[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Notices]
[Page 28063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12708]



[[Page 28063]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Lutetium-177 
Radiotherapeutics Against Somatostatin-Receptor Expressing 
Neuroendocrine Tumors

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National 
Institutes of Health, Department of Health and Human Services, is 
contemplating amending an existing license to include a exclusive 
patent license to Molecular Targeting Technologies, Inc. (MTTI); a 
Delaware corporation, with its principle place of business in West 
Chester, Pennsylvania, to practice the inventions embodied in the 
patent application listed in the SUPPLEMENTARY INFORMATION section of 
this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NHLBI Office of Technology Transfer and Development 
July 2, 2019 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: Michael Shmilovich, Esq., Senior Licensing and 
Patent Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 
20892-2479, phone number 301-435-5019, or [email protected].

SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and 
foreign patents/patent applications thereof are the intellectual 
properties to be licensed under the prospective agreement to MTTI:

----------------------------------------------------------------------------------------------------------------
                                       Patent No. or patent
           NIH ref No.                    application No.                 Filing date                Title
----------------------------------------------------------------------------------------------------------------
E-150-2016-0-US-01...............  62/333,427..................  May 9, 2019.................  Chemical
                                                                                                Conjugates of
                                                                                                Evans Blue
                                                                                                Derivatives and
                                                                                                Their Use as
                                                                                                Radiotherapy and
                                                                                                Imaging Agents.
E-150-2016-0-PCT-02..............  PCT/US2017/031696...........  May 9, 2017.................  Chemical
                                                                                                Conjugates of
                                                                                                Evans Blue
                                                                                                Derivatives and
                                                                                                Their Use as
                                                                                                Radiotherapy and
                                                                                                Imaging Agents.
E-150-2016-0-CN-03...............  201780029003X...............  November 9, 2018............  Chemical
                                                                                                Conjugates of
                                                                                                Evans Blue
                                                                                                Derivatives and
                                                                                                Their Use as
                                                                                                Radiotherapy and
                                                                                                Imaging Agents.
E-150-2016-0-EP-04...............  17796666.0..................  November 12, 2018...........  Chemical
                                                                                                Conjugates of
                                                                                                Evans Blue
                                                                                                Derivatives and
                                                                                                Their Use as
                                                                                                Radiotherapy and
                                                                                                Imaging Agents.
E-150-2016-0-JP-05...............  2018-558662.................  November 8, 2018............  Chemical
                                                                                                Conjugates of
                                                                                                Evans Blue
                                                                                                Derivatives and
                                                                                                Their Use as
                                                                                                Radiotherapy and
                                                                                                Imaging Agents.
E-150-2016-0-US-06...............  16/099,488..................  November 7, 2018............  Chemical
                                                                                                Conjugates of
                                                                                                Evans Blue
                                                                                                Derivatives and
                                                                                                Their Use as
                                                                                                Radiotherapy and
                                                                                                Imaging Agents.
----------------------------------------------------------------------------------------------------------------

    The patent rights in these inventions have been assigned to the 
Government of the United States of America. The prospective patent 
license will be granted worldwide and limited to the extent that the 
above referenced patents or patent applications cover lutetium-177 
radiotherapeutics for somatostatin-receptor expressing neuroendocrine 
tumors.
    The invention pertains to a radiotherapeutic against neuroendocrine 
tumors that express somatostatin receptor. Radionuclide therapies 
directed against tumors that express somatostatin receptors (SSTRs) 
have proven effective for the treatment of advanced, low- to 
intermediate-grade neuroendocrine tumors. The subject radiotherapeutic 
covered by the subject patent estate includes a somatostatin (SST) 
peptide derivative like octreotate (TATE), conjugated to an Evans Blue 
(EB) analog, and further chelated via DOTA to therapeutic radionuclide. 
The EB analog reversibly binds to circulating serum albumin and 
improves the pharmacokinetics of SST peptide derivatives and reduce 
peptide-receptor radionuclide therapy toxicity. EB analog conjugated to 
octreotate (EB-DOTATATE) has been shown by the inventors to provide 
reversible albumin binding in vivo and extended half-life in 
circulation. When EB-TATE is slowly released into the tumor 
microenvironment, tumor uptake and internalization into SSTR positive 
tumors resulted in delivery of radioactive particles and tumor cell 
killing. EB-TATE displayed significantly more favorable 
pharmacokinetics than TATE alone by achieving higher tumor to non-tumor 
penetration as evidenced by positron emission tomography.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent license will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the NHLBI 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 timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent license.
    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: June 3, 2019.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2019-12708 Filed 6-14-19; 8:45 am]
 BILLING CODE 4140-01-P