81 FR 96023 - Prospective Grant of Exclusive Patent License: Development and Commercialization of Nitrite Salts for the Treatment, Amelioration, and Prevention by Any Route of Administration of Pulmonary Hypertension, Including All WHO Classifications of Pulmonary Hypertension, e.g., Groups 1-5

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 250 (December 29, 2016)

Page Range		96023-96023
FR Document		2016-31437

The National Heart, Lung, and Blood Institute (``NHLBI''), an institute of the National Institutes of Health; an agency within the Department of Health and Human Services, is contemplating the grant of an exclusive patent license to commercialize the invention(s) embodied in the intellectual property estate stated in the Summary Information section of this notice to United Therapeutics Corporation (``United'') located in Silver Spring, MD and incorporated under the laws of Delaware.

Federal Register, Volume 81 Issue 250 (Thursday, December 29, 2016)

[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Page 96023]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31437]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Development and 
Commercialization of Nitrite Salts for the Treatment, Amelioration, and 
Prevention by Any Route of Administration of Pulmonary Hypertension, 
Including All WHO Classifications of Pulmonary Hypertension, e.g., 
Groups 1-5

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Heart, Lung, and Blood Institute (``NHLBI''), an 
institute of the National Institutes of Health; an agency within the 
Department of Health and Human Services, is contemplating the grant of 
an exclusive patent license to commercialize the invention(s) embodied 
in the intellectual property estate stated in the Summary Information 
section of this notice to United Therapeutics Corporation (``United'') 
located in Silver Spring, MD and incorporated under the laws of 
Delaware.

DATES: Only written comments and/or applications for a license which 
are received by the NHLBI Office of Technology Transfer and Development 
on or before January 13, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Cristina Thalhammer-Reyero, Ph.D., MBA, Senior Licensing 
and Patenting Manager, NHLBI Office of Technology Transfer and 
Development, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-
2479; Telephone: +1-301-435-4507; Fax: +1-301-594-3080; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement:
    PCT Application Number: PCT/US2004/21985, filed 9 July 2004, and 
corresponding US, EP, CA, AU and JP filings; and PCT Patent Application 
PCT/US2004/22232 filed 9 July 2004, and corresponding issued patents in 
EP, CA, AU and JP, as well as US 8,927,030 issued 01/06/2015; US 
9,387,224 issued 07/12/2016, and two pending US patent applications; 
Titled ``Use of Nitrite Salts for the treatment of Cardiovascular 
Conditions'' (NIH Reference No. E-254-2003/0,1,2,3)
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, the patent rights in these inventions have been assigned to 
the Government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to: ``Use of the Licensed Patent Rights 
for the treatment, amelioration, and prevention of any kind or nature 
and by any route of administration of Pulmonary Hypertension, including 
all WHO classifications of pulmonary hypertension, e.g., Groups 1-5''.
    The invention pertains to the unexpected finding that low, 
physiological and non-toxic concentrations of sodium nitrite are able 
to increase blood flow and produce vasodilation by infused and 
nebulized routes of administration.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Exclusive Patent License will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the NHLBI 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.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated Exclusive Patent License. 
Comments and objections to this notice submitted will not be made 
available for public inspection and, to the extent permitted by law, 
will not be released under the Freedom of Information Act, 5 U.S.C. 
552.

    Dated: December 21, 2016.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager, Office of Technology Transfer 
and Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2016-31437 Filed 12-28-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96023

Date: February 13, 2017. and incorporated under the laws of Transfer and Development receives
Time: 12:01 p.m. to 5:00 p.m. Delaware. written evidence and argument that
Agenda: To review and evaluate grant establishes that the grant of the license
applications. DATES: Only written comments and/or
applications for a license which are would not be consistent with the
Place: National Institute on Aging,
Gateway Building, Suite 2W200, 7201 received by the NHLBI Office of requirements of 35 U.S.C. 209 and 37
Wisconsin Ave., Bethesda, MD 20892. Technology Transfer and Development CFR part 404.
Contact Person: Maurizio Grimaldi, MD, on or before January 13, 2017 will be Complete applications for a license in
Ph.D., Scientific Review Officer, National considered. the prospective field of use that are
Institute on Aging, National Institutes of timely filed in response to this notice
Health, 7201 Wisconsin Avenue, Room ADDRESSES: Requests for copies of the
will be treated as objections to the grant
2C218, Bethesda, MD 20892, 301–496–9374, patent application, inquiries, and of the contemplated Exclusive Patent
grimaldim2@mail.nih.gov. comments relating to the contemplated License. Comments and objections to
Name of Committee: National Institute on exclusive license should be directed to: this notice submitted will not be made
Aging Special Emphasis Panel; 2017 Beeson Cristina Thalhammer-Reyero, Ph.D., available for public inspection and, to
Review. MBA, Senior Licensing and Patenting
Date: February 24, 2017. the extent permitted by law, will not be
Manager, NHLBI Office of Technology released under the Freedom of
Time: 11:00 a.m. to 3:30 p.m. Transfer and Development, 31 Center
Agenda: To review and evaluate grant Information Act, 5 U.S.C. 552.
Drive Room 4A29, MSC2479, Bethesda,
applications. Dated: December 21, 2016.
Place: National Institute on Aging,
MD 20892–2479; Telephone: +1–301–
435–4507; Fax: +1–301–594–3080; Cristina Thalhammer-Reyero,
Gateway Building, Suite 2W200, 7201
Wisconsin Avenue, Bethesda, MD 20892 Email: thalhamc@mail.nih.gov. Senior Licensing and Patenting Manager,
(Telephone Conference Call). SUPPLEMENTARY INFORMATION: The Office of Technology Transfer and
Contact Person: Alexander Parsadanian, following represents the intellectual Development, National Heart, Lung, and
Ph.D., Scientific Review Officer, National Blood Institute.
property to be licensed under the
Institute on Aging, Gateway Building 2C/212, prospective agreement: [FR Doc. 2016–31437 Filed 12–28–16; 8:45 am]
7201 Wisconsin Avenue, Bethesda, MD PCT Application Number: PCT/ BILLING CODE 4140–01–P
20892, 301–496–9666, Parsadaniana@
US2004/21985, filed 9 July 2004, and
nia.nih.gov.
corresponding US, EP, CA, AU and JP
(Catalogue of Federal Domestic Assistance DEPARTMENT OF HEALTH AND
filings; and PCT Patent Application
Program Nos. 93.866, Aging Research, HUMAN SERVICES
National Institutes of Health, HHS) PCT/US2004/22232 filed 9 July 2004,
and corresponding issued patents in EP,
Dated: December 23, 2016. National Institutes of Health
CA, AU and JP, as well as US 8,927,030
Melanie J. Pantoja, issued 01/06/2015; US 9,387,224 issued National Center for Complementary
Program Analyst, Office of Federal Advisory 07/12/2016, and two pending US patent and Integrative Health; Notice of
Committee Policy. applications; Titled ‘‘Use of Nitrite Salts Meeting
[FR Doc. 2016–31566 Filed 12–28–16; 8:45 am] for the treatment of Cardiovascular
BILLING CODE 4140–01–P Conditions’’ (NIH Reference No. E–254– Pursuant to section 10(d) of the
2003/0,1,2,3) Federal Advisory Committee Act, as
With respect to persons who have an amended (5 U.S.C. App.), notice is
DEPARTMENT OF HEALTH AND obligation to assign their right, title and hereby given of a meeting of the
HUMAN SERVICES interest to the Government of the United National Advisory Council for
States of America, the patent rights in Complementary and Integrative Health.
National Institutes of Health these inventions have been assigned to The meeting will be open to the
the Government of the United States of public as indicated below, with
Prospective Grant of Exclusive Patent attendance limited to space available.
America.
License: Development and The prospective exclusive license Individuals who plan to attend and
Commercialization of Nitrite Salts for territory may be worldwide and the need special assistance, such as sign
the Treatment, Amelioration, and field of use may be limited to: ‘‘Use of language interpretation or other
Prevention by Any Route of the Licensed Patent Rights for the reasonable accommodations, should
Administration of Pulmonary treatment, amelioration, and prevention notify the Contact Person listed below
Hypertension, Including All WHO of any kind or nature and by any route in advance of the meeting.
Classifications of Pulmonary of administration of Pulmonary The meeting will be closed to the
Hypertension, e.g., Groups 1–5 Hypertension, including all WHO public in accordance with the
AGENCY: National Institutes of Health, classifications of pulmonary provisions set forth in sections
HHS. hypertension, e.g., Groups 1–5’’. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
ACTION: Notice. The invention pertains to the as amended. The grant applications and
unexpected finding that low, the discussions could disclose
SUMMARY: The National Heart, Lung, and physiological and non-toxic confidential trade secrets or commercial
Blood Institute (‘‘NHLBI’’), an institute concentrations of sodium nitrite are able property such as patentable material,
of the National Institutes of Health; an to increase blood flow and produce and personal information concerning
agency within the Department of Health vasodilation by infused and nebulized
asabaliauskas on DSK3SPTVN1PROD with NOTICES

individuals associated with the grant
and Human Services, is contemplating routes of administration. applications, the disclosure of which
the grant of an exclusive patent license This notice is made in accordance would constitute a clearly unwarranted
to commercialize the invention(s) with 35 U.S.C. 209 and 37 CFR part 404. invasion of personal privacy.
embodied in the intellectual property The prospective Exclusive Patent Name of Committee: National Advisory
estate stated in the Summary License will be royalty bearing and may Council for Complementary and Integrative
Information section of this notice to be granted unless within fifteen (15) Health.
United Therapeutics Corporation days from the date of this published Date: February 3, 2017.
(‘‘United’’) located in Silver Spring, MD notice, the NHLBI Office of Technology Closed: 8:30 a.m. to 9:15 a.m.

VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1

Document Created: 2016-12-29 01:58:21
Document Modified: 2016-12-29 01:58:21

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 NHLBI Office of Technology Transfer and Development on or before January 13, 2017 will be considered.
FR Citation		81 FR 96023

81 FR 96023 - Prospective Grant of Exclusive Patent License: Development and Commercialization of Nitrite Salts for the Treatment, Amelioration, and Prevention by Any Route of Administration of Pulmonary Hypertension, Including All WHO Classifications of Pulmonary Hypertension, e.g., Groups 1-5

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 250 (December 29, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health