[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:
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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