[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Notices]
[Pages 49387-49388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Start-Up Patent License for 
Evaluation: Immunotherapy for Relapsed/Refractory Diffuse Large B Cell 
Lymphoma

AGENCY: National Institutes of Health, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The National Heart, Lung, and Blood Institute, of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an exclusive start-up patent license for 
evaluation to ONK Therapeutics, a start-up company spun-off from the 
National University of Ireland Galway, and incorporated under the laws 
of the Republic of Ireland, to practice, for a limited time, the 
inventions covered by the patent estate listed in the Supplementary 
Information section of this notice. Upon expiration of the evaluation 
period the granted licenses may be converted into a fully exclusive 
patent commercialization license for the term of the last to expire of 
the patent estate upon the company providing NHLBI with a commercial 
development plan supporting such a conversion. This notice is intended 
to apprise the public of a aforementioned license and provide a fifteen 
(15) day notice period for the objection.

DATES: Only written comments and/or applications for a license which 
are received by the National Heart, Lung, and Blood Institute on or 
before August 28, 2020 will be considered.

ADDRESSES: Requests for copies of patent applications (electronic 
only), inquiries, and comments relating to the contemplated an 
exclusive patent license should be emailed to: Michael Shmilovich, 
Esq., Senior Licensing and Patent Manager, 31 Center Drive Room 4A29, 
MSC2479, Bethesda, MD 20892-2479, phone number 301-435-5019 
[email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property (Patent Estate)

    HHS Ref. No. E-036-2015-0 and -1, U.S. Provisional Patent 
Application 62/079,975 filed November 14, 2014 (expired), International 
Patent Application PCT/US2015/060646 filed November 13, 2015 
(nationalized), U.S. Patent Application 15/525,921 having an effective 
filing date of November 13, 2015, and U.S. Divisional Patent 
Application 16/985,797 filed August 5, 2020, any and all continuation 
or divisional applications claiming priority to any of the above.
    The patent rights in these inventions have been assigned or 
exclusively licensed to the Government of the United States of America.
    The prospective exclusive license territory may be worldwide and in 
field of use that may be limited to Immunotherapy against relapsed or 
refractory diffuse large B cell lymphoma, and where the ``Licensed 
Products'' may be defined to be limited to transgenically modified 
allogeneic natural killer cells within the scope of the Licensed Patent 
Rights that transiently express one or more of a (1) CCR7 receptor, (2) 
CD16a (HA-CD16), (3) a DR5 specific TRAIL, or (4) CD19 chimeric antigen 
receptor.
    The aforementioned patent estates cover methods of treating a 
subject with a tumor by administering transgenically modified adoptive 
NK (natural killer cells), methods of generating transgenic NK cells, 
and transgenic NK cells per se.

[[Page 49388]]

In particular, the claims cover include transgenic NKs expressing CCR7 
and CD16a (HA-CD16). The treatment methods also include dependent 
claims where the transgenic NK cells are co-administered with a 
monoclonal antibody therapeutic (e.g., rituximab). CCR7 is a chemokine 
receptor (chemokine (C--C motif) receptor 7) known to direct cellular 
migration to secondary lymphoid tissues, including lymph nodes where 
hematological malignancies such as diffuse large B cell lymphoma 
(DLBCL) reside. Normally, CCR7 is expressed by only a small subset of 
resting primary NK cells.
    CD16 includes Fc receptors Fc[gamma]RIIIa (CD16a) and 
Fc[gamma]RIIIb (CD16b) found on the surface of natural killer (NK) 
cells and other leukocytes. CD16a binds to the Fc tail of IgG 
antibodies which then activates the NK cell for antibody-dependent 
cellular toxicity (ADCC). Human wild type CD16 has a relatively low 
affinity for IgG1 antibodies. However, a single nucleotide polymorphism 
(SNP rs396991) in the CD16a gene (F to V at position 158; referred to 
hereafter as HA-CD16) results in substantially higher IgG1 affinity and 
superior NK mediated ADCC.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive licenses, both the one granted for 
the evaluation period and if converted into a full exclusive patent 
commercialization license, will be royalty bearing. The prospective 
exclusive license may be granted unless within fifteen (15) days from 
the date of this published notice, the National Heart, Lung, and Blood 
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 August 5, 2020.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute.
[FR Doc. 2020-17703 Filed 8-12-20; 8:45 am]
BILLING CODE 4140-01-P