Prospective Grant of an Exclusive Patent License: RP2 AAV-Based Gene Human Therapy for Ocular Diseases and Disorders Including XLRP, 36565-36566 [2021-14682]

Download as PDF Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices 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. Name of Committee: National Heart, Lung, and Blood Advisory Council. Date: August 24, 2021. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Laura K. Moen, Ph.D., Director, Division of Extramural Research Activities, National Heart, Lung, and Blood Institute, National Institutes of Health, 6705 Rockledge Drive, Room 206–Q, Bethesda, MD 20892, 301–827–5517, moenl@mail.nih.gov. Information is also available on the Institute’s/Center’s home page: www.nhlbi.nih.gov/meetings/nhlbac/ index.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: July 6, 2021. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–14698 Filed 7–9–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health khammond on DSKJM1Z7X2PROD with NOTICES Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, July 7, 2021, 9:00 a.m. to July 8, 2021, 7:00 p.m., National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on June 10, 2021, FR Doc 2021–12144, 86 FR 30965. This notice is being amended to change the meeting date from July 7–8, 2021 to July 28–29, 2021. The meeting time remains the same. The meeting is closed to the public. VerDate Sep<11>2014 17:26 Jul 09, 2021 Jkt 253001 Dated: July 6, 2021. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–14738 Filed 7–9–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Sleep Disorders Research Advisory Board. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: Sleep Disorders Research Advisory Board. Date: August 5, 2021. Time: 12:00 p.m. to 5:00 p.m. Agenda: The purpose of this meeting is to update the Advisory Board and public stakeholders on the progress of sleep and circadian research activities across NIH, and the activities of professional societies. Place: Virtual-Teleconference and Zoomgov. Telephone Access: 1–666–254–5252 (Meeting ID: 160 375 9848 Passcode: 558748). Virtual Access: Meeting ID: 160 375 9848 Passcode: 558748, https://nih.zoomgov.com/ j/1603759848?pwd=a1ZzMmdSZTJ4WTh OWDBJQlRqbEYvUT09. Contact Person: Marishka Brown, Ph.D., SDRAB Executive Secretary, Director, National Center on Sleep Disorders Research, National Institutes of Health, National Heart, Lung, and Blood Institute, Division of Lung Diseases, 6705 Rockledge Drive, Suite 407B, Bethesda 20892, 301–435–0199, ncsdr@ nih.gov. Any member of the public interested in presenting oral comments to the committee may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee by forwarding their statement to the Contact Person listed on this notice. The statement should include the name, address, PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 36565 telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: www.nhlbi.nih.gov/meetings/index.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: July 6, 2021. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–14699 Filed 7–9–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: RP2 AAV-Based Gene Human Therapy for Ocular Diseases and Disorders Including XLRP AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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 PTC Therapeutics GT, Inc. located in 100 Corporate, Middlesex Business Center, South Plainfield, NJ 07080. 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 July 27, 2021 will be considered. SUMMARY: Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Hiba Alsaffar, Ph.D., Licensing and Patenting Manager at (240)-276–5530; or at Email: hiba.alsaffar@nih.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: Intellectual Property I. United States Provisional Patent Application No. 62/131,661 filed Mar. E:\FR\FM\12JYN1.SGM 12JYN1 khammond on DSKJM1Z7X2PROD with NOTICES 36566 Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices 11, 2015, [HHS Ref. No. E–050–2015–0– US–01]; II. International Patent Application No. PCT/US2016/022072 filed Mar. 11, 2015, [HHS Reference No. E–050–2015– 0–PCT–03]; expired III. Australian National Stage Patent Application No. 2016228751, filed Mar. 11, 2016, [HHS Ref. No. E–050–2015–0– AU–04]; pending IV. Canadian National Stage Patent Application No. 2979229 filed Mar. 11, 2016, [HHS Ref. No. E–050–2015–0– CA–05]; pending V. European national Stage Patent Application No. 1662623.3 filed Oct. 11, 2016, [HHS Ref. No. E–050–2015–0–EP– 06]; issued (validated in DE, FR and GB) VI. U.S. national Stage Patent Application No. 15/556,746 filed Sep. 8, 2017 [HHS Ref. No. E–050–2015–0–US– 08]; issued VII. Japanese National Stage Patent Application No. 2017–547425 filed Sep. 8, 2017 [HHS Ref. No. E–050–2015–0– JP–07]; pending VIII. Divisional European Patent Application No. 20176667.2 filed May 26, 2020 [HHS Ref. No. E–050–2015–0– EP–13]; pending IX. Divisional Japanese Patent Application No. 2020–167984 filed Oct. 2, 2020 [HHS Ref. No. E–050–2015–0– JP–14]; pending 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: ‘‘Development and commercialization of RP2 AAV-based gene human therapy for any ocular disease, disorder or condition, including human X-linked retinitis pigmentosa (XLRP)’’. This technology discloses AdenoAssociated Viral (AAV) vectors comprising nucleotide sequences encoding RP2 or RPGR- ORF 15 transgenes and their use in treating or preventing X-linked forms of retinitis pigmentosa (XLRP). 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 VerDate Sep<11>2014 17:26 Jul 09, 2021 Jkt 253001 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: July 2, 2021. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2021–14682 Filed 7–9–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting 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. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Motor function in healthy and clinical populations. Date: August 3, 2021. Time: 1:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Maribeth Champoux, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3170, MSC 7848, Bethesda, MD 20892, 301–594– 3163, champoum@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Dated: July 6, 2021. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–14697 Filed 7–9–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary & Integrative Health; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council for Complementary and Integrative Health. 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. The meeting will be held as a virtual meeting and is open to the public as indicated below. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The Open Session will be open to the public via NIH Videocast. The URL link to access this meeting is https://videocast.nih.gov. Name of Committee: National Advisory Council for Complementary and Integrative Health. Date: September 10, 2021. Closed: 10:00 a.m. to 11:30 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Democracy 2, 6707 Democracy Boulevard, Bethesda, MD 20817 (Virtual Meeting). Open: 11:40 a.m. to 5:00 p.m. Agenda: A report from the Director of the Center and Other Staff. Place: National Institutes of Health, Democracy 2, 6707 Democracy Boulevard, Bethesda, MD 20817 (Virtual Meeting). Contact Person: Partap Singh Khalsa, Ph.D., DC, Director, Division of Extramural Activities, National Center for Complementary and Integrative Health, National Institutes of Health, 6707 Democracy Blvd., Suite 401, Bethesda, MD 20892–5475, 301–594–3462, khalsap@ mail.nih.gov. Any interested person may file written comments with the committee by forwarding E:\FR\FM\12JYN1.SGM 12JYN1

Agencies

[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36565-36566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14682]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: RP2 AAV-Based 
Gene Human Therapy for Ocular Diseases and Disorders Including XLRP

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 PTC 
Therapeutics GT, Inc. located in 100 Corporate, Middlesex Business 
Center, South Plainfield, NJ 07080.

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 July 27, 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: Hiba Alsaffar, Ph.D., Licensing and Patenting 
Manager at (240)-276-5530; or at Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    I. United States Provisional Patent Application No. 62/131,661 
filed Mar.

[[Page 36566]]

11, 2015, [HHS Ref. No. E-050-2015-0-US-01];
    II. International Patent Application No. PCT/US2016/022072 filed 
Mar. 11, 2015, [HHS Reference No. E-050-2015-0-PCT-03]; expired
    III. Australian National Stage Patent Application No. 2016228751, 
filed Mar. 11, 2016, [HHS Ref. No. E-050-2015-0-AU-04]; pending
    IV. Canadian National Stage Patent Application No. 2979229 filed 
Mar. 11, 2016, [HHS Ref. No. E-050-2015-0-CA-05]; pending
    V. European national Stage Patent Application No. 1662623.3 filed 
Oct. 11, 2016, [HHS Ref. No. E-050-2015-0-EP-06]; issued (validated in 
DE, FR and GB)
    VI. U.S. national Stage Patent Application No. 15/556,746 filed 
Sep. 8, 2017 [HHS Ref. No. E-050-2015-0-US-08]; issued
    VII. Japanese National Stage Patent Application No. 2017-547425 
filed Sep. 8, 2017 [HHS Ref. No. E-050-2015-0-JP-07]; pending
    VIII. Divisional European Patent Application No. 20176667.2 filed 
May 26, 2020 [HHS Ref. No. E-050-2015-0-EP-13]; pending
    IX. Divisional Japanese Patent Application No. 2020-167984 filed 
Oct. 2, 2020 [HHS Ref. No. E-050-2015-0-JP-14]; pending
    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:
    ``Development and commercialization of RP2 AAV-based gene human 
therapy for any ocular disease, disorder or condition, including human 
X-linked retinitis pigmentosa (XLRP)''.
    This technology discloses Adeno-Associated Viral (AAV) vectors 
comprising nucleotide sequences encoding RP2 or RPGR- ORF 15 transgenes 
and their use in treating or preventing X-linked forms of retinitis 
pigmentosa (XLRP).
    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: July 2, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-14682 Filed 7-9-21; 8:45 am]
BILLING CODE 4140-01-P
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