[Federal Register Volume 84, Number 96 (Friday, May 17, 2019)]
[Notices]
[Pages 22503-22504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10285]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: RP2 AAV Vectors 
for Treating X-Linked Retinitis Pigmentosa

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Eye 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 U.S. and foreign Patents and Patent 
Applications listed in the Supplementary Information section of this 
notice to IVERIC bio, Inc. located in New York, NY.

DATES: Only written comments and/or applications for a license which 
are received by the National Eye Institute c/o National Cancer 
Institute's Technology Transfer Center on or before June 3, 2019 will 
be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Alan Hubbs, Ph.D., Senior Technology Transfer 
Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, Rm. 
1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, 
MD 20850-9702, Telephone: (240)-276-5530, Email: [email protected].

SUPPLEMENTARY INFORMATION:  The following represents the intellectual 
property to be licensed under the prospective agreement:

Intellectually Property

    1. U.S. Provisional Patent Application No. 62/131,661, filed March 
11, 2015 [HHS Reference No. E-050-2015/0-US-01];
    2. PCT Patent Application No. PCT/US2016/022072 filed March 11, 
2016 [HHS Reference No. E-050-2015-0-PCT-03];
    3. Australian Patent Application No. AU2016228751A, filed on March 
11, 2016 [HHS Reference No. E-050-2015-0-AU-04];
    4. Canadian Patent Application No. CA2979229A, filed on March 11, 
2016 [HHS Reference No. E-050-2015-0-CA-05];
    5. European Patent Application No. EP16762623.3A, filed on March 
11, 2016 [HHS Reference No. E-050-2015-0-EP-06];
    6. Japanese Patent Application No. JP2017547425A, filed on March 
11, 2016 [HHS Reference No. E-050-2015-0-JP-07];
    7. United States Patent Application No. US15/556,746, filed on 
March 11, 2016 [HHS Reference No. E-050-2015-0-US-08].
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, the patent rights in these inventions have been assigned to 
the Government of the United States of America. The prospective 
exclusive license territory may be world-wide, and the field of use may 
be limited to the use of Licensed Patent Rights for the following: 
``Human therapeutics for treating x-linked retinitis pigmentosa: The 
license will also be limited by licensed products covered by patent 
rights that pertain to AAV-mediated gene therapy delivering an RP2 
transgene.''
    This technology discloses adeno-associated virus (AAV) vectors 
comprising nucleotide sequences encoding RPGR-ORF15 or RP2 and related 
pharmaceutical compositions. It also discloses methods of treating or 
preventing x-linked retinitis pigmentosa, increasing photoreceptor 
number in the retina of a mammal, and increasing visual acuity of a 
mammal using the vectors and pharmaceutical compositions.
    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 
Eye 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

[[Page 22504]]

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: May 9, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-10285 Filed 5-16-19; 8:45 am]
 BILLING CODE 4140-01-P