[Federal Register Volume 78, Number 136 (Tuesday, July 16, 2013)]
[Notices]
[Pages 42530-42531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16949]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive License: Human Papillomavirus
16 E2 and E6 Peptides for Cervical Cancer Vaccine Development
AGENCY: National Institutes of Health, HHS.
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 National Institutes of Health (NIH), Department of
Health and Human Services, is contemplating the grant of an exclusive
worldwide license to practice the inventions embodied in:
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Patent Issued patent no.
NIH Ref. No. application No. Filing date (if any)
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NIH Ref. E-126-2001/0-AU-06....... 2002258614 March 22, 2002........................ 2002258614
NIH Ref. E-126-2001/0-CA-04....... 2441947 March 22, 2002........................ .................
NIH Ref. E-126-2001/0-EP-05....... 2728570.9 March 22, 2002........................ .................
NIH Ref. E-126-2001/0-PCT-02...... PCT/US02/09261 March 22, 2002........................ (Expired)
NIH Ref. E-126-2001/0-US-01....... 60/278,520 March 23, 2001........................ (Expired)
NIH Ref. E-126-2001/0-US-03....... 10/472,661 September 23, 2003.................... 7,189,513
NIH Ref. E-126-2001/0-US-07....... 11/685,632 March 13, 2007........................ 7,507,538
NIH Ref. E-155-2005/0-US-01....... 60/671,463 April 15, 2005........................ (Expired)
NIH Ref. E-155-2005/1-US-01....... 60/680,000 May 12, 2005.......................... (Expired)
NIH Ref. E-155-2005/2-US-01....... 60/724,783 October 11, 2005...................... (Expired)
NIH Ref. E-155-2005/3-AU-04....... 2006236905 April 11, 2006........................ .................
[[Page 42531]]
NIH Ref. E-155-2005/3-CA-05....... 2604909 April 11, 2006........................ .................
NIH Ref. E-155-2005/3-EP-03 (CH, 6749659.6 April 11, 2007........................ 1877087
DE, FR, GB, and IE).
NIH Ref. E-155-2005/3-PCT-01...... PCT/US2006/1331 April 11, 2006........................ (Expired)
NIH Ref. E-155-2005/3-US-02....... 11/918,557 October 11, 2006...................... 7,691,579
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to Georgia Health Sciences University Research Institute, Inc. having a
principal place of business in Augusta, Georgia.
The United States of America is an assignee to the patent rights of
these inventions.
The contemplated exclusive license may be in a field of use
directed to cervical cancer vaccines.
DATES: Only written comments and/or applications for a license that are
received by the NIH Office of Technology Transfer on or before August
15, 2013 will be considered.
ADDRESSES: Requests for a copy of the patent application, inquiries,
comments and other materials relating to the contemplated license
should be directed to: Michael Shmilovich, Esq, CLP, Senior Licensing
and Patent Manager, Office of Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5019; Facsimile: (301) 402-0220; Email:
[email protected]. A signed confidential disclosure agreement may be
required to receive copies of patent applications assuming it has not
already issued or been published under either the publication rules of
either the US Patent and Trademark Office or World Intellectual
Property Organization.
SUPPLEMENTARY INFORMATION:
NIH Ref. No. E-155-2005/0-3 (as Above)
The invention pertains primarily to CD8+ T cell epitopes from HPV16
E2. These epitopes generated from amino acid positions 69-77
(ALQAIELQL) and 138-147 (YICEEASVTV) bind to HLA.A2 and elicit CD8+
cytotoxic T cell responses that lyse tumor cells of low-grade cervical
neoplasia (wart).
NIH Ref. No. E-126-2001/0 (as Above)
Immunogenic peptides from the HPV-18E6
(X1KLPDLCTELX2;, wherein X2 and
X1 are peptides of 0-11 amino acids in length comprising
contiguous HPV 18 E6 amino acid sequences) protein that comprise class
I restricted T cell epitopes and methods of administering the same. The
HPV-18E6 peptide cross-reacts immunologically with both HPV type 16 and
HPV type 18 with higher affinity than most common human lymphocyte
antigen (HLA), HLA-A2 than the homologous peptide from HPV 16. E6
peptide vaccines are potentially prophylactic or therapeutic for
cervical cancer, other genital cancers, head and neck cancers, and
upper digestive tract cancers. It could also be potentially used in the
treatment of patients presenting with pre-malignant cervical disease,
especially in underdeveloped countries with no access to surgical
treatment or to completely avoid surgical treatment.
The prospective exclusive license will be royalty-bearing and
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
thirty (30) days from the date of this published notice, NIH 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 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 under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: July 9, 2013.
Richard Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-16949 Filed 7-15-13; 8:45 am]
BILLING CODE 4140-01-P