80 FR 58493 - Prospective Intent To Grant Start-Up Exclusive Patent License: Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 188 (September 29, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 188 (September 29, 2015)
| Page Range | 58493-58495 | |
| FR Document | 2015-24674 |
[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)] [Notices] [Pages 58493-58495] From the Federal Register Online [www.thefederalregister.org] [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: [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 [[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
![Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices 58493
‘‘ADDENDUM’’ before it begins work on harmonization is to identify and then The draft guidance provides additional
the final version of the guidance, submit reduce differences in technical detail regarding recommendations for
either electronic or written comments requirements for drug development use of electronic trial data handling and
on the ‘‘ADDENDUM’’ sections of the among regulatory agencies. remote electronic trial data systems.
draft guidance by November 30, 2015. ICH was organized to provide an This draft guidance includes
ADDRESSES: Submit written requests for opportunity for tripartite harmonization additions to ICH E6(R1) that are
single copies of the draft guidance to the initiatives to be developed with input identified as ‘‘ADDENDUM’’ and are
Division of Drug Information (HFD– from both regulatory and industry marked with vertical lines on both sides
240), Center for Drug Evaluation and representatives. FDA also seeks input of the text. FDA is making the draft
Research (CDER), Food and Drug from consumer representatives and guidance available for comment on the
Administration, 10001 New Hampshire others. ICH is concerned with ‘‘ADDENDUM’’ text added to ICH
Ave., Hillandale Building, 4th Floor, harmonization of technical E6(R1).
Silver Spring, MD 20993–0002, or the requirements for the registration of This draft guidance is being issued
Office of Communication, Outreach, and pharmaceutical products among three consistent with FDA’s good guidance
Development, Center for Biologics regions: The European Union, Japan, practices regulation (21 CFR 10.115).
Evaluation and Research (CBER), Food and North America. The eight ICH The draft guidance, when finalized, will
and Drug Administration, 10903 New sponsors are the European Commission; represent the current thinking of FDA
Hampshire Ave., Bldg. 71, Rm. 3128, the European Federation of on E6(R2) Good Clinical Practice. It does
Silver Spring, MD 20993–0002. Send Pharmaceutical Industries Associations; not establish any rights for any person
one self-addressed adhesive label to the Japanese Ministry of Health, Labour, and is not binding on FDA or the public.
assist the office in processing your and Welfare; the Japanese You can use an alternative approach if
requests. The draft guidance may also be Pharmaceutical Manufacturers it satisfies the requirements of the
obtained by mail by calling CBER at 1– Association; CDER and CBER, FDA; the applicable statutes and regulations.
800–835–4709 or 240–402–7800. See Pharmaceutical Research and
Manufacturers of America; Health II. Comments
the SUPPLEMENTARY INFORMATION section
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for electronic access to the draft
Secretariat, which coordinates the electronic comments regarding this
guidance document.
Submit electronic comments on the preparation of documentation, is document to http://www.regulations.gov
provided by the International or written comments to the Division of
draft guidance to http://
Federation of Pharmaceutical Dockets Management (see ADDRESSES). It
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observers from the World Health comments may be seen in the Division
FOR FURTHER INFORMATION CONTACT: Organization. of Dockets Management between 9 a.m.
Regarding the guidance: Dianne In June 2015, the ICH Steering and 4 p.m., Monday through Friday, and
Paraoan, Center for Drug Evaluation and Committee agreed that a draft guidance will be posted to the docket at http://
Research, Food and Drug entitled ‘‘Good Clinical Practice E6(R2)’’ www.regulations.gov.
Administration, 10903 New Hampshire should be made available for public
Ave., Bldg. 51, Rm. 3326, Silver Spring, comment. The draft guidance is the III. Electronic Access
MD 20993–0002, 301–796–2500; or product of the ICH E6 Expert Working Persons with access to the Internet
Stephen Ripley, Center for Biologics Group of the ICH. Comments about this may obtain the document at http://
Evaluation and Research, Food and draft will be considered by FDA and the www.regulations.gov, http://www.fda.
Drug Administration, 10903 New ICH E6 Expert Working Group. gov/Drugs/GuidanceCompliance
Hampshire Ave., Bldg. 71, Rm. 7301, The draft guidance provides guidance RegulatoryInformation/Guidances/
Silver Spring, MD 20993–0002, 240– on approaches to clinical trial design, default.htm, or http://www.fda.gov/
402–7911. conduct, oversight, recording, and BiologicsBloodVaccines/Guidance
Regarding the ICH: Michelle Limoli, reporting as well as updated standards ComplianceRegulatoryInformation/
Center for Drug Evaluation and regarding electronic records and Guidances/default.htm.
Research, International Programs, Food essential documents. The additions to
and Drug Administration, 10903 New ICH E6(R1) are intended to encourage Dated: September 23, 2015.
Hampshire Ave., Bldg. 71, rm. 7208, implementation of the described Leslie Kux,
Silver Spring, MD 20993–0002, 301– approaches and processes to improve Associate Commissioner for Policy.
796–8377. clinical trial quality and efficiency [FR Doc. 2015–24623 Filed 9–28–15; 8:45 am]
SUPPLEMENTARY INFORMATION: while maintaining human subject BILLING CODE 4164–01–P
protection. Evolutions in technology
I. Background and risk management processes offer
In recent years, many important new opportunities to increase clinical DEPARTMENT OF HEALTH AND
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regulatory authorities and industry trial activities essential to ensuring
asabaliauskas on DSK5VPTVN1PROD with NOTICES
associations to promote international human subject protection and the National Institutes of Health
harmonization of regulatory reliability of trial results. For example,
Prospective Intent To Grant Start-Up
requirements. FDA has participated in the draft guidance recommends
Exclusive Patent License: Real-Time
many meetings designed to enhance sponsors implement a system to manage
PCR Point Mutation Assays for
harmonization and is committed to quality throughout clinical trials and
Detecting HIV–1 Resistance to Antiviral
seeking scientifically based harmonized recommends sponsors develop a
Drugs
technical procedures for pharmaceutical systematic, prioritized, risk-based
development. One of the goals of approach to monitoring clinical trials. AGENCY: Public Health Service, HHS.
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![Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices 58495
under the Freedom of Information Act, Review Branch, DEA, NIDDK, National 5452, (301) 594–7797, connaughtonj@
5 U.S.C. 552. Institutes of Health, Room 754, 6707 extra.niddk.nih.gov.
Democracy Boulevard, Bethesda, MD 20892– (Catalogue of Federal Domestic Assistance
Dated: September 24, 2015. 5452, (301) 402–7172, woynarowskab@ Program Nos. 93.847, Diabetes,
Richard U. Rodriguez, niddk.nih.gov. Endocrinology and Metabolic Research;
Acting Director, Office of Technology Name of Committee: National Institute of 93.848, Digestive Diseases and Nutrition
Transfer, National Institutes of Health. Diabetes and Digestive and Kidney Diseases Research; 93.849, Kidney Diseases, Urology
[FR Doc. 2015–24674 Filed 9–28–15; 8:45 am] Initial Review Group; Digestive Diseases and and Hematology Research, National Institutes
BILLING CODE 4140–01–P Nutrition C Subcommittee. of Health, HHS)
Date: October 21–23, 2015.
Open: October 21, 2015, 6:00 p.m. to 6:30 Dated: September 24, 2015.
p.m. David Clary,
DEPARTMENT OF HEALTH AND
Agenda: To review policy and procedures. Program Analyst, Office of Federal Advisory
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National Institutes of Health Closed: October 21, 2015, 6:30 p.m. to
[FR Doc. 2015–24660 Filed 9–28–15; 8:45 am]
10:00 p.m. BILLING CODE 4140–01–P
National Institute of Diabetes and Agenda: To review and evaluate grant
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Date: October 28–30, 2015. individuals associated with the grant
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10:00 p.m. Applications—Neurosciences [ZAA1 DD
Initial Review Group; Kidney, Urologic and
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p.m. Place: Bethesda North Marriott Hotel & Alcohol Abuse and Alcoholism Special
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applications. Bethesda, MD 20852. Applications—Neurosciences [ZAA1 DD
Place: Hyatt Regency Bethesda, One Contact Person: John F. Connaughton, (04)].
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Document Created: 2015-12-15 09:47:21
Document Modified: 2015-12-15 09:47:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
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| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 80 FR 58493 |
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