81_FR_30638 81 FR 30543 - Government-Owned Inventions; Availability for Licensing

81 FR 30543 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 95 (May 17, 2016)

Page Range30543-30543
FR Document2016-11556

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development.

Federal Register, Volume 81 Issue 95 (Tuesday, May 17, 2016) 
[Federal Register Volume 81, Number 95 (Tuesday, May 17, 2016)]
[Notices]
[Page 30543]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-11556]


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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 and/or co-development in the 
U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development.

ADDRESSES: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD 20850-9702.

FOR FURTHER INFORMATION CONTACT: Information on licensing and co-
development research collaborations, and copies of the U.S. patent 
applications listed below may be obtained by contacting: Attn. 
Invention Development and Marketing Unit, Technology Transfer Center, 
National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, 
Rockville, MD 20850-9702, Tel. 240-276-5515 or email 
[email protected]. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of invention: Method for Purifying Antibodies.
    Description of Technology: This technology is a method for 
purifying a biologic composition, comprising diafiltering the biologic 
composition into a composition comprising phosphate buffered saline 
(PBS) to obtain a purified composition. The method is particularly 
useful for removing one or more impurities from the biologic 
composition, such as bis(2-hydroxyethyl)amino-
tris(hydroxymethyl)methane (Bis-tris).The technology is directed to 
large scale manufacturing of Chimeric 14.18 (Ch14.18) monoclonal 
antibodies. Ch14.18 is an anti-GD2 monoclonal antibody and has been 
described in Gillies et al., Journal of Immunological Methods 125:191-
202 (1989).
    Potential Commercial Applications:
     Large scale manufacturing of chimeric monoclonal 
antibodies
    Value Proposition:
     Cost effective means of removing impurities to produce GMP 
grade chimeric antibodies for regulatory approval.
    Development Stage: Clinical Phase II, FDA/EMA approved Chemistry, 
Manufacturing and Controls (CMC) large scale manufacturing to produce 
GMP grade chimeric antibodies.
    Inventor(s): David A. Meh (United Therapeutics Corporation), 
Timothy Atolagbe (United Therapeutics Corporation), G. Mark Farquharson 
(United Therapeutics Corporation), Samir Shaban (National Cancer 
Institute), Mary Koleck (National Cancer Institute), George Mitra 
(National Cancer Institute).
    Intellectual Property:

    HHS Ref. No. E-291-2014/0-US-01, corresponding to US Provisional 
Patent App. No. 62/028,994, filed July 25, 2014, entitled ``Method for 
Purifying Antibodies using PBS''
    HHS Ref. No. E-291-2014/0-US-02, corresponding to US Patent App. 
No. 14/809,211, filed July 25, 2015, entitled ``Method for Purifying 
Antibodies using PBS''
    HHS Ref. No. E-291-2014/0-PCT-03, corresponding to International 
Patent App. No. PCT/US2015/042241, filed July 27, 2015, entitled 
``Method for Purifying Antibodies''

    Publications:

    1. FDA published document: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125516Orig1s000TOC.cfm
    2. US Food and Drug Administration. FDA approves first therapy for 
high-risk neuroblastoma.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437460.htm
    3. WO2016015048 METHOD FOR PURIFYING ANTIBODIES https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2016015048

    Contact Information: Requests for copies of the patent application 
or inquiries about licensing, research collaborations, and co-
development opportunities should be sent to John D. Hewes, Ph.D., 
email: [email protected].

    Dated: May 11, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-11556 Filed 5-16-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Notices 30543 ESTIMATED ANNUALIZED BURDEN HOURS—Continued Estimated Average Annual Number of number of Type of respondent burden hours burden hours respondents responses per per response requested respondent Total ................................................................................................... 13,218 ........................ ........................ 33,242 Dated: May 11, 2016. diafiltering the biologic composition 2. US Food and Drug Administration. Lawrence A. Tabak, into a composition comprising FDA approves first therapy for high-risk Deputy Director, National Institutes of Health. phosphate buffered saline (PBS) to neuroblastoma.http://www.fda.gov/ [FR Doc. 2016–11618 Filed 5–16–16; 8:45 am] obtain a purified composition. The NewsEvents/Newsroom/ BILLING CODE 4140–01–P method is particularly useful for PressAnnouncements/ucm437460.htm removing one or more impurities from 3. WO2016015048 METHOD FOR the biologic composition, such as bis(2- PURIFYING ANTIBODIES https:// DEPARTMENT OF HEALTH AND hydroxyethyl)amino- patentscope.wipo.int/search/en/ HUMAN SERVICES tris(hydroxymethyl)methane (Bis- detail.jsf?docId=WO2016015048 tris).The technology is directed to large Contact Information: Requests for National Institutes of Health scale manufacturing of Chimeric 14.18 copies of the patent application or (Ch14.18) monoclonal antibodies. inquiries about licensing, research Government-Owned Inventions; Ch14.18 is an anti-GD2 monoclonal collaborations, and co-development Availability for Licensing antibody and has been described in opportunities should be sent to John D. AGENCY: National Institutes of Health, Gillies et al., Journal of Immunological Hewes, Ph.D., email: john.hewes@ HHS. Methods 125:191–202 (1989). nih.gov. Potential Commercial Applications: ACTION: Notice. • Large scale manufacturing of Dated: May 11, 2016. chimeric monoclonal antibodies John D. Hewes, SUMMARY: The invention listed below is owned by an agency of the U.S. Value Proposition: Technology Transfer Specialist, Technology • Cost effective means of removing Transfer Center, National Cancer Institute. Government and is available for impurities to produce GMP grade [FR Doc. 2016–11556 Filed 5–16–16; 8:45 am] licensing and/or co-development in the chimeric antibodies for regulatory BILLING CODE 4140–01–P U.S. in accordance with 35 U.S.C. 209 approval. and 37 CFR part 404 to achieve Development Stage: Clinical Phase II, expeditious commercialization of FDA/EMA approved Chemistry, DEPARTMENT OF HEALTH AND results of federally-funded research and Manufacturing and Controls (CMC) large HUMAN SERVICES development. Foreign patent scale manufacturing to produce GMP applications are filed on selected grade chimeric antibodies. National Institutes of Health inventions to extend market coverage Inventor(s): David A. Meh (United for companies and may also be available Therapeutics Corporation), Timothy Government-Owned Inventions; for licensing and/or co-development. Atolagbe (United Therapeutics Availability for Licensing ADDRESSES: Invention Development and Corporation), G. Mark Farquharson AGENCY: National Institutes of Health, Marketing Unit, Technology Transfer (United Therapeutics Corporation), HHS. Center, National Cancer Institute, 9609 Samir Shaban (National Cancer ACTION: Notice. Medical Center Drive, Mail Stop 9702, Institute), Mary Koleck (National Cancer Rockville, MD 20850–9702. Institute), George Mitra (National Cancer SUMMARY: The invention listed below is FOR FURTHER INFORMATION CONTACT: Institute). owned by an agency of the U.S. Information on licensing and co- Intellectual Property: Government and is available for development research collaborations, HHS Ref. No. E–291–2014/0–US–01, licensing and/or co-development in the and copies of the U.S. patent corresponding to US Provisional Patent U.S. in accordance with 35 U.S.C. 209 applications listed below may be App. No. 62/028,994, filed July 25, and 37 CFR part 404 to achieve obtained by contacting: Attn. Invention 2014, entitled ‘‘Method for Purifying expeditious commercialization of Development and Marketing Unit, Antibodies using PBS’’ results of federally-funded research and Technology Transfer Center, National HHS Ref. No. E–291–2014/0–US–02, development. Foreign patent Cancer Institute, 9609 Medical Center corresponding to US Patent App. No. applications are filed on selected Drive, Mail Stop 9702, Rockville, MD 14/809,211, filed July 25, 2015, entitled inventions to extend market coverage 20850–9702, Tel. 240–276–5515 or ‘‘Method for Purifying Antibodies using for companies and may also be available email ncitechtransfer@mail.nih.gov. A PBS’’ for licensing and/or co-development. signed Confidential Disclosure HHS Ref. No. E–291–2014/0–PCT–03, ADDRESSES: Invention Development and Agreement may be required to receive corresponding to International Patent Marketing Unit, Technology Transfer copies of the patent applications. App. No. PCT/US2015/042241, filed Center, National Cancer Institute, 9609 jstallworth on DSK7TPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: July 27, 2015, entitled ‘‘Method for Medical Center Drive, Mail Stop 9702, Technology description follows. Purifying Antibodies’’ Rockville, MD 20850–9702. Title of invention: Method for Publications: FOR FURTHER INFORMATION CONTACT: Purifying Antibodies. 1. FDA published document: http:// Information on licensing and co- Description of Technology: This www.accessdata.fda.gov/drugsatfda_ development research collaborations, technology is a method for purifying a docs/nda/2015/ and copies of the U.S. patent biologic composition, comprising 125516Orig1s000TOC.cfm applications listed below may be VerDate Sep<11>2014 15:32 May 16, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\17MYN1.SGM 17MYN1


Document Created: 2018-02-07 15:05:20
Document Modified: 2018-02-07 15:05:20
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.
ContactInformation on licensing and co- development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD 20850-9702, Tel. 240-276-5515 or email [email protected] A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.
FR Citation81 FR 30543 
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