[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Pages 41607-41608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent Commercialization License: 
N6, a Novel, Broad, Highly Potent HIV-Specific Antibody and a Broadly 
Neutralizing Human Anti-HIV Monoclonal Antibody (10E8) Capable of 
Neutralizing Most HIV-1 Strains

AGENCY: National Institutes of Health.

ACTION: Notice.

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SUMMARY: The National Institute of Allergy and Infectious Diseases 
(NIAID), an institute of the National Institutes of Health, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive patent commercialization license to RNAceuticals, Inc. 
located at 12 Indian Trail Road, Woodbridge, CT, USA 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 27, 2020 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: Chris Kornak, Lead 
Technology Transfer and Patent Specialist, Technology Transfer and 
Intellectual Property Office, National Institute of Allergy and 
Infectious Diseases, 5601 Fishers Lane, Suite 6D, MSC 9804, Rockville, 
MD 20852-9804, phone number 240-627-3705; Email: [email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement.
    N6: To date, NIAID has filed the following patent applications for 
this matter: Two U.S. Provisionals (E-131-

[[Page 41608]]

2015-0-US-01, 62/136,228, filed on 03/20/2015 and E-131-2015-1-US-01, 
62/250,378 filed on 11/03/2015) that were combined into one PCT 
Application (E-131-2015-2-PCT-01, PCT/US2016/023145, filed on 03/18/
2016), and entered the national stage in the United States (E-131-2015-
2-US-07, 15/559,791, filed on 09/19/2017 and E-131-2015-2-US-09, 16/
786,267, filed on 02/10/2020), Europe (E-131-2015-2-EP-05, 16716979.6 
and E-131-2015-2-EP-10, 20156388.9), Canada (E-131-2015-2-CA-03, 
2,980,005), Australia (E-131-2015-2-AU-02, 2016235541), China (E-131-
2015-2-CN-04, 201680028822.8), South Africa (E-131-2015-2-ZA-08, 2017/
06155), and India (E-131-2015-2-IN-06, 201737032671).
    10E8: NIAID has filed the following patent applications for this 
matter, three U.S. Provisionals (E-253-2011-0-US-01, 61/556,660, filed 
on 11/07/2011, E-253-2011-1-US-01, 61/672,708, filed on 07/17/2012, and 
E-253-2011-2-US-01, 61/698,480, filed on 09/07/2012) that were combined 
into one PCT application (E-253-2011-3-PCT-01, PCT/US2012/063958, filed 
on 11/07/2012), and entered the national stage, in seven countries: 
United States (E-253-2011-3-US-05, 14/356,557, filed on 05/06/2014, E-
253-2011-4-US-01, 14/450,773, filed on 08/04/2014, E-253-2011-3-US-09, 
15/226,744, filed on 08/02/2016, E-253-2011-3-US-13, 15/699,902, filed 
on 09/08/2017), Europe (E-253-2011-3-EP-03, 12847241.2), China (E-253-
2011-3-CN-02, 201280065580.1), India (E-253-2011-3-IN-04, 3678/DELNP/
2014), South Africa (E-253-2011-3-ZA-06, 2014/03264), Brazil (E-253-
2011-3-BR-07, BR112014010823-4), and Russia (E-253-2011-3-RU-08, 
2014118462).
    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: (1) 
Administration to humans of DNA and/or RNA including without limitation 
modified RNA encoding a protein or proteins, containing all or some of 
the CDRs of N6 and (2) Administration to humans of DNA and/or RNA 
including without limitation modified RNA encoding a protein or 
proteins, containing all or some of the CDRs of 10E8.
    The N6 antibody has evolved a unique mode of binding that depends 
less on a variable area of the HIV envelope known as the V5 region and 
focuses more on conserved regions, which change relatively little among 
HIV strains. This allows N6 to tolerate changes in the HIV envelope, 
including the attachment of sugars in the V5 region, a major mechanism 
by which HIV develops resistance to other VRC01-class antibodies. N6 
was shown in pre-clinical studies to neutralize approximately 98 
percent of HIV isolates tested. The studies also demonstrate that N6 
neutralizes approximately 80 percent of HIV isolates which were 
resistant to other antibodies of the same class, and does so very 
potently. Its breadth and potency makes N6 a highly desirable candidate 
for development in therapeutic or prophylactic strategies. An abstract 
for this invention was published in the Federal Register on March 13, 
2017.
    The other invention, 10E8, has great potential to provide passive 
protection from infection, as a therapeutic, or as a tool for the 
development of vaccine immunogens. 10E8 is one of the most potent HIV-
neutralizing antibodies isolated thus far and it can potently 
neutralize up to 98% of genetically diverse HIV-1 strains. 10E8 is 
specific to the membrane-proximal external region (MPER) of the HIV 
envelope protein, GP41. An abstract for this invention was published in 
the Federal Register on April 24th, 2012 and June 24th, 2014.
    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 from these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-14836 Filed 7-9-20; 8:45 am]
BILLING CODE 4140-01-P