[Federal Register Volume 88, Number 59 (Tuesday, March 28, 2023)]
[Notices]
[Pages 18324-18326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06318]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of Metarrestin and Its Analogs for the Treatment of 
Metastatic Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Center for Advancing Translational Sciences, 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 Oncala Bio Inc. (``Oncala Bio''), headquartered in Bend, OR.

DATES: Only written comments and/or applications for a license which 
are received by the National Center for Advancing Translational 
Sciences'

[[Page 18325]]

Office of Strategic Alliances on or before April 12, 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: Sury Vepa, Ph.D., J.D., Senior Licensing and 
Patenting Manager, Office of Strategic Alliances, Telephone: (301)-642-
0460; Email: [email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    1. U.S. Provisional Patent Application No. 61/576,780 filed on 12/
16/2011 which is entitled ``Compounds and Methods for the Prevention 
and Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-
276-2011-0-US-01);
    2. International Patent Application No. PCT/US2012/070155 filed on 
12/17/2012 which is entitled ``Compounds and Methods for The Prevention 
and Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-
276-2011-0-PCT-02);
    3. Australian Patent Application No. 2012353651 filed on 12/17/2012 
which is entitled ``Compounds and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' which was issued as 
Patent No. 2012353651 on 03/29/2018(HHS Ref. No. E-276-2011-0-AU-03);
    4. Australian Patent Application No. 2017276258 filed on 12/17/2012 
which is entitled ``Compounds and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' which was issued as 
Patent No. 201727658 on 01/16/2020 (HHS Ref. No. E-276-2011-0-AU-10);
    5. Canadian Patent Application No. 2859370 filed on 12/17/2012 
which is entitled ``Compounds and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' which was issued as 
Patent No. 2859370 on 01/26/2021(HHS Ref. No. E-276-2011-0-CA-04);
    6. European Patent Application No. 12806846.7 filed on 12/17/2012 
which is entitled ``Compounds and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' which was issued as 
Patent No. 2791142 on 07/03/2019 and validated in Germany, Spain, 
France, Great Britain, Italy and Turkey (HHS Ref. No. E-276-2011-0-EP-
05);
    7. U.S. Patent Application No. 14/364,759 filed on 06/12/2014 which 
is entitled ``Compounds and Methods for the Prevention and Treatment of 
Tumor Metastasis and Tumorigenesis'' which was issued as Patent No. 
9,663,521 on 05/30/2017 (HHS Ref. No. E-276-2011-0-US-07);
    8. U.S. Patent Application No. 15/606,740 filed on 05/26/2017 which 
is entitled ``Compounds and Methods for the Prevention and Treatment of 
Tumor Metastasis and Tumorigenesis'' which was issued as Patent No. 
10,301,314 on 05/28/2019 (HHS Ref. No. E-276-2011-0-US-08);
    9. Japanese Patent Application No. 547550/2014 filed on 06/13/2014 
which is entitled ``Compounds and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' which was issued as 
Patent No. 6463130 on 01/01/2019 (HHS Ref. No. E-276-2011-0-JP-06);
    10. Japanese Patent Application No. 102107/2017 filed on 05/23/2017 
which is entitled ``Compounds and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' which was issued as 
Patent No. 6726640 on 07/01/2020 (HHS Ref. No. E-276-2011-0-JP-09);
    11. U.S. Provisional Patent Application No. 62/671,964 filed on 05/
15/2018 which is entitled ``Formulations and Methods for the Prevention 
and Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-
114-2018-0-US-01);
    12. International Patent Application No. PCT/US2019/32461 filed on 
05/15/2019 which is entitled ``Formulations and Methods for the 
Prevention and Treatment of Tumor Metastasis and Tumorigenesis'' (HHS 
Ref. No. E-114-2018-0-PCT-02);
    13. Canadian Patent Application No. 3100211 filed on 11/12/2020 
which is entitled ``Formulations and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-114-
2018-0-CA-03);
    14. Australian Patent Application No. 2019271208 filed on 11/13/
2020 which is entitled ``Formulations and Methods for the Prevention 
and Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-
114-2018-0-AU-04);
    15. Japanese Patent Application No. 2020-564095 filed on 11/13/2020 
which is entitled ``Formulations and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-114-
2018-0-JP-06);
    16. U.S. Patent Application No. 17/055,256 filed on 11/13/2020 
which is entitled ``Formulations and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-114-
2018-0-US-07); and
    17. European Patent Application No. 19728226.2 filed on 12/09/2020 
which is entitled ``Formulations and Methods for the Prevention and 
Treatment of Tumor Metastasis and Tumorigenesis'' (HHS Ref. No. E-114-
2018-0-EP-05).
    The patent rights in these inventions have been either assigned 
and/or exclusively licensed to the government of the United States of 
America, University of Kansas and Northwestern University.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to the following:
    ``Development, manufacture, use and commercialization of 
Metarrestin and its analogs disclosed and claimed in the prospective 
licensed patent rights, for the treatment of perinucleolar compartment 
(PNC) positive cancers or metastatic cancers.''
    E-276-2011 and E-104-2018 patent families are primarily directed to 
novel compositions, methods and formulations, which are selective 
against metastasis across different preclinical cancer histologies and 
without appreciable toxicity. Among others, the subject patent families 
disclose or claim the use of the small molecule metarrestin for the 
treatment of several types of metastatic cancers by disrupting a 
subcellular structure called the perinucleolar compartment (PNC) which 
is frequently found in metastatic tumors and cancer stem 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 
Center for Advancing Translational Sciences 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.


[[Page 18326]]


    Dated: March 21, 2023.
Joni L. Rutter,
Director, Office of the Director, National Center for Advancing 
Translational Sciences.
[FR Doc. 2023-06318 Filed 3-27-23; 8:45 am]
BILLING CODE 4140-01-P