[Federal Register Volume 85, Number 144 (Monday, July 27, 2020)]
[Notices]
[Pages 45227-45228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16138]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1207]


Certain Pre-Filled Syringes for Intravitreal Injection and 
Components Thereof; Institution of Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that a complaint was filed with the 
U.S. International Trade Commission on June 19, 2020, under section 337 
of the Tariff Act of 1930, as amended, on behalf of Novartis Pharma AG 
of Switzerland; Novartis Pharmaceuticals Corporation of East Hanover, 
New Jersey; and Novartis Technology LLC of East Hanover, New Jersey. A 
letter supplementing the complaint was filed on July 10, 2020. The 
complaint alleges violations of section 337 based upon the importation 
into the United States, the sale for importation, and the sale within 
the United States after importation of certain pre-filled syringes for 
intravitreal injection and components thereof by reason of infringement 
of certain claims of U.S. Patent No. 9,220,631 (``the '631 patent''). 
The complaint further alleges that an industry in the United States 
exists or is in the process of being established as required by the 
applicable Federal Statute. The complainants request that the 
Commission institute an investigation and, after the investigation, 
issue a limited exclusion order and a cease and desist order.

ADDRESSES: The complaint, except for any confidential information 
contained therein, may be viewed on the Commission's electronic docket 
(EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email 
[email protected]. Hearing impaired individuals are advised that 
information on this matter can be obtained by contacting the 
Commission's TDD terminal on (202) 205-1810. Persons with mobility 
impairments who will need special assistance in gaining access to the 
Commission should contact the Office of the Secretary at (202) 205-
2000. General information concerning the Commission may also be 
obtained by accessing its internet server at https://www.usitc.gov.

FOR FURTHER INFORMATION CONTACT: Pathenia M. Proctor, The Office of 
Unfair Import Investigations, U.S. International Trade Commission, 
telephone (202) 205-2560.

SUPPLEMENTARY INFORMATION:

    Authority: The authority for institution of this investigation 
is contained in section 337 of the Tariff Act of 1930, as amended, 
19 U.S.C. 1337, and in Sec.  210.10 of the Commission's Rules of 
Practice and Procedure, 19 CFR 210.10 (2020).
    Scope of Investigation: Having considered the complaint, the U.S. 
International Trade Commission, on July 21, 2020, 2020, ordered that--
    (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 
1930, as

[[Page 45228]]

amended, an investigation be instituted to determine whether there is a 
violation of subsection (a)(1)(B) of section 337 in the importation 
into the United States, the sale for importation, or the sale within 
the United States after importation of certain products identified in 
paragraph (2) by reason of infringement of one or more of claims 1-6 
and 11-26 of the '631 patent, and whether an industry in the United 
States exists as required by subsection (a)(2) of section 337;
    (2) Pursuant to Sec.  210.10(b)(1) of the Commission's Rules of 
Practice and Procedure, 19 CFR 210.10(b)(1), the plain language 
description of the accused products or category of accused products, 
which defines the scope of the investigation, is ``syringes that are 
pre-filled with ophthalmic medication, and components of such syringes, 
including barrels, plungers, and stoppers'';
    (3) Pursuant to Commission Rule Sec.  210.50(b)(1), 19 CFR 
210.50(b)(1), the presiding administrative law judge shall take 
evidence or other information and hear arguments from the parties or 
other interested persons with respect to the public interest in this 
investigation, as appropriate, and provide the Commission with findings 
of fact and a recommended determination on this issue, which shall be 
limited to the statutory public interest factors set forth in 19 U.S.C. 
1337(d)(1), (f)(1), (g)(1);
    (4) For the purpose of the investigation so instituted, the 
following are hereby named as parties upon which this notice of 
investigation shall be served:
    (a) The complainants are:

Novartis Pharma AG, Forum 1, Novartis Campus, CH-4056 Basel, 
Switzerland.
Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, 
New Jersey, 07936.
Novartis Technology LLC, One Health Plaza, East Hanover, New Jersey, 
07936.
    (b) The respondent is the following entity alleged to be in 
violation of section 337, and is the party upon which the complaint is 
to be served:

Regeneron Pharmaceuticals, Inc., 77 Old Saw Mill River Road, Tarrytown, 
New York 10591.
    (c) The Office of Unfair Import Investigations, U.S. International 
Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
    (5) For the investigation so instituted, the Chief Administrative 
Law Judge, U.S. International Trade Commission, shall designate the 
presiding Administrative Law Judge.
    Responses to the complaint and the notice of investigation must be 
submitted by the named respondent in accordance with Sec.  210.13 of 
the Commission's Rules of Practice and Procedure, 19 CFR 210.13. 
Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 
(March 19, 2020), such responses will be considered by the Commission 
if received not later than 20 days after the date of service by the 
complainants of the complaint and the notice of investigation. 
Extensions of time for submitting responses to the complaint and the 
notice of investigation will not be granted unless good cause therefor 
is shown.
    Failure of the respondent to file a timely response to each 
allegation in the complaint and in this notice may be deemed to 
constitute a waiver of the right to appear and contest the allegations 
of the complaint and this notice, and to authorize the administrative 
law judge and the Commission, without further notice to the respondent, 
to find the facts to be as alleged in the complaint and this notice and 
to enter an initial determination and a final determination containing 
such findings, and may result in the issuance of an exclusion order or 
a cease and desist order or both directed against the respondent.

    By order of the Commission.
    Issued: July 21, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020-16138 Filed 7-24-20; 8:45 am]
BILLING CODE 7020-02-P