Prospective Grant of Exclusive Patent License: Antibody-Based Therapeutics and Chimeric Antigen Receptors Targeting Glypican-2, 4332 [2020-01154]

Download as PDF 4332 Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Antibody-Based Therapeutics and Chimeric Antigen Receptors Targeting Glypican-2 AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Stanford University, (‘‘Stanford’’), a non-profit university located in California, in its rights to the inventions and patents listed in the SUPPLEMENTARY INFORMATION section of this notice. DATES: Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center February 10, 2020 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: Rose M. Freel, Ph.D., Senior Licensing and Patenting Manager, NCI Technology Transfer Center, 8490 Progress Drive, Suite 400, Frederick MD 21701 (for business mail), Telephone: (301) 624–8775; Facsimile: (301) 631– 3027; Email: rose.freel@nih.gov. 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 Stanford: United States Provisional Patent Application No. 62/ 844,695, filed May 7, 2019 and entitled ‘‘CHIMERIC ANTIGEN RECEPTORS TARGETING GLYCIPAN–2’’ [HHS Reference No. E–064–2019/0–US–01]. The patent rights in these inventions have been assigned to the Government of the United States of America, Stanford University, and Children’s Hospital of Philadelphia. The prospective patent license will be for the purpose of consolidating the patent rights to Stanford, one of the co-owners of said rights, for commercial development and marketing. Consolidation of these co-owned rights is intended to expedite development of the invention, consistent with the goals of the Bayh-Dole Act codified as 35 U.S.C. 200–212. The prospective patent license will be worldwide, exclusive, and may be lotter on DSKBCFDHB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:03 Jan 23, 2020 Jkt 250001 limited to those fields of use commensurate in scope with the patent rights. It will be sublicensable, and any sublicenses granted by Stanford will be subject to the provisions of 37 CFR part 401 and 404. The invention pertains to novel antibody binders and chimeric antigen receptors (CARs) that target glypican-2 (GPC–2), a cell surface heparin sulfate proteoglycan with very restricted expression in normal tissue but with expression on many hard-to-treat pediatric and adult solid tumors such as glioblastoma, small cell lung cancer, uterine carcinoma, neuroblastoma, and medulloblastoma. Based on current available data, the intended use for the invention is as a therapeutic for the treatment of GPC–2 expressing solid tumors. This notice is made pursuant to 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent license will include terms for the sharing of royalty income with NCI from commercial sublicenses of the patent rights and may be granted unless within fifteen (15) days from the date of this published notice the NCI 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 that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent license. 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 from 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: January 15, 2020. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2020–01154 Filed 1–23–20; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. ADDRESSES: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: David Sharlip, Office of Administrative and Management Analysis Services, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-tollfree number (301) 827–6361, or Email your request, including your address to: sharlipd@mail.nih.gov. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on November 19, 2019, pages 63884–5 (84 FR 63884) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Library of Medicine (NLM), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. In compliance with Section 3507(a)(1)(D) of the Paperwork SUMMARY: E:\FR\FM\24JAN1.SGM 24JAN1

Agencies

[Federal Register Volume 85, Number 16 (Friday, January 24, 2020)]
[Notices]
[Page 4332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01154]



[[Page 4332]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Antibody-Based 
Therapeutics and Chimeric Antigen Receptors Targeting Glypican-2

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Cancer Institute (NCI), National Institutes of 
Health, Department of Health and Human Services, is contemplating the 
grant of an exclusive, sublicensable patent license to Stanford 
University, (``Stanford''), a non-profit university located in 
California, in its rights to the inventions and patents listed in the 
SUPPLEMENTARY INFORMATION section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NCI Technology Transfer Center February 10, 2020 
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: Rose M. Freel, Ph.D., Senior Licensing and 
Patenting Manager, NCI Technology Transfer Center, 8490 Progress Drive, 
Suite 400, Frederick MD 21701 (for business mail), Telephone: (301) 
624-8775; Facsimile: (301) 631-3027; Email: [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 Stanford: 
United States Provisional Patent Application No. 62/844,695, filed May 
7, 2019 and entitled ``CHIMERIC ANTIGEN RECEPTORS TARGETING GLYCIPAN-
2'' [HHS Reference No. E-064-2019/0-US-01].
    The patent rights in these inventions have been assigned to the 
Government of the United States of America, Stanford University, and 
Children's Hospital of Philadelphia. The prospective patent license 
will be for the purpose of consolidating the patent rights to Stanford, 
one of the co-owners of said rights, for commercial development and 
marketing. Consolidation of these co-owned rights is intended to 
expedite development of the invention, consistent with the goals of the 
Bayh-Dole Act codified as 35 U.S.C. 200-212.
    The prospective patent license will be worldwide, exclusive, and 
may be limited to those fields of use commensurate in scope with the 
patent rights. It will be sublicensable, and any sublicenses granted by 
Stanford will be subject to the provisions of 37 CFR part 401 and 404.
    The invention pertains to novel antibody binders and chimeric 
antigen receptors (CARs) that target glypican-2 (GPC-2), a cell surface 
heparin sulfate proteoglycan with very restricted expression in normal 
tissue but with expression on many hard-to-treat pediatric and adult 
solid tumors such as glioblastoma, small cell lung cancer, uterine 
carcinoma, neuroblastoma, and medulloblastoma. Based on current 
available data, the intended use for the invention is as a therapeutic 
for the treatment of GPC-2 expressing solid tumors.
    This notice is made pursuant to 35 U.S.C. 209 and 37 CFR part 404. 
The prospective exclusive patent license will include terms for the 
sharing of royalty income with NCI from commercial sublicenses of the 
patent rights and may be granted unless within fifteen (15) days from 
the date of this published notice the NCI 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 that are timely filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive patent license. 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 from these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. Sec.  552.

    Dated: January 15, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2020-01154 Filed 1-23-20; 8:45 am]
BILLING CODE 4140-01-P
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