may be worldwide and the
not be released under the Freedom of
field of use may be limited to: National Heart, Lung, and Blood
Information Act, 5 U.S.C. 552.
‘‘Development and commercialization of Institute; Notice of Closed Meeting
gene therapy using adeno-associated Date: May 19, 2016.
viral vectors for the treatment of Richard U. Rodriguez, Pursuant to section 10(d) of the
Glycogen Storage Disease Type Ia.’’ Associate Director, NCI, National Institutes Federal Advisory Committee Act, as
of Health. amended (5 U.S.C. App.), notice is
DATES: Only written comments and/or
hereby given of the following meeting.
applications for a license which are [FR Doc. 2016–12168 Filed 5–23–16; 8:45 am]
The meeting will be closed to the
received by the NIH Office of BILLING CODE 4140–01–P
public in accordance with the
Technology Transfer on or before June provisions set forth in sections
8, 2016 will be considered. 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
ADDRESSES: Requests for copies of the DEPARTMENT OF HEALTH AND
HUMAN SERVICES as amended. The grant applications and
patent application, inquiries, comments, the discussions could disclose
and other materials relating to the confidential trade secrets or commercial
National Institutes of Health
contemplated exclusive license should property such as patentable material,
be directed to: Surekha Vathyam, Ph.D., National Heart, Lung, and Blood and personal information concerning
Senior Licensing and Patenting Institute; Notice of Closed Meeting individuals associated with the grant
Manager, National Cancer Institute applications, the disclosure of which
Technology Transfer Center, 9609 Pursuant to section 10(d) of the would constitute a clearly unwarranted
Medical Center Drive, Rm 1E–530 Federal Advisory Committee Act, as invasion of personal privacy.
MSC9702, Rockville, MD 20850–9702, amended (5 U.S.C. App.), notice is
Name of Committee: Heart, Lung, and
Email: vathyams@mail.nih.gov. hereby given of the following meeting.
Blood Initial Review Group; Heart, Lung, and
SUPPLEMENTARY INFORMATION: The The meeting will be closed to the Blood Program Project Review Committee.
subject technology discloses novel public in accordance with the Date: June 17, 2016.
adeno-associated virus (AAV) vectors provisions set forth in sections Time: 8:00 a.m. to 1:00 p.m.
expressing human G6Pase-alpha (or 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Agenda: To review and evaluate grant
sradovich on DSK3TPTVN1PROD with NOTICES

G6PC) for the treatment of glycogen as amended. The grant applications and applications.
storage disease, particularly GSD-Ia. the discussions could disclose Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
GSD-Ia is an inherited disorder of confidential trade secrets or commercial Avenue, Bethesda, MD 20814.
metabolism associated with life- property such as patentable material, Contact Person: Jeffrey H. Hurst, Ph.D.,
threatening hypoglycemia, hepatic and personal information concerning Scientific Review Officer, Office of Scientific
malignancy, and renal failure caused by individuals associated with the grant Review/DERA, National Heart, Lung, and
the deficiency of G6Pase-alpha, a key applications, the disclosure of which Blood Institute, National Institutes of Health,

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Document Created: 2016-05-24 05:21:36
Document Modified: 2016-05-24 05:21:36

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 NIH Office of Technology Transfer on or before June 8, 2016 will be considered.
FR Citation		81 FR 32762

81 FR 32762 - Prospective Grant of Exclusive Patent License: Development of Adeno-Associated Virus Vectors for the Treatment of Glycogen Storage Disease Type Ia

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 100 (May 24, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health