65696 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive Patent 

License: Production of Live 

Respiratory Syncytial Virus and 

Parainfluenza Virus Vaccines 

AGENCY: National Institutes of Health, 

HHS. 

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 

applications for a license which are 

received by the National Institute of 

Allergy and Infectious Diseases’ 

Technology Transfer and Intellectual 

Property Office on or before January 7, 

2019 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments 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 62/661,320, filed April 23, 2018 

and entitled ‘‘Chimeric Vaccines,’’ [HHS 

Reference No. E–018–2018–0]; and U.S. 

and foreign patent applications claiming 

priority to the aforementioned 

applications. 

The patent rights in this invention 

have been assigned to the Government 

of the United States of America. 

The prospective exclusive licensed 

territory may be worldwide, and the 

field of use may be limited to: ‘‘Live 

Respiratory Syncytial Virus (RSV) and 

Parainfluenza Virus (PIV) vaccines.’’ 

Human respiratory syncytial virus 

(RSV) continues to be the leading viral 

cause of severe acute lower respiratory 

tract disease in infants and children 

worldwide. A licensed vaccine or 

antiviral drug suitable for routine use 

remains unavailable. This invention 

relates to the use of murine pneumonia 

virus (MPV), a virus to which humans 

normally are not exposed and that is not 

cross-protected with RSV, as a vector to 

express the RSV fusion (F) glycoprotein 

as an RSV vaccine candidate. The RSV 

F ORF was codon optimized. The RSV 

F ORF was placed under the control of 

MPV transcription signals and inserted 

at the first (rMPV–F1), third (rMPV29 

F3), or fourth (rMPV–F4) gene position 

of a version of the MPV genome that 

contained a codon pair optimized L 

polymerase gene. The recovered viruses 

replicated in vitro as efficiently as the 

empty vector, with stable expression of 

RSV F protein. Replication and 

immunogenicity of rMPV–F1 and 

rMPV–F3 were evaluated in rhesus 

macaques following administration by 

the combined intranasal and 

intratracheal routes. Both viruses 

replicated at low levels in the upper and 

lower respiratory tract, maintained 

stable RSV F expression, and induced 

similar high levels of RSV-neutralizing 

serum antibodies that reached peak 

titers by fourteen (14) days postvaccination. rMPV provides a highly 

attenuated yet immunogenic vector for 

the expression of RSV F protein, with 

potential application in RSV-naı ̈ve and 

RSV experienced populations. The 

technology relates to live, chimeric nonhuman Mononegavirales vectors that 

allow a cell to express at least one 

protein from at least one human 

pathogen as well as compositions 

comprising the vectors, methods and 

kits for eliciting an immune response in 

a host, and methods of making the 

vectors. 

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 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: December 11, 2018. 

Suzanne M. Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2018–27674 Filed 12–20–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Co-Exclusive 

Patent License: Production of 

Monovalent Live Attenuated Zika 

Vaccines and Multivalent Live 

Attenuated Zika and Dengue Vaccines 

AGENCY: National Institutes of Health, 

HHS. 

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 a Co-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, 

and Panacea Biotec Ltd., having a place 

of business in New Delhi, India. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Institute of 

Allergy and Infectious Diseases’ 

Technology Transfer and Intellectual 

Property Office on or before January 22, 

2019 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments relating to the contemplated 

Co-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: 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 65697 

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,’’ [HHS Reference No. E– 

118–2016–0–US–01]; PCT Patent 

Application Number PCT/US2017/ 

0021989, filed March 11, 2017 and 

entitled ‘‘Live Attenuated Zika Virus 

Vaccines,’’ [HHS Reference No. E–118– 

2016–0–PCT–02]; Indian Patent 

Application Number 201817036778 

filed September 28, 2018 and entitled 

‘‘Live Attenuated Zika Virus Vaccines,’’ 

[HHS Reference No. E–118–2016–0–IN– 

09]; and U.S. and foreign patent 

applications claiming priority to the 

aforementioned applications. 

The patent rights in this invention 

have been assigned to the Government 

of the United States of America. 

The prospective co-exclusive licensed 

territory may be limited to India, and 

the field of use may be limited to: 

‘‘Monovalent live attenuated Zika 

vaccines and multivalent live attenuated 

flavivirus vaccines.’’ 

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 co-exclusive license 

will be royalty bearing, and the 

prospective co-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 licenses 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 co-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: December 11, 2018, 

Suzanne M. Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2018–27672 Filed 12–20–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive Patent 

License: Production of Monovalent 

Live Attenuated Zika Vaccines and 

Multivalent Live Attenuated Zika and 

Dengue Vaccines 

AGENCY: National Institutes of Health, 

HHS. 

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 

Fundacao Butantan (Butantan), having a 

place of business in Sao Paulo, Brazil. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Institute of 

Allergy and Infectious Diseases’ 

Technology Transfer and Intellectual 

Property Office on or before January 22, 

2019 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments 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,’’ [HHS Reference No. E– 

118–2016–0–US–01]; PCT Patent 

Application Number PCT/US2017/ 

0021989, filed March 11, 2017 and 

entitled ‘‘Live Attenuated Zika Virus 

Vaccines,’’ [HHS Reference No. E–118– 

2016–0–PCT–02]; U.S. Patent 

Application Number 16/083,652 filed 

September 10, 2018 and entitled ‘‘Live 

Attenuated Zika Virus Vaccines,’’ [HHS 

Reference No. E–118–2016–0–US–14]; 

Canadian Patent Application Number 

3016697 filed March 11, 2017 and 

entitled ‘‘Live Attenuated Zika Virus 

Vaccines,’’ [HHS Reference No. E–118– 


amozie on DSK3GDR082PROD with NOTICES1