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[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Page 35663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16065]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive Patent License: 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 the grant of an 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 
August 27, 2018 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: HHS 
Ref. E-150-2016-1-PCT-01, International Patent Application PCT/US2017/
054863 filed October 3, 2017, entitled ``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 in a field of use not broader 
than 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 
\177\Lu, a beta emitter. 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: July 20, 2018.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2018-16065 Filed 7-26-18; 8:45 am]
 BILLING CODE 4140-01-P
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