[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36565-36566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14682]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: RP2 AAV-Based 
Gene Human Therapy for Ocular Diseases and Disorders Including XLRP

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer 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 Patents and Patent Applications listed in 
the Supplementary Information section of this notice to PTC 
Therapeutics GT, Inc. located in 100 Corporate, Middlesex Business 
Center, South Plainfield, NJ 07080.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before July 27, 2021 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: Hiba Alsaffar, Ph.D., Licensing and Patenting 
Manager at (240)-276-5530; or at Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    I. United States Provisional Patent Application No. 62/131,661 
filed Mar.

[[Page 36566]]

11, 2015, [HHS Ref. No. E-050-2015-0-US-01];
    II. International Patent Application No. PCT/US2016/022072 filed 
Mar. 11, 2015, [HHS Reference No. E-050-2015-0-PCT-03]; expired
    III. Australian National Stage Patent Application No. 2016228751, 
filed Mar. 11, 2016, [HHS Ref. No. E-050-2015-0-AU-04]; pending
    IV. Canadian National Stage Patent Application No. 2979229 filed 
Mar. 11, 2016, [HHS Ref. No. E-050-2015-0-CA-05]; pending
    V. European national Stage Patent Application No. 1662623.3 filed 
Oct. 11, 2016, [HHS Ref. No. E-050-2015-0-EP-06]; issued (validated in 
DE, FR and GB)
    VI. U.S. national Stage Patent Application No. 15/556,746 filed 
Sep. 8, 2017 [HHS Ref. No. E-050-2015-0-US-08]; issued
    VII. Japanese National Stage Patent Application No. 2017-547425 
filed Sep. 8, 2017 [HHS Ref. No. E-050-2015-0-JP-07]; pending
    VIII. Divisional European Patent Application No. 20176667.2 filed 
May 26, 2020 [HHS Ref. No. E-050-2015-0-EP-13]; pending
    IX. Divisional Japanese Patent Application No. 2020-167984 filed 
Oct. 2, 2020 [HHS Ref. No. E-050-2015-0-JP-14]; pending
    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 license territory may be worldwide, and 
the field of use may be limited to:
    ``Development and commercialization of RP2 AAV-based gene human 
therapy for any ocular disease, disorder or condition, including human 
X-linked retinitis pigmentosa (XLRP)''.
    This technology discloses Adeno-Associated Viral (AAV) vectors 
comprising nucleotide sequences encoding RP2 or RPGR- ORF 15 transgenes 
and their use in treating or preventing X-linked forms of retinitis 
pigmentosa (XLRP).
    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 
Cancer 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 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: July 2, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-14682 Filed 7-9-21; 8:45 am]
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