[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Notices]
[Pages 39001-39002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Institutes of Health

Prospective Grant of Exclusive Patent License: Lutetium-177 
Radiotherapeutics Against Glioblastoma Multiforme and Small-Cell Lung 
Carcinoma

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 23, 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, 2016..............  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.
E-150-2016-0-SG-07.................  11201809982R.............  November 9, 2018.........  Chemical Conjugates
                                                                                            of Evans Blue
                                                                                            Derivatives and
                                                                                            Their Use as
                                                                                            Radiotherapy and
                                                                                            Imaging Agents.
E-150-2016-1-PCT-01................  PCT/US2017/054863........  October 3, 2017..........  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 Lutetium-177 radiotherapeutics containing RGD-peptide moieties 
targeting integrin [alpha]v[beta]3-expressing glioblastoma multiforme 
and small cell lung cancers.
    The invention pertains to a radiotherapeutic against cancers that 
overexpress integrin [alpha]v[beta]3. RGD peptide-targeted radionuclide 
therapy directed against tumors that express integrin [alpha]v[beta]3 
has proven effective for the treatment of advanced, low- to 
intermediate-grade tumors. The subject radiotherapeutic covered by the 
patent estate includes an RGD peptide (arginylglycylaspartic acid [Arg-
Gly-Asp], linear or cyclical), 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 RGD peptide DOTA 
conjugated radiotherapeutics and potentially toxicity. The EB analog 
conjugated has been shown by the inventors to provide reversible 
albumin binding in vivo and extended half-life in circulation. 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

[[Page 39002]]

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: August 1, 2019.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2019-16965 Filed 8-7-19; 8:45 am]
 BILLING CODE 4140-01-P