Document ID: FDA-2020-N-1992-0001
Agency: fda
Document Type: Notice
Title: Prospective Grant of an Exclusive Patent License: Field-Deployable Mass Spectrometer Diagnostic for SARS, SARS–CoV–2 and Other Viruses, Bacteria and Bacterial Serovar, and Drug Impurities
Posted Date: 2020-11-13T05:00Z

[Federal Register Volume 85, Number 220 (Friday, November 13, 2020)]
[Notices]
[Page 72672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25142]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1992]

Prospective Grant of an Exclusive Patent License: Field-
Deployable Mass Spectrometer Diagnostic for SARS, SARS-CoV-2 and Other 
Viruses, Bacteria and Bacterial Serovar, and Drug Impurities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is contemplating the 
grant of an Exclusive Patent License to practice the invention embodied 
in the U.S. Patent listed in the Supplementary Information section of 
this notice to Advion, Inc. located in Ithaca, New York.

DATES: Only written comments and/or applications for a license which 
are received by the Food and Drug Administration's Technology Transfer 
Program on or before November 30, 2020 will be considered.

ADDRESSES: Inquiries and comments relating to the contemplated 
Exclusive Patent License should be directed to: Ken Millburne, Food and 
Drug Administration Technology Transfer Program, Bldg. 1, Rm. 4213, 
Silver Spring, MD 20993, 240-478-1662; email: 
Kenneth.millburne@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Intellectual Property

    FDA Reference No.: E-2011-021: ``Direct Impact Ionization (DII) 
Mass Spectrometry.''
    I. U.S. Non-Provisional Application 13/271,182, filed October 11, 
2011 (FDA Reference No.: E-2011-021/US-02).
    II. U.S. Patent granted April 22, 2014: U.S. Patent 8,704,169 B2 
(FDA Reference No. E-2011-021/U.S.-02)
    The patent rights in this invention have been assigned 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 a field-deployable mass spectrometer diagnostic for the rapid 
detection of SARS, SARS-CoV-2 and other viruses, bacteria and bacterial 
serovar, and drug impurities.
    Above listed patent covers inventions directed to a mass 
spectrometer for analyzing samples suspected of having microorganisms. 
It is also directed to methods for generating a mass spectrum profile 
of a sample.
    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 15 days 
from the date of this published notice, FDA 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: November 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25142 Filed 11-12-20; 8:45 am]
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