[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56623-56624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25745]


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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

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 GlaxoSmithKline 
Intellectual Property Development Ltd (GSK) located at 980 Great West 
Road, Brentford, Middlesex, TW8 9GS, United Kingdom, 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 December 14, 2017 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 301-496-2644, or [email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement: HHS Reference 
No. E-131-2015/0-US-01, United States Provisonal Patent Application 
Serial No. 62/136,228, filed on 03/20/2015; HHS Reference No. E-131-
2015/1-US-01, United States Provisional Patent Application Serial No. 
62/250,378 filed on 11/03/2015; HHS Reference No. E-131-2015/2-PCT-01, 
PCT Patent Application Serial No. PCT/US2016/023145, filed on 03/18/
2016; HHS Reference No. E-131-2015/2-US-07, United States Patent 
Application Serial No. 15/559,791, filed on 09/19/2017; HHS Reference 
No. E-131-2015/2-EP-05, European Patent Application Serial No. 
16716979.6, filed on 10/19/2017; HHS Reference No. E-131-2015/2-CA-03, 
Canadian Patent Application Serial No. 2,980,005, filed on 09/15/2017; 
HHS Reference No. E-131-2015/2-AU-02, Australian Patent Application 
Serial No. 2016235541, filed on 09/08/2017; HHS Reference No. E-131-
2015/2-CN-04, filing in process, HHS Reference No. E-131-2015/2-ZA-08, 
South African Patent Application Serial No. 2017/06155, filed on 09/11/
2017; and HHS Reference No. E-131-2015/ 2-IN-06, Indian Patent 
Application

[[Page 56624]]

Serial No. 201737032671, filed on 09/14/2017.
    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: 
``Administration to humans of a GP120-binding protein or proteins, 
containing the 6 CDRs of the N6 antibody, all as described in the 
Licensed Patent Rights. This field of use does not include bi-specific/
multi-specific constructs utilizing the Licensed Patent Rights.''
    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 
of the subject invention was published in the Federal Register on March 
13, 2017.
    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. Comments and objections submitted in 
response to this notice 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.

Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-25745 Filed 11-28-17; 8:45 am]
 BILLING CODE 4140-01-P