[Federal Register Volume 85, Number 186 (Thursday, September 24, 2020)]
[Notices]
[Page 60249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21060]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent Commercialization 
License: Method of Treating Periodontal Disease via ENPP1 Inhibition

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Institute of Arthritis and Musculoskeletal and 
Skin Diseases, of the National Institutes of Health, Department of 
Health and Human Services, is contemplating the grant of an exclusive 
patent commercialization license to Petragen, Inc., a start-up company 
incorporated in the state of Delaware, to practice the inventions 
covered by the patent estate listed in the Supplementary Information 
section of this notice. This notice is intended to apprise the public 
of the aforementioned license and provide a fifteen (15) day notice 
period for the objection.

DATES: Only written comments and/or applications for a license which 
are received by the National Heart, Lung, and Blood Institute Office of 
Technology Transfer and Development on or before October 9, 2020 will 
be considered.

ADDRESSES: Requests for copies of patent applications (electronic 
only), inquiries, and comments relating to the contemplated an 
exclusive patent license should be emailed to: Benfeard Williams, II, 
Ph.D., Technology Transfer Manager, 31 Center Drive, Room 4A29, MSC 
2479, Bethesda, MD 20892-2479, phone number 301-435-4507, or 
[email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property (Patent Estate)

    HHS Ref. No. E-024-2018-0, U.S. Provisional Patent Application 62/
590,824 filed November 27, 2017, International Patent Application PCT/
US2018/062593 filed November 27, 2018, Chinese Patent Application 
201880076753.7 filed November 27, 2018, European Patent Application 
18816451.1 filed November 27, 2018, Israeli Patent Application 274529 
filed November 27, 2018 and U.S. Patent Application 16/765,420 filed 
May 19, 2020, and any and all continuation or divisional applications 
claiming priority to any of the above.
    The patent rights in these inventions have been assigned or 
exclusively licensed to the Government of the United States of America.
    The aforementioned patent estate covers methods of treating or 
preventing periodontal disease in a subject by administering an 
inhibitor of ENPP1. In addition, the claims cover pharmaceutical 
compositions for use in the treatment or prevention of periodontal 
disease, or for increasing cementum formation. In particular, the 
dependent claims cover ENPP1 inhibitors comprising analogues of ATP 
derivatives, wherein the ENPP1 inhibitor is bound to nanoparticles, 
nanofibers, suture materials, microspheres, polymers, fibers, matrices, 
gels, or a combination thereof. The treatment methods also include 
dependent claims wherein treating or preventing periodontal disease 
comprises increasing cementum formation and wherein the composition is 
formulated for injection in gum tissue, local delivery at a surgical 
flap, buccal delivery, delivery by a resorbable suture, delivery by a 
wound healing dressing, or a combination of the foregoing.
    Inhibition of the glycoprotein ENPP1 promotes cementum formation in 
mammals. Cementum, an avascular mineralized tooth root structure, 
attaches the tooth to the periodontal ligament and supporting bone. 
Cementum has limited turnover and subjects with periodontal disease 
experience localized loss of cementum resulting in the detachment of 
the periodontal ligament from the tooth root. Increasing cementum 
formation can be used to treat periodontal disease.
    The prospective exclusive license territory may be worldwide and in 
a field of use that may be limited to Therapeutics for periodontitis or 
gingivitis, and where the ``Licensed Products'' are expected to be 
inhibitors of ecto-nucleotide pyrophosphate/phosphodiesterase-I (ENPP1) 
within the scope of the Licensed Patent Rights.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent commercialization 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 Heart, Lung, and Blood Institute Office of 
Technology Transfer and Development 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: September 17, 2020.
Bruce D. Goldstein,
Director, Office of Technology Transfer and Development, National 
Heart, Lung, and Blood Institute.
[FR Doc. 2020-21060 Filed 9-23-20; 8:45 am]
BILLING CODE 4140-01-P