Government-Owned Inventions; Availability for Licensing, 30543 [2016-11556]
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30543
Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Total ...................................................................................................
Dated: May 11, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016–11618 Filed 5–16–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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 codevelopment 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 ncitechtransfer@mail.nih.gov. 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
jstallworth on DSK7TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
15:32 May 16, 2016
Jkt 238001
Estimated
number of
responses per
respondent
Average
burden hours
per response
........................
........................
Number of
respondents
Type of respondent
13,218
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(2hydroxyethyl)aminotris(hydroxymethyl)methane (Bistris).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: https://
www.accessdata.fda.gov/drugsatfda_
docs/nda/2015/
125516Orig1s000TOC.cfm
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Annual
burden hours
requested
33,242
2. US Food and Drug Administration.
FDA approves first therapy for high-risk
neuroblastoma.https://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: john.hewes@
nih.gov.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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 codevelopment research collaborations,
and copies of the U.S. patent
applications listed below may be
SUMMARY:
E:\FR\FM\17MYN1.SGM
17MYN1
]]>Agencies
[Federal Register Volume 81, Number 95 (Tuesday, May 17, 2016)]
[Notices]
[Page 30543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11556]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
ncitechtransfer@mail.nih.gov. 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: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125516Orig1s000TOC.cfm
2. US Food and Drug Administration. FDA approves first therapy for
high-risk neuroblastoma.https://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: john.hewes@nih.gov.
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
