[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Notices]
[Pages 57743-57744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23481]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: The Development 
of an Anti-GPC3 Radionuclide Immunoconjugate for the Treatment of GPC3-
Expressing Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 Xsto 
BioSciences, Inc. (Xsto), located in San Carlos, California.

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 November 12, 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: David A. Lambertson, Ph.D., 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: 

Intellectual Property

    U.S. Provisional Patent Application 61/477,020 entitled ``Human 
Monoclonal Antibody Specific for Glypican-3 And Use Thereof'' [HHS Ref. 
E-130-2011-0-US-01], PCT Patent Application PCT/US2012/034186 entitled 
``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' 
[HHS Ref. E-130-2011-0-PCT-02], Chinese Patent 201280029201.3 entitled 
``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' 
[HHS Ref. E-130-2011-0-CN-03], European Patent 2699603 entitled ``Human 
Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS 
Ref. E-130-2011-0-EP-04], and validated in France [HHS Ref. E-130-2011-
0-FR-09], Germany [HHS Ref. E-130-2011-0-DE-08] and the United Kingdom 
[HHS Ref. E-130-2011-0-GB-10] and lodged in Hong Kong [HHS Ref. E-130-
2011-0-HK-11], United States Patent 9,206,257 entitled ``Human 
Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS 
Ref. E-130-2011-0-US-05], United States Patent 9,394,364, entitled 
``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' 
[HHS Ref. E-130-2011-0-US-06], European Patent 2998320 entitled ``Human 
Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS 
Ref. E-130-2011-0-EP-07], and validated in France [HHS Ref. E-130-2011-
0-FR-23], Germany [HHS Ref. E-130-2011-0-DE-22] and the United Kingdom 
[HHS Ref. E-130-2011-0-GB-24], United States Patent 9,932,406 entitled 
``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' 
[HHS Ref. E-130-2011-0-US-12], Chinese Patent Application 
201610290837.3 entitled ``Human Monoclonal Antibodies Specific for 
Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011-0-CN-13], European 
Patent 3070104 entitled ``Human Monoclonal Antibodies Specific for 
Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011-0-EP-14], and 
validated in France [HHS Ref. E-130-2011-0-FR-18], Germany [HHS Ref. E-
130-2011-0-DE-16], the United Kingdom [HHS Ref. E-130-2011-0-GB-19], 
Italy [HHS Ref. E-130-2011-0-IT-20] and Spain [HHS Ref. E-130-2011-0-
ES-17] and lodged in Hong Kong [HHS Ref. E-130-2011-0-HK-15], United 
States Patent Application 15/843,256 entitled ``Human Monoclonal 
Antibodies Specific for Glypican-3 And Use

[[Page 57744]]

Thereof'' [HHS Ref. E-130-2011-0-US-21], and U.S. and foreign patent 
applications claiming priority to the aforementioned applications.
    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
    (I) The development and commercialization of glypican-3 (GPC3) 
antibody-based radionuclide conjugates comprising of at least:
    a. The complementary determining region (CDR) sequences of the 
anti-GPC3 antibody known as HN3, and
    b. A radionuclide, including but not limited to an alpha, beta, 
positron, gamma or auger emitting radionuclide, for the treatment of 
GPC3-expressing cancers.
    (II) The development of an FDA-approved in vivo 
radiopharmaceutical, using a binder having the CDR sequences of the 
anti-GPC3 antibody known as HN3, for the diagnosis and monitoring of 
GPC3-expressing cancers.
    The licensed field of use excludes any (a) non-specified 
immunoconjugates, including, but not limited to, chimeric antigen 
receptors (CARs) and variants thereof, immunotoxins, and antibody drug 
conjugates, and (b) unconjugated antibodies.
    This technology discloses monoclonal antibodies that are specific 
for the cell surface domain of GPC3. These antibodies can potentially 
be used for the treatment of GPC3-expressing cancers such as HCC. In 
the subject situation, the antibodies can be used in conjunction to 
target a radionuclide specifically to GPC3-expressing cells, leading to 
the selective destruction of the cancerous cells.
    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: October 23, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-23481 Filed 10-25-19; 8:45 am]
 BILLING CODE 4140-01-P