Prospective Grant of an Exclusive Patent License: Gene Therapy for Treatment or Prevention of Niemann-Pick Disease Type C1, Subject to Existing Three Non-Exclusive Licenses, 43246 [2020-15342]

Download as PDF 43246 Federal Register / Vol. 85, No. 137 / Thursday, July 16, 2020 / Notices HISTORY: V. European Application 16717228.7 filed November 8, 2017, issued as EP 3280451, validated in Italy, Spain, France, UK, and Germany (HHS Reference No.: E–185–2014–0–EP–06). None. [FR Doc. 2020–15380 Filed 7–15–20; 8:45 am] BILLING CODE 4150–28–P Group B, HHS Reference No.: E–100– 2017–0: ‘‘Codon-Optimized Human NPC1 Genes for the Treatment of Niemann-Pick Type C1 Deficiency and Related Conditions’’ DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Gene Therapy for Treatment or Prevention of NiemannPick Disease Type C1, Subject to Existing Three Non-Exclusive Licenses National Institutes of Health, Health and Human Services (HHS). ACTION: Notice. AGENCY: The National Human Genome Research Institute is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the United States, European and Canadian Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to AveXis, Inc., located in Bannockburn, Illinois, USA. DATES: Only written comments and/or applications for a license which are received by the National Human Genome Research Institute’s Technology Transfer Office on or before July 31, 2020 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Anna Solowiej, Ph.D., J.D., Senior Licensing and Patenting Manager, NHGRI Technology Transfer Office, 6700B Rockledge Drive, Suite 3100, Bethesda, MD 20817 (for business mail); Telephone (301) 435–7791; Email: anna.solowiej@nih.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Intellectual Property Group A, HHS Reference No.: E–185– 2014–0: ‘‘Viral Gene Therapy as Treatment for Cholesterol Storage Disease or Disorder’’ I. U.S. Provisional Application 62/ 144,702, filed April 8, 2015, expired (HHS Reference No.: E–185–2014–0– US–01). II. PCT Application PCT/US2016/ 026524, filed April 7, 2016, expired (HHS Reference No.: E–185–2014–0– PCT–02). III. U.S. Application 15/565,065, filed October 6, 2017 (HHS Reference No.: E– 185–2014–0–US–04). IV. Canadian Application 2,982,129, filed October 6, 2017 (HHS Reference No.: E–185–2014–0–CA–05). VerDate Sep<11>2014 17:43 Jul 15, 2020 Jkt 250001 I. U.S. Provisional Application U.S. 62/522,677, filed June 20, 2017, expired (HHS Reference No.: E–100–2017–0– US–01). II. PCT Application PCT/US2018/ 038584, filed June 20, 2018, expired (HHS Reference No.: E–100–2017–0– PCT–02). III. U.S. Application U.S. 16/623,863 filed December 19, 2019 (HHS Reference No.: E–100–2017–0–US–05). IV. Canadian Application 3,068,010, filed December 19, 2019 (E–100–2017– 0–CA–03). V. European Application 18740403.3 filed January 20, 2020 (HHS Reference No.: E–100–2017–0–EP–04). The patent rights in these inventions have been assigned or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide and in fields of use that may be limited to manufacture and commercialization of pharmaceutical products for the treatment and/or prevention of Niemann Pick disease, Type C1 (NPC1) using gene therapy in humans that incorporate the Licensed Product(s), in combination with AAV9, subject to three existing non-exclusive licenses for this technology. Above listed patent portfolio cover inventions directed to gene therapy and specifically, expression vectors and therapeutic methods of using such vectors in the treatment of NiemannPick Disease Type C1. 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. The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Human Genome Research 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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 7, 2020 Claire T. Driscoll, Director, Technology Transfer Office, National Human Genome Research Institute. [FR Doc. 2020–15342 Filed 7–15–20; 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: Gene Therapy for Ocular Disease National Institutes of Health, Health and Human Services (HHS). ACTION: Notice. AGENCY: The National Eye Institute, the National Institute on Deafness and Other Communication Disorders, and the National Heart, Lung, and Blood Institute, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an exclusive patent license to VegaVect, Inc., a startup company spun-off from the University of Pittsburgh Medical Center Enterprises and incorporated as a C corporation under the laws of the state of Delaware, to practice the inventions covered by the patent estate listed in the SUPPLEMENTARY INFORMATION section of this notice. This is a second notice intended to apprise the public of a change in prospective licensee of the subject intellectual property rights in the stated field of use from a first notice: Prospective Grant of An Exclusive Patent License: Gene Therapy for Ocular Disease, published in the Federal Register on November 26, 2019. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center (representing the National Eye Institute and the National Heart, Lung, and Blood Institute (representing the National Institute on Deafness and Other Communication Disorders) on or before July 31, 2020 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and SUMMARY: E:\FR\FM\16JYN1.SGM 16JYN1

Agencies

[Federal Register Volume 85, Number 137 (Thursday, July 16, 2020)]
[Notices]
[Page 43246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15342]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Gene Therapy 
for Treatment or Prevention of Niemann-Pick Disease Type C1, Subject to 
Existing Three Non-Exclusive Licenses

AGENCY: National Institutes of Health, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The National Human Genome Research Institute is contemplating 
the grant of an Exclusive Patent License to practice the inventions 
embodied in the United States, European and Canadian Applications 
listed in the SUPPLEMENTARY INFORMATION section of this notice to 
AveXis, Inc., located in Bannockburn, Illinois, USA.

DATES: Only written comments and/or applications for a license which 
are received by the National Human Genome Research Institute's 
Technology Transfer Office on or before July 31, 2020 will be 
considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Anna Solowiej, Ph.D., J.D., Senior Licensing and 
Patenting Manager, NHGRI Technology Transfer Office, 6700B Rockledge 
Drive, Suite 3100, Bethesda, MD 20817 (for business mail); Telephone 
(301) 435-7791; Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

Group A, HHS Reference No.: E-185-2014-0: ``Viral Gene Therapy as 
Treatment for Cholesterol Storage Disease or Disorder''

    I. U.S. Provisional Application 62/144,702, filed April 8, 2015, 
expired (HHS Reference No.: E-185-2014-0-US-01).
    II. PCT Application PCT/US2016/026524, filed April 7, 2016, expired 
(HHS Reference No.: E-185-2014-0-PCT-02).
    III. U.S. Application 15/565,065, filed October 6, 2017 (HHS 
Reference No.: E-185-2014-0-US-04).
    IV. Canadian Application 2,982,129, filed October 6, 2017 (HHS 
Reference No.: E-185-2014-0-CA-05).
    V. European Application 16717228.7 filed November 8, 2017, issued 
as EP 3280451, validated in Italy, Spain, France, UK, and Germany (HHS 
Reference No.: E-185-2014-0-EP-06).

Group B, HHS Reference No.: E-100-2017-0: ``Codon-Optimized Human NPC1 
Genes for the Treatment of Niemann-Pick Type C1 Deficiency and Related 
Conditions''

    I. U.S. Provisional Application U.S. 62/522,677, filed June 20, 
2017, expired (HHS Reference No.: E-100-2017-0-US-01).
    II. PCT Application PCT/US2018/038584, filed June 20, 2018, expired 
(HHS Reference No.: E-100-2017-0-PCT-02).
    III. U.S. Application U.S. 16/623,863 filed December 19, 2019 (HHS 
Reference No.: E-100-2017-0-US-05).
    IV. Canadian Application 3,068,010, filed December 19, 2019 (E-100-
2017-0-CA-03).
    V. European Application 18740403.3 filed January 20, 2020 (HHS 
Reference No.: E-100-2017-0-EP-04).
    The patent rights in these inventions have been assigned or 
exclusively licensed to the Government of the United States of America.
    The prospective exclusive license territory may be worldwide and in 
fields of use that may be limited to manufacture and commercialization 
of pharmaceutical products for the treatment and/or prevention of 
Niemann Pick disease, Type C1 (NPC1) using gene therapy in humans that 
incorporate the Licensed Product(s), in combination with AAV9, subject 
to three existing non-exclusive licenses for this technology.
    Above listed patent portfolio cover inventions directed to gene 
therapy and specifically, expression vectors and therapeutic methods of 
using such vectors in the treatment of Niemann-Pick Disease Type C1.
    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. 
The prospective exclusive license may be granted unless within fifteen 
(15) days from the date of this published notice, the National Human 
Genome Research 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 7, 2020
Claire T. Driscoll,
Director, Technology Transfer Office, National Human Genome Research 
Institute.
[FR Doc. 2020-15342 Filed 7-15-20; 8:45 am]
BILLING CODE 4140-01-P

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