[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Notices]
[Pages 65179-65180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20487]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of Engineered T Cell Therapies for the Treatment of 
HPV-Positive Cancer(s)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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 Patents and Patent Applications listed in 
the Supplementary Information section of this Notice to Scarlet TCR, 
Inc. (``Scarlet''), presently headquartered in Kingston, New Jersey.

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 October 6, 2023 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Andrew Burke, Ph.D., Senior Technology Transfer 
Manager, NCI Technology Transfer Center, Telephone: (240) 276-5484; 
Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    1. United States Provisional Patent Application No. 62/004,335 
filed May 29, 2014, entitled ``Anti-Human Papillomavirus 16 E7 T Cell 
Receptors'' [HHS Reference No. E-176-2014-0-US-01];
    2. PCT Patent Application No. PCT/US2015/033129 filed May 29, 2015, 
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS 
Reference No. E-176-2014-0-PCT-02];
    3. Australian Patent No. 2015266818 issued January 16, 2020, 
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS 
Reference No. E-176-2014-0-AU-03];
    4. Brazilian Patent Application No. BR112016027805-4 effective 
filing date of May 29, 2015, entitled ``Anti-Human Papillomavirus 16 E7 
T Cell Receptors'' [HHS Reference No. E-176-2014-0-BR-04];
    5. Canadian Patent Application No. 2,950,192 effective filing date 
of May 29, 2015, entitled ``Anti-Human Papillomavirus 16 E7 T Cell 
Receptors'' [HHS Reference No. E-176-2014-0-CA-05];
    6. Chinese Patent No. ZL201580031789.X issued May 4, 2021, entitled 
``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference No. 
E-176-2014-0-CN-06];
    7. European Patent No. 3149031 issued December 18, 2019, entitled 
``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference No. 
E-176-2014-0-EP-07];
    a. Validated in: AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, 
FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MK, MT, NL, NO, PL, PT, RO, 
SE, SI, SK, SM and TR.
    8. Israeli Patent No. 248797 issued September 1, 2021, entitled 
``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference No. 
E-176-2014-0-IL-08];

[[Page 65180]]

    9. Japanese Patent No. 6742991 issued August 19, 2020, entitled 
``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference No. 
E-176-2014-0-JP-09];
    10. Korean Patent No. 10-2445667 issued September 16, 2022, 
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS 
Reference No. E-176-2014-0-KR-10];
    11. Mexican Patent No. 375379 issued September 25, 2020, entitled 
``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference No. 
E-176-2014-0-MX-11];
    12. Saudi Arabian Patent No. 7456 issued January 5, 2021, entitled 
``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference No. 
E-176-2014-0-SA-12];
    13. United States Patent No. 10,174,098 issued January 8, 2019, 
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS 
Reference No. E-176-2014-0-US-13];
    14. Hong Kong Patent No. HK1236203 issued January 8, 2021, entitled 
``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference No. 
E-176-2014-0-HK-14];
    15. United States Patent No. 10,870,687 issued December 22, 2020, 
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS 
Reference No. E-176-2014-0-US-15];
    16. European Patent Application No. 19217074.4 filed December 17, 
2019, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' 
[HHS Reference No. E-176-2014-0-EP-16];
    17. Australian Patent No. 2019283892 issued May 13, 2021, entitled 
``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference No. 
E-176-2014-0-AU-17];
    18. Japanese Patent No. 6997267 issued December 20, 2021, entitled 
``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference No. 
E-176-2014-0-JP-53];
    19. Saudi Arabian Patent Application No. 520412601 filed August 10, 
2020, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' 
[HHS Reference No. E-176-2014-0-SA-54];
    20. Hong Kong Patent Application No. 42020020661.3 filed November 
24, 2020, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' 
[HHS Reference No. E-176-2014-0-HK-55];
    21. Mexican Patent Application No. MX/a/2020/010035 filed September 
24, 2020, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' 
[HHS Reference No. E-176-2014-0-MX-56];
    22. United States Patent No. 11,434,272 issued September 6, 2020, 
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS 
Reference No. E-176-2014-0-US-57];
    23. Australian Patent No. 2021202227 issued February 23, 2023, 
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS 
Reference No. E-176-2014-0-AU-58];
    24. Chinese Patent Application No. 20210399056.9 filed April 14, 
2021, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' 
[HHS Reference No. E-176-2014-0-CN-59];
    25. Israeli Patent No. 282518 issued July 2, 2022, entitled ``Anti-
Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference No. E-176-
2014-0-IL-60];
    26. Hong Kong Patent Application No. 42022046605.6 filed January 
19, 2022, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' 
[HHS Reference No. E-176-2014-0-HK-62];
    27. Japanese Patent No. 7291196 issued June 6, 2023, entitled 
``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS Reference No. 
E-176-2014-0-JP-63];
    28. Israeli Patent Application No. 290655 filed February 16, 2022, 
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS 
Reference No. E-176-2014-0-IL-64];
    29. United States Patent Application No. 17/816,496 filed August 1, 
2022, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' 
[HHS Reference No. E-176-2014-0-US-65];
    30. Korean Patent Application No. 2022-7032043 filed September 15, 
2022, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' 
[HHS Reference No. E-176-2014-0-KR-66];
    31. Australian Patent Application No. 2023200608 filed February 6, 
2023, entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' 
[HHS Reference No. E-176-2014-0-AU-01]; and
    32. Japanese Patent Application No. 2023-091878 filed June 2, 2023, 
entitled ``Anti-Human Papillomavirus 16 E7 T Cell Receptors'' [HHS 
Reference No. E-176-2014-0-JP-01].
    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 following:
    ``Development, manufacture and commercialization of autologous T 
cell therapy products that are genetically engineered to have stable 
expression of a T cell receptor (TCR) targeting human papillomavirus 
(``HPV'')-16 E7, as claimed in the Licensed Patent Rights, for the 
treatment of HPV-associated cancers and premalignant conditions in 
humans.''
    The E-176-2014 patent family is primarily directed to an isolated 
TCR reactive to HPV 16 E7 antigen in the context of HLA-A*02. HPV 
describes a group of human viruses known to cause malignancy. Of the 
group, HPV-16 is the most prevalent strain. Approximately 90% of adults 
are estimated to have been exposed at some point in their lifetime. HPV 
drives transformation of infected cells through the expression of 
certain oncoproteins, chiefly E5, E6 and E7. The latter two are 
constitutively expressed in malignant cells and are necessary to 
maintain a transformed state, rendering them useful therapeutic 
targets.
    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 from 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: September 18, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2023-20487 Filed 9-20-23; 8:45 am]
BILLING CODE 4140-01-P