[Federal Register Volume 82, Number 135 (Monday, July 17, 2017)]
[Pages 32712-32713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14860]



National Institutes of Health

Prospective Grant of Exclusive Patent License: Development, 
Commercial Application and Use of Fulvestrant in Combination Therapy 
for the Treatment of Cancers

AGENCY: National Institutes of Health, HHS.

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 Commercialization 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 NantBioScience, Inc., located in, California, USA.

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 1, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Commercialization 
Patent License should be directed to: Sabarni K. Chatterjee, Ph.D., 
M.B.A., Senior Licensing and Patenting 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].


Intellectual Property

     United States Provisional Patent Application No. 62/
290,117 filed February 02, 2016, and entitled ``Fulvestrant Improves 
Immune-mediated Cytotoxic Lysis of Cancer Cells.'' [HHS Reference No. 
     International PCT Application No. PCT/US2017/015829 filed 
January 31, 2017, entitled ``Fulvestrant Improves Immune-mediated 
Cytotoxic Lysis of Cancer Cells.'' [HHS Reference No. E-066-2016/0-PCT-
02]; and U.S. and foreign patent applications claiming priority to the 
aforementioned applications.
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.

[[Page 32713]]

    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: ``Development, commercial application and use of 
fulvestrant in estrogen receptor positive cancers, in combination with 
other products and therapies, excluding poxvirus-based vaccines.'' For 
avoidance of doubt, the field of use specifically excludes the use of 
fulvestrant in combination with poxvirus-based vaccines.
    This technology discloses the use of fulvestrant, an estrogen 
receptor antagonist, as an immune modulating agent that enhances the 
effects of immunotherapy and/or chemotherapy in cancer cells. 
Fulvestrant treatment of mesenchymal-like lung carcinoma cells 
increases immune-mediated lysis by reversing epithelial mesenchymal 
transition (EMT), potentially repairing defective cell death mechanisms 
driven by EMT, and restoring immune-mediated lysis to chemo-resistant 
cells. Overall, treatment of cancer cells with fulvestrant in 
combination with immunotherapy or chemotherapy agents results in 
increased cancer cell death. Although immunotherapy is leading the 
charge in cancer treatments, its efficacy is limited by patient 
resistance to immunotherapy and/or non-responsiveness. Combination 
therapy with fulvestrant that enhances the therapeutic effects of 
immunotherapy and chemotherapy, is a promising strategy to improve the 
clinical outcome for patients with resistant or unresponsive tumors.
    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 Commercialization 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.

    Dated: July 6, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
[FR Doc. 2017-14860 Filed 7-14-17; 8:45 am]