Notice2021-25873
Prospective Grant of Exclusivity Under Non-Exclusive Patent License: AAV Isolate and Fusion Protein Comprising Nerve Growth Factor Signal Peptide and Parathyroid Hormone
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
November 29, 2021
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Institute of Diabetes and Digestive and Kidney Disease and National Institute of Dental and Craniofacial Research, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an exclusive rights under active Non-exclusive Patent License to practice the inventions embodied in the United States, European and Japan Applications listed in the Supplementary Information section of this notice to Atsena Therapeutics, Inc., located in Durham, North Carolina, USA.
Full Text
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<title>Federal Register, Volume 86 Issue 226 (Monday, November 29, 2021)</title>
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[Federal Register Volume 86, Number 226 (Monday, November 29, 2021)]
[Notices]
[Pages 67712-67713]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-25873]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusivity Under Non-Exclusive Patent
License: AAV Isolate and Fusion Protein Comprising Nerve Growth Factor
Signal Peptide and Parathyroid Hormone
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Institute of Diabetes and Digestive and Kidney
Disease and National Institute of Dental and Craniofacial Research,
institutes of the National Institutes of Health, Department of Health
and Human Services, are contemplating the grant of an exclusive rights
under active Non-exclusive Patent License to practice the inventions
embodied in the United States, European and Japan Applications listed
in the Supplementary Information section of this notice to Atsena
Therapeutics, Inc., located in Durham, North Carolina, USA.
DATES: Only written comments and/or applications for a license which
are received by the National Institute of Diabetes and Digestive and
Kidney Disease's Technology Advancement Office on or before December
14, 2021 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated an Exclusive Patent License
should be directed to: Vladimir Knezevic, MD, (Senior) Advisor for
Commercial Evaluation, Technology Advancement Office, Building 12A,
Room 3011, Bethesda, MD 20817-5632 (for business mail), Telephone:
(301) 435-5560; Email: <a href="/cdn-cgi/l/email-protection#8afce6ebeee5a4e1e4eff0effce3e9cae4e3e2a4ede5fc"><span class="__cf_email__" data-cfemail="e5938984818acb8e8b809f80938c86a58b8c8dcb828a93">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Intellectual Property
I. European Patent National Stage: EP3294894 granted 2019-08-14,
entitled ``AAV isolate and fusion protein comprising nerve growth
factor signal peptide and parathyroid hormone'' (HHS Reference
Number E-175-2015-1-EP-03), validated in Great Britain, France and
Germany.
II. Japanese Application No. 2017-558710 granted 2020-12-20,
entitled ``AAV isolate and fusion protein comprising nerve growth
factor signal peptide and parathyroid hormone'' (HHS Reference
Number E-175-2015-1-JP-04).
III. U.S. Patent Application No. 15/573,214 filed 2017-11-10,
entitled ``AAV isolate and fusion protein comprising nerve growth
factor signal peptide and parathyroid hormone'' (HHS Reference
Number E-175-2015-1-US-05).
IV. Canadian Patent Application No. 2,985,786 filed 2017-11-10,
entitled ``AAV isolate and fusion protein comprising nerve growth
factor signal peptide and parathyroid hormone'' (HHS Reference
Number E-175-2015-1-CA-02).
The patent rights in these inventions have been assigned or
exclusively licensed to the Government of the United States of America.
The prospective exclusive license territory may be worldwide and in
fields of use that may be limited to treatment of limited number of
monogenic inherited retinal diseases that affect the photoreceptors
and/or retinal pigmented epithelium.
The above-listed patent portfolio covers inventions directed to
gene therapy and specifically, expression vectors and therapeutic
methods of using such vectors.
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.
The prospective exclusive license may be granted unless within fifteen
(15) days from the date of this published notice, the National
Institute of Diabetes and Digestive and Kidney Disease 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
[[Page 67713]]
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: November 22, 2021.
Vladimir Knezevic,
Senior Advisor for Commercial Evaluation, Technology Advancement
Office, National Institute of Diabetes and Digestive and Kidney
Disease.
[FR Doc. 2021-25873 Filed 11-26-21; 8:45 am]
BILLING CODE 4140-01-P
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