[Federal Register Volume 85, Number 246 (Tuesday, December 22, 2020)]
[Notices]
[Pages 83610-83611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28158]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1145]


Certain Botulinum Toxin Products, Processes for Manufacturing or 
Relating to Same and Certain Products Containing Same Commission Final 
Determination Finding a Violation of Section 337; Issuance of a Limited 
Exclusion Order and a Cease and Desist Order; Termination of the 
Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has found a violation of section 337 in the above-captioned 
investigation. The Commission has determined to issue a limited 
exclusion order (``LEO'') prohibiting the importation by respondents 
Daewoong Pharmaceuticals Co., Ltd. (``Daewoong'') of Seoul, South Korea 
and Evolus, Inc. (``Evolus'') of Irvine, California (collectively, 
``Respondents'') of certain botulinum toxin products, processes for 
manufacturing or relating to same and certain products containing same. 
The Commission has also issued a cease and desist order (``CDO'') 
directed to respondent Evolus. The investigation is terminated.

FOR FURTHER INFORMATION CONTACT: Houda Morad, Office of the General 
Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 708-4716. 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. The public record for this investigation may be viewed 
on the Commission's electronic docket (EDIS) at https://edis.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 March 6, 2019, the Commission instituted 
this investigation under section 337 of the Tariff Act of 1930, as 
amended, 19 U.S.C. 1337 (``section 337''), based on a complaint filed 
by Medytox Inc. of Seoul, South Korea; Allergan Limited of Dublin, 
Ireland; and Allergan, Inc. of

[[Page 83611]]

Irvine, California (collectively, ``Complainants''). See 84 FR 8112-13 
(Mar. 6, 2019). The complaint, as supplemented, alleges a violation of 
section 337 based upon the importation and sale in the United States of 
certain botulinum toxin products, processes for manufacturing or 
relating to same and certain products containing same by reason of 
misappropriation of trade secrets, the threat or effect of which is to 
destroy or substantially injure a domestic industry in the United 
States. See id. The notice of investigation names Daewoong and Evolus 
as respondents in this investigation. See id. The Office of Unfair 
Import Investigations is also a party to the investigation. See id.
    On July 6, 2020, the Administrative Law Judge (``ALJ'') issued a 
final initial determination (``FID'') finding a violation of section 
337 based on the importation and sale in the United States of 
Respondents' botulinum neurotoxin products by reason of the 
misappropriation of trade secrets, the threat or effect of which is to 
destroy or substantially injure an industry in the United States. See 
FID at 273. The ALJ issued a recommended determination (``RD'') 
recommending that, if a violation is found, the Commission issue: (1) 
An LEO barring entry of certain botulinum toxin products that are 
imported and/or sold by respondents Daewoong and Evolus; and (2) a CDO 
against Evolus. The RD also recommends that the Commission impose a 
bond based on price differential during the period of Presidential 
review.
    On July 28, 2020, the Commission issued a notice requesting 
statements on the public interest. See 85 FR 46711 (Aug. 3, 2020) 
(``the PI Notice''). On August 17-18, 2020, several non-parties filed 
submissions in response to the PI Notice.
    On September 21, 2020, the Commission issued a notice determining 
to review the FID in part. See 85 FR 60489-90 (Sept. 25, 2020) (``the 
WTR/Remedy Notice''). Specifically, the Commission determined to review 
the FID's findings with respect to subject matter jurisdiction, 
standing, trade secret existence and misappropriation, and domestic 
industry, including the existence of such domestic industry as well as 
any actual or threatened injury thereto. See id. The Commission 
determined not to review the remainder of the FID. See id. The 
Commission's notice also requested written submissions on remedy, the 
public interest, and bonding. See id.
    On October 9, 2020, the parties, including the IA, filed written 
submissions in response to the WTR/Remedy Notice, and on October 16, 
2020, the parties filed responses to each other's submissions. In 
addition, on October 5-9, 2020, several non-parties filed submissions 
on the proposed remedy and/or the public interest in response to the 
WTR/Remedy Notice.
    Having examined the record of this investigation, including the 
FID, the RD, and the parties' and non-parties' submissions, the 
Commission has determined to affirm the FID in part and reverse in 
part. Specifically, as explained in the Commission Opinion filed 
concurrently herewith, the Commission has determined to affirm with 
modification the FID's findings with respect to subject matter 
jurisdiction, standing, domestic industry as to BOTOX[supreg], and 
trade secret existence and misappropriation as it relates to Medytox's 
manufacturing processes. The Commission has also determined to reverse 
the FID's finding that a trade secret exists with respect to Medytox's 
bacterial strain. All findings in the FID that are not inconsistent 
with the Commission's determination are affirmed.
    Accordingly, the Commission finds that there is a violation of 
section 337. The Commission has determined that the appropriate remedy 
is an LEO against Respondents' botulinum toxin products, and a CDO 
against Evolus, barring Respondents' unfair acts for a duration of 21 
months. The Commission has also determined that the public interest 
factors enumerated in subsections 337(d)(1) and (f)(1) (19 U.S.C. 
1337(d)(1), (f)(1)) do not preclude the issuance of the LEO and CDO. 
The Commission has further determined to set a bond during the period 
of Presidential review in an amount of $441 per 100U vial of 
Respondents' accused products.
    The Commission's orders and opinion were delivered to the President 
and to the United States Trade Representative on the day of their 
issuance.
    The investigation is terminated.
    The Commission's vote on this determination took place on December 
16, 2020.
    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: December 16, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020-28158 Filed 12-21-20; 8:45 am]
BILLING CODE 7020-02-P