82 FR 56623 - Prospective Grant of Exclusive Patent Commercialization License: N6, A Novel, Broad, Highly Potent HIV-Specific Antibody
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 228 (November 29, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 228 (November 29, 2017)
| Page Range | 56623-56624 | |
| FR Document | 2017-25745 |
[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)] [Notices] [Pages 56623-56624] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25745] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices 56623
on or before December 14, 2017 will be created. The vector can be used to SUMMARY: The National Institute of
considered. transduce and expand normal T cells Allergy and Infectious Diseases (NIAID),
ADDRESSES: Requests for copies of the from HLA–A11 patients with metastatic an institute of the National Institutes of
patent application, inquiries, and ccRCC with the TCR. The transduced Health, Department of Health and
comments relating to the contemplated cytotoxic T cells can then be Human Services, is contemplating the
exclusive license should be directed to: administered to subjects to treat or grant of an exclusive patent
Cristina Thalhammer-Reyero, Ph.D., inhibit metastatic kidney cancer. Kidney commercialization license to
MBA, Senior Licensing and Patenting cancer is responsible for approximately GlaxoSmithKline Intellectual Property
Manager, NHLBI Office of Technology 12,000 deaths every year in the United Development Ltd (GSK) located at 980
Transfer and Development, 31 Center States alone. As with most cancer, when Great West Road, Brentford, Middlesex,
Drive Room 4A29, MSC2479, Bethesda, detected at early stages, surgical TW8 9GS, United Kingdom, to practice
MD 20892–2479; Telephone: +1–301– intervention is highly effective. Phase I/ the inventions embodied in the patent
435–4507; Fax: +1–301–594–3080; II clinical trials are currently being applications listed in the
Email: thalhamc@mail.nih.gov. planned in patients with metastatic SUPPLEMENTARY INFORMATION section of
ccRCC using normal patient’s T-cells this notice.
SUPPLEMENTARY INFORMATION: The
following represents the intellectual transduced with this vector. DATES: Only written comments and/or
property to be licensed under the This notice is made in accordance applications for a license which are
prospective agreement: with 35 U.S.C. 209 and 37 CFR part 404. received by the Technology Transfer
US Provisional Patent Application The prospective Exclusive Patent and Intellectual Property Office,
No. 62/357,265, filed June 30, 2016; and License will be royalty bearing and may National Institute of Allergy and
PCT Patent Application PCT/US2017/ be granted unless within fifteen (15) Infectious Diseases on or before
040449, filed June 30, 2017, ‘‘HERV–E days from the date of this published December 14, 2017 will be considered.
Reactive T Cell Receptors and Methods notice, the NHLBI Office of Technology ADDRESSES: Requests for copies of the
of Use’’, NIH Reference No. E–120– Transfer and Development receives patent applications, inquiries, and
2016/0,1. written evidence and argument that comments relating to the contemplated
With respect to persons who have an establishes that the grant of the license exclusive patent commercialization
obligation to assign their right, title and would not be consistent with the license should be directed to: Chris
interest to the Government of the United requirements of 35 U.S.C. 209 and 37 Kornak, Lead Technology Transfer and
States of America, the patent rights in CFR part 404. Patent Specialist, Technology Transfer
these inventions have been assigned to The public may file comments or and Intellectual Property Office,
the Government of the United States of objections in response to this Notice. National Institute of Allergy and
America. Comments and objections, other than Infectious Diseases, 5601 Fishers Lane,
The prospective exclusive license those in the form of a license Suite 6D, MSC 9804, Rockville, MD
territory may be worldwide and the application, will not be treated 20852–9804, phone number 301–496–
field of use may be limited to the use confidentially, and may be made 2644, or chris.kornak@nih.gov.
of Licensed Patent Rights for the publicly available. SUPPLEMENTARY INFORMATION: The
following: ‘‘Development and License applications submitted in following represents the intellectual
commercialization of T cell receptor response to this Notice will be property to be licensed under the
based cancer immunotherapy for Renal presumed to contain business prospective agreement: HHS Reference
Cell Carcinoma’’. confidential information and any release No. E–131–2015/0–US–01, United
The subject technology is based on an of information in these license States Provisonal Patent Application
allogeneic T cell clone isolated from a applications will be made only as Serial No. 62/136,228, filed on 03/20/
clear cell renal cell carcinoma (ccRCC) required and upon a request under the 2015; HHS Reference No. E–131–2015/
HLA–A11 patient who showed Freedom of Information Act, 5 U.S.C. 1–US–01, United States Provisional
prolonged tumor regression after an 552. Patent Application Serial No. 62/
allogeneic transplant. This clone was 250,378 filed on 11/03/2015; HHS
found to have tumor specific Dated: November 16, 2017. Reference No. E–131–2015/2–PCT–01,
cytotoxicity, killing patient’s tumor cells Cristina Thalhammer-Reyero, PCT Patent Application Serial No. PCT/
in vitro. The antigen recognized by this Senior Licensing and Patenting Manager, US2016/023145, filed on 03/18/2016;
clone is an HLA–A11 restricted peptide Office of Technology Transfer and HHS Reference No. E–131–2015/2–US–
(named CT–RCC–1) and it is encoded by Development, National Heart, Lung, and 07, United States Patent Application
a novel human endogenous retrovirus-E Blood Institute. Serial No. 15/559,791, filed on 09/19/
(named CT–RCC HERV–E) whose [FR Doc. 2017–25743 Filed 11–28–17; 8:45 am] 2017; HHS Reference No. E–131–2015/
expression was discovered to be BILLING CODE 4140–01–P 2–EP–05, European Patent Application
restricted to ccRCC, but not observed in Serial No. 16716979.6, filed on 10/19/
normal tissues or other tumor types. 2017; HHS Reference No. E–131–2015/
More than 80% of ccRCC tumors DEPARTMENT OF HEALTH AND 2–CA–03, Canadian Patent Application
express CT–RCC HERV–E provirus, HUMAN SERVICES Serial No. 2,980,005, filed on 09/15/
which makes it an ideal target for T cell 2017; HHS Reference No. E–131–2015/
National Institutes of Health
based immunotherapy. The genes for a 2–AU–02, Australian Patent Application
pmangrum on DSK3GDR082PROD with NOTICES1
T cell receptor (TCR) that specifically Prospective Grant of Exclusive Patent Serial No. 2016235541, filed on 09/08/
recognizes an HLA–A11 restricted CT– Commercialization License: N6, A 2017; HHS Reference No. E–131–2015/
RCC–1 antigen were sequenced and Novel, Broad, Highly Potent HIV- 2–CN–04, filing in process, HHS
cloned. A retroviral vector encoding this Specific Antibody Reference No. E–131–2015/2–ZA–08,
TCR as well as a truncated CD34 protein South African Patent Application Serial
lacking the intracellular domain, which AGENCY: National Institutes of Health. No. 2017/06155, filed on 09/11/2017;
can be used to facilitate the isolation of and HHS Reference No. E–131–2015/
ACTION: Notice.
T-cells transduced with this TCR, was 2–IN–06, Indian Patent Application
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![56624 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices
Serial No. 201737032671, filed on 09/ under the Freedom of Information Act, DEPARTMENT OF HEALTH AND
14/2017. 5 U.S.C. 552. HUMAN SERVICES
All rights in these inventions have Suzanne Frisbie, National Institutes of Health
been assigned to the Government of the Deputy Director, Technology Transfer and
United States of America. Intellectual Property Office, National Institute National Center for Advancing
The prospective exclusive patent of Allergy and Infectious Diseases. Translational Sciences; Notice of
commercialization license territory may [FR Doc. 2017–25745 Filed 11–28–17; 8:45 am] Meetings
be worldwide and the field of use may BILLING CODE 4140–01–P Pursuant to section 10(d) of the
be limited to: ‘‘Administration to Federal Advisory Committee Act, as
humans of a GP120-binding protein or amended, notice is hereby given of
proteins, containing the 6 CDRs of the DEPARTMENT OF HEALTH AND meetings of the National Center for
N6 antibody, all as described in the HUMAN SERVICES Advancing Translational Sciences.
Licensed Patent Rights. This field of use The meetings will be open to the
does not include bi-specific/multi- National Institutes of Health public as indicated below, with
specific constructs utilizing the attendance limited to space available.
Licensed Patent Rights.’’ National Institute on Aging; Notice of
Individuals who plan to attend and
Closed Meeting
The N6 antibody has evolved a need special assistance, such as sign
unique mode of binding that depends Pursuant to section 10(d) of the language interpretation or other
less on a variable area of the HIV Federal Advisory Committee Act, as reasonable accommodations, should
envelope known as the V5 region and notify the Contact Person listed below
amended, notice is hereby given of the
focuses more on conserved regions, in advance of the meeting.
following meeting. The meetings will be closed to the
which change relatively little among
The meeting will be closed to the public in accordance with the
HIV strains. This allows N6 to tolerate
changes in the HIV envelope, including public in accordance with the provisions set forth in sections
the attachment of sugars in the V5 provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
region, a major mechanism by which 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and
as amended. The grant applications and the discussions could disclose
HIV develops resistance to other VRC01-
the discussions could disclose confidential trade secrets or commercial
class antibodies. N6 was shown in pre-
confidential trade secrets or commercial property such as patentable material,
clinical studies to neutralize
property such as patentable material, and personal information concerning
approximately 98 percent of HIV
and personal information concerning individuals associated with the grant
isolates tested. The studies also applications, the disclosure of which
demonstrate that N6 neutralizes individuals associated with the grant
applications, the disclosure of which would constitute a clearly unwarranted
approximately 80 percent of HIV invasion of personal privacy.
isolates which were resistant to other would constitute a clearly unwarranted
antibodies of the same class, and does invasion of personal privacy. Name of Committee: Cures Acceleration
Network Review Board.
so very potently. Its breadth and Name of Committee: National Institute on Date: January 11, 2018.
potency makes N6 a highly desirable Aging Special Emphasis Panel; AD Time: 8:30 a.m. to 3:00 p.m.
candidate for development in Sequencing II. Agenda: Report from the Institute Director.
therapeutic or prophylactic strategies. Date: December 1, 2017. Place: National Institutes of Health,
An abstract of the subject invention was Time: 1:00 p.m. to 5:00 p.m. Building 31, Conference Room 10, 31 Center
published in the Federal Register on Agenda: To review and evaluate grant Drive, Bethesda, MD 20892.
applications. Contact Person: Anna L. Ramsey-Ewing,
March 13, 2017.
Place: National Institute on Aging, Ph.D., Executive Secretary, National Center
This notice is made in accordance Gateway Building, Suite 2C212, 7201 for Advancing Translational Sciences, 1
with 35 U.S.C. 209 and 37 CFR part 404. Wisconsin Avenue, Bethesda, MD 20814 Democracy Plaza, Room 1072, Bethesda, MD
The prospective exclusive patent 20892, 301–435–0809, anna.ramseyewing@
(Telephone Conference Call).
commercialization license will be nih.gov.
Contact Person: Bita Nakhai, Ph.D.,
royalty bearing and may be granted Scientific Review Branch, National Institute Name of Committee: National Center for
unless within fifteen (15) days from the Advancing Translational Sciences Advisory
on Aging, Gateway Bldg., 2C212, 7201
Council.
date of this published notice, the Wisconsin Avenue, Bethesda, MD 20814, Date: January 11, 2018.
National Institute of Allergy and 301–402–7701, nakhaib@nia.nih.gov. Open: 8:30 a.m. to 3:00 p.m.
Infectious Diseases receives written This notice is being published less than 15 Agenda: Report from the Institute Director
evidence and argument that establishes days prior to the meeting due to the timing and other staff.
that the grant of the license would not limitations imposed by the review and Place: National Institutes of Health,
be consistent with the requirements of funding cycle. Building 31, Conference Room 10, 31 Center
35 U.S.C. 209 and 37 CFR part 404. Drive, Bethesda, MD 20892.
(Catalogue of Federal Domestic Assistance Closed: 3:15 p.m. to 4:30 p.m.
Complete applications for a license in Program Nos. 93.866, Aging Research, Agenda: To review and evaluate grant
the prospective field of use that are National Institutes of Health, HHS) applications.
pmangrum on DSK3GDR082PROD with NOTICES1
timely filed in response to this notice Dated: November 22, 2017. Place: National Institutes of Health,
will be treated as objections to the grant Building 31, Conference Room 10, 31 Center
Melanie J. Pantoja, Drive, Bethesda, MD 20892.
of the contemplated exclusive patent
Program Analyst, Office of Federal Advisory Contact Person: Anna L. Ramsey-Ewing,
commercialization license. Comments Committee Policy. Ph.D., Executive Secretary, National Center
and objections submitted in response to for Advancing Translational Sciences, 1
[FR Doc. 2017–25734 Filed 11–28–17; 8:45 am]
this notice will not be made available Democracy Plaza, Room 1072, Bethesda, MD
BILLING CODE 4140–01–P
for public inspection and, to the extent 20892, 301–435–0809, anna.ramseyewing@
permitted by law, will not be released nih.gov.
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Document Created: 2017-11-29 01:26:13
Document Modified: 2017-11-29 01:26:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | 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. | |
| FR Citation | 82 FR 56623 |
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