[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Notices]
[Pages 84359-84361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28570]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Use of A CD47 
Phosphorodiamidate Morpholino Oligomer for the Treatment, Prevention, 
and Diagnosis Of Cancer

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 January 12, 2021 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 M. Greene, Senior Licensing and Patenting 
Manager at [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

     U.S. Provisional Patent Application No. 60/850,132, filed 
October 6, 2006, now abandoned (HHS Ref. No. E-227-2006-0-US-01);
     U.S. Provisional Patent Application No. 60/864,153, filed 
November 02, 2006, now abandoned (HHS Ref. No. E-227-2006-1-US-01);
     U.S. Provisional Patent Application No. 60/888,754, filed 
February 07, 2007, now
     abandoned (HHS Ref. No. E-227-2006-2-US-01);
     U.S. Provisional Patent Application No. 60/910,549, filed 
April 06, 2007, now abandoned (HHS Ref. No. E-227-2006-3-US-01);
     U.S. Provisional Patent Application No. 60/956,375, filed 
August 16, 2007, now abandoned (HHS Ref. No. E-227-2006-4-US-01);
     PCT Patent Application No. PCT/2007/080647, filed October 
5, 2007, now abandoned (HHS Ref. No. E-227-2006-5-PCT-01);
     U.S. Patent No. 8,236,313, filed April 3, 2009, issued 
August 7, 2012 (HHS Ref. No. E-227-2006-5-US-02);
     Canadian Patent Application No. 2,665,287, October 5, 2007 
(HHS Ref. No. E-227-2006-5-CA-03);
     Australian Patent No. 2007319576, filed October 5, 2007, 
issued May 1, 2014 (HHS Ref. No. E-227-2006-5-AU-04);
     European Patent No. 2076537, filed March 27, 2009, issued 
August 22, 2018 (HHS Ref. No. E-227-2006-5-EP-05);
     U.S. Patent Application No. 13/546,931, filed July 11, 
2012 (HHS Ref. No. E-227-2006-5-US-06);
     U.S. Patent Number 8,557,788, filed July 11, 2012, issued 
October 15, 2013 (HHS Ref. No. E-227-2006-5-US-07);
     European Patent No. 2695896, filed October 5, 2007, issued 
August 22, 2018(HHS Ref. No. E-227-2006-5-EP-08);
     Australian Patent No. 2014201936, filed April 4, 2014, 
issued October 20, 2016 (HHS Ref. No. E-227-2006-5-AU-09);
     U.S. Patent No. 10370439, filed September 29, 2014, issued 
August 6, 2019 (HHS Ref. No. E-227-2006-5-US-10);
     Australian Patent No. 2016238894, filed October 6, 2016, 
issued February 22, 2018 (HHS Ref. No. E-227-2006-5-AU-11);
     Australian Patent No. 2018200921, filed February 8, 2018, 
issued September 24, 2020 (HHS Ref. No. E-227-2006-5-AU-12)

[[Page 84360]]

     European Patent Application No. 18183780.8, filed July 16, 
2018 (HHS Ref. No. E-227-2006-5-EP-13);
     German Patent No. 2076537, issued August 22, 2018, filed 
March 27, 2009 (HHS Ref. No. E-227-2006-5-DE-14);
     French Patent No. 2076537, issued August 22, 2018, filed 
March 27, 2009 (HHS Ref. No. E-227-2006-5-FR-15);
     United Kingdom Patent No. 2076537, issued August 22, 2018, 
filed March 27, 2009 (HHS Ref. No. E-227-2006-5-GB-16);
     German Patent No. 2695896, issued August 22, 2018, filed 
October 5, 2007 (HHS Ref. No. E-227-2006-5-DE-17);
     French Patent No. 2695896, issued August 22, 2018, filed 
October 5, 2007 (HHS Ref. No. E-227-2006-5-FR-18);
     United Kingdom Patent No. 2695896, issued August 22, 2018, 
filed October 5, 2007 (HHS Ref. No. E-227-2006-5-GB-19);
     U.S. Patent Application No. 16/443,415, filed June 17, 
2019 (HHS Ref. No. E-227-2006-5-US-20);
     Australia Patent Application No. 2020230283, filed 
September 10, 2020 Pending (HHS Ref. No. E-227-2006-5-AU-21);
     Provisional Patent Application No. 61/621,994, filed April 
9, 2012, now abandoned (HHS Ref. No. E-086-2012-0-US-01);
     Provisional Patent Application No. 61/735,701, filed 
December 11, 2012, now abandoned (HHS Ref. No. E-086-2012-1-US-01);
     PCT Patent Application No. PCT/US2013/035838, filed April 
9, 2013, now abandoned (HHS Ref. No. E-086-2012-2-PCT-01);
     Australian Patent No. 2013246040, issued March 14, 2019, 
filed April 9, 2013 (HHS Ref. No. E-086-2012-2-AU-02);
     Canadian Patent No. 2869913, issued September 10, 2019, 
filed April 9, 2013 (HHS Ref. No. E-086-2012-2-CA-03);Start Printed 
Page 327
     European Patent No. 2836591, filed April 9, 2013, issued 
June 6, 2018 (HHS Ref. No. E-086-2012-2-EP-04);
     US Patent No. 10407665, issued September 10, 2019, filed 
October 2, 2014 (HHS Ref. No. E-086-2012-2-US-05);
     German Patent No. 2836591, issued June 6, 2018, filed 
April 9, 2013 (HHS Ref. No. E-086-2012-2-DE-07);
     French Patent No. 2836591, issued June 6, 2018, filed 
April 9, 2013 (HHS Ref. No. E-086-2012-2-FR-08);
     United Kingdom Patent No. 2836591, issued June 6, 2018, 
filed April 9, 2013 (HHS Ref. No. E-086-2012-2-GB-09);
     US Patent Application No. 16/521,251, filed July 24, 2019 
(HHS Ref. No. E-086-2012-2-US-10);
     Provisional Patent Application No. 61/086,991, filed 
August 7, 2008, now abandoned (HHS Ref. No. E-153-2008-0-US-01);
     PCT Patent Application No. PCT/US2009/052902, filed August 
5, 2009, now abandoned (HHS Ref. No. E-153-2008-0-PCT-02);
     Australian Patent No. 2009279676, issued July 30, 2015, 
filed August 5, 2009 (HHS Ref. No. E-153-2008-0-AU-03);
     Canadian Patent No. 2732102, issued January 2, 2018, filed 
August 5, 2009 (HHS Ref. No. E-153-2008-0-CA-04);
     European Patent No. 2340034, filed August 5, 2009, issued 
January 27, 2016 (HHS Ref. No. E-153-2008-0-EP-05);
     US Patent No. 8951527, issued February 10, 2015, filed 
February 3, 2011 (HHS Ref. No. E-153-2008-0-US-06);
     German Patent No. 602009036069.8, issued January 27, 2016, 
filed August 5, 2009 (HHS Ref. No. E-153-2008-0-DE-07);
     French Patent No. 2340034, issued January 27, 2016, filed 
August 5, 2009 (HHS Ref. No. E-153-2008-0-FR-08);
     United Kingdom Patent No. 2340034, issued January 27, 
2016, filed August 5, 2009 (HHS Ref. No. E-153-2008-0-GB-09);
     Provisional Patent Application No. 61/779,587, filed March 
13, 2013, now abandoned (HHS Ref. No. E-296-2011-0-US-01);
     PCT Patent Application No. PCT/US2014/025989, filed March 
13, 2014, now abandoned (HHS Ref. No. E-296-2011-0-PCT-02);
     Australian Patent No. 2014244083, issued January 10, 2019, 
filed March 13, 2014, now abandoned (HHS Ref. No. E-296-2011-0-AU-03);
     Canadian Patent Application No. 2905418, filed March 13, 
2014 (HHS Ref. No. E-296-2011-0-CA-04);
     European Patent Application No. 14718255.4, filed March 
13, 2014 (HHS Ref. No. E-296-2011-0-EP-05);
     US Patent Application No. 14/775,428, filed September 11, 
2015 (HHS Ref. No. E-296-2011-0-US-06).
     U.S. Provisional Patent Application No. 62/062,675, filed 
October 10, 2014, now abandoned (HHS Ref. No E-263-2014-0-US-01);
     PCT Patent Application No. PCT/US2015/055029, filed 
October 9, 2015, now abandoned (HHS Ref. No E-263-2014-0-PCT-02);
     Australia Patent Application No. 2015329696, filed October 
9, 2015(HHS Ref. No E-263-2014-0-AU-03);
     Canadian Patent Application No. 2964173, filed October 9, 
2015 (HHS Ref. No. E-263-2014-0-CA-04);
     European Patent No. 3204420, filed October 9, 2015, issued 
September 2, 2020 (HHS Ref. No E-263-2014-0-EP-05);
     U.S. Patent Application No. 15/517,345, filed April 6, 
2017 (HHS Ref. No E-263-2014-0-US-06);
     German Patent No. 3204420, issued September 2, 2020, filed 
October 9, 2015 (HHS Ref. No E-263-2014-0-DE-07);
     French Patent No. 3204420, issued September 2, 2020, filed 
October 9, 2015 (HHS Ref. No E-263-2014-0-FR-08);
     United Kingdom Patent No. 3204420, issued September 2, 
2020, filed October 9, 2015 (HHS Ref. No E-263-2014-0-GB-09).
    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 all of the above Licensed 
Patent Rights for the following: ``The use of the CD47 
phosphorodiamidate morpholino oligomers (PMO, morpholino, Sequence: 5'-
CGTCACAGGCAGGACCCACTGCCCA-3'), in combination with radiotherapy, for 
the treatment, prevention, and diagnosis of cancer.'' For the Licensed 
Patent Rights encompassed by technologies with the HHS. Ref. No. 
starting with E-263-2014, 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 cancer.''
    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

[[Page 84361]]

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 17, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2020-28570 Filed 12-23-20; 8:45 am]
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