[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]
-----------------------------------------------------------------------
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