[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Pages 1764-1765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00909]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Use of the CD47 
Phosphorodiamidate Morpholino Oligomers for the Treatment, Prevention, 
and Diagnosis of Solid Tumors

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the Patents and Patent Applications listed in 
the Supplementary Information section of this notice to Morphiex 
Biotherapeutics (``Morphiex'') located in Boston, MA.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before February 20, 2019 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: Jaime Greene, Senior Licensing and Patenting 
Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 
1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, 
MD 20850-9702 Telephone: (240)-276-5530; Facsimile: (240)-276-5504 
Email: [email protected].

SUPPLEMENTARY INFORMATION: This is in reference to a previous notice 83 
FR 22501, which was a Prospective Grant of an Exclusive Patent License 
to Morphiex for the field of use ``the use of the CD47 
phosphorodiamidate morpholino oligomers (PMO, morpholino, Sequence: 5'-
CGTCACAGGCAGGACCCACTGCCCA-3') for the treatment, prevention, and 
diagnosis of hematological cancers (e.g. lymphoma, leukemia, multiple 
myeloma), excluding uses in combination with radiotherapy.''

Intellectual Property

    1. U.S. Provisional Patent Application No. 60/850,132, filed 
October 6, 2006, now abandoned (HHS Ref. No. E-227-2006/0-US-01);
    2. U.S. Provisional Patent Application No. 60/864,153, filed 
November 02,

[[Page 1765]]

2006, now abandoned (HHS Ref. No. E-227-2006/1-US-01);
    3. U.S. Provisional Patent Application No. 60/888,754, filed 
February 07, 2007, now abandoned (HHS Ref. No. E-227-2006/2-US-01);
    4. U.S. Provisional Patent Application No. 60/910,549, filed April 
06, 2007, now abandoned (HHS Ref. No. E-227-2006/3-US-01);
    5. U.S. Provisional Patent Application No. 60/956,375, filed August 
16, 2007, now abandoned (HHS Ref. No. E-227-2006/4-US-01);
    6. PCT Patent Application No. PCT/2007/080647, filed October 5, 
2007, now abandoned (HHS Ref. No. E-227-2006/5-PCT-01);
    7. U.S. Patent No. 8,236,313, filed April 3, 2009, Issued August 7, 
2012 (HHS Ref. No. E-227-2006/5-US-02);
    8. Canadian Patent Application No. 2,665,287, October 5, 2007 (HHS 
Ref. No. E-227-2006/5-CA-03);
    9. Australian Patent No. 2007319576, filed October 5, 2007, Issued 
May 1, 2014 (HHS Ref. No. E-227-2006/5-AU-04);
    10. European Patent Application No. 07868382.8, filed March 27, 
2009 (HHS Ref. No. E-227-2006/5-EP-05);
    11. U.S. Patent Application No. 13/546,931, filed July 11, 2012 
(HHS Ref. No. E-227-2006/5-US-06);
    12. U.S. Patent Number 8,557,788, filed July 11, 2012, Issued 
October 15, 2013 (HHS Ref. No. E-227-2006/5-US-07);
    13. European Patent Application No. 13180563.2, filed October 5, 
2007 (HHS Ref. No. E-227-2006/5-EP-08);
    14. Australian Patent No. 2014201936, filed October 5, 2007, Issued 
October 20, 2016 (HHS Ref. No. E-227-2006/5-AU-09);
    15. U.S. Patent Application No. 14/500,861, filed September 29, 
2014 (HHS Ref. No. E-227-2006/5-US-10);
    16. Australian Patent No. 2016238894, filed October 6, 2016, Issued 
February 22, 2018 (HHS Ref. No. E-227-2006/5-AU-11); and
    17. Australian Patent Application No. 2018200921, filed February 8, 
2018 (HHS Ref. No. E-227-2006/5-AU-12).
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to: ``The use of the CD47 
phosphorodiamidate morpholino oligomers (PMO, morpholino, Sequence: 5'-
CGTCACAGGCAGGACCCACTGCCCA-3') for the treatment, prevention, and 
diagnosis of solid tumors, excluding uses in combination with 
radiotherapy.''
    This technology concerns CD47, originally named integrin-associated 
protein, which is a receptor for thrombospondin-1 (TSP1), a major 
component of platelet [alpha]-granules from which it is secreted on 
platelet activation. A number of important roles for CD47 have been 
defined in regulating the migration, proliferation, and survival of 
vascular cells, and in regulation of innate and adaptive immunity. 
Nitric Oxide (NO) plays an important role as a major intrinsic 
vasodilator, and it increases blood flow to tissues and organs. 
Disruption of this process leads to peripheral vascular disease, 
ischemic heart disease, stroke, diabetes and many more significant 
diseases. The inventors have discovered that TSP1 blocks the beneficial 
effects of NO and prevents it from dilating blood vessels and 
increasing blood flow to organs and tissues. Additionally, they 
discovered that this regulation requires TSP1 interaction with its cell 
receptor, CD47. These inventors have also found that blocking TSP1-CD47 
interaction through the use of antisense morpholino oligonucleotides, 
peptides or antibodies have several therapeutic benefits including the 
treatment of cancer.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Cancer Institute 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.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: December 18, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-00909 Filed 2-4-19; 8:45 am]
BILLING CODE 4140-01-P