[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]


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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.

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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: [email protected]. 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

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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