[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Notices]
[Pages 28002-28003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12838]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent Commercialization License: 
Streptococcus Pneumonia PSAA Peptide for Treatment of Sepsis and 
Infection

AGENCY: National Institutes of Health, Centers for Disease Control and 
Prevention, Department of Health and Human Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Institute of Allergy and Infectious Diseases, an 
institute of the National Institutes of Health, Department of Health 
and Human Services, on behalf of the Centers for Disease Control and 
Prevention, Department of Health and Human Services, is contemplating 
the grant of an exclusive patent commercialization license to The 
University of Liverpool, located in Liverpool, UK, to practice the 
inventions embodied in the patent applications listed in the 
Supplementary Information section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases on or 
before July 2, 2018 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent 
commercialization license should be directed to: Karen Surabian, 
Licensing and Patenting Manager, Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Suite 6D, MSC9804, Rockville, MD 20852-9804, phone 
number 301-496-2644, or [email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement: United States 
Provisional Patent Application Number 61/085,208, filed 07/31/2008, 
entitled ``Methods of Enhancing Opsonophagocytosis in Response to a 
Pathogen'' (HHS Reference No. E-329-2013/0-US-01); PCT Patent 
Application Number PCT/US2009/052384, filed 07/31/2009, entitled 
``Methods of Enhancing Opsonophagocytosis in Response to a Pathogen'' 
(HHS Reference No. E-329-2013/0-PCT-02); China Patent Number 
200980137625.X, issued 11/26/2014, entitled ``Methods of Enhancing 
Opsonophagocytosis in Response to a Pathogen'' (HHS Reference No. E-
329-2013/0-CN-03); European Patent Number 2323684, issued 05/21/2014, 
entitled ``Use of a Pneumococcal P4 Peptide for Enhancing 
Opsonophagocytosis in Response to a Pathogen'' (HHS Reference No. E-
329-2013/0-EP-04), and validated in Germany, Spain, France, the United 
Kingdom, and Ireland; Hong Kong Patent Number 1160391, issued 07/31/
2015, entitled ``Methods of Enhancing Opsonophagocytosis in Response to 
a Pathogen'' (HHS Reference No. E-329-2013/0-HK-05); United States 
Patent Number 8,431,134, issued 04/30/2013, entitled ``Use of a 
Pneumococcal P4 Peptide for Enhancing Opsonophagocytosis in Response to 
a Pathogen'' (HHS Reference No. E-329-2013/0-US-06); United States 
Patent Number 9,101,582, issued 08/11/2015, entitled ``Use of a 
Pneumococcal P4 Peptide for Enhancing Opsonophagocytosis in Response to 
a Pathogen'' (HHS Reference No. E-329-2013/0-US-07); United States 
Provisional Patent Application Number 60/682,495, filed 05/19/2005, 
entitled ``Functional Epitopes of Streptococcus Pneumonia PSAA Antigen 
and Uses Thereof'' (HHS Reference No. E-338-2013/0-US-01); PCT Patent 
Application Number PCT/US2005/027290, filed 07/29/2005, entitled 
``Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses 
Thereof'' (HHS Reference No. E-338-2013/0-PCT-02); Australia Patent 
Number 2005332058, issued 03/15/2012, entitled ``Functional Epitopes of 
Streptococcus Pneumonia PSAA Antigen and Uses Thereof'' (HHS Reference 
No. E-338-2013/0-AU-03); European Patent Number 1931700, issued 07/17/
2003, entitled ``Functional Epitopes of Streptococcus Pneumonia PSAA 
Antigen and Uses Thereof'' (HHS Reference No. E-338-2013/0-EP-04), and 
validated in: Germany, Spain, France, the United Kingdom, and Ireland; 
Hong Kong Patent Number 1115144, issued 02/14/2014, entitled 
``Functional Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses 
Thereof'' (HHS Reference No. E-338-2013/0-HK-05); United States Patent 
Number 7,919,104, issued 04/05/2011, entitled ``Functional Epitopes of 
Streptococcus Pneumonia PSAA Antigen and Uses Thereof'' (HHS Reference 
No. E-338-2013/0-US-06); Canada Patent Application Number 2,631,556, 
filed 09/15/2014, entitled ``Functional Epitopes of Streptococcus 
Pneumonia PSAA Antigen and Uses Thereof'' (HHS Reference No. E-338-
2013/0-CA-07); Australia Patent Number 2012201107, issued 06/06/2013, 
entitled ``Functional Epitopes of Streptococcus Pneumonia PSAA Antigen 
and Uses Thereof'' (HHS Reference No. E-338-2013/0-AU-08); Hong Kong 
Patent Number HK1163113, issued 06/05/2015, entitled ``Functional 
Epitopes of Streptococcus Pneumonia PSAA Antigen and Uses Thereof'' 
(HHS Reference No. E-338-2013/0-HK-09); European Patent Number 2371843, 
issued 09/17/2014, entitled ``Functional Epitopes of Streptococcus 
Pneumonia PSAA Antigen and Uses Thereof'' (HHS Reference No. E-338-
2013/0-EP-10), and validated in: Germany, France, and the United 
Kingdom.
    All rights in these inventions have been assigned to the Government 
of the United States of America.
    The prospective exclusive patent commercialization license 
territory may be worldwide and the field of use may be limited to: 
``Development, manufacture, and sale of a P4 peptide therapeutic for 
the treatment of infection and sepsis.''
    These inventions, developed within the National Center for 
Immunization and Respiratory Diseases (NCIRD), at the Centers for 
Disease Control and Prevention (CDC), describe methods to bolster the 
human body's own mechanisms to fight infection by enhancing an innate 
immune response, opsonophagocytosis. The specific 24 amino acid peptide 
sequence (P4) acts as a polymorphonuclear cell activator. P4 can be 
administered in vivo along with disease-specific antibodies to enhance 
systemic bacterial clearance,

[[Page 28003]]

thus leading to prolonged survival. This technology enhances the body's 
response to a variety of bacterial infections, including S. pneumoniae 
and S. aureus.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent commercialization license 
will be royalty bearing and may be granted unless within fifteen (15) 
days from the date of this published notice, the National Institute of 
Allergy and Infectious Diseases 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 
commercialization license. 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 11, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-12838 Filed 6-14-18; 8:45 am]
 BILLING CODE 4140-01-P