83 FR 24320 - Prospective Grant of Exclusive License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Flavivirus Vaccines
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 102 (May 25, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 102 (May 25, 2018)
| Page Range | 24320-24320 | |
| FR Document | 2018-11258 |
[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)] [Notices] [Page 24320] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11258] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Flavivirus Vaccines AGENCY: National Institute of Allergy and Infectious Diseases, National Institutes of Health, Public Health Service, DHHS. 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, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Medigen Vaccines Biologics Corp. (Medigen), having a place of business in Zhubei, Taiwan. DATES: Only written comments and/or application for a license which are received by the NIAID Technology Transfer and Intellectual Property Office on or before June 25, 2018 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated Exclusive Commercialization Patent License should be directed to: Peter Soukas, Technology Transfer and Patent Specialist, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Suite 6D, Rockville, MD 20852-9804; Email: ps193c@nih.gov; Telephone: (301) 496-2644; Facsimile: (240) 627-3117. SUPPLEMENTARY INFORMATION: Intellectual Property U.S. Provisional Patent Application Number 62/307,170, filed March 11, 2016 and entitled ``Live Attenuated Zika Virus Vaccines,'' Whitehead et al., and PCT Patent Application Number PCT/US2017/0021989, filed March 11, 2017 and entitled ``Live Attenuated Zika Virus Vaccines,'' Whitehead et al. [HHS Reference E-118-2016/0]; and U.S. and foreign patent applications claiming priority to the aforementioned applications. The patent rights in these inventions have been assigned to the government of the United States of America. The field of use may be limited to monovalent live attenuated Zika vaccines and multivalent live attenuated flavivirus vaccines. The Licensed Territory may be limited to Europe, China, South Korea, Japan, India, Australia and New Zealand. Zika virus (ZIKV) is an emerging infectious disease that was first identified in 1947, and that has more recently become a major public health threat around the world. ZIKV has recently been shown to cause devastating neurological damage in infants and serious complications in adults in some cases, and may have other effects that have not yet been identified or definitively linked to the virus. There are no treatments or vaccines for this insidious virus. Recommendations that women who live in or travel to endemic areas avoid pregnancy for long periods of time are unrealistic, particularly in contexts where access to reproductive services is limited, and threaten to leave those most likely to suffer the devastating consequences of Zika without effective protection. There is therefore urgent need to develop biomedical interventions in parallel with ongoing public health efforts against ZIKV. No vaccine exists today to prevent ZIKV infections. The methods and compositions of this invention provide a means for prevention of ZIKV infection by immunization with live attenuated, immunogenic viral vaccines against ZIKV and/or Dengue virus. Many entities, governmental, academic, and commercial, are actively pursuing development of ZIKV vaccines each using a different approach to address this public health need. The U.S. Government is coordinating its vaccine development response to ZIKV and has published this plan at https://www.phe.gov/Preparedness/planning/Pages/zika-white-paper.aspx. Vaccine development approaches for ZIKV include but are not limited to inactivated virus (dead virus), live attenuated virus (weakened virus), recombinant viral vectors (weakened virus with target genes added), and subunit (portion of a virus) as well as mRNA- and DNA-based (gene-targeted). These various strategies provide multiple redundancies, expanded choice, and ensure short and long term maximal benefits to the public. 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, and the prospective exclusive license may be granted unless within thirty (30) 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 filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Commercialization Patent License Agreement. Comments and objections submitted 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. Dated: May 14, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2018-11258 Filed 5-24-18; 8:45 am] BILLING CODE 4140-01-P
![24320 Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices
Contact Person: Julia Berzhanskaya, Ph.D., (Medigen), having a place of business in consequences of Zika without effective
Scientific Review Officer, Office of Zhubei, Taiwan. protection. There is therefore urgent
Extramural Policy and Review, Division of need to develop biomedical
DATES: Only written comments and/or
Extramural Research, National Institute on
application for a license which are interventions in parallel with ongoing
Drug Abuse, NIH, DHHS, 6001 Executive
Boulevard, Room 4234, MSC 9550, Bethesda, received by the NIAID Technology public health efforts against ZIKV.
MD 20892, 301–827–5840, Transfer and Intellectual Property Office No vaccine exists today to prevent
julia.berzhanskaya@nih.gov. on or before June 25, 2018 will be ZIKV infections. The methods and
This notice is being published less than 15 considered. compositions of this invention provide
days prior to the meeting due to the timing ADDRESSES: Requests for a copy of the a means for prevention of ZIKV
limitations imposed by the review and infection by immunization with live
funding cycle.
patent application, inquiries, comments
and other materials relating to the attenuated, immunogenic viral vaccines
Name of Committee: National Institute on against ZIKV and/or Dengue virus.
Drug Abuse Special Emphasis Panel; SBIR
contemplated Exclusive
Phase II ‘‘Virtual Reality Tools for Treatment Commercialization Patent License Many entities, governmental,
of Substance Use Disorders’’ (5583). should be directed to: Peter Soukas, academic, and commercial, are actively
Date: June 4, 2018. Technology Transfer and Patent pursuing development of ZIKV vaccines
Time: 10:00 a.m. to 11:30 a.m. Specialist, Technology Transfer and each using a different approach to
Agenda: To review and evaluate contract Intellectual Property Office, National address this public health need. The
proposals. Institute of Allergy and Infectious U.S. Government is coordinating its
Place: National Institutes of Health, Diseases, National Institutes of Health,
Neuroscience Center, 6001 Executive
vaccine development response to ZIKV
5601 Fishers Lane, Suite 6D, Rockville, and has published this plan at https://
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
MD 20852–9804; Email: ps193c@ www.phe.gov/Preparedness/planning/
Contact Person: Julia Berzhanskaya, Ph.D., nih.gov; Telephone: (301) 496–2644; Pages/zika-white-paper.aspx.
Scientific Review Officer, Office of Facsimile: (240) 627–3117.
Vaccine development approaches for
Extramural Policy and Review, Division of SUPPLEMENTARY INFORMATION:
ZIKV include but are not limited to
Extramural Research, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive Intellectual Property inactivated virus (dead virus), live
Boulevard, Room 4234, MSC 9550, Bethesda, attenuated virus (weakened virus),
U.S. Provisional Patent Application
MD 20892, 301–827–5840, recombinant viral vectors (weakened
Number 62/307,170, filed March 11,
julia.berzhanskaya@nih.gov. virus with target genes added), and
2016 and entitled ‘‘Live Attenuated Zika
(Catalogue of Federal Domestic Assistance subunit (portion of a virus) as well as
Virus Vaccines,’’ Whitehead et al., and
Program No.: 93.279, Drug Abuse and mRNA- and DNA-based (gene-targeted).
PCT Patent Application Number PCT/
Addiction Research Programs, National These various strategies provide
US2017/0021989, filed March 11, 2017
Institutes of Health, HHS) multiple redundancies, expanded
and entitled ‘‘Live Attenuated Zika
Dated: May 21, 2018. choice, and ensure short and long term
Virus Vaccines,’’ Whitehead et al. [HHS
Natasha M. Copeland, maximal benefits to the public.
Reference E–118–2016/0]; and U.S. and
Program Analyst, Office of Federal Advisory foreign patent applications claiming This notice is made in accordance
Committee Policy. priority to the aforementioned with 35 U.S.C. 209 and 37 CFR part 404.
[FR Doc. 2018–11216 Filed 5–24–18; 8:45 am] applications. The prospective exclusive license will
BILLING CODE 4140–01–P The patent rights in these inventions be royalty bearing, and the prospective
have been assigned to the government of exclusive license may be granted unless
the United States of America. within thirty (30) days from the date of
DEPARTMENT OF HEALTH AND The field of use may be limited to this published notice, the National
HUMAN SERVICES monovalent live attenuated Zika Institute of Allergy and Infectious
vaccines and multivalent live attenuated Diseases receives written evidence and
National Institutes of Health flavivirus vaccines. The Licensed argument that establishes that the grant
Territory may be limited to Europe, of the license would not be consistent
Prospective Grant of Exclusive China, South Korea, Japan, India, with the requirements of 35 U.S.C. 209
License: Production of Monovalent Australia and New Zealand. and 37 CFR part 404.
Live Attenuated Zika Vaccines and Zika virus (ZIKV) is an emerging
Multivalent Live Attenuated Flavivirus Complete applications for a license in
infectious disease that was first the prospective field of use that are filed
Vaccines identified in 1947, and that has more in response to this notice will be treated
AGENCY: National Institute of Allergy recently become a major public health as objections to the grant of the
and Infectious Diseases, National threat around the world. ZIKV has contemplated Exclusive
Institutes of Health, Public Health recently been shown to cause Commercialization Patent License
Service, DHHS. devastating neurological damage in Agreement. Comments and objections
ACTION: Notice. infants and serious complications in submitted to this notice will not be
adults in some cases, and may have made available for public inspection
SUMMARY: The National Institute of other effects that have not yet been and, to the extent permitted by law, will
Allergy and Infectious Diseases, an identified or definitively linked to the not be released under the Freedom of
institute of the National Institutes of virus. There are no treatments or Information Act, 5 U.S.C. 552.
Health, Department of Health and vaccines for this insidious virus.
amozie on DSK3GDR082PROD with NOTICES1
Human Services, is contemplating the Recommendations that women who live Dated: May 14, 2018.
grant of an Exclusive Commercialization in or travel to endemic areas avoid Suzanne M. Frisbie,
Patent License to practice the inventions pregnancy for long periods of time are Deputy Director, Technology Transfer and
embodied in the Patents and Patent unrealistic, particularly in contexts Intellectual Property Office, National Institute
Applications listed in the Summary where access to reproductive services is of Allergy and Infectious Diseases.
Information section of this notice to limited, and threaten to leave those [FR Doc. 2018–11258 Filed 5–24–18; 8:45 am]
Medigen Vaccines Biologics Corp. most likely to suffer the devastating BILLING CODE 4140–01–P
VerDate Sep<11>2014 18:28 May 24, 2018 Jkt 241001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\25MYN1.SGM 25MYN1](https://thefederalregister.org/doc/83_FR_24422/page/1.svg)
Document Created: 2018-05-25 02:13:23
Document Modified: 2018-05-25 02:13:23
| 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 application for a license which are received by the NIAID Technology Transfer and Intellectual Property Office on or before June 25, 2018 will be considered. | |
| FR Citation | 83 FR 24320 |
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