80 FR 72729 - Prospective Grant of Exclusive License: Development of In Vitro Diagnostics for the Detection of Diseases or Pathogenic Agents
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 224 (November 20, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 224 (November 20, 2015)
| Page Range | 72729-72730 | |
| FR Document | 2015-29650 |
[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)] [Notices] [Pages 72729-72730] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29650] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Development of In Vitro Diagnostics for the Detection of Diseases or Pathogenic Agents AGENCY: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Public Health Service, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), at the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Omega Diagnostics Group PLC (``Omega''), a company incorporated under the laws of the United Kingdom, having an office in Alva, Scotland, an exclusive patent license to practice the following inventions embodied in the following patent applications: US Provisional Patent Application No.60/846,354, entitled, ``(S,S)-trans- 1,2-cyclopentane Diamine-modified and Gamma-lysine-modified Peptide Nucleic Acids as Probes for Nucleic Acid Detection: Synthesis and Applications,'' filed 22 Sep 2006 [HHS Ref No. E-308-2006/0-US-01]; US Provisional Patent Application No. 60/896,667, entitled, ``Synthesis of Trans-tert-butyl-2-aminocyclopentylcarbamate,'' filed 23 Mar 2007 [HHS Ref No. E-308-2006/1-US-01]; International Application PCT/US2007/ 020466, entitled, ``Synthesis of Trans-tert-butyl-2- aminocyclopentylcarbamate,'' filed 21 Sep 2007 [HHS Ref No. E-308-2006/ 2-PCT-01]; US Patent Application No. 12/441,925, filed 21 Sep 2007, [HHS Ref No. E-308-2006/2-US-02]; US Patent Application No. 12/409,159, entitled, ``Cross-Coupled Peptide Nucleic Acids for Detection of Nucleic Acids of Pathogens,'' filed 23 Mar 2009 [HHS Ref No. E-308- 2006/3-US-01]; US Patent No. 9,156,778, entitled, ``Cross-Coupled Peptide Nucleic Acids for Detection of Nucleic Acids of Pathogens,'' issued 13 Oct 2015 [HHS Ref No. E-308-2006/3-US-02]; US Provisional Patent Application No. 61/684,354, entitled, Cyclopentane-peptide Nucleic Acids for Qualitative and Quantitative Detection of Nucleic Acids,'' filed 17 Aug 2012 [HHS Ref No. E-260-2012/0-US-01]; International Application PCT/US2013/055252, filed 16 Aug 2013 [HHS Ref No. E-260-2012/0-PCT-02]; European Patent Application No. 13753962.3, filed 11 Feb 2015, [HHS Ref No E-260-2012/0-EP-03]; Korea Patent Application No. 10-2015-7006286, filed 11 Mar 2015, [HHS Ref No E-260- 2012/0-KR-04]; and US Patent Application No. 14/421,732, filed 13 Feb 2015, [HHS Ref No E-260-2012/0-US-05]. The patent rights in these inventions have been assigned to the United States of America. Omega is seeking a worldwide territory for this license. The field of use may be limited to use of the Patent Rights for the development and sale of trans-cyclopentane-modified peptide nucleic acids (PNA) in a diagnostic system incorporating an enzyme-linked immunosorbent assay or Omega's proprietary VISITECT[supreg] technology for the detection of diseases or pathogenic agents including viruses and microorganisms. DATES: Only written comments or applications for a license (or both) which are received by the Technology Advancement Office, NIDDK, on or before December 7, 2015 will be considered. ADDRESSES: Requests for copies of the patent application, patents, inquiries, [[Page 72730]] comments, and other materials relating to the contemplated exclusive license should be directed to: The Patrick McCue, Ph.D., Senior Licensing and Patenting Manager, Technology Advancement Office, The National Institutes of Diabetes and Digestive and Kidney Diseases, 12A South Drive, Bethesda, MD 20892, Telephone: (301) 451-5560; Email: patrick.mccue@nih.gov. A signed confidentiality non-disclosure agreement will be required to receive copies of any patent applications that have not been published by the United States Patent and Trademark Office or the World Intellectual Property Organization. SUPPLEMENTARY INFORMATION: These technologies, and the corresponding patent applications, are directed to cyclopentane-peptide nucleic acids (PNA) and their use in qualitative and quantitative detection of nucleic acids. The technologies overcome a stability problem and sensitivity to outside contamination that is inherent to PCR-based detection systems, wherein the PNA probes bind to DNA with greater stability and selectivity compared to a complementary DNA sequence. 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 Technology Advancement Office, NIDDK, receives written evidence and argument that establishes that the grant of the 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 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 under the Freedom of Information Act, 5 U.S.C. 552. Dated: November 17, 2015. Anna Z. Amar, Acting Deputy Director, Technology Advancement Office, NIDDK. [FR Doc. 2015-29650 Filed 11-19-15; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Notices 72729
from sale, but must be made prior to We have also independently evaluated 846,354, entitled, ‘‘(S,S)-trans-1,2-
approving an ANDA that refers to the relevant literature and data for possible cyclopentane Diamine-modified and
listed drug (§ 314.161 (21 CFR 314.161)). postmarketing adverse events. We have Gamma-lysine-modified Peptide
FDA may not approve an ANDA that found no information that would Nucleic Acids as Probes for Nucleic
does not refer to a listed drug. indicate that these products were Acid Detection: Synthesis and
LIPTRUZET (ezetimibe and withdrawn from sale for reasons of Applications,’’ filed 22 Sep 2006 [HHS
atorvastatin) tablets, 10 mg/10 mg, 10 safety or effectiveness. Ref No. E–308–2006/0–US–01]; US
mg/20 mg, 10 mg/40 mg, and 10 mg/80 Accordingly, the Agency will Provisional Patent Application No. 60/
mg, are the subject of NDA 20–0153, continue to list LIPTRUZET (ezetimibe 896,667, entitled, ‘‘Synthesis of Trans-
held by Merck Sharp & Dohme Corp., and atorvastatin) tablets, 10 mg/10 mg, tert-butyl-2-
and initially approved on May 3, 2013. 10 mg/20 mg, 10 mg/40 mg, and 10 mg/ aminocyclopentylcarbamate,’’ filed 23
LIPTRUZET is indicated for the 80 mg, in the ‘‘Discontinued Drug Mar 2007 [HHS Ref No. E–308–2006/1–
reduction of elevated total cholesterol Product List’’ section of the Orange US–01]; International Application PCT/
(total-C), low-density lipoprotein Book. The ‘‘Discontinued Drug Product US2007/020466, entitled, ‘‘Synthesis of
cholesterol (LDL–C), apolipoprotein B List’’ delineates, among other items, Trans-tert-butyl-2-
(Apo B), triglycerides (TG), and non- drug products that have been aminocyclopentylcarbamate,’’ filed 21
high-density lipoprotein cholesterol discontinued from marketing for reasons Sep 2007 [HHS Ref No. E–308–2006/2–
(non-HDL–C), and to increase high- other than safety or effectiveness. PCT–01]; US Patent Application No. 12/
density lipoprotein cholesterol (HDL–C) ANDAs that refer to LIPTRUZET 441,925, filed 21 Sep 2007, [HHS Ref
in patients with primary (heterozygous (ezetimibe and atorvastatin) tablets, 10 No. E–308–2006/2–US–02]; US Patent
familial and non-familial) mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, Application No. 12/409,159, entitled,
hyperlipidemia or mixed and 10 mg/80 mg, may be approved by ‘‘Cross-Coupled Peptide Nucleic Acids
hyperlipidemia. LIPTRUZET is also the Agency as long as they meet all for Detection of Nucleic Acids of
indicated for the reduction of elevated other legal and regulatory requirements Pathogens,’’ filed 23 Mar 2009 [HHS Ref
total-C and LDL–C in patients with for the approval of ANDAs. If FDA No. E–308–2006/3–US–01]; US Patent
homozygous familial determines that labeling for these drug No. 9,156,778, entitled, ‘‘Cross-Coupled
hypercholesterolemia, as an adjunct to products should be revised to meet Peptide Nucleic Acids for Detection of
other lipid-lowering treatments (e.g., current standards, the Agency will Nucleic Acids of Pathogens,’’ issued 13
LDL apheresis) or if such treatments are advise ANDA applicants to submit such Oct 2015 [HHS Ref No. E–308–2006/3–
unavailable. labeling. US–02]; US Provisional Patent
In a letter dated June 1, 2015, Merck Application No. 61/684,354, entitled,
Sharpe & Dohme Corp. notified FDA Dated: November 16, 2015.
Leslie Kux,
Cyclopentane-peptide Nucleic Acids for
that LIPTRUZET (ezetimibe and Qualitative and Quantitative Detection
atorvastatin) tablets, 10 mg/10 mg, 10 Associate Commissioner for Policy.
of Nucleic Acids,’’ filed 17 Aug 2012
mg/20 mg, 10 mg/40 mg, and 10 mg/80 [FR Doc. 2015–29639 Filed 11–19–15; 8:45 am]
[HHS Ref No. E–260–2012/0–US–01];
mg, were being discontinued, and FDA BILLING CODE 4164–01–P International Application PCT/US2013/
moved the drug products to the 055252, filed 16 Aug 2013 [HHS Ref No.
‘‘Discontinued Drug Product List’’ E–260–2012/0–PCT–02]; European
section of the Orange Book. DEPARTMENT OF HEALTH AND
Patent Application No. 13753962.3,
Lupin Pharmaceuticals, Inc. HUMAN SERVICES
filed 11 Feb 2015, [HHS Ref No E–260–
submitted a citizen petition dated 2012/0–EP–03]; Korea Patent
September 21, 2015 (Docket No. FDA– National Institutes of Health
Application No. 10–2015–7006286, filed
2015–P–3404), under 21 CFR 10.30,
Prospective Grant of Exclusive 11 Mar 2015, [HHS Ref No E–260–2012/
requesting that the Agency determine
License: Development of In Vitro 0–KR–04]; and US Patent Application
whether LIPTRUZET (ezetimibe and
Diagnostics for the Detection of No. 14/421,732, filed 13 Feb 2015, [HHS
atorvastatin) tablets, 10 mg/10 mg, 10
Diseases or Pathogenic Agents Ref No E–260–2012/0–US–05].
mg/20 mg, 10 mg/40 mg, and 10 mg/80 The patent rights in these inventions
mg, were withdrawn from sale for AGENCY: National Institute of Diabetes have been assigned to the United States
reasons of safety or effectiveness. and Digestive and Kidney Diseases, of America. Omega is seeking a
After considering the citizen petition National Institutes of Health, Public worldwide territory for this license. The
and reviewing Agency records and Health Service, HHS. field of use may be limited to use of the
based on the information we have at this ACTION: Notice.
time, FDA has determined under Patent Rights for the development and
§ 314.161 that LIPTRUZET (ezetimibe SUMMARY: This notice, in accordance sale of trans-cyclopentane-modified
and atorvastatin) tablets, 10 mg/10 mg, with 35 U.S.C. 209(c)(1) and 37 CFR peptide nucleic acids (PNA) in a
10 mg/20 mg, 10 mg/40 mg, and 10 mg/ part 404.7(a)(1)(i), that the National diagnostic system incorporating an
80 mg, were not withdrawn for reasons Institute of Diabetes and Digestive and enzyme-linked immunosorbent assay or
of safety or effectiveness. The petitioner Kidney Diseases (NIDDK), at the Omega’s proprietary VISITECT®
has identified no data or other National Institutes of Health, technology for the detection of diseases
information suggesting that LIPTRUZET Department of Health and Human or pathogenic agents including viruses
(ezetimibe and atorvastatin) tablets, 10 Services, is contemplating the grant to and microorganisms.
mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, Omega Diagnostics Group PLC DATES: Only written comments or
applications for a license (or both)
tkelley on DSK3SPTVN1PROD with NOTICES
and 10 mg/80 mg, were withdrawn for (‘‘Omega’’), a company incorporated
reasons of safety or effectiveness. We under the laws of the United Kingdom, which are received by the Technology
have carefully reviewed our files for having an office in Alva, Scotland, an Advancement Office, NIDDK, on or
records concerning the withdrawal of exclusive patent license to practice the before December 7, 2015 will be
LIPTRUZET (ezetimibe and atorvastatin) following inventions embodied in the considered.
tablets, 10 mg/10 mg, 10 mg/20 mg, 10 following patent applications: US ADDRESSES: Requests for copies of the
mg/40 mg, and 10 mg/80 mg, from sale. Provisional Patent Application No.60/ patent application, patents, inquiries,
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![72730 Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Notices
comments, and other materials relating DEPARTMENT OF HOMELAND are to respond, including through the
to the contemplated exclusive license SECURITY use of appropriate automated,
should be directed to: The Patrick electronic, mechanical, or other
McCue, Ph.D., Senior Licensing and United States Immigration and technological collection techniques or
Patenting Manager, Technology Customs Enforcement other forms of information technology,
Advancement Office, The National e.g., permitting electronic submission of
Agency Information Collection
Institutes of Diabetes and Digestive and responses.
Activities: Extension, Without Change,
Kidney Diseases, 12A South Drive, of an Existing Information Collection; Overview of This Information
Bethesda, MD 20892, Telephone: (301) Comment Request Collection
451–5560; Email: patrick.mccue@
nih.gov. A signed confidentiality non- ACTION: 30-Day notice of Information (1) Type of Information Collection:
disclosure agreement will be required to Collection for review; Form No. I–515A; Extension, without change, of a
receive copies of any patent Notice to Student or Exchange Visitor; currently approved information
applications that have not been OMB Control No. 1653–0037. collection.
published by the United States Patent (2) Title of the Form/Collection:
and Trademark Office or the World The Department of Homeland
Security, U.S. Immigration and Customs Notice to Student or Exchange Visitor.
Intellectual Property Organization.
Enforcement (USICE), is submitting the (3) Agency form number, if any, and
SUPPLEMENTARY INFORMATION: These following information collection request the applicable component of the
technologies, and the corresponding for review and clearance in accordance Department of Homeland Security
patent applications, are directed to with the Paperwork Reduction Act of sponsoring the collection: (No. Form
cyclopentane-peptide nucleic acids 1995. The information collection is I–515A); U.S. Immigration and Customs
(PNA) and their use in qualitative and published in the Federal Register to Enforcement.
quantitative detection of nucleic acids. obtain comments from the public and
affected agencies. This information (4) Affected public who will be asked
The technologies overcome a stability
collection was previously published in or required to respond, as well as a brief
problem and sensitivity to outside
the Federal Register on August 19, abstract: Primary: Individuals or
contamination that is inherent to PCR-
2015, Vol. 80 No. 20396 allowing for a Households. When an academic student
based detection systems, wherein the
60 day comment period. No comments (F–1), vocational student (M–1),
PNA probes bind to DNA with greater
were received on this information exchange visitor (J–1), or dependent
stability and selectivity compared to a
collection. The purpose of this notice is (F–2, M–2 or J–2) is admitted to the
complementary DNA sequence.
to allow an additional 30 days for public United States as a nonimmigrant alien
The prospective exclusive license will comments. under section 101(a)(15) of the
be royalty bearing and will comply with Written comments and suggestions Immigration and Nationality Act (Act),
the terms and conditions of 35 U.S.C. regarding items contained in this notice he or she is required to have certain
209 and 37 CFR part 404. The and especially with regard to the documentation. If the student or
prospective exclusive license may be estimated public burden and associated exchange visitor or dependent is
granted unless within fifteen (15) days response time should be directed to the missing documentation, he or she is
from the date of this published notice, Office of Information and Regulatory provided with the Form
the Technology Advancement Office, Affairs, Office of Management and I–515A, Notice to Student or Exchange
NIDDK, receives written evidence and Budget. Comments should be addressed Visitor. The Form I–515A provides a list
argument that establishes that the grant to the OMB Desk Officer for U.S. of the documentation the student or
of the license would not be consistent Immigration and Customs Enforcement, exchange visitor or dependent will need
with the requirements of 35 U.S.C. 209 Department of Homeland Security, and
to provide to the Department of
and 37 CFR part 404. sent via electronic mail to oira_
Homeland Security (DHS), Student and
submission@omb.eop.gov or faxed to
Properly filed competing applications Exchange Visitor Program (SEVP) office
(202) 395–5806.
for a license in response to this notice Written comments and suggestions within 30 days of admission.
will be treated as objections to the from the public and affected agencies (5) An estimate of the total number of
contemplated license. Comments and concerning the proposed collection of respondents and the amount of time
objections submitted in response to this information should address one or more estimated for an average respondent to
notice will not be made available for of the following four points: respond: 10,701 responses at 10 minutes
public inspection and, to the extent (1) Evaluate whether the proposed (0.1667 hours) per response.
permitted by law, will not be released collection of information is necessary (6) An estimate of the total public
under the Freedom of Information Act, for the proper performance of the burden (in hours) associated with the
5 U.S.C. 552. functions of the agency, including
collection: 1,776. annual burden hours.
Dated: November 17, 2015. whether the information will have
practical utility; Dated: November 16, 2015.
Anna Z. Amar,
(2) Evaluate the accuracy of the Scott Elmore,
Acting Deputy Director, Technology agencies estimate of the burden of the
Advancement Office, NIDDK. Program Manager, Forms Management Office,
proposed collection of information, Office of the Chief Information Officer, U.S.
tkelley on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2015–29650 Filed 11–19–15; 8:45 am] including the validity of the Immigration and Customs Enforcement,
BILLING CODE 4140–01–P methodology and assumptions used; Department of Homeland Security.
(3) Enhance the quality, utility, and [FR Doc. 2015–29582 Filed 11–19–15; 8:45 am]
clarity of the information to be BILLING CODE 9111–28–P
collected; and
(4) Minimize the burden of the
collection of information on those who
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Document Created: 2015-12-14 13:59:06
Document Modified: 2015-12-14 13:59:06
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Only written comments or applications for a license (or both) which are received by the Technology Advancement Office, NIDDK, on or before December 7, 2015 will be considered. | |
| FR Citation | 80 FR 72729 |
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