Prospective Intent To Grant Start-Up Exclusive Patent License: Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs, 58493-58495 [2015-24674]
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Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
‘‘ADDENDUM’’ before it begins work on
the final version of the guidance, submit
either electronic or written comments
on the ‘‘ADDENDUM’’ sections of the
draft guidance by November 30, 2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research (CDER), Food and Drug
Administration, 10001 New Hampshire
Ave., Hillandale Building, 4th Floor,
Silver Spring, MD 20993–0002, or the
Office of Communication, Outreach, and
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assist the office in processing your
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800–835–4709 or 240–402–7800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
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comments to the Division of Dockets
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Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Dianne
Paraoan, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 3326, Silver Spring,
MD 20993–0002, 301–796–2500; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
Regarding the ICH: Michelle Limoli,
Center for Drug Evaluation and
Research, International Programs, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, rm. 7208,
Silver Spring, MD 20993–0002, 301–
796–8377.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
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harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
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representatives. FDA also seeks input
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others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and North America. The eight ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; the
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The ICH Steering Committee includes
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sponsors and the IFPMA, as well as
observers from the World Health
Organization.
In June 2015, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘Good Clinical Practice E6(R2)’’
should be made available for public
comment. The draft guidance is the
product of the ICH E6 Expert Working
Group of the ICH. Comments about this
draft will be considered by FDA and the
ICH E6 Expert Working Group.
The draft guidance provides guidance
on approaches to clinical trial design,
conduct, oversight, recording, and
reporting as well as updated standards
regarding electronic records and
essential documents. The additions to
ICH E6(R1) are intended to encourage
implementation of the described
approaches and processes to improve
clinical trial quality and efficiency
while maintaining human subject
protection. Evolutions in technology
and risk management processes offer
new opportunities to increase clinical
trial efficiency, in part by focusing on
trial activities essential to ensuring
human subject protection and the
reliability of trial results. For example,
the draft guidance recommends
sponsors implement a system to manage
quality throughout clinical trials and
recommends sponsors develop a
systematic, prioritized, risk-based
approach to monitoring clinical trials.
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58493
The draft guidance provides additional
detail regarding recommendations for
use of electronic trial data handling and
remote electronic trial data systems.
This draft guidance includes
additions to ICH E6(R1) that are
identified as ‘‘ADDENDUM’’ and are
marked with vertical lines on both sides
of the text. FDA is making the draft
guidance available for comment on the
‘‘ADDENDUM’’ text added to ICH
E6(R1).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on E6(R2) Good Clinical Practice. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://www.fda.
gov/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm.
Dated: September 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–24623 Filed 9–28–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Intent To Grant Start-Up
Exclusive Patent License: Real-Time
PCR Point Mutation Assays for
Detecting HIV–1 Resistance to Antiviral
Drugs
AGENCY:
E:\FR\FM\29SEN1.SGM
Public Health Service, HHS.
29SEN1
58494
ACTION:
Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the Public Health Service,
Department of Health and Human
Services, is contemplating the grant of
an exclusive license to Research Think
Tank Molecular Diagnostics, Inc.
(RTTMDx) having a principal place of
business in Georgia, U.S.A., to practice
the inventions embodied in U.S.
Provisional Patent Application No. 60/
577,696, filed June 07, 2004, entitled
‘‘Real-Time PCR Point Mutation Assays
for Detecting the 103N and 184V
Mutations in the Reverse Transcriptase
of HIV–1’’ (HHS Ref. No. E–198–2013/
0–U.S.–01); PCT Application No. PCT/
U.S.2005/019907, filed June 07, 2005,
entitled ‘‘Real-Time PCR Point Mutation
Assays for Detecting HIV–1 Resistance
to Antiviral Drugs’’ (HHS Ref. No. E–
198–2013/0–PCT–02); U.S. Patent
Application No. 14/059,085, filed
October 21, 2013, entitled ‘‘Real-Time
PCR Point Mutation Assays for
Detecting HIV–1 Resistance to Antiviral
Drugs’’ (HHS Ref. No. E–198–2013/0–
U.S.–11); U.S. Patent No. 8,043,809,
filed December 07, 2006, entitled ‘‘RealTime PCR Point Mutation Assays for
Detecting HIV–1 Resistance to Antiviral
Drugs’’ (HHS Ref. No. E–198–2013/0–
U.S.–07); U.S. Patent No. 8,318,428,
filed January 24, 2012, entitled ‘‘RealTime PCR Point Mutation Assays for
Detecting HIV–1 Resistance for Antiviral
Drugs’’ (HHS Ref. No. E–198–2013/0–
U.S.–08); U.S. Patent No. 8,592,146,
filed September 04, 2013, entitled
‘‘Real-Time PCR Point Mutation Assays
for Detecting HIV–1 Resistance to
Antiviral Drugs’’ (HHS Ref. No. E–198–
2013/0–U.S.–09); Australian Patent No.
20055252685, issued March 31, 2011,
entitled ‘‘Real-Time PCR Point Mutation
Assays for Detecting HIV–1 Resistance
to Anti-Viral Drugs,’’ (HHS Ref. No. E–
198–2013/0–AU–03); Indian Patent No.
19/DELNP/2007, issued December 19,
2013, entitled ‘‘Real-Time PCR Point
Mutation Assays for Detecting HIV–1
Resistance to Anti-Viral Drugs’’ (HHS
Ref. No. E–198–2013/0–IN–06);
Canadian Patent Application No.
2,891,079, filed May 19, 2015, entitled
‘‘Real-Time PCR Point Mutation Assays
for Detecting HIV–1 Resistance to AntiViral Drugs’’ (HHS Ref. No. E–198–
2013/0–CA–12); Canadian Patent
Application No. 259747, filed December
07, 2006, entitled ‘‘Real-Time PCR Point
Mutation Assays for Detecting HIV–1
Resistance to Anti-Viral Drugs’’ (HHS
Ref. No. E–198–2013/0–CA–04); U.S.
Provisional Patent Application No. 61/
443,926, filed February 17, 2011,
entitled ‘‘Real-Time PCR Point Mutation
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:54 Sep 28, 2015
Jkt 235001
Assays for Detecting HIV–1 Resistance
to Antiviral Drugs’’ (HHS Ref. No. E–
214–2013/0–U.S.–01); PCT Patent
Application No. PCT/U.S.2012/025638,
filed February 17, 2012, entitled ‘‘RealTime PCR Point Mutation Assays for
Detecting HIV–1 Resistance to AntiViral Drugs’’ (HHS Ref. No. E–214–
2013/0–PCT–02); U.S. Application No.
13/985,499, filed February 17, 2012,
entitled ‘‘Real-Time PCR Point Mutation
Assays for Detecting HIV–1 Resistance
to Anti-Viral Drugs’’ (HHS Ref. No. E–
214–2013/0–U.S.–06); Canadian Patent
Application No. 2827324, filed February
17, 2012, entitled ‘‘Real-Time PCR Point
Mutation Assays for Detecting HIV–1
Resistance to Anti-Viral Drugs’’ (HHS
Ref. No. E–214–2013/0–CA–03);
European Patent Application No.
12747199.3, filed February 17, 2012,
entitled ‘‘Real-Time PCR Point Mutation
Assays for Detecting HIV–1 Resistance
to Anti-Viral Drugs’’ (HHS Ref. No. E–
214–2013/0–EP–04); Indian Patent
Application No. 7110/DELNP/2013,
filed February 17, 2012, entitled ‘‘RealTime PCR Point Mutation Assays for
Detecting HIV–1 Resistance to AntiViral Drugs’’ (HHS Ref. No. E–214–
2013/0–IN–05); U.S. Provisional Patent
Application No. 61/829,473, filed May
31, 2013, entitled ‘‘Real-Time PCR Point
Mutation Assays for Detecting HIV–1
Resistance to Anti-Viral Drugs (HHS
Ref. No. E–511–2013/0–U.S.–01); PCT
Application No. PCT/U.S.2014/040514,
filed June 02, 2014, entitled, ‘‘Real-Time
PCR Point Mutation Assays for
Detecting HIV–1 Resistance to AntiViral Drugs’’ (HHS Ref. No. E–511–
2013/0–PCT–02).
The patent rights in these inventions
have been assigned to the Government
of the United States of America. The
territory of the prospective Start-Up
Exclusive Patent License may be
worldwide, and the field of use may be
limited to ‘‘Development, manufacture,
and sale of an FDA-approved or foreign
equivalent-approved Class III real-time
PCR diagnostic assay for HIV–1
genotyping utilizing whole HIV–1 pol
viral sequencing, limited to use in
humans.’’
DATES: Only written comments and/or
applications for a license that are
received by the NIH Office of
Technology Transfer on or before
October 14, 2015 will be considered.
ADDRESSES: Requests for a copy of the
patent application(s), inquiries,
comments and other materials relating
to the contemplated license should be
directed to: Karen Surabian, J.D.,
M.B.A., Licensing and Patenting
Manager, CDC Unit, Office of
Technology Transfer, National Institutes
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of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Telephone: (301) 594–3232; Facsimile:
(301) 402–0220; Email: karen.surabian@
nih.gov. A signed confidential
disclosure agreement may be required to
receive copies of the patent application
assuming it has not already been
published under the publication rules of
either the United States Patent and
Trademark Office or the World
Intellectual Property Organization.
SUPPLEMENTARY INFORMATION: The use of
antiretroviral compounds to treat HIV
infection has proliferated; consequently
viruses have adapted and evolved
mutations limiting the efficacy of these
drugs and disrupting the success of
treatment. The CDC has developed a
novel assay featuring real-time PCR
reagents and methods for detecting
drug-resistance related mutations in
HIV, for newly diagnosed patients and
those individuals currently receiving
antiretroviral therapies.
This RT–PCR assay can diagnose
different point mutations in patient
samples at an achievable sensitivity of
1–2 log greater than conventional pointmutation sequencing methods. More
specifically, this assay measures the
differential amplifications of common
and mutation-specific reactions that
target specific codons of interest, which
are the HIV–1 proteins of reverse
transcriptase, protease, and integrase
(HIV–1 pol).
Given its low cost, simplicity, highthroughput capability, and tremendous
diagnostic sensitivity, this assay will be
useful for detection and surveillance of
drug resistance-associated mutations
and will aid in the clinical management
of HIV infection both domestically and
in developing countries where the cost
of surveillance has been prohibitive.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404. The
prospective exclusive license may be
granted unless, within fifteen (15) days
from the date of this published notice,
the NIH Office of Technology Transfer
receives written evidence and argument
that establishes that the grant of the
contemplated license would not be
consistent with the requirements of 35
U.S.C. 209 and 37 CFR part 404.
Properly filed competing 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 contemplated license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
E:\FR\FM\29SEN1.SGM
29SEN1
Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: September 24, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–24674 Filed 9–28–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meetings
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Initial Review Group; Kidney, Urologic and
Hematologic Diseases D Subcommittee.
Date: October 14–15, 2015.
Open: October 14, 2015, 8:00 a.m. to 8:30
a.m.
Agenda: To review policy and procedures.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Closed: October 14, 2015, 8:30 a.m. to 4:00
p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Closed October 15, 2015, 8:00 a.m. to 4:00
p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Barbara A. Woynarowska,
Ph.D., Scientific Review Administrator,
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Review Branch, DEA, NIDDK, National
Institutes of Health, Room 754, 6707
Democracy Boulevard, Bethesda, MD 20892–
5452, (301) 402–7172, woynarowskab@
niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Initial Review Group; Digestive Diseases and
Nutrition C Subcommittee.
Date: October 21–23, 2015.
Open: October 21, 2015, 6:00 p.m. to 6:30
p.m.
Agenda: To review policy and procedures.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Closed: October 21, 2015, 6:30 p.m. to
10:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Closed: October 22, 2015, 8:30 a.m. to 5:00
p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Closed: October 23, 2015, 8:30 a.m. to 5:00
p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Robert Wellner, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 706, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, rw175w@nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Initial Review Group, Diabetes,
Endocrinology and Metabolic Diseases B
Subcommittee.
Date: October 28–30, 2015.
Open: October 28, 2015, 5:30 p.m. to 6:00
p.m.
Agenda: To review policy and procedures.
Place: Bethesda North Marriott Hotel &
Conference Center; 5701 Marinelli Road;
Bethesda, MD 20852.
Closed: October 28, 2015, 6:00 p.m. to
10:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Closed: October 29, 2015, 8:00 a.m. to 6:30
p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Closed: October 30, 2015, 8:00 a.m. to 2:00
p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: John F. Connaughton,
Ph.D., Chief, Chartered Committees Section,
Review Branch, DEA, NIDDK, National
Institutes of Health, Room 753, 6707
Democracy Boulevard, Bethesda, MD 20892–
PO 00000
Frm 00034
Fmt 4703
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58495
5452, (301) 594–7797, connaughtonj@
extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: September 24, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–24660 Filed 9–28–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel, NIAAA Member Conflict
Applications—Neurosciences [ZAA1 DD
(05)].
Date: November 10, 2015.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: NIAAA, NIH, 5635 Fishers Lane,
CR2098, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Ranga Srinivas, Ph.D.,
Chief, Extramural Project Review Branch,
National Institute on Alcohol Abuse and
Alcoholism, NIH, 5635 Fishers Lane; Room
2019, Rockville, MD 20852, (301) 451–2067,
srinivar@mail.nih.gov.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; NIAAA Member Conflict
Applications—Neurosciences [ZAA1 DD
(04)].
Date: November 13, 2015.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\29SEN1.SGM
29SEN1
]]>Agencies
[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Notices]
[Pages 58493-58495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24674]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Intent To Grant Start-Up Exclusive Patent License:
Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to
Antiviral Drugs
AGENCY: Public Health Service, HHS.
[[Page 58494]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
part 404, that the Public Health Service, Department of Health and
Human Services, is contemplating the grant of an exclusive license to
Research Think Tank Molecular Diagnostics, Inc. (RTTMDx) having a
principal place of business in Georgia, U.S.A., to practice the
inventions embodied in U.S. Provisional Patent Application No. 60/
577,696, filed June 07, 2004, entitled ``Real-Time PCR Point Mutation
Assays for Detecting the 103N and 184V Mutations in the Reverse
Transcriptase of HIV-1'' (HHS Ref. No. E-198-2013/0-U.S.-01); PCT
Application No. PCT/U.S.2005/019907, filed June 07, 2005, entitled
``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to
Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-PCT-02); U.S. Patent
Application No. 14/059,085, filed October 21, 2013, entitled ``Real-
Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to
Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-11); U.S. Patent No.
8,043,809, filed December 07, 2006, entitled ``Real-Time PCR Point
Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs''
(HHS Ref. No. E-198-2013/0-U.S.-07); U.S. Patent No. 8,318,428, filed
January 24, 2012, entitled ``Real-Time PCR Point Mutation Assays for
Detecting HIV-1 Resistance for Antiviral Drugs'' (HHS Ref. No. E-198-
2013/0-U.S.-08); U.S. Patent No. 8,592,146, filed September 04, 2013,
entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1
Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-09);
Australian Patent No. 20055252685, issued March 31, 2011, entitled
``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to
Anti-Viral Drugs,'' (HHS Ref. No. E-198-2013/0-AU-03); Indian Patent
No. 19/DELNP/2007, issued December 19, 2013, entitled ``Real-Time PCR
Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral
Drugs'' (HHS Ref. No. E-198-2013/0-IN-06); Canadian Patent Application
No. 2,891,079, filed May 19, 2015, entitled ``Real-Time PCR Point
Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs''
(HHS Ref. No. E-198-2013/0-CA-12); Canadian Patent Application No.
259747, filed December 07, 2006, entitled ``Real-Time PCR Point
Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs''
(HHS Ref. No. E-198-2013/0-CA-04); U.S. Provisional Patent Application
No. 61/443,926, filed February 17, 2011, entitled ``Real-Time PCR Point
Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs''
(HHS Ref. No. E-214-2013/0-U.S.-01); PCT Patent Application No. PCT/
U.S.2012/025638, filed February 17, 2012, entitled ``Real-Time PCR
Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral
Drugs'' (HHS Ref. No. E-214-2013/0-PCT-02); U.S. Application No. 13/
985,499, filed February 17, 2012, entitled ``Real-Time PCR Point
Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs''
(HHS Ref. No. E-214-2013/0-U.S.-06); Canadian Patent Application No.
2827324, filed February 17, 2012, entitled ``Real-Time PCR Point
Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs''
(HHS Ref. No. E-214-2013/0-CA-03); European Patent Application No.
12747199.3, filed February 17, 2012, entitled ``Real-Time PCR Point
Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs''
(HHS Ref. No. E-214-2013/0-EP-04); Indian Patent Application No. 7110/
DELNP/2013, filed February 17, 2012, entitled ``Real-Time PCR Point
Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs''
(HHS Ref. No. E-214-2013/0-IN-05); U.S. Provisional Patent Application
No. 61/829,473, filed May 31, 2013, entitled ``Real-Time PCR Point
Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs (HHS
Ref. No. E-511-2013/0-U.S.-01); PCT Application No. PCT/U.S.2014/
040514, filed June 02, 2014, entitled, ``Real-Time PCR Point Mutation
Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref.
No. E-511-2013/0-PCT-02).
The patent rights in these inventions have been assigned to the
Government of the United States of America. The territory of the
prospective Start-Up Exclusive Patent License may be worldwide, and the
field of use may be limited to ``Development, manufacture, and sale of
an FDA-approved or foreign equivalent-approved Class III real-time PCR
diagnostic assay for HIV-1 genotyping utilizing whole HIV-1 pol viral
sequencing, limited to use in humans.''
DATES: Only written comments and/or applications for a license that are
received by the NIH Office of Technology Transfer on or before October
14, 2015 will be considered.
ADDRESSES: Requests for a copy of the patent application(s), inquiries,
comments and other materials relating to the contemplated license
should be directed to: Karen Surabian, J.D., M.B.A., Licensing and
Patenting Manager, CDC Unit, Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
MD 20852-3804; Telephone: (301) 594-3232; Facsimile: (301) 402-0220;
Email: karen.surabian@nih.gov. A signed confidential disclosure
agreement may be required to receive copies of the patent application
assuming it has not already been published under the publication rules
of either the United States Patent and Trademark Office or the World
Intellectual Property Organization.
SUPPLEMENTARY INFORMATION: The use of antiretroviral compounds to treat
HIV infection has proliferated; consequently viruses have adapted and
evolved mutations limiting the efficacy of these drugs and disrupting
the success of treatment. The CDC has developed a novel assay featuring
real-time PCR reagents and methods for detecting drug-resistance
related mutations in HIV, for newly diagnosed patients and those
individuals currently receiving antiretroviral therapies.
This RT-PCR assay can diagnose different point mutations in patient
samples at an achievable sensitivity of 1-2 log greater than
conventional point-mutation sequencing methods. More specifically, this
assay measures the differential amplifications of common and mutation-
specific reactions that target specific codons of interest, which are
the HIV-1 proteins of reverse transcriptase, protease, and integrase
(HIV-1 pol).
Given its low cost, simplicity, high-throughput capability, and
tremendous diagnostic sensitivity, this assay will be useful for
detection and surveillance of drug resistance-associated mutations and
will aid in the clinical management of HIV infection both domestically
and in developing countries where the cost of surveillance has been
prohibitive.
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part
404. The prospective exclusive license may be granted unless, within
fifteen (15) days from the date of this published notice, the NIH
Office of Technology Transfer receives written evidence and argument
that establishes that the grant of the contemplated license would not
be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part
404.
Properly filed competing 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 contemplated license. Comments and
objections submitted in response to this notice will not be made
available for public inspection, and, to the extent permitted by law,
will not be released
[[Page 58495]]
under the Freedom of Information Act, 5 U.S.C. 552.
Dated: September 24, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-24674 Filed 9-28-15; 8:45 am]
BILLING CODE 4140-01-P
