Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics for Depression and Bipolar Disorder, 19090-19091 [2019-09099]

Download as PDF 19090 Federal Register / Vol. 84, No. 86 / Friday, May 3, 2019 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meeting National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of General Medical Sciences Special Emphasis Panel; Review of Centers of Biomedical Research Excellence (COBRE) P20 Applications. Date: June 27–28, 2019. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: The Doubletree Hotel, 8120 Wisconsin Avenue, Bethesda, MD 20814, 301–664–7305. Contact Person: Manas Chattopadhyay, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, Building 45, Room 3An12N, 45 Center Drive, Bethesda, MD 20892, 301–827– 5320, manasc@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) amozie on DSK9F9SC42PROD with NOTICES Dated: April 30, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–09097 Filed 5–2–19; 8:45 am] BILLING CODE 4140–01–P Name of Committee: National Cancer Institute Special Emphasis Panel; ImmunoOncology Translation Network. Date: June 13–14, 2019. Time: 8:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites Baltimore Inner Harbor, 222 Saint Paul Place, Room Dorie, Baltimore, MD 21202. Contact Person: Eun Ah Cho, Ph.D. Scientific Review Officer Research Programs Review Branch Division of Extramural Activities National Cancer Institute, NIH 9609 Medical Center Drive, Room 7W124 Bethesda, MD 20892–9750 240–276–6342 choe@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: April 30, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–09098 Filed 5–2–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics for Depression and Bipolar Disorder AGENCY: National Institutes of Health, HHS. VerDate Sep<11>2014 16:41 May 02, 2019 Jkt 247001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 ACTION: Notice. The National Institute of Mental Health (NIMH), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Repurposed Therapeutics, Inc. (‘‘Repurposed Therapeutics’’) located in Tampa, Florida, 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 NIMH Technology Transfer Office May 20, 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: Jennifer Wong, MS, Technology Development Coordinator, NIMH Technology Transfer Office, 35A Convent Drive, GE–400, Bethesda, MD 20892, phone number 301–480–4821, or wongje@mail.nih.gov. SUPPLEMENTARY INFORMATION: The following patents/patent applications are the intellectual properties to be licensed under the prospective agreement to Repurposed Therapeutics: U.S. Patent 8,859,585, issued October 14, 2014, entitled ‘‘Scopolamine for the Treatment of Depression and Anxiety’’ [HHS Ref. No. E–175–2004–0–US–01]; Patent Cooperation Treaty (PCT) Application PCT/US2006/019335 filed May 18, 2006, entitled ‘‘Scopolamine for the Treatment of Depression and Anxiety’’ [HHS Ref. No. E–175–2004–0– PCT–02]; European Patent 1896025, issued December 28, 2011 entitled ‘‘Scopolamine for the Treatment of Depression and Anxiety’’ [HHS Ref. No. E–175–2004–0–EP–03]; Canadian Patent 2610025, issued July 22, 2014, entitled ‘‘Scopolamine for the Treatment of Depression and Anxiety’’ [HHS Ref. No. E–175–2004–0–CA–04]; German Patent 602006026717.7, issued December 28, 2011, entitled ‘‘Scopolamine for the Treatment of Depression and Anxiety’’ [HHS Ref. No. E–175–2004–0–DE–07]; French Patent 1896025, issued December 28, 2011, entitled ‘‘Scopolamine for the Treatment of Depression and Anxiety’’ [HHS Ref. No. E–175–2004–0–FR–08]; UK Patent 1896025, issued December 28, 2011, entitled ‘‘Scopolamine for the Treatment of Depression and Anxiety’’ [HHS Ref. No. E–175–2004–0–GB–09], and US Patent No. Patent 9,707,220, issued July 18, 2017, entitled ‘‘Scopolamine for the Treatment of Depression and Anxiety’’ SUMMARY: E:\FR\FM\03MYN1.SGM 03MYN1 Federal Register / Vol. 84, No. 86 / Friday, May 3, 2019 / Notices [HHS Ref. No. E–175–2004–0–US–10]. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective patent license may be worldwide, and the field of use may be limited to intranasal and intravenous scopolamine therapeutics for depression and bipolar disorder. The invention pertains to the use of scopolamine for the treatment of depression and other indications associated with depression, such as the depressive phase of bipolar disorder. Although scopolamine has been employed in the treatment of nausea and motion sickness, the suitability of scopolamine for treating depression was unrecognized prior to this invention. Current depression treatments can be ineffective in large percentage of patients and typically do not take effect until four weeks after administration. In contrast, treatment with scopolamine suggests it may be effective either as a stand-alone treatment or as a treatment for patients who are unresponsive to currently available drugs. 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 published notice, the NIMH 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. Jennifer S. Wong, Technology Development Coordinator, Technology Transfer Office, National Institute of Mental Health. amozie on DSK9F9SC42PROD with NOTICES [FR Doc. 2019–09099 Filed 5–2–19; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 16:41 May 02, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments AGENCY: National Institutes of Health, HHS. ACTION: Notice. This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public and registration is requested for both attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at https:// ntp.niehs.nih.gov/go/165. DATES: Meeting: Scheduled for June 17, 2019 at 8:30 a.m. to adjournment on June 18, 2019 at approximately 2:30 p.m. Eastern Daylight Time (EDT). Written Public Comment Submissions: Deadline is June 10, 2019. Registration for Oral Comments: Deadline is June 10, 2019. Registration to Attend Meeting Inperson or to View Webcast: Deadline is June 18, 2019. Registration to view the meeting via the webcast is required. ADDRESSES: Meeting Location: Rodbell Auditorium, Rall Building, National Institute of Environmental Health Sciences (NIEHS), 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. Meeting Webpage: The preliminary agenda, registration, and other meeting materials are at https://ntp.niehs.nih.gov/ go/165. Webcast: The URL for viewing the meeting webcast will be provided to registrants. SUMMARY: Dr. Mary Wolfe, Designated Federal Official for the BSC, Office of Liaison, Policy and Review, Division of NTP, NIEHS, P.O. Box 12233, K2–03, Research Triangle Park, NC 27709. Phone: 984– 287–3209, Fax: 301–451–5759, Email: wolfe@niehs.nih.gov. Hand Deliver/ Courier address: 530 Davis Drive, Room K2130, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: The BSC will provide input to the NTP on FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 19091 programmatic activities and issues. The agenda on June 17 includes an update on status of NTP’s strategic realignment with presentations by partner agencies on activities in support of NTP, as well as NTP’s 40th anniversary recognition. On June 18, talks will focus on the new NTP Health Effects Innovation programs and reports on several meetings. Please see the preliminary agenda for information about the specific presentations. The preliminary agenda, roster of BSC members, background materials, public comments, and any additional information, when available, will be posted on the BSC meeting website (https://ntp.niehs.nih.gov/go/ 165) or may be requested in hardcopy from the Designated Federal Official for the BSC. Following the meeting, summary minutes will be prepared and made available on the BSC meeting website. Meeting Attendance Registration: The meeting is open to the public with time set aside for oral public comment; inperson attendance at the NIEHS is limited by the space available (∼100 attendees). Registration for in-person attendance is on a first-come, firstserved basis, and registrants will be assigned a number in their confirmation email. After the first 100 registrants, persons will be placed on a wait list and notified should an opening become available. Registration to attend the meeting in-in person or view the webcast is by June 18, 2019 at https:// ntp.niehs.nih.gov/go/165. Registration is required to view the webcast; the URL for the webcast will be provided in the email confirming registration. Visitor and security information for those attending in-person is available at niehs.nih.gov/about/visiting/index.cfm. Individuals with disabilities who need accommodation to participate in this event should contact Ms. Robbin Guy at phone: (984) 287–3136 or email: guyr2@ niehs.nih.gov. TTY users should contact the Federal TTY Relay Service at 800– 877–8339. Requests should be made at least five business days in advance of the event. Written Public Comments: NTP invites written public comments. Guidelines for public comments are available at https://ntp.niehs.nih.gov/ ntp/about_ntp/guidelines_public_ comments_508.pdf. The deadline for submission of written comments is June 10, 2019. Written public comments should be submitted through the meeting website. Persons submitting written comments should include name, affiliation, mailing address, phone, email, and sponsoring organization (if any). Written comments received in response to this E:\FR\FM\03MYN1.SGM 03MYN1

Agencies

[Federal Register Volume 84, Number 86 (Friday, May 3, 2019)]
[Notices]
[Pages 19090-19091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09099]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Scopolamine 
Therapeutics for Depression and Bipolar Disorder

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Institute of Mental Health (NIMH), National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an exclusive patent license to Repurposed 
Therapeutics, Inc. (``Repurposed Therapeutics'') located in Tampa, 
Florida, 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 NIMH Technology Transfer Office May 20, 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: Jennifer Wong, MS, Technology Development 
Coordinator, NIMH Technology Transfer Office, 35A Convent Drive, GE-
400, Bethesda, MD 20892, phone number 301-480-4821, or 
[email protected].

SUPPLEMENTARY INFORMATION: The following patents/patent applications 
are the intellectual properties to be licensed under the prospective 
agreement to Repurposed Therapeutics: U.S. Patent 8,859,585, issued 
October 14, 2014, entitled ``Scopolamine for the Treatment of 
Depression and Anxiety'' [HHS Ref. No. E-175-2004-0-US-01]; Patent 
Cooperation Treaty (PCT) Application PCT/US2006/019335 filed May 18, 
2006, entitled ``Scopolamine for the Treatment of Depression and 
Anxiety'' [HHS Ref. No. E-175-2004-0-PCT-02]; European Patent 1896025, 
issued December 28, 2011 entitled ``Scopolamine for the Treatment of 
Depression and Anxiety'' [HHS Ref. No. E-175-2004-0-EP-03]; Canadian 
Patent 2610025, issued July 22, 2014, entitled ``Scopolamine for the 
Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004-0-CA-
04]; German Patent 602006026717.7, issued December 28, 2011, entitled 
``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. 
No. E-175-2004-0-DE-07]; French Patent 1896025, issued December 28, 
2011, entitled ``Scopolamine for the Treatment of Depression and 
Anxiety'' [HHS Ref. No. E-175-2004-0-FR-08]; UK Patent 1896025, issued 
December 28, 2011, entitled ``Scopolamine for the Treatment of 
Depression and Anxiety'' [HHS Ref. No. E-175-2004-0-GB-09], and US 
Patent No. Patent 9,707,220, issued July 18, 2017, entitled 
``Scopolamine for the Treatment of Depression and Anxiety''

[[Page 19091]]

[HHS Ref. No. E-175-2004-0-US-10]. The patent rights in these 
inventions have been assigned to the Government of the United States of 
America.
    The prospective patent license may be worldwide, and the field of 
use may be limited to intranasal and intravenous scopolamine 
therapeutics for depression and bipolar disorder.
    The invention pertains to the use of scopolamine for the treatment 
of depression and other indications associated with depression, such as 
the depressive phase of bipolar disorder. Although scopolamine has been 
employed in the treatment of nausea and motion sickness, the 
suitability of scopolamine for treating depression was unrecognized 
prior to this invention. Current depression treatments can be 
ineffective in large percentage of patients and typically do not take 
effect until four weeks after administration. In contrast, treatment 
with scopolamine suggests it may be effective either as a stand-alone 
treatment or as a treatment for patients who are unresponsive to 
currently available drugs.
    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 published notice, the NIMH 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.

Jennifer S. Wong,
Technology Development Coordinator, Technology Transfer Office, 
National Institute of Mental Health.
[FR Doc. 2019-09099 Filed 5-2-19; 8:45 am]
BILLING CODE 4140-01-P

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