[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.

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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