83 FR 35663 - Prospective Grant of Exclusive Patent License: Radiotherapeutics Against Somatostatin-Receptor Expressing Neuroendocrine Tumors
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 145 (July 27, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 145 (July 27, 2018)
| Page Range | 35663-35663 | |
| FR Document | 2018-16065 |
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)] [Notices] [Page 35663] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16065] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35663
rsvp.fitness@hhs.gov or by calling (240) The patent rights in these inventions Dated: July 20, 2018.
276–9567. Registration for public have been assigned to the Government Michael A. Shmilovich,
attendance must be completed before of the United States of America. The Senior Licensing and Patenting Manager,
close of business Wednesday, prospective patent license will be National Heart, Lung, and Blood Institute,
September 12, 2018. granted worldwide and in a field of use Office of Technology Transfer and
not broader than radiotherapeutics for Development.
Dated: July 12, 2018.
Holli M. Richmond, somatostatin-receptor expressing [FR Doc. 2018–16065 Filed 7–26–18; 8:45 am]
Executive Director, Office of the President’s
neuroendocrine tumors. BILLING CODE 4140–01–P
Council on Sports, Fitness, and Nutrition, The invention pertains to a
U.S. Department of Health and Human radiotherapeutic against neuroendocrine
Services. DEPARTMENT OF HEALTH AND
tumors that express somatostatin
HUMAN SERVICES
[FR Doc. 2018–16056 Filed 7–26–18; 8:45 am] receptor. Radionuclide therapies
BILLING CODE 4150–35–P directed against tumors that express National Institutes of Health
somatostatin receptors (SSTRs) have
proven effective for the treatment of National Cancer Institute; Notice of
DEPARTMENT OF HEALTH AND advanced, low- to intermediate-grade Closed Meetings
HUMAN SERVICES neuroendocrine tumors. The subject
Pursuant to section 10(d) of the
radiotherapeutic covered by the subject
National Institutes of Health Federal Advisory Committee Act, as
patent estate includes a somatostatin
amended, notice is hereby given of the
Prospective Grant of Exclusive Patent (SST) peptide derivative like octreotate
following meetings.
License: Radiotherapeutics Against (TATE), conjugated to an Evans Blue
The meetings will be closed to the
Somatostatin-Receptor Expressing (EB) analog, and further chelated via
public in accordance with the
Neuroendocrine Tumors DOTA to therapeutic radionuclide
177Lu, a beta emitter. The EB analog
provisions set forth in sections
AGENCY: National Institutes of Health, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
reversibly binds to circulating serum as amended. The grant applications and
HHS. albumin and improves the the discussions could disclose
ACTION: Notice. pharmacokinetics of SST peptide confidential trade secrets or commercial
derivatives and reduce peptide-receptor property such as patentable material,
SUMMARY: The National Heart, Lung and
radionuclide therapy toxicity. EB analog and personal information concerning
Blood Institute (NHLBI), National
conjugated to octreotate (EB- individuals associated with grant
Institutes of Health, Department of
DOTATATE) has been shown by the applications, the disclosure of which
Health and Human Services, is
inventors to provide reversible albumin would constitute a clearly unwarranted
contemplating the grant of an exclusive
binding in vivo and extended half-life in invasion of personal privacy.
patent license to Molecular Targeting
circulation. When EB-TATE is slowly
Technologies, Inc. (MTTI); a Delaware Name of Committee: National Cancer
released into the tumor
corporation, with its principle place of Institute Special Emphasis Panel; U01 SEP:
microenvironment, tumor uptake and
business in West Chester, Pennsylvania, Glycobiologists Alliance for Cancer Research.
internalization into SSTR positive Date: August 30, 2018.
to practice the inventions embodied in
the patent application listed in the tumors resulted in delivery of Time: 10:00 a.m. to 5:00 p.m.
SUPPLEMENTARY INFORMATION section of
radioactive particles and tumor cell Agenda: To review and evaluate grant
this notice. killing. EB-TATE displayed significantly applications.
more favorable pharmacokinetics than Place: National Cancer Institute, Shady
DATES: Only written comments and/or Grove, 9609 Medical Center Drive, Room
TATE alone by achieving higher tumor
applications for a license which are 7W102, Rockville, MD 20850 (Telephone
to non-tumor penetration as evidenced
received by the NHLBI Office of Conference Call).
by positron emission tomography. Contact Person: Shakeel Ahmad, Ph.D.,
Technology Transfer and Development
August 27, 2018 will be considered. This notice is made in accordance Scientific Review Officer, Research
with 35 U.S.C. 209 and 37 CFR part 404. Technology and Contract Review Branch,
ADDRESSES: Requests for copies of the
The prospective exclusive patent license Division of Extramural Activities, National
patent applications, inquiries, and Cancer Institute, NIH, 9609 Medical Center
comments relating to the contemplated will be royalty bearing and may be
Drive, Room 7W102, Bethesda, MD 20892–
exclusive patent license should be granted unless within fifteen (15) days 9750, 240–276–6349, ahmads@mail.nih.gov.
directed to: Michael Shmilovich, Esq., from the date of this published notice,
Name of Committee: National Cancer
Senior Licensing and Patent Manager, the NHLBI receives written evidence Institute Special Emphasis Panel; NCI
31 Center Drive, Room 4A29, MSC2479, and argument that establishes that the Program Project IV (P01).
Bethesda, MD 20892–2479, phone grant of the license would not be Date: September 27–28, 2018.
number 301–435–5019, or shmilovm@ consistent with the requirements of 35 Time: 4:00 p.m. to 5:00 p.m.
mail.nih.gov. U.S.C. 209 and 37 CFR part 404. Agenda: To review and evaluate grant
applications.
SUPPLEMENTARY INFORMATION: The Complete applications for a license in Place: Bethesda North Marriott Hotel &
following and all continuing U.S. and the prospective field of use that are Conference Center, 5701 Marinelli Road,
foreign patents/patent applications timely filed in response to this notice North Bethesda, MD 20852.
thereof are the intellectual properties to will be treated as objections to the grant Contact Person: Sanita Bharti, Ph.D.,
be licensed under the prospective of the contemplated exclusive patent Scientific Review Officer, Research Program
amozie on DSK3GDR082PROD with NOTICES1
license. Review Branch, Division of Extramural
agreement to MTTI: HHS Ref. E–150–
Activities, National Cancer Institute, NIH,
2016–1–PCT–01, International Patent Comments and objections submitted 9609 Medical Center Drive, Room 7W122,
Application PCT/US2017/054863 filed to this notice will not be made available Bethesda, MD 20892–9750, 240–276–5909,
October 3, 2017, entitled ‘‘Chemical for public inspection and, to the extent sanitab@mail.nih.gov.
Conjugates of Evans Blue Derivatives permitted by law, will not be released (Catalogue of Federal Domestic Assistance
and Their Use As Radiotherapy And under the Freedom of Information Act, Program Nos. 93.392, Cancer Construction;
Imaging Agents.’’ 5 U.S.C. 552. 93.393, Cancer Cause and Prevention
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Document Created: 2018-07-27 04:06:10
Document Modified: 2018-07-27 04:06:10
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | 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. | |
| FR Citation | 83 FR 35663 |
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