[Federal Register Volume 84, Number 188 (Friday, September 27, 2019)]
[Notices]
[Page 51171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20992]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Capsid-Free AAV 
Vectors, Compositions, and Methods for Vector Production and Gene 
Delivery

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an exclusive patent license to Generation 
Bio Co. (``Generation Bio''), a company based in Cambridge, 
Massachusetts (in the exclusive field specified below), and a co-
exclusive license to Generation Bio and Spark Therapeutics, a company 
based in Philadelphia, Pennsylvania (in the co-exclusive field 
specified below), to practice the inventions embodied in the patent 
application listed in the Supplementary Information section of this 
notice.

DATES: Only written comments and/or applications for a license which 
are received by the NHLBI Office of Technology Transfer and Development 
within 15 days from the date of publication of this notice in the 
Federal Register will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent license 
should be directed to: Uri Reichman, Ph.D., MBA, Senior Licensing and 
Patenting Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 
20892-2479, phone number 301-435-4616, or [email protected].

SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and 
foreign patents/patent applications thereof are included in the 
intellectual property to be licensed under the prospective agreements 
to Generation Bio and Spark Therapeutics: NIH reference #E-241-2010.
    U.S. patent 9,598,703 issued March 03, 2017; Israeli patent 228328 
issued December 01, 2018; Australian patent 2012228376 issued October 
05, 2017, and pending applications in Brazil (BR 11 2013 023185 8 A2), 
Canada (application 2829518), China (application 201280022523.5), 
Europe (application 12 708035.6), India (application 8000/DELNP/2013), 
Japan (application 2013-557138), and S. Korea (application10-2013-
7026982).
    The invention is jointly owned by the Government of the United 
States and by the following French institutions: Association Institut 
De Myologie, Sorbonne University, INSERM, and CNRS. The patent rights 
in these inventions have been assigned to the Government of the United 
States of America, and to the French institutions by their respective 
employees who are the inventors of the subject matter claimed in the 
patent rights. The prospective patent license will be granted worldwide 
and in fields of use not broader than the following:
    Exclusive field: Electroporation-mediated delivery of DNA-based 
vectors to express therapeutic molecules for the treatment or 
prevention of human diseases.
    Co-exclusive field: The treatment or prevention of cancer by 
administration of DNA-based vectors (with the exception of 
electroporation mediation) to express therapeutic molecules.
    All Fields of Use with the exception of the aforementioned fields 
are available for licensing by other parties on nonexclusive terms.
    The subject technology provides DNA-based constructs for human 
therapeutics or preventative therapies. Such DNA-based constructs may 
be useful in gene therapy for treating genetic disorders, or other 
diseases by expressing therapeutic molecules. These constructs are AAV 
genome-based, where the gene of interest (therapeutic payload) is 
inserted between two ITRs (Inverted Terminal Repeats). The resulting 
constructs are devoid of the AAV capsid, and thus nonviral. They are 
advantageous over conventionally used AAV vectors, as they are non-
immunogenic. They are also advantageous over plasmid-based expression 
constructs since they are of eukaryotic origin and thus devoid of the 
bacterial-type DNA methylation as typically present in plasmids.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent license will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the NHLBI 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. 
Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent license. 
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.

    Dated: September 17, 2019.
Uri Reichman Sr.,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2019-20992 Filed 9-26-19; 8:45 am]
 BILLING CODE 4140-01-P