Notice2021-14682
Prospective Grant of an Exclusive Patent License: RP2 AAV-Based Gene Human Therapy for Ocular Diseases and Disorders Including XLRP
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 12, 2021
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 130 (Monday, July 12, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36565-36566]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14682]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: <a href="/cdn-cgi/l/email-protection#c0a8a9a2a1eea1acb3a1a6a6a1b280aea9a8eea7afb6"><span class="__cf_email__" data-cfemail="056d6c67642b6469766463636477456b6c6d2b626a73">[email protected]</span></a>.
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]
BILLING CODE 4140-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on July 12, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.