Commission Determination To Review an Initial Determination Granting Summary Determination and on Review To Vacate as Moot; Notice of Commission Determination Not To Review an Initial Determination Terminating the Investigation in Its Entirety Based on a Withdrawal of the Complaint; Termination of the Investigation; Certain Pre-Filled Syringes for Intravitreal Injection and Components Thereof, 24413-24414 [2021-09576]

Agencies

• INTERNATIONAL TRADE COMMISSION

[Federal Register Volume 86, Number 86 (Thursday, May 6, 2021)]
[Notices]
[Pages 24413-24414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09576]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1207]


Commission Determination To Review an Initial Determination 
Granting Summary Determination and on Review To Vacate as Moot; Notice 
of Commission Determination Not To Review an Initial Determination 
Terminating the Investigation in Its Entirety Based on a Withdrawal of 
the Complaint; Termination of the Investigation; Certain Pre-Filled 
Syringes for Intravitreal Injection and Components Thereof

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission (``Commission'') has determined to review an initial 
determination (``ID'') (Order No. 31) granting summary determination of 
infringement and of domestic industry, and on review, to vacate that ID 
as moot, and not to review a second ID (Order No. 33) terminating the 
investigation based on a withdrawal of the complaint. The investigation 
is terminated.

FOR FURTHER INFORMATION CONTACT: Robert Needham, Office of the General 
Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 708-5468. Copies of non-
confidential documents filed in connection with this investigation may 
be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email 
[email protected]. General information concerning the Commission may 
also be obtained by accessing its internet server at https://www.usitc.gov. Hearing-impaired persons are advised that information on 
this matter can be obtained by contacting the Commission's TDD terminal 
on (202) 205-1810.

SUPPLEMENTARY INFORMATION: On July 27, 2020, the Commission instituted 
this investigation based on a complaint filed by Novartis Pharma AG, 
Novartis Pharmaceuticals Corporation, and Novartis Technology LLC 
(collectively, ``Novartis''). 85 FR 45227-28. The complaint alleges 
violations of section 337 of the Tariff Act of 1930, as amended, 19 
U.S.C. 1337, based on the importation into the United States, sale for 
importation, or sale in the United States after importation of certain 
pre-filled syringes for intravitreal injections and components thereof 
that infringe

[[Page 24414]]

one or more of claims 1-6 and 11-26 of U.S. Patent No. 9,220,631 (``the 
'631 patent''). Id. The complaint also alleges the existence of a 
domestic industry. Id. The notice of investigation names Regeneron 
Pharmaceuticals Inc. of Tarrytown, New York (``Regeneron'') as the sole 
respondent and the Office of Unfair Import Investigations (``OUII'') as 
a party. Id. at 45228.
    On February 18, 2021, Novartis filed a motion for summary 
determination that Regeneron directly infringes the '631 patent and 
that Novartis satisfied the domestic industry requirement. On March 1, 
2021, OUII filed a response in support of the motion, and Regeneron 
filed a response opposing Novartis's argument that it satisfied the 
economic prong of the domestic industry requirement.
    On April 2, 2021, the presiding administrative law judge (``ALJ'') 
issued the first ID (Order No. 31), granting summary determination of 
infringement and domestic industry. No petitions for review of the ID 
were received.
    On April 8, 2021, Novartis filed an unopposed motion to terminate 
the investigation in its entirety based on its withdrawal of the 
complaint. The motion indicated that Regeneron and OUII did not oppose 
the motion, and Regeneron did not file a response to the motion. OUII 
filed a response in support of the motion. The motion to terminate the 
investigation was filed before the deadline to petition for review of 
Order No. 31 had passed. See 19 CFR 210.43(a).
    On April 8, 2021, the ALJ issued the second ID (Order No. 33), 
granting the motion and terminating the investigation. Order No. 33 was 
issued before the deadline to petition for review of Order No. 31 had 
passed. No petitions for review of the second ID were filed.
    The Commission has determined to review the first ID, Order No. 31, 
in its entirety, and on review, to vacate that ID as moot because the 
summary determination issues became moot in light of Novartis's motion 
to withdraw its complaint and terminate the investigation. Vice Chair 
Stayin and Commissioner Johanson do not join the Commission's decision 
to review and vacate Order No. 31. In the absence of a request from any 
party to review or vacate the Order, or any other grounds for review 
set forth in 19 CFR 210.44, they would not review Order No. 31.
    The Commission has further determined not to review the second ID, 
Order No. 33, terminating the investigation. The investigation is 
hereby terminated in its entirety.
    The Commission vote for this determination took place on May 3, 
2021.
    The authority for the Commission's determination is contained in 
Section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and 
in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR 
part 210).

    By order of the Commission.

    Issued: May 3, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021-09576 Filed 5-5-21; 8:45 am]
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