[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Notices]
[Page 29127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13443]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Methods of 
Modulating Erythropoiesis With Arginine Vasopressin Receptor 1B 
Molecules

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Institute of Dental and Craniofacial Research, 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 Patent Applications 
listed in the Supplementary Information section of this notice to 
ERYTHRYx Therapeutics, located in Los Angeles, California.

DATES: Only written comments and/or applications for a license which 
are received by the Office of Technology Transfer and Innovation 
Access, National Institute of Dental and Craniofacial Research on or 
before July 9, 2018 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: Yun Mei, Technology Transfer and Patent 
Specialist, Office of Technology Transfer and Innovation Access, 
National Institute of Dental and Craniofacial Research, National 
Institutes of Health, BLDG 1 DEM, RM667, 6701 Democracy Blvd., 
Bethesda, MD 20817; Telephone: (301) 827-4639; Facsimile: (301) 496-
1005; Email: <a href="/cdn-cgi/l/email-protection#fd848893d3909894bd939495d39a928b"><span class="__cf_email__" data-cfemail="6c151902420109052c020504420b031a">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Intellectual Property

    1. U.S. Provisional Patent Application No. 61/885,258, filed 
October 1, 2013 and entitled ``Methods of Modulating Erythropoiesis 
with Arginine Vasopressin Receptor 1B Molecules'' (HHS Reference No. E-
619-2013-0-US-01);
    2. PCT Application No. PCT/US2014/058613, filed October 1, 2014 and 
entitled ``Methods of Modulating Erythropoiesis with Arginine 
Vasopressin Receptor 1B Molecules'' (HHS Reference No. E-619-2013-0-
PCT-02);
    3. U.S. Patent Application No. 15/022,531, filed March 16, 2016 and 
entitled ``Methods of Modulating Erythropoiesis with Arginine 
Vasopressin Receptor 1B Molecules'' (HHS Reference No. E-619-2013-0-US-
03);
    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 the United 
States and the field of use may be limited to ``Use of arginine 
vasopressin receptor 1B agonists to treat anemia caused by (i) chronic 
renal failure on dialysis, (ii) receiving myelosuppressive 
chemotherapy, or (iii) lacking antidiuretic hormone.''
    The subject technology is a method of using arginine vasopressin 
receptor 1B (AVPR1B) agonists to increase the number of red blood cells 
to treat anemia. The inventors discovered that hematopoietic stem cells 
express AVPR1B receptor, and these receptors play a key role in 
promoting hematopoietic stem and progenitor cell proliferation. The 
number of red blood cells and their precursors significantly increased 
on day 2 following vasopressin administration, an onset time much 
faster than erythropoietin (EPO), which is commonly used to stimulate 
red blood cell production for anemia treatment. EPO takes about a week 
to manifest its clinical effects. The AVPR1B agonists can be used to 
jumpstart the hematopoietic system and erythropoietin can be used to 
sustain the effect.
    The subject technology is a repurposing of an existing drug, 
vasopressin, an AVPR1B agonist, also called antidiuretic hormone. It is 
a nine-amino acid peptide secreted from the posterior pituitary and 
used to treat patients with central diabetes insipidus, an uncommon 
disorder that causes an imbalance of water in the body. This imbalance 
leads to excretion of large amount of urine (polyuria) and intense 
thirst even after drinking fluids (polydipsia).
    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 
Institute of Dental and Craniofacial Research 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: June 19, 2018.
David W. Bradley,
Director, Office of Technology Transfer and Innovation Access, National 
Institute of Dental and Craniofacial Research, National Institutes of 
Health.
[FR Doc. 2018-13443 Filed 6-21-18; 8:45 am]
BILLING CODE 4140-01-P


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