[Federal Register Volume 86, Number 87 (Friday, May 7, 2021)]
[Notices]
[Pages 24665-24666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09652]


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INTERNATIONAL TRADE COMMISSION

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


Certain Botulinum Toxin Products, Processes for Manufacturing or 
Relating to Same and Certain Products Containing Same; Commission 
Decision To Institute a Rescission Proceeding and Rescind the Remedial 
Orders, To Grant the Motion To Limit Service of the Settlement 
Agreement, To Deny as Moot the Motion To Terminate, and To Indicate 
Ruling on Motion To Vacate; Termination of the Rescission Proceeding

AGENCY: United States International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has determined to institute a rescission proceeding and 
rescind the remedial orders issued in the underlying investigation, to 
grant the motion to limit service of the settlement agreement, and to 
deny as moot the motion to terminate the investigation. The Commission 
has further determined that if the Federal Circuit dismisses the 
pending appeals as moot, the Commission will vacate its final 
determination. The rescission proceeding 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

[[Page 24666]]

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 (``Medytox''); Allergan plc of 
Dublin, Ireland; and Allergan, Inc. of Irvine, California 
(collectively, ``Allergan'') (all collectively, ``Complainants''). See 
84 FR 8112-13 (March 6, 2019). The complaint, as supplemented, alleges 
a violation 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 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 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 July 6, 2020, the Administrative Law Judge issued a final 
initial determination (``FID'') finding a violation of section 337 
based on the misappropriation of Complainants' asserted trade secrets 
(including the Medytox bacterial strain and Medytox manufacturing 
processes), the threat or effect of which is to destroy or 
substantially injure an industry in the United States. On September 21, 
2020, the Commission issued a notice determining to review the FID in 
part. See 85 FR 60489-90 (September 25, 2020).
    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 (``LEO'') against certain botulinum 
neurotoxin products that are imported and/or sold by Respondents 
Daewoong and Evolus and a cease and desist order (``CDO'') against 
Evolus. 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. On the same 
day, Respondents also filed an appeal from the Commission's final 
determination of a violation of section 337. On February 18, 2021, 
Complainants and Evolus (collectively, ``the Settling Parties'') 
announced that they had reached a settlement agreement to resolve all 
pending issues between them.
    On March 3, 2021, the Settling Parties filed a joint petition to 
rescind the LEO and CDO (collectively, ``the remedial orders'') based 
on the settlement agreement. On the same day, the Settling Parties also 
filed a joint motion to limit service of the settlement agreement. On 
March 16, 2021, Daewoong filed a notice of non-opposition to the joint 
motion to limit service. On April 1, 2021, the Settling Parties further 
filed a joint motion to terminate the investigation without prejudice 
pursuant to 19 CFR 210.21(b). On April 5, 2021, Daewoong filed a 
response to the Settling Parties' petition to rescind the remedial 
orders stating that it does not oppose the Settling Parties' petition 
for recission. Daewoong's response also included a motion for vacatur 
of the Commission's final determination. On April 8, 2021, OUII filed a 
response in support of the Settling Parties' petition to rescind and 
their joint motion to limit service. On April 12, 2021, Daewoong filed 
a response to the Settling Parties' motion to terminate the 
investigation, arguing that the motion to terminate should be denied as 
moot and opposing termination without prejudice. On April 15, 2021, 
Medytox filed a response in opposition to Daewoong's motion to vacate 
the final determination. On April 23, 2021, Daewoong filed a motion for 
leave to file a reply in support of its motion to vacate and on April 
29, 2021, Medytox filed a response in opposition to the motion for 
leave to file a reply; the Commission accepts both of these filings and 
Daewoong's motion for leave to file a reply is granted.
    Having reviewed the parties' submissions relating to (and in 
response to) the Settling Parties' petition to rescind, their joint 
motion to limit service, their joint motion to terminate, and 
Daewoong's motion to vacate, and for the reasons discussed in the 
Commission Opinion issued concurrently herewith, the Commission has 
determined to grant the joint petition to rescind the remedial orders 
and the joint motion to limit service, and to deny as moot the joint 
motion to terminate the investigation. The Commission has further 
determined that, if the Federal Circuit dismisses the pending appeals 
as moot, the Commission will vacate its final determination. 
Commissioner Karpel concurs in the determination to grant the Settling 
Parties' motion to rescind the remedial orders and their motion to 
limit service; and to deny as moot their motion to terminate the 
investigation. However, Commissioner Karpel would deny Daewoong's 
motion to vacate the Commission's final determination as procedurally 
improper. She would also deny Daewoong's motion for leave to file a 
reply. Further, Commissioner Karpel would decline to issue an 
indicative ruling as to whether Daewoong has established equitable 
entitlement to the extraordinary remedy of vacatur on the basis of the 
record before the Commission.
    The rescission proceeding is terminated.
    The Commission's vote on 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. 2021-09652 Filed 5-6-21; 8:45 am]
BILLING CODE 7020-02-P