[Federal Register Volume 86, Number 209 (Tuesday, November 2, 2021)]
[Notices]
[Pages 60469-60470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23866]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1145 (Remand)]


Certain Botulinum Toxin Products, Processes for Manufacturing or 
Relating to Same and Certain Products Containing Same; Notice of 
Commission Decision To Vacate Its Final Determination on Remand

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 vacated its final determination following dismissal of 
the appeals to the U.S. Court of Appeals for the Federal Circuit 
(``Federal Circuit'') challenging various aspects of that 
determination.

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. 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

[[Page 60470]]

U.S.C. 1337 (``section 337''), based on a complaint filed by Medytox 
Inc. of Seoul, South Korea (``Medytox''); Allergan plc of Dublin, 
Ireland; and Allergan, Inc. of Irvine, California (collectively, 
``Allergan'') (all 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 the 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 an industry in the United States. See 
id. The notice of investigation names as respondents Daewoong 
Pharmaceuticals Co., Ltd. (``Daewoong'') of Seoul, South Korea and 
Evolus, Inc. (``Evolus'') of Irvine, California (collectively, 
``Respondents''). See id. The Office of Unfair Import Investigations 
(``OUII'') was also a party to the investigation. See id.
    On December 16, 2020, the Commission found a violation of section 
337 based on the misappropriation of Complainants' trade secrets 
(including the Medytox manufacturing processes but not the Medytox 
bacterial strain). See 85 FR 83610-11 (Dec. 22, 2020). The Commission 
issued a limited exclusion order against certain botulinum neurotoxin 
(``BTX'') products that are imported and/or sold by Respondents 
Daewoong and Evolus and a cease and desist order against Evolus 
(collectively, ``the remedial orders''). Id. The Commission also set a 
bond during the period of Presidential review in an amount of $441 per 
100U vial of Respondents' accused products. Id.
    On February 12, 2021, Complainants filed an appeal from the 
Commission's final determination with the Federal Circuit (Appeal No. 
21-1653). On the same day, Respondents also filed an appeal from the 
Commission's final determination of a violation of section 337 (Appeal 
No. 21-1654). On February 18, 2021, Complainants and Evolus 
(collectively, ``the Settling Parties'') announced that they had 
reached a settlement to resolve all pending issues between them.
    On March 3, 2021, the Settling Parties filed a joint petition to 
rescind the remedial orders based on settlement agreements and other 
confidential agreements between and among several of the Settling 
Parties. On April 5, 2021, Daewoong filed a response to the Settling 
Parties' petition not opposing recission of the remedial orders and 
also including a motion for vacatur of the Commission's final 
determination. On April 8, 2021, OUII filed a response in support of 
the joint petition to rescind. On April 15, 2021, Medytox filed a 
response in opposition to Daewoong's motion to vacate the final 
determination.
    On May 3, 2021, the Commission determined to rescind the remedial 
orders. See 86 FR 24665-66 (May 7, 2021). The Commission also issued an 
indicative ruling that, if the Federal Circuit dismisses the pending 
appeals as moot, the Commission will vacate its final determination. 
See id. The Commission explained that ``if the Federal Circuit finds 
that the . . . appeals are moot'' and ``[i]f appellate review for 
Daewoong is prevented, it would be plainly through happenstance, and 
vacatur would be warranted to prevent any preclusive effect of the 
final determination against Daewoong.'' See Comm'n Op. at 8 (May 3, 
2021).
    On June 21, 2021, Medytox also reached a settlement agreement with 
AEON Biopharma (``AEON''). AEON is Daewoong's exclusive licensee in the 
United States for therapeutic applications of BTX products, while 
Evolus is the exclusive licensee for aesthetic applications. 
Consequently, as Medytox stated before the Federal Circuit, ``the 
result of the two settlements is that Medytox has now resolved its 
disputes with and granted licenses to the two companies that hold the 
exclusive rights to distribute Daewoong's BTX products in the United 
States.'' See ECF 69, Medytox Statement of Non-Opposition at 2 (Fed. 
Cir. Docket No. 21-1653); ECF 68, Medytox Letter at 1 (Fed. Cir. Docket 
No. 21-1653). Thus, Medytox did not oppose the Commission's and 
Daewoong's motions to dismiss the appeals as moot and no longer opposes 
vacatur of the Commission's final determination upon remand. On July 
26, 2021, the Federal Circuit issued an order dismissing the appeals 
``to the extent that the appeals are deemed moot'' and remanding ``the 
matter . . . for the Commission to address vacatur of its final 
determination.'' Medytox v. ITC, No. 21-1653, Order at 2 (Fed. Cir. 
July 26, 2021).
    In accordance with the Commission's May 3, 2021 indicative ruling 
of vacatur and the Commission's reasoning related thereto, and in view 
of the Federal Circuit's dismissal of the related appeals as moot, the 
Commission hereby vacates on remand its final determination. 
Commissioner Karpel does not join the Commission's decision to vacate. 
As she has previously stated, the Commission's decision to exercise its 
discretion to grant the extraordinary remedy of vacatur requires an 
analysis, based on a complete record and after having heard from all 
parties on the issue, that includes a careful balancing of the 
equities, including with respect to the public interest. See Comm'n Op. 
at 9-10 n.15 (May 3, 2021). Commissioner Karpel does not consider that 
such an analysis was done when the Commission issued its indicative 
ruling regarding vacatur, see id., or on remand.
    The Commission's vote on this determination took place on October 
28, 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: October 28, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021-23866 Filed 11-1-21; 8:45 am]
BILLING CODE 7020-02-P