[Federal Register Volume 86, Number 151 (Tuesday, August 10, 2021)]
[Notices]
[Pages 43670-43671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Multi-Domain 
Amphipathic Helical Peptide for Use as A Human Therapeutic in Patients 
With Atherosclerotic Cardiovascular Disease, Including Patients 
Undergoing Cardiovascular Surgery Who Are at risk of Acute Kidney 
Injury

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Heart, Lung, and Blood Institute, an institute of 
the National Institutes of Health, Department of Health and Human 
Services, is contemplating the grant of an exclusive patent license to 
Phyxius Therapeutics, Inc., a start-up company incorporated as a C 
corporation under the laws of the state of Delaware, to practice the 
inventions covered by the patent estate listed in the Supplementary 
Information section of this notice. This is a first notice intended to 
apprise the public of a change in prospective licensee of the subject 
intellectual property rights in the stated field of use.

DATES: Only written comments and/or applications for a license which 
are received by the National Heart, Lung, and Blood Institute on or 
before August 25, 2021 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: Michael Davis, J.D., Ph.D., Senior Technology 
Transfer Manager, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 
20892-2479, phone number 301-451-9032, or [email protected].

SUPPLEMENTARY INFORMATION: Intellectual Property

----------------------------------------------------------------------------------------------------------------
                                                      Patent
          NIH REF No.                 Title         Application     Filing Date    Issued Patent    Issue Date
                                                        No.                             No.
----------------------------------------------------------------------------------------------------------------
E-114-2004-0-US-01............  Multi-Domain          60/619,392        10/15/04  ..............  ..............
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-PCT-02...........  Multi-Domain         PCT/US2005/        10/14/05  ..............  ..............
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-AU-03............  Multi-Domain          2005295640        10/14/05      2005295640        11/10/11
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-CA-04............  Multi-Domain             2584048        10/14/05         2584048        08/09/16
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-EP-05............  Multi-Domain          05815961.7        10/14/05         1812474        05/26/10
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-JP-06............  Multi-Domain         2007-536912        10/14/05       5,091,679        09/21/12
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-US-07............  Multi-Domain          11/577,259        04/13/07       7,572,771        08/11/09
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-US-08............  Multi-Domain          12/497,443        07/02/09       8,071,746        12/06/11
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-US-09............  Multi-Domain          12/766,761        04/23/10       8,148,323        04/03/12
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-CH-11............  Multi-Domain          05815961.7        10/14/05         1812474        05/26/10
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-DE-12............  Multi-Domain          05815961.7        10/14/05         1812474        05/26/10
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-ES-13............  Multi-Domain          05815961.7        10/14/05         1812474        05/26/10
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-FR-14............  Multi-Domain          05815961.7        10/14/05         1812474        05/26/10
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-GB-15............  Multi-Domain          05815961.7        10/14/05         1812474        05/26/10
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-IT-16............  Multi-Domain          05815961.7        10/14/05         1812474        05/26/10
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
E-114-2004-0-US-17............  Multi-Domain          13/407,132        02/28/12       8,835,378        09/16/14
                                 Amphipathic
                                 Helical
                                 Peptides And
                                 Methods Of
                                 Their Use.
----------------------------------------------------------------------------------------------------------------

    All U.S. and foreign patents and applications claiming priority to 
any member 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 prospective exclusive license territory may be worldwide and in 
fields of use that may be limited to use as a human therapeutic in 
patients with atherosclerotic cardiovascular disease (ASCVD), including 
patients undergoing cardiovascular surgery who are at risk of acute 
kidney injury.
    The patents listed above cover an invention directed to peptides or

[[Page 43671]]

peptide analogs with multiple amphipathic alpha helical domains that 
promote lipid efflux from cells via an ABCA1-dependent pathway. This 
invention is also directed to methods of identifying non-cytotoxic 
peptides that promote ABCA1-dependent lipid efflux from cells, and to 
methods of using multi-domain amphipathic alpha helical peptides or 
peptide analogs to treat or inhibit dyslipidemic disorders.
    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. 
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 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.

Bruce D. Goldstein,
Director, Office of Technology Transfer and Development, National 
Heart, Lung, and Blood Institute.
[FR Doc. 2021-17011 Filed 8-9-21; 8:45 am]
BILLING CODE 4140-01-P