83 FR 35665 - Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cancer Immunotherapy

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 145 (July 27, 2018)

Page Range		35665-35665
FR Document		2018-16058

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 Midissia Therapeutics (``Midissia'') located in San Francisco, CA.

Federal Register, Volume 83 Issue 145 (Friday, July 27, 2018)

[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Page 35665]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16058]



[[Page 35665]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of Cancer Immunotherapy

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 Midissia 
Therapeutics (``Midissia'') located in San Francisco, CA.

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 August 13, 2018 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Ricquita Pollard, 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) 276-5530; Facsimile: (240) 276-5504; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

1. United States Provisional Patent Application No. 62/248,964 filed 
Oct. 30, 2015 for ``Compositions and Methods for the Treatment of 
HER2-Expressing Solid Tumor ``[HHS Ref. No. E-187-2015/0US-01];
2. International Patent Application No. PCT/US2016/059680 filed 
October 31, 2016 for ``Compositions and Methods for Treatment of 
HER2-Expressing Solid Tumor'' [HHS Reference No. E-187-2015/0-PCT-
02];
3. Canadian National Stage Patent Application (No. not yet 
assigned), filed April 30, 2018 [HHS Ref. No. E-187-2015/0-CA-03];
4. Japanese National Stage Patent Application No. 2018-521518, filed 
April 30, 2018 [HHS Ref. No. E-187-2015/0-JP-04];
5. Australian National Stage Patent Application No. 2016343845, 
filed April 30, 2018 [HHS Ref. No. E-187-2015/0-AU-05];
6. European National Stage Patent Application. (No. not yet 
assigned), filed April 30, 2018 [HHS Ref. No. E-187-2015/0-EP-06];
7. U.S. National Stage Patent Application No. 15/771,932, filed 
April 30, 2018 [HHS Ref. No. E-187-2015/0-US-07];

    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 ``development and commercialization 
of Ad-HER2 vaccines as a therapeutic against HER2-positive cancers as 
covered within the scope of the Licensed Patent Rights, excluding uses 
in combination with vectors/adjuvants, checkpoint inhibitors or other 
immune modulators.''
    This technology describes a recombinant adenoviral vector that 
expresses the extracellular (EC) and transmembrane (TM) domains of the 
human HER2 protein and is designed to induce a polyclonal anti-tumor 
response. HER2 is a member of the epidermal growth factor family and is 
overexpressed in subsets of breast, ovarian, gastric, colorectal, 
pancreatic and endometrial cancers. This vaccine encodes for the entire 
EC and TM domains of human HER2neu and is specifically contained within 
a recombinant adenoviral vector that has the knob of Adenovirus 5 and 
substituted fiber of Adenovirus 35. The substitution of the knob of 
Adenovirus 35 whose receptor is CD46 allows for efficient and maximal 
transduction of human dendritic and hematopoietic cells.
    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.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: July 19, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2018-16058 Filed 7-26-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35665

DEPARTMENT OF HEALTH AND 6. European National Stage Patent required and upon a request under the
HUMAN SERVICES Application. (No. not yet assigned), filed Freedom of Information Act, 5 U.S.C.
April 30, 2018 [HHS Ref. No. E–187– 552.
National Institutes of Health 2015/0–EP–06];
7. U.S. National Stage Patent Application No. Dated: July 19, 2018.
Prospective Grant of an Exclusive 15/771,932, filed April 30, 2018 [HHS Richard U. Rodriguez,
Ref. No. E–187–2015/0–US–07]; Associate Director, Technology Transfer
Patent License: Development and
Commercialization of Cancer The patent rights in these inventions Center, National Cancer Institute.
Immunotherapy have been assigned and/or exclusively [FR Doc. 2018–16058 Filed 7–26–18; 8:45 am]
licensed to the government of the BILLING CODE 4140–01–P
AGENCY: National Institutes of Health, United States of America.
Department of Health and Human The prospective exclusive license
Services. territory may be worldwide and the DEPARTMENT OF HEALTH AND
ACTION: Notice. field of use may be limited to HUMAN SERVICES
SUMMARY: The National Cancer Institute, ‘‘development and commercialization of
Ad-HER2 vaccines as a therapeutic National Institutes of Health
an institute of the National Institutes of
Health, Department of Health and against HER2-positive cancers as
Proposed Collection; 60-Day Comment
Human Services, is contemplating the covered within the scope of the
Request; Intramural Continuing
grant of an Exclusive Patent License to Licensed Patent Rights, excluding uses
Umbrella of Research Experiences
practice the inventions embodied in the in combination with vectors/adjuvants,
(iCURE) Application (National Cancer
U.S. Patents and Patent Applications checkpoint inhibitors or other immune
Institute)
listed in the Supplementary Information modulators.’’
This technology describes a AGENCY: National Institutes of Health,
section of this notice to Midissia
recombinant adenoviral vector that Department of Health and Human
Therapeutics (‘‘Midissia’’) located in
expresses the extracellular (EC) and Services.
San Francisco, CA.
transmembrane (TM) domains of the ACTION: Notice.
DATES: Only written comments and/or human HER2 protein and is designed to
applications for a license which are induce a polyclonal anti-tumor SUMMARY: In compliance with the
received by the National Cancer response. HER2 is a member of the requirement of the Paperwork
Institute’s Technology Transfer Center epidermal growth factor family and is Reduction Act of 1995 to provide
on or before August 13, 2018 will be overexpressed in subsets of breast, opportunity for public comment on
considered. ovarian, gastric, colorectal, pancreatic proposed data collection projects, the
ADDRESSES: Requests for copies of the and endometrial cancers. This vaccine National Cancer Institute (NCI) will
patent application, inquiries, and encodes for the entire EC and TM publish periodic summaries of propose
comments relating to the contemplated domains of human HER2neu and is projects to be submitted to the Office of
Exclusive Patent License should be specifically contained within a Management and Budget (OMB) for
directed to: Ricquita Pollard, recombinant adenoviral vector that has review and approval.
Technology Transfer Manager, NCI the knob of Adenovirus 5 and DATES: Comments regarding this
Technology Transfer Center, 9609 substituted fiber of Adenovirus 35. The information collection are best assured
Medical Center Drive, RM 1E530 MSC substitution of the knob of Adenovirus of having their full effect if received
9702, Bethesda, MD 20892–9702 (for 35 whose receptor is CD46 allows for within 60 days of the date of this
business mail), Rockville, MD 20850– efficient and maximal transduction of publication.
9702; Telephone: (240) 276–5530; human dendritic and hematopoietic FOR FURTHER INFORMATION CONTACT: To
Facsimile: (240) 276–5504; Email: cells. obtain a copy of the data collection
pollardrd@mail.nih.gov. This notice is made in accordance
plans and instruments, submit
SUPPLEMENTARY INFORMATION: with 35 U.S.C. 209 and 37 CFR part 404.
comments in writing, or request more
The prospective exclusive license will
Intellectual Property information on the proposed project,
be royalty bearing, and the prospective
contact: Alison Lin, 9609 Medical
1. United States Provisional Patent exclusive license may be granted unless
Center Drive, Rockville, MD 20850 or
Application No. 62/248,964 filed Oct. 30, within fifteen (15) days from the date of
2015 for ‘‘Compositions and Methods for call non-toll-free number (240) 276–
this published notice, the National
the Treatment of HER2-Expressing Solid 6177 or Email your request, including
Cancer Institute receives written
Tumor ‘‘[HHS Ref. No. E–187–2015/ your address to: linaj@mail.nih.gov.
evidence and argument that establishes
0US–01]; Formal requests for additional plans and
that the grant of the license would not
2. International Patent Application No. PCT/ instruments must be requested in
US2016/059680 filed October 31, 2016 be consistent with the requirements of
writing.
for ‘‘Compositions and Methods for 35 U.S.C. 209 and 37 CFR part 404.
Treatment of HER2-Expressing Solid In response to this Notice, the public SUPPLEMENTARY INFORMATION: Section
Tumor’’ [HHS Reference No. E–187– may file comments or objections. 3506(c)(2)(A) of the Paperwork
2015/0–PCT–02]; Comments and objections, other than Reduction Act of 1995 requires: Written
3. Canadian National Stage Patent those in the form of a license comments and/or suggestions from the
Application (No. not yet assigned), filed application, will not be treated public and affected agencies are invited
April 30, 2018 [HHS Ref. No. E–187– confidentially, and may be made to address one or more of the following
amozie on DSK3GDR082PROD with NOTICES1

2015/0–CA–03]; publicly available. points: (1) Whether the proposed
4. Japanese National Stage Patent Application License applications submitted in collection of information is necessary
No. 2018–521518, filed April 30, 2018
[HHS Ref. No. E–187–2015/0–JP–04];
response to this Notice will be for the proper performance of the
5. Australian National Stage Patent presumed to contain business function of the agency, including
Application No. 2016343845, filed April confidential information and any release whether the information will have
30, 2018 [HHS Ref. No. E–187–2015/0– of information in these license practical utility; (2) The accuracy of the
AU–05]; applications will be made only as agency’s estimate of the burden of the

VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1

Document Created: 2018-07-27 04:05:35
Document Modified: 2018-07-27 04:05:35

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 August 13, 2018 will be considered.
FR Citation		83 FR 35665

83 FR 35665 - Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cancer Immunotherapy

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 145 (July 27, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health