82 FR 23012 - Prospective Grant of Exclusive Patent License: Chimeric L1/L2 Protein and Virus-Like Particles Based Human Papillomavirus Vaccines
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 96 (May 19, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 96 (May 19, 2017)
| Page Range | 23012-23013 | |
| FR Document | 2017-10153 |
[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)] [Notices] [Pages 23012-23013] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10153] [[Page 23012]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Chimeric L1/L2 Protein and Virus-Like Particles Based Human Papillomavirus Vaccines AGENCY: National Institutes of Health, Department of Health and Human Services. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to PathoVax, LLC located in Baltimore, MD. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before June 5, 2017 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Kevin W. Chang, Ph.D., Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850- 9702 Telephone: (240)-276-6910; Facsimile: (240)-276-5504 Email: [email protected]. SUPPLEMENTARY INFORMATION: Intellectual Property United States Provisional Patent Application No. 60/649,249 filed February 1, 2005 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Reference No. E-103-2005/0-US-01]; United States Provisional Patent Application No. 60/697,655 filed July 7, 2005 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Reference No. E-103-2005/1-US-01]; United States Provisional Patent Application No. 60/752,268 filed December 21, 2005 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Reference No. E-103-2005/2-US-01]; International PCT Application No. PCT/US2006/003601 filed February 1, 2006, and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Reference No. E-103-2005/3-PCT- 01]; United States Patent No. 8,404,244, issued March 26, 2013 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-US- 02]; United States Patent No. 9,388,221 issued July 12, 2016 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-US- 10]; Canadian Patent Application No. 2,596,698 filed February 1, 2006 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3- CA-03]; Australian Patent No. 2006210792 issued November 8, 2012 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-AU- 04]; Japanese Patent No. 5224821 issued March 22, 2013 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-JP-05]; Brazilian Patent Application No. PI0607097-3 filed February 1, 2006 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-BR- 06]; Chinese Patent No. 200680011079.1 issued March 27, 2013 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-CN- 07]; Indian Patent No. 263255 issued October 16, 2014 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-IN-08]; European Patent No. 1853307 issued December 14, 2016 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-EP-09]; German Patent No. 1853307 issued December 14, 2016 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-DE-11]; French Patent No. 1853307 issued December 14, 2016 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-FR-12]; and United Kingdom Patent No. 1853307 issued December 14, 2016 and entitled, ``Papillomavirus L2 N-terminal Peptides For The Induction Of Broadly Cross-neutralizing Antibodies'' [HHS Ref. No. E-103-2005/3-GB- 13]. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensed Patent Rights for the following: ``Use of Human Papillomavirus Virus (HPV) L1/L2 chimeric proteins and Virus Like Particles (VLPs) for the prevention and/or treatment of cutaneous, mucosal HPV infections and diseases.'' The subject technologies are papillomavirus L2 capsid protein based vaccines against HPV. The L2 protein is the minor papillomavirus capsid protein for papillomaviruses. It is known that antibodies to this protein can neutralize homologous infection. Furthermore, L2 proteins can induce cross-neutralizing antibodies. Specifically, epitopes at the N-terminus of L2 shared by cutaneous and mucosal types of papillomavirus types and by types that infect divergent species are broadly cross-neutralizing. These epitopes at the N-terminus of L2 can be used to elicit cross-neutralizing antibodies against different types of HPV. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute 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. Complete 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 grant of the contemplated Exclusive Patent License Agreement. Comments and objections submitted 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. [[Page 23013]] Dated: May 11, 2017. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2017-10153 Filed 5-18-17; 8:45 am] BILLING CODE 4140-01-P
![23012 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices
DEPARTMENT OF HEALTH AND Cross-neutralizing Antibodies’’ [HHS December 14, 2016 and entitled,
HUMAN SERVICES Reference No. E–103–2005/2–US–01]; ‘‘Papillomavirus L2 N-terminal Peptides
International PCT Application No. PCT/ For The Induction Of Broadly Cross-
National Institutes of Health US2006/003601 filed February 1, 2006, neutralizing Antibodies’’ [HHS Ref. No.
and entitled, ‘‘Papillomavirus L2 N- E–103–2005/3–FR–12]; and United
Prospective Grant of Exclusive Patent terminal Peptides For The Induction Of Kingdom Patent No. 1853307 issued
License: Chimeric L1/L2 Protein and Broadly Cross-neutralizing Antibodies’’ December 14, 2016 and entitled,
Virus-Like Particles Based Human [HHS Reference No. E–103–2005/3– ‘‘Papillomavirus L2 N-terminal Peptides
Papillomavirus Vaccines PCT–01]; United States Patent No. For The Induction Of Broadly Cross-
AGENCY: National Institutes of Health, 8,404,244, issued March 26, 2013 and neutralizing Antibodies’’ [HHS Ref. No.
Department of Health and Human entitled, ‘‘Papillomavirus L2 N-terminal E–103–2005/3–GB–13]. The patent
Services. Peptides For The Induction Of Broadly rights in these inventions have been
Cross-neutralizing Antibodies’’ [HHS assigned and/or exclusively licensed to
ACTION: Notice.
Ref. No. E–103–2005/3–US–02]; United the government of the United States of
SUMMARY: The National Cancer Institute, States Patent No. 9,388,221 issued July America.
an institute of the National Institutes of 12, 2016 and entitled, ‘‘Papillomavirus The prospective exclusive license
Health, Department of Health and L2 N-terminal Peptides For The territory may be worldwide and the
Human Services, is contemplating the Induction Of Broadly Cross-neutralizing field of use may be limited to the use
grant of an exclusive patent license to Antibodies’’ [HHS Ref. No. E–103–2005/ of Licensed Patent Rights for the
practice the inventions embodied in the 3–US–10]; Canadian Patent Application following: ‘‘Use of Human
U.S. Patents and Patent Applications No. 2,596,698 filed February 1, 2006 Papillomavirus Virus (HPV) L1/L2
listed in the Supplementary Information and entitled, ‘‘Papillomavirus L2 N- chimeric proteins and Virus Like
section of this notice to PathoVax, LLC terminal Peptides For The Induction Of Particles (VLPs) for the prevention and/
located in Baltimore, MD. Broadly Cross-neutralizing Antibodies’’ or treatment of cutaneous, mucosal HPV
[HHS Ref. No. E–103–2005/3–CA–03]; infections and diseases.’’
DATES: Only written comments and/or
Australian Patent No. 2006210792 The subject technologies are
applications for a license which are
issued November 8, 2012 and entitled, papillomavirus L2 capsid protein based
received by the National Cancer
‘‘Papillomavirus L2 N-terminal Peptides vaccines against HPV. The L2 protein is
Institute’s Technology Transfer Center
For The Induction Of Broadly Cross- the minor papillomavirus capsid protein
on or before June 5, 2017 will be
neutralizing Antibodies’’ [HHS Ref. No. for papillomaviruses. It is known that
considered.
E–103–2005/3–AU–04]; Japanese Patent antibodies to this protein can neutralize
ADDRESSES: Requests for copies of the No. 5224821 issued March 22, 2013 and homologous infection. Furthermore, L2
patent application, inquiries, and entitled, ‘‘Papillomavirus L2 N-terminal proteins can induce cross-neutralizing
comments relating to the contemplated Peptides For The Induction Of Broadly antibodies. Specifically, epitopes at the
exclusive license should be directed to: Cross-neutralizing Antibodies’’ [HHS N-terminus of L2 shared by cutaneous
Kevin W. Chang, Ph.D., Senior Ref. No. E–103–2005/3–JP–05]; and mucosal types of papillomavirus
Technology Transfer Manager, NCI Brazilian Patent Application No. types and by types that infect divergent
Technology Transfer Center, 9609 PI0607097–3 filed February 1, 2006 and species are broadly cross-neutralizing.
Medical Center Drive, RM 1E530 MSC entitled, ‘‘Papillomavirus L2 N-terminal These epitopes at the N-terminus of L2
9702, Bethesda, MD 20892–9702 (for Peptides For The Induction Of Broadly can be used to elicit cross-neutralizing
business mail), Rockville, MD 20850– Cross-neutralizing Antibodies’’ [HHS antibodies against different types of
9702 Telephone: (240)-276–6910; Ref. No. E–103–2005/3–BR–06]; Chinese HPV.
Facsimile: (240)-276–5504 Email: Patent No. 200680011079.1 issued This notice is made in accordance
changke@mail.nih.gov. March 27, 2013 and entitled, with 35 U.S.C. 209 and 37 CFR part 404.
SUPPLEMENTARY INFORMATION: ‘‘Papillomavirus L2 N-terminal Peptides The prospective exclusive license will
For The Induction Of Broadly Cross- be royalty bearing, and the prospective
Intellectual Property neutralizing Antibodies’’ [HHS Ref. No. exclusive license may be granted unless
United States Provisional Patent E–103–2005/3–CN–07]; Indian Patent within fifteen (15) days from the date of
Application No. 60/649,249 filed No. 263255 issued October 16, 2014 and this published notice, the National
February 1, 2005 and entitled, entitled, ‘‘Papillomavirus L2 N-terminal Cancer Institute receives written
‘‘Papillomavirus L2 N-terminal Peptides Peptides For The Induction Of Broadly evidence and argument that establishes
For The Induction Of Broadly Cross- Cross-neutralizing Antibodies’’ [HHS that the grant of the license would not
neutralizing Antibodies’’ [HHS Ref. No. E–103–2005/3–IN–08]; be consistent with the requirements of
Reference No. E–103–2005/0–US–01]; European Patent No. 1853307 issued 35 U.S.C. 209 and 37 CFR part 404.
United States Provisional Patent December 14, 2016 and entitled, Complete applications for a license in
Application No. 60/697,655 filed July 7, ‘‘Papillomavirus L2 N-terminal Peptides the prospective field of use that are filed
2005 and entitled, ‘‘Papillomavirus L2 For The Induction Of Broadly Cross- in response to this notice will be treated
N-terminal Peptides For The Induction neutralizing Antibodies’’ [HHS Ref. No. as objections to the grant of the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Of Broadly Cross-neutralizing E–103–2005/3–EP–09]; German Patent contemplated Exclusive Patent License
Antibodies’’ [HHS Reference No. E– No. 1853307 issued December 14, 2016 Agreement. Comments and objections
103–2005/1–US–01]; United States and entitled, ‘‘Papillomavirus L2 N- submitted to this notice will not be
Provisional Patent Application No. 60/ terminal Peptides For The Induction Of made available for public inspection
752,268 filed December 21, 2005 and Broadly Cross-neutralizing Antibodies’’ and, to the extent permitted by law, will
entitled, ‘‘Papillomavirus L2 N-terminal [HHS Ref. No. E–103–2005/3–DE–11]; not be released under the Freedom of
Peptides For The Induction Of Broadly French Patent No. 1853307 issued Information Act, 5 U.S.C. 552.
VerDate Sep<11>2014 20:24 May 18, 2017 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1](https://thefederalregister.org/doc/82_FR_23108/page/1.svg)
![Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices 23013
Dated: May 11, 2017. DEPARTMENT OF HEALTH AND ‘‘High-affinity Monoclonal Antibodies
Richard U. Rodriguez, HUMAN SERVICES To Glypican-3 And Use Thereof’’ [HHS
Associate Director, Technology Transfer Ref. E–136–2012/0–SG–06], and United
Center, National Cancer Institute. National Institutes of Health States Patent 9,409,994 entitled ‘‘High-
[FR Doc. 2017–10153 Filed 5–18–17; 8:45 am] affinity Monoclonal Antibodies To
Prospective Grant of Exclusive Patent Glypican-3 And Use Thereof’’ [HHS Ref.
BILLING CODE 4140–01–P License: The Development of E–136–2012/0–US–07], and all
Monospecific and Bispecific continuing U.S. and foreign patents/
Antibodies to GPC3 for the Treatment patent applications for the technology
DEPARTMENT OF HEALTH AND of Human Liver Cancers
HUMAN SERVICES family, to AbPro. The patent rights in
AGENCY: National Institutes of Health, these inventions have been assigned to
National Institutes of Health HHS. and/or exclusively licensed to the
ACTION: Notice. Government of the United States of
National Institute on Alcohol Abuse America.
and Alcoholism; Notice of Closed SUMMARY: The National Cancer Institute, With respect to persons who have an
Meeting National Institutes of Health, obligation to assign their right, title and
Department of Health and Human interest to the Government of the United
Pursuant to section 10(d) of the Services, is contemplating the grant of States of America, the patent rights in
Federal Advisory Committee Act, as an Exclusive Patent License to AbPro, these inventions have been assigned to
amended (5 U.S.C. App.), notice is located in Woburn, Massachusetts, to the Government of the United States of
hereby given of the following meeting. practice the inventions embodied in the America.
patent applications listed in the The prospective Exclusive Patent
The meeting will be closed to the License territory may be worldwide for
public in accordance with the SUPPLEMENTARY INFORMATION section of
this notice. the following field of use:
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., DATES: Only written comments and/or The use of the YP7, YP8 and YP9.1 anti-
as amended. The grant applications and applications for a license which are GPC3 monoclonal antibodies as monospecific
received by the NCI Technology or bispecific antibodies for the treatment of
the discussions could disclose liver cancer. The licensed field of use
confidential trade secrets or commercial Transfer Center on or before June 5,
excludes any non-specified
property such as patentable material, 2017 will be considered. immunoconjugates, including, but not
and personal information concerning ADDRESSES: Requests for copies of the limited to, chimeric antigen receptors (CARs)
individuals associated with the grant patent applications, inquiries, and and variants thereof, Immunotoxins, and
applications, the disclosure of which comments relating to the contemplated antibody-drug conjugates (ADCs).
would constitute a clearly unwarranted Exclusive Patent License should be The present inventions to be licensed
invasion of personal privacy. directed to: David A. Lambertson, Ph.D., concern monoclonal antibodies that are
Senior Licensing and Patenting specific for the cell surface domain of
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Manager, NCI Technology Transfer GPC3: YP6, YP7, YP8, YP9 and YP9.1.
Emphasis Panel; NIAAA Fellowship Review. Center, 9609 Medical Center Drive, RM These antibodies can potentially be
Date: July 21, 2017. 1E530 MSC 9702, Bethesda, MD 20892– used for the treatment of GPC3-
Time: 8:00 a.m. to 5:00 p.m. 9702 (for business mail), Rockville, MD expressing cancers such as HCC. By
Agenda: To review and evaluate grant 20850–9702, Telephone: (240)–276– binding to and blocking GPC3 function,
applications. 6467; Email: david.lambertson@nih.gov. these antibodies can inhibit the growth
Place: National Institutes of Health, SUPPLEMENTARY INFORMATION: The of HCC cells, thereby decreasing the
National Institute on Alcohol Abuse and following represents the intellectual ability of tumors to grow and
Alcoholism, Terrace Level Conference Room, property to be licensed under the metastasize. Alternatively, the
5635 Fishers Lane, Bethesda, M.D 20892 prospective agreement: U.S. Provisional antibodies can be used to induce
Contact Person: Richard A. Rippe, Ph.D., Patent Application 61/654,232 entitled antibody-dependent anti-tumor activity
Scientific Review Officer , Extramural Project ‘‘High-affinity Monoclonal Antibodies by selectively killing cells which
Review Branch, Office of Extramural To Glypican-3 And Use Thereof’’ [HHS overexpress GPC3 while leaving
Activities, National Institute on Alcohol Ref. E–136–2012/0–US–01], PCT Patent healthy, normal cells unscathed.
Abuse and Alcoholism, 5635 Fishers Lane,
Application PCT/US2013/043633 Finally, a secondary antibody capable of
Room 2109, Rockville, MD 20852, 301–443–
entitled ‘‘High-affinity Monoclonal recruiting T cells to the tumor can be
8599, rippera@mail.nih.gov.
Antibodies To Glypican-3 And Use attached to the antibodies, thereby
(Catalogue of Federal Domestic Assistance Thereof’’ [HHS Ref. E–136–2012/0– allowing for the localization of T cells
Program Nos. 93.271, Alcohol Research
PCT–02], Chinese Patent Application or NK cells only to those cells which
Career Development Awards for Scientists
201380039993.7 entitled ‘‘High-affinity express GPC3, similarly leading to the
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Monoclonal Antibodies To Glypican-3 selective killing of the cancer cells.
Training; 93.273, Alcohol Research Programs; And Use Thereof’’ [HHS Ref. E–136– This notice is made in accordance
93.891, Alcohol Research Center Grants; 2012/0–CN–03], Japanese Patent with 35 U.S.C. 209 and 37 CFR part 404.
93.701, ARRA Related Biomedical Research Application 2015–515243 entitled The prospective Exclusive Patent
‘‘High-affinity Monoclonal Antibodies License will be royalty bearing and may
asabaliauskas on DSK3SPTVN1PROD with NOTICES
and Research Support Awards., National
Institutes of Health, HHS) To Glypican-3 And Use Thereof’’ [HHS be granted unless within fifteen (15)
Ref. E–136–2012/0–JP–04], South days from the date of this published
Dated: May 15, 2017.
Korean Patent Application 10–2014– notice, the National Cancer Institute
Melanie J. Pantoja, 7037046 entitled ‘‘High-affinity receives written evidence and argument
Program Analyst, Office of Federal Advisory Monoclonal Antibodies To Glypican-3 that establishes that the grant of the
Committee Policy. And Use Thereof’’ [HHS Ref. E–136– license would not be consistent with the
[FR Doc. 2017–10113 Filed 5–18–17; 8:45 am] 2012/0–KR–05], Singapore Patent requirements of 35 U.S.C. 209 and 37
BILLING CODE 4140–01–P Application 11201407972R entitled CFR part 404.
VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1](https://thefederalregister.org/doc/82_FR_23108/page/2.svg)
Document Created: 2018-11-08 08:47:22
Document Modified: 2018-11-08 08:47:22
| 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 and/or applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before June 5, 2017 will be considered. | |
| FR Citation | 82 FR 23012 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR