82_FR_23110 82 FR 23014 - Government-Owned Inventions; Availability for Licensing

82 FR 23014 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 96 (May 19, 2017)

Page Range23014-23015
FR Document2017-10156

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Federal Register, Volume 82 Issue 96 (Friday, May 19, 2017) 
[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23014-23015]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Dr. Dianca Finch, 240-669-5503; 
[email protected]. Licensing information and copies of the patent 
applications listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD, 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Products for Treatment and Prevention of Ebola Zaire Disease

Description of Technology

    Scientists at the NIAID Vaccine Research Center have developed 
human

[[Page 23015]]

monoclonal neutralizing antibodies for treatment and prevention of 
Ebola Zaire disease. The monoclonal antibodies (mAbs) bind to different 
regions of the Ebola glycoprotein that are unique for these two mAbs. 
Alone or in combination, the mAbs prevent or reverse Ebola Zaire virus 
disease in non-human primates. Nonclinical studies have demonstrated 
complete protection against disease with a single antibody and complete 
protection against viremia by addition of a second antibody. The 
current nonclinical pharmacology demonstrates a favorable 
pharmacokinetic profile and there is a first-in-time human clinical 
trial projected for 2017. The anticipated indications for this 
technology include pre-and post-symptomatic treatment, and pre-and 
post-exposure prophylaxis.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.

Potential Commercial Applications

     Therapeutics
     Diagnostics

Competitive Advantages

     Favorable pharmacokinetic profile
     Favorable manufacturing
     Complete protection against disease with a single unique 
mAb
     Complete protection with fewer administrations and/or 
lower doses than any other mAb
     Complete protection against viremia with two antibodies

Development Stage

     In vivo data available (animal)
     Entering first-in-time human clinical trial (2017)
    Inventors: Nancy J. Sullivan (NIAID); Barney S. Graham (NIAID); 
Julie Ledgerwood (NIAID); Daphne A. Stanley (NIAID); Antonio 
Lanzavecchia (IRB) Davide Corti (IRB); John Trefry (USAMRIID/WR)

Publications

Corti D, et al., Protective monotherapy against lethal Ebola virus 
infection by a potently neutralizing antibody. Science. 2016 Mar 
18;351:1339-42. [PMID: 26917593]
Misasi J, et al., Structural and molecular basis for Ebola virus 
neutralization by protective human antibodies. Science. 2016 Mar 
18;3511343-6. [PMID: 26917592].

Intellectual Property

    HHS Reference No. E-045-2015--U.S. Provisional Application No. 62/
087,087, filed December 3, 2014; PCT Application No. PCT/US2015/060733, 
filed November 13, 2015 HHS Reference No. E-278-2016- U.S. Provisional 
Application No.62,080,094, filed November 14, 2014; PCT Application No. 
PCT/IB2015/002342, filed November 13, 2015
    Licensing Contact: Dr. Dianca Finch, 240-669-5503; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize products for treatment and 
prevention of Ebola Zaire disease. For collaboration opportunities, 
please contact Dr. Dianca Finch, 240-669-5503; [email protected].

    Dated: May 9, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-10156 Filed 5-18-17; 8:45 am]
 BILLING CODE 4140-01-P

23014 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices Complete applications for a license in Intellectual Property be consistent with the requirements of the prospective field of use that are United States Provisional Patent 35 U.S.C. 209 and 37 CFR part 404. timely filed in response to this notice Application No. 62/173,777, filed June Complete applications for a license in will be treated as objections to the grant 10, 2015 and entitled ‘‘Processes for the prospective field of use that are filed of the contemplated Exclusive Patent Production and Purification of Nucleic in response to this notice will be treated License. Comments and objections Acid Containing Compositions’’ [HHS as objections to the grant of the submitted to this notice will not be Reference No. E–267–2014/0–US–01]; contemplated Exclusive made available for public inspection PCT Patent Application PCT/US2016/ Commercialization Patent License and, to the extent permitted by law, will 036888, filed E–267–2014/0–PCT–02 Agreement. Comments and objections not be released under the Freedom of and entitled ‘‘Processes for Production submitted to this notice will not be Information Act, 5 U.S.C. 552. and Purification of Nucleic Acid made available for public inspection Dated: May 11, 2017. Containing Compositions’’ [HHS and, to the extent permitted by law, will Richard U. Rodriguez, Reference No. E–267–2014/0–PCT–02]; not be released under the Freedom of United States Provisional Patent Information Act, 5 U.S.C. 552. Associate Director, Technology Transfer Center, National Cancer Institute. Application No. 62/199,663, filed July Dated: May 12, 2017. [FR Doc. 2017–10154 Filed 5–18–17; 8:45 am] 31, 2015 and entitled ‘‘Methods of Richard U. Rodriguez, BILLING CODE 4140–01–P Analyzing Virus-Derived Therapeutics’’ Associate Director, Technology Transfer [HHS Reference No. E–240–2015/0–US– Center, National Cancer Institute. 01]; [FR Doc. 2017–10155 Filed 5–18–17; 8:45 am] DEPARTMENT OF HEALTH AND PCT Patent Application PCT/US2016/ BILLING CODE 4140–01–P HUMAN SERVICES 044788, filed July 29, 2016 and entitled ‘‘Methods of Analyzing Virus-Derived National Institutes of Health Therapeutics’’ [HHS Reference No. E– DEPARTMENT OF HEALTH AND 240–2015/1–PCT–01]; and U.S. and HUMAN SERVICES Prospective Grant of an Exclusive foreign patent applications claiming Patent License: Manufacturing and priority to the aforementioned National Institutes of Health Testing of PVSRIPO in the Treatment applications. of Solid, Non-lymphoid Tumors The patent rights in these inventions Government-Owned Inventions; Expressing Poliovirus Receptor CD155 have been assigned and/or exclusively Availability for Licensing licensed to the government of the AGENCY: National Institutes of Health, AGENCY: National Institutes of Health, United States of America. HHS. HHS. The prospective exclusive license ACTION: Notice. ACTION: Notice. territory may be worldwide and the field of use may be limited to the use SUMMARY: The invention listed below is SUMMARY: The National Cancer Institute, of Licensed Patent Rights for the owned by an agency of the U.S. an institute of the National Institutes of following: ‘‘Manufacturing and Testing Government and is available for Health, Department of Health and of PVSRIPO in the Treatment of Solid, licensing to achieve expeditious Human Services, is contemplating the Non-lymphoid Tumors expressing commercialization of results of grant of an Exclusive Commercialization Poliovirus Receptor CD155, wherein federally-funded research and Patent License to practice the inventions PVSRIPO is genetically recombinant, development. Foreign patent embodied in the Patents and Patent non-pathogenic poliovirus:rhinovirus applications are filed on selected Applications listed in the chimera that consists of the genome of inventions to extend market coverage Supplementary Information section of the live attenuated poliovirus serotype 1 for companies and may also be available this notice to Istari Oncology (SABIN) vaccine (PV1S) with its cognate for licensing. Incorporated located in North Carolina, IRES element replaced with that of U.S.A. FOR FURTHER INFORMATION CONTACT: Dr. HRV2.’’ Dianca Finch, 240–669–5503; DATES: Only written comments and/or The E–267–2014 technology discloses dianca.finch@nih.gov. Licensing applications for a license which are improved methods for large scale information and copies of the patent received by the National Cancer production of highly purified, applications listed below may be Institute’s Technology Transfer Center therapeutic grade, oncolytic obtained by communicating with the on or before June 5, 2017 will be polioviruses. Invention processes indicated licensing contact at the considered. provide industrial scale, and cGMP Technology Transfer and Intellectual compliant manufacturing of PVSRIPO. Property Office, National Institute of ADDRESSES: Requests for copies of the The E–240–2015 technology discloses patent application, inquiries, and Allergy and Infectious Diseases, 5601 improved methods for detecting genetic Fishers Lane, Rockville, MD, 20852; tel. comments relating to the contemplated micro-heterogeneity in manufactured Exclusive Commercialization Patent 301–496–2644. A signed Confidential batches of RNA virus-derived Disclosure Agreement will be required License should be directed to: Lauren therapeutics, such as PVSRIPO. Nguyen-Antczak, Ph.D., J.D., Senior to receive copies of unpublished patent This notice is made in accordance applications. Licensing and Patenting Manager, NCI with 35 U.S.C. 209 and 37 CFR part 404. asabaliauskas on DSK3SPTVN1PROD with NOTICES Technology Transfer Center, 9609 SUPPLEMENTARY INFORMATION: The prospective exclusive license will Medical Center Drive, RM 1E530 MSC be royalty bearing, and the prospective Technology description follows. 9702, Bethesda, MD 20892–9702 (for exclusive license may be granted unless Products for Treatment and Prevention business mail), Rockville, MD 20850– within fifteen (15) days from the date of of Ebola Zaire Disease 9702, Telephone: (240) 276–5530; this published notice, the National Facsimile: (240) 276–5504, Email: Cancer Institute receives written Description of Technology lauren.nguyen-antczak@nih.gov. evidence and argument that establishes Scientists at the NIAID Vaccine SUPPLEMENTARY INFORMATION: that the grant of the license would not Research Center have developed human VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1

Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices 23015 monoclonal neutralizing antibodies for filed December 3, 2014; PCT FOR FURTHER INFORMATION CONTACT: treatment and prevention of Ebola Zaire Application No. PCT/US2015/060733, Robert Dinerstein, Valuation and disease. The monoclonal antibodies filed November 13, 2015 HHS Reference Special Programs Branch, Regulations (mAbs) bind to different regions of the No. E–278–2016- U.S. Provisional and Rulings, Office of Trade, at (202) Ebola glycoprotein that are unique for Application No.62,080,094, filed 325–0132. these two mAbs. Alone or in November 14, 2014; PCT Application SUPPLEMENTARY INFORMATION: Notice is combination, the mAbs prevent or No. PCT/IB2015/002342, filed hereby given that on May 08, 2017, reverse Ebola Zaire virus disease in non- November 13, 2015 pursuant to subpart B of Part 177, U.S. human primates. Nonclinical studies Licensing Contact: Dr. Dianca Finch, Customs and Border Protection have demonstrated complete protection 240–669–5503; dianca.finch@nih.gov. Regulations (19 CFR part 177, subpart against disease with a single antibody Collaborative Research Opportunity: B), CBP issued a final determination and complete protection against viremia The National Institute of Allergy and concerning the country of origin of a by addition of a second antibody. The Infectious Diseases is seeking statements certain visitor management system current nonclinical pharmacology of capability or interest from parties known as the Raptor Basic System, demonstrates a favorable interested in collaborative research to which may be offered to the U.S. pharmacokinetic profile and there is a further develop, evaluate or Government under an undesignated first-in-time human clinical trial commercialize products for treatment government procurement contract. This projected for 2017. The anticipated and prevention of Ebola Zaire disease. final determination, HQ H277116, was indications for this technology include For collaboration opportunities, please issued under procedures set forth at 19 pre-and post-symptomatic treatment, contact Dr. Dianca Finch, 240–669– CFR part 177, subpart B, which and pre-and post-exposure prophylaxis. 5503; dianca.finch@nih.gov. implements Title III of the Trade This technology is available for Dated: May 9, 2017. Agreements Act of 1979, as amended licensing for commercial development Suzanne Frisbie, (19 U.S.C. 2511–18). In the final in accordance with 35 U.S.C. 209 and 37 Deputy Director, Technology Transfer and determination, CBP concluded that the CFR part 404, as well as for further Intellectual Property Office, National Institute identification scanner and printer development and evaluation under a of Allergy and Infectious Diseases. components of the Raptor Basic System research collaboration. [FR Doc. 2017–10156 Filed 5–18–17; 8:45 am] were not substantially transformed in Potential Commercial Applications BILLING CODE 4140–01–P the United States, and thus remain products of China. Additionally, CBP • Therapeutics concluded that the label component of • Diagnostics DEPARTMENT OF HOMELAND the Raptor Basic System was a product Competitive Advantages SECURITY of the United States and that the barcode scanner that is compatible with • Favorable pharmacokinetic profile U.S. Customs and Border Protection the Raptor Basic System was a product • Favorable manufacturing of Taiwan. Therefore, for purposes of • Complete protection against disease Notice of Issuance of Final U.S. Government procurement, China is with a single unique mAb Determination Concerning a Certain the country of origin of the • Complete protection with fewer Visitor Management System identification scanner and printer administrations and/or lower doses than AGENCY: U.S. Customs and Border components of the Raptor Basic System, any other mAb Protection, Department of Homeland the United States is the country of origin • Complete protection against viremia Security. of the label component of the Raptor with two antibodies ACTION: Notice of final determination. Basic System, and Taiwan is the country Development Stage of origin of the barcode scanner that is • In vivo data available (animal) SUMMARY: This document provides compatible with the Raptor Basic • Entering first-in-time human notice that U.S. Customs and Border System. clinical trial (2017) Protection (‘‘CBP’’) has issued a final Section 177.29, CBP Regulations (19 Inventors: Nancy J. Sullivan (NIAID); determination concerning the country of CFR 177.29), provides that a notice of Barney S. Graham (NIAID); Julie origin of a certain visitor management final determination shall be published Ledgerwood (NIAID); Daphne A. system known as the Raptor Basic in the Federal Register within 60 days Stanley (NIAID); Antonio Lanzavecchia System. Based upon the facts presented of the date the final determination is (IRB) Davide Corti (IRB); John Trefry for purposes of U.S. Government issued. Section 177.30, CBP Regulations (USAMRIID/WR) procurement, CBP has concluded that (19 CFR 177.30), provides that any China is the country of origin of the party-at-interest, as defined in 19 CFR Publications identification scanner and printer 177.22(d), may seek judicial review of a Corti D, et al., Protective monotherapy components of the Raptor Basic System, final determination within 30 days of against lethal Ebola virus infection by that the United States is the country of publication of such determination in the a potently neutralizing antibody. origin of the label component of the Federal Register. Science. 2016 Mar 18;351:1339–42. Raptor Basic System, and that Taiwan is Dated: May 08, 2017. [PMID: 26917593] the country of origin of the barcode Alice A. Kipel, scanner that is compatible with the asabaliauskas on DSK3SPTVN1PROD with NOTICES Misasi J, et al., Structural and molecular Executive Director, Regulations and Rulings, basis for Ebola virus neutralization by Raptor Basic System. Office of Trade. protective human antibodies. Science. DATES: The final determination was issued on May 08, 2017. A copy of the HQ H277116 2016 Mar 18;3511343–6. [PMID: 26917592]. final determination is attached. Any May 08, 2017 party-at-interest, as defined in 19 CFR OT:RR:CTF:VS H277116 AJR Intellectual Property 177.22(d), may seek judicial review of Ms. Heather Mims HHS Reference No. E–045–2015—U.S. this final determination within June 19, Centre Law and Consulting LLC Provisional Application No. 62/087,087, 2017. 8330 Boone Boulevard, Suite 300 VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1


Document Created: 2018-11-08 08:48:05
Document Modified: 2018-11-08 08:48:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactDr. Dianca Finch, 240-669-5503; [email protected] Licensing information and copies of the patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD, 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.
FR Citation82 FR 23014 
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