[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Page 96023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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