[Federal Register Volume 86, Number 226 (Monday, November 29, 2021)]
[Notices]
[Pages 67712-67713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: [email protected].

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