83 FR 29127 - Prospective Grant of an Exclusive Patent License: Methods of Modulating Erythropoiesis With Arginine Vasopressin Receptor 1B Molecules

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 121 (June 22, 2018)

Page Range		29127-29127
FR Document		2018-13443

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.

Federal Register, Volume 83 Issue 121 (Friday, June 22, 2018)

[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Notices]
[Page 29127]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].

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

Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Notices 29127

Enhancement Award; 93.936, NIH Acquired (HHS Reference No. E–619–2013–0–US– within fifteen (15) days from the date of
Immunodeficiency Syndrome Research Loan 01); this published notice, the National
Repayment Program; 93.187, Undergraduate 2. PCT Application No. PCT/US2014/ Institute of Dental and Craniofacial
Scholarship Program for Individuals from 058613, filed October 1, 2014 and Research receives written evidence and
Disadvantaged Backgrounds, National entitled ‘‘Methods of Modulating
Institutes of Health, HHS)
argument that establishes that the grant
Erythropoiesis with Arginine of the license would not be consistent
Dated: June 19, 2018. Vasopressin Receptor 1B Molecules’’ with the requirements of 35 U.S.C. 209
Natasha M. Copeland, (HHS Reference No. E–619–2013–0– and 37 CFR part 404.
PCT–02); In response to this Notice, the public
Program Analyst, Office of Federal Advisory
Committee Policy.
3. U.S. Patent Application No. 15/ may file comments or objections.
022,531, filed March 16, 2016 and Comments and objections, other than
[FR Doc. 2018–13419 Filed 6–21–18; 8:45 am]
entitled ‘‘Methods of Modulating those in the form of a license
BILLING CODE 4140–01–P
Erythropoiesis with Arginine application, will not be treated
Vasopressin Receptor 1B Molecules’’ confidentially, and may be made
(HHS Reference No. E–619–2013–0–US– publicly available.
DEPARTMENT OF HEALTH AND
03); License applications submitted in
HUMAN SERVICES The patent rights in these inventions response to this Notice will be
National Institutes of Health have been assigned and/or exclusively presumed to contain business
licensed to the government of the confidential information and any release
Prospective Grant of an Exclusive United States of America. of information in these license
Patent License: Methods of Modulating The prospective exclusive license applications will be made only as
Erythropoiesis With Arginine territory may be the United States and required and upon a request under the
Vasopressin Receptor 1B Molecules the field of use may be limited to ‘‘Use Freedom of Information Act, 5 U.S.C.
of arginine vasopressin receptor 1B 552.
AGENCY: National Institutes of Health, agonists to treat anemia caused by (i)
HHS. chronic renal failure on dialysis, (ii) Dated: June 19, 2018.
receiving myelosuppressive David W. Bradley,
ACTION: Notice.
chemotherapy, or (iii) lacking Director, Office of Technology Transfer and
SUMMARY: The National Institute of antidiuretic hormone.’’ Innovation Access, National Institute of
Dental and Craniofacial Research, an The subject technology is a method of Dental and Craniofacial Research, National
using arginine vasopressin receptor 1B Institutes of Health.
institute of the National Institutes of
Health, Department of Health and (AVPR1B) agonists to increase the [FR Doc. 2018–13443 Filed 6–21–18; 8:45 am]
Human Services, is contemplating the number of red blood cells to treat BILLING CODE 4140–01–P

grant of an Exclusive Patent License to anemia. The inventors discovered that
practice the inventions embodied in the hematopoietic stem cells express
Patent Applications listed in the AVPR1B receptor, and these receptors DEPARTMENT OF HEALTH AND
Supplementary Information section of play a key role in promoting HUMAN SERVICES
this notice to ERYTHRYx Therapeutics, hematopoietic stem and progenitor cell
proliferation. The number of red blood National Institutes of Health
located in Los Angeles, California.
DATES: Only written comments and/or
cells and their precursors significantly Government-Owned Inventions;
applications for a license which are increased on day 2 following Availability for Licensing
received by the Office of Technology vasopressin administration, an onset
time much faster than erythropoietin AGENCY: National Institutes of Health,
Transfer and Innovation Access,
(EPO), which is commonly used to HHS.
National Institute of Dental and
Craniofacial Research on or before July stimulate red blood cell production for ACTION: Notice.
9, 2018 will be considered. anemia treatment. EPO takes about a
week to manifest its clinical effects. The SUMMARY: The invention listed below is
ADDRESSES: Requests for copies of the AVPR1B agonists can be used to owned by an agency of the U.S.
patent application, inquiries, and jumpstart the hematopoietic system and Government and is available for
comments relating to the contemplated erythropoietin can be used to sustain licensing to achieve expeditious
an Exclusive Patent License should be the effect. commercialization of results of
directed to: Yun Mei, Technology The subject technology is a federally-funded research and
Transfer and Patent Specialist, Office of repurposing of an existing drug, development. Foreign patent
Technology Transfer and Innovation vasopressin, an AVPR1B agonist, also applications are filed on selected
Access, National Institute of Dental and called antidiuretic hormone. It is a nine- inventions to extend market coverage
Craniofacial Research, National amino acid peptide secreted from the for companies and may also be available
Institutes of Health, BLDG 1 DEM, posterior pituitary and used to treat for licensing.
RM667, 6701 Democracy Blvd., patients with central diabetes insipidus, FOR FURTHER INFORMATION CONTACT: Dr.
Bethesda, MD 20817; Telephone: (301) an uncommon disorder that causes an Barry Buchbinder, 240–627–3678;
827–4639; Facsimile: (301) 496–1005; imbalance of water in the body. This barry.buchbinder@nih.gov. Licensing
Email: yun.mei@nih.gov. imbalance leads to excretion of large information and copies of the U.S.
SUPPLEMENTARY INFORMATION: amount of urine (polyuria) and intense patent application listed below may be
daltland on DSKBBV9HB2PROD with NOTICES

thirst even after drinking fluids obtained by communicating with the
Intellectual Property indicated licensing contact at the
(polydipsia).
1. U.S. Provisional Patent Application This notice is made in accordance Technology Transfer and Intellectual
No. 61/885,258, filed October 1, 2013 with 35 U.S.C. 209 and 37 CFR part 404. Property Office, National Institute of
and entitled ‘‘Methods of Modulating The prospective exclusive license will Allergy and Infectious Diseases, 5601
Erythropoiesis with Arginine be royalty bearing, and the prospective Fishers Lane, Rockville, MD 20852; tel.
Vasopressin Receptor 1B Molecules’’ exclusive license may be granted unless 301–496–2644. A signed Confidential

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Document Created: 2018-11-06 09:50:04
Document Modified: 2018-11-06 09:50:04

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
FR Citation		83 FR 29127

83 FR 29127 - Prospective Grant of an Exclusive Patent License: Methods of Modulating Erythropoiesis With Arginine Vasopressin Receptor 1B Molecules

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 121 (June 22, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health