CHAIR
`
`
`
`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C. 20436
`
`May 3, 2021
`
`
`The Honorable Janet L. Yellen
`Secretary of the Treasury
`Washington, D.C. 20220
`
`Dear Madame Secretary:
`
`
`
`On December 16, 2020, the United States International Trade Commission issued a
`limited exclusion order pursuant to section 337 of the Tariff Act of 1930, as amended (19 U.S.C.
`§ 1337), in USITC Investigation No. 337-TA-1145, Certain Botulinum Toxin Products,
`Processes for Manufacturing or Relating to Same and Certain Products Containing Same. The
`limited exclusion order prohibits Daewoong Pharmaceuticals Co., Ltd. of Seoul, South Korea
`and Evolus, Inc. of Irvine, California (“Evolus”) from importing into the United States botulinum
`neurotoxin products that misappropriate certain trade secrets owned or licensed by Medytox Inc.
`of Seoul, South Korea; Allergan plc of Dublin, Ireland; and Allergan, Inc. of Irvine, California
`(collectively, “Complainants”).
`
`In view of settlement, on March 3, 2021, Complainants and Evolus filed a joint petition
`to rescind the limited exclusion order. On May 3, 2021, the Commission determined to rescind
`the limited exclusion order.
`
`
`
`Sincerely,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Jason E. Kearns
`Chair
`
`
`

`

`
`Secretary Yellen
`May 3, 2021
`Page 2
`
`
`Enclosures
`
`cc: Dax Terrill, Chief
`Exclusion Order Enforcement
`Office of International Trade
`Regulation and Rulings
`U.S. Customs and Border Protection
`90 K Street, N.E.
`Washington, D.C. 20229-1177
`
`
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`
`
`
`In the Matter of
`
`
`
`
`
`CERTAIN BOTULINUM TOXIN
`PRODUCTS, PROCESSES FOR
`MANUFACTURING OR RELATING TO
`SAME AND CERTAIN PRODUCTS
`CONTAINING SAME
`
`
`Investigation No. 337-TA-1145
`(Rescission)
`
`
`
`NOTICE OF 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
`
` U.S. International Trade Commission.
`
`Notice.
`
`
`AGENCY:
`
`ACTION:
`
`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 Commission’s electronic docket (EDIS) at
`https://edis.usitc.gov. For help accessing EDIS, please email EDIS3Help@usitc.gov. 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 (Mar. 6, 2019). The complaint, as
`supplemented, alleges a violation of section 337 based upon the importation into the United
`
`1
`
`

`

`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 (Sept. 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
`
`2
`
`

`

`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 R. Barton
`Secretary to the Commission
`
`
`
`3
`
`

`

`
`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`
`
`
`
`
`In the Matter of
`
`
`
`CERTAIN BOTULINUM TOXIN
`PRODUCTS, PROCESSES FOR
`MANUFACTURING OR RELATING
`TO SAME AND CERTAIN PRODUCTS
`CONTAINING SAME
`
`
`Inv. No. 337-TA-1145
`(Rescission)
`
`COMMISSION ORDER
`
`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
`
`complainants Medytox Inc. of Seoul, South Korea (“Medytox”); and Allergan Limited 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 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 Complainants’ trade secrets. See id. The
`
`notice of investigation names Daewoong Pharmaceuticals Co., Ltd. of Seoul, South Korea
`
`(“Daewoong”) and Evolus, Inc. of Irvine, California (“Evolus”) as 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
`
`1
`
`

`

`United States. On September 21, 2020, the Commission issued a notice determining to review
`
`the FID in part. See 85 FR 60489-90 (Sept. 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 section 337 violation. On February 18, 2021,
`
`Complainants and Evolus (collectively, “the Settling Parties”) announced that they 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 5, 2021, Daewoong filed a response not opposing the Settling Parties’ joint petition to
`
`rescind and moved for vacatur of the Commission’s final determination. On April 8, 2021,
`
`OUII filed a response in support of the joint petition to rescind and the joint motion to limit
`
`service. On April 12, 2021, Daewoong filed a response to the joint motion to terminate, arguing
`
`that the motion to terminate should be denied as moot and opposing termination without
`
`2
`
`

`

`prejudice. On April 15, 2021, Medytox filed a response in opposition to Daewoong’s motion to
`
`vacate.
`
`Having reviewed the parties’ submissions relating to (and in response to) the joint
`
`petition to rescind and the joint motion to limit service, 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 to grant the joint motion to limit service.
`
`Accordingly, it is hereby ORDERED that:
`
`(1)
`
`Pursuant to 19 U.S.C. § 1337(k) and 19 C.F.R. § 210.76, the remedial orders are
`
`RESCINDED.
`
`(2) The Secretary shall serve a copy of this Order on the Secretary of the Treasury
`
`and all parties of record and shall publish notice thereof in the Federal Register.
`
`By order of the Commission.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Issued: May 3, 2021
`
`Lisa R. Barton
`Secretary to the Commission
`
`
`
`3
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`
`
`
`
`
`In the Matter of
`
`
`
`CERTAIN BOTULINUM TOXIN
`PRODUCTS, PROCESSES FOR
`MANUFACTURING OR RELATING
`TO SAME AND CERTAIN PRODUCTS
`CONTAINING SAME
`
`
`Inv. No. 337-TA-1145
`(Rescission)
`
`COMMISSION OPINION
`
`On December 16, 2020, the Commission found a violation of section 337 of the Tariff
`
`
`
`
`
`
`
`Act of 1930, as amended (19 U.S.C. § 1337) (“section 337”) based on the misappropriation of
`
`trade secrets owned or licensed by complainants Medytox Inc. of Seoul, South Korea
`
`(“Medytox”); and Allergan Limited of Dublin, Ireland and Allergan, Inc. of Irvine, California
`
`(collectively, “Allergan”) (all collectively, “Complainants”). See 85 Fed. Reg. 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 Pharmaceuticals
`
`Co., Ltd. of Seoul, South Korea (“Daewoong”) and Evolus, Inc. of Irvine, California (“Evolus”)
`
`(collectively, “Respondents”) 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 March 3, 2021, Complainants and Evolus (collectively, “the Settling Parties”) filed a
`
`joint petition to rescind the LEO and CDO (collectively, “the remedial orders”) based on
`
`settlement. On the same day, the Settling Parties filed an unopposed motion to limit service of
`
`the settlement agreements. On April 1, 2021, the Settling Parties further filed a joint motion to
`
`1
`
`

`

`terminate the investigation without prejudice pursuant to Commission Rule 210.21(b), 19 C.F.R.
`
`§ 210.21(b). On April 5, 2021, Daewoong filed a response stating that it does not oppose the
`
`Settling Parties’ petition. Daewoong’s response also included a motion to vacate the final
`
`determination. 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. On April 29, 2021, Medytox filed a response in
`
`opposition to the motion for leave to file a reply.
`
`Having reviewed the parties’ submissions relating to (and in response to) the joint
`
`petition to rescind, the joint motion to limit service, the joint motion to terminate, and
`
`Daewoong’s motion to vacate, the Commission has determined to institute a rescission
`
`proceeding and rescind the remedial orders. The Commission has also determined to grant the
`
`joint motion to limit service and to deny the joint motion to terminate the investigation as moot.
`
`The Commission has further determined that, if the Federal Circuit dismisses the pending
`
`appeals as moot, the Commission will vacate its final determination.
`
`I.
`
`BACKGROUND
`
`On March 6, 2019, the Commission instituted this investigation under section 337 based
`
`on a complaint filed by Medytox and Allergan. See 84 Fed. Reg. 8112-13 (Mar. 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 Complainants’ trade secrets. See id.
`
`The notice of investigation names Daewoong and Evolus as respondents. See id. The Office of
`
`Unfair Import Investigations (“OUII”) was also a party to the investigation. See id.
`
`
`
`2
`
`

`

`On July 6, 2020, the Administrative Law Judge (“ALJ”) 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 Fed. Reg. 60489-90 (Sept. 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 Fed. Reg. 83610-11 (Dec. 22, 2020).
`
`The Commission issued an LEO against certain botulinum neurotoxin products that are imported
`
`and/or sold by Respondents Daewoong and Evolus and a 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. On February 18, 2021, Complainants and Evolus
`
`(collectively, “the Settling Parties”) announced that they reached settlement agreements 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 the settlement agreements.1 On the same day, the Settling Parties also filed a joint
`
`
`1 See Joint Petition of Complainants Medytox and Allergan and Respondent Evolus to Rescind
`the Limited Exclusion Order and the Cease and Desist Order (Mar. 3, 2021) (hereinafter, “Joint
`Pet.”).
`
`3
`
`

`

`motion to limit service of the settlement agreements.2 On March 4, 2021, Daewoong filed a
`
`submission to provide a “correction” with respect to the joint petition’s characterization of
`
`Daewoong’s position regarding the Settling Parties’ joint petition to rescind and joint motion to
`
`limit service of the settlement agreements.3 On March 16, 2021, Daewoong filed a notice of
`
`non-opposition to the joint motion to limit service.4 On April 1, 2021, the Settling Parties
`
`further filed a joint motion to terminate the investigation without prejudice pursuant to
`
`Commission Rule 210.21(b), 19 C.F.R. § 210.21(b).5 On April 5, 2021, Daewoong filed a
`
`response to the Settling Parties’ petition to rescind the orders and moved for vacatur of the
`
`Commission’s final determination.6 Daewoong states that it does not oppose rescission but
`
`argues that the Commission’s final determination should be vacated under United States v.
`
`Munsingwear, Inc., 340 U.S. 36 (1950). On April 8, 2021, OUII filed a response in support of
`
`the joint petition to rescind and the joint motion to limit service.7 On April 12, 2021, Daewoong
`
`
`2 See Joint Motion of Complainants Medytox and Allergan and Respondent Evolus to Limit
`Service of Confidential Settlement Agreements to Settling Parties and Commission Investigative
`Attorney (Mar. 3, 2021) (hereinafter, “Service Mot.”).
`3 Respondent Daewoong Pharmaceutical Co., Ltd.’s Correction to Settling Parties’ Petition to
`Rescind the Remedial Orders and Motion to Limit Service of Settlement Agreements (Mar. 4,
`2021).
`4 See Respondent Daewoong Pharmaceutical Co., Ltd.’s Notice of Non-Opposition to Settling
`Parties’ Motion to Limit Service of Settlement Agreements (Mar. 16, 2021).
`5 See Joint Motion of Complainants Medytox and Allergan and Respondent Evolus for
`Termination of the Investigation without Prejudice on the Basis of Settlement (Apr. 1, 2021)
`(hereinafter, “Joint Mot.”).
`6 See Respondent Daewoong Pharmaceutical Co., Ltd.’s: (1) Response to Complainants
`Medytox and Allergan’s and Respondent Evolus’s Joint Petition to Rescind the Remedial
`Orders; and (2) Motion to Vacate the Commission’s Opinion (Apr. 5, 2021) (hereinafter,
`“Daewoong’s Pet. Resp.”).
`7 See Office of Unfair Import Investigation’s Response to Joint Petition of Complainants
`Medytox and Allergan and Respondent Evolus to Rescind the Limited Exclusion Order and
`Cease and Desist Order (Apr. 8, 2021) (hereinafter, “OUII’s Pet. Resp.”).
`
`4
`
`

`

`filed a response to the joint motion to terminate.8 Daewoong argues that the motion to terminate
`
`should be denied as moot and opposes termination without prejudice. On April 15, 2021,
`
`Medytox filed a response in opposition to Daewoong’s motion to vacate.9 Medytox opposes
`
`vacatur on procedural and substantive grounds, arguing that vacatur is improper before the
`
`appeals are dismissed as moot and that the appeals are not moot because the Commission’s final
`
`determination carries collateral consequences.
`
`On April 23, 2021, Daewoong filed a motion for leave to file a reply in support of its
`
`motion to vacate.10 On April 29, 2021, Medytox filed a response in opposition to the motion for
`
`leave to file a reply.11 The Commission accepts both filings for a complete record of the parties’
`
`arguments on the motion to vacate.
`
`II.
`
`ANALYSIS
`
`A.
`
`Rescission and Termination
`
`Section 337(k) provides that “any exclusion from entry or order under this section shall
`
`continue in effect until the Commission finds, and in the case of exclusion from entry notifies the
`
`Secretary of the Treasury, that the conditions which led to such exclusion from entry or order no
`
`longer exist.” See 19 U.S.C. § 1337(k)(1). Section 337(k) further provides that a person who
`
`has previously been found by the Commission to be in violation of section 337 may petition the
`
`
`8 See Respondent Daewoong Pharmaceuticals Co., Ltd.’s Response to Settling Parties’ Joint
`Motion for Termination of the Investigation without Prejudice on the Basis of Settlement (Apr.
`12, 2021) (hereinafter, “Daewoong’s Mot. Resp.”).
`9 See Complainant Medytox’s Opposition to Daewoong’s Motion to Vacate the Commission’s
`Opinion (Apr. 15, 2021) (hereinafter, “Medytox’s Mot. Resp.”).
`10 See Respondent Daewoong Pharmaceutical Co., Ltd.’s Motion for Leave to File a Brief Reply
`in Support of Their Motion to Vacate the Commission’s Opinion (Apr. 23, 2021).
`11 See Complainant Medytox Inc.’s Opposition to Respondent Daewoong Pharmaceutical Co.,
`Ltd.’s Motion for Leave to File a Reply Brief (Apr. 29, 2021).
`
`5
`
`

`

`Commission for a determination that the petitioner is no longer in violation of this section or for
`
`a modification or rescission of an exclusion from entry or order under subsection (d), (e), (f), (g),
`
`or (i). See 19 U.S.C. § 1337(k)(2); see also 19 C.F.R. § 210.76.
`
`The Commission has determined to institute a rescission proceeding and rescind the
`
`remedial orders. Complainants seek to rescind the orders in their entirety due to the settlement
`
`with Evolus. In addition, the petition to rescind is unopposed by Daewoong and OUII. See
`
`Daewoong’s Pet. Resp. at 1, 6; OUII’s Pet. Resp. at 7. Under these facts, and in view of the
`
`settlement agreements between Complainants and Evolus, the Commission finds that the
`
`conditions that led to the exclusion of Respondents’ products no longer exist (see Joint Pet. at 1).
`
`See 19 U.S.C. § 1337(k); 19 C.F.R. § 210.76. Accordingly, the Commission has determined to
`
`grant the joint petition to rescind the remedial orders. The Commission also grants the
`
`unopposed motion to limit service of the settlement agreements.12
`
`The Commission has also determined to deny as moot the Settling Parties’ motion to
`
`terminate the underlying investigation without prejudice. Daewoong’s Mot. Resp. at 1. The
`
`Commission previously terminated the investigation when it issued its final determination. As
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`such, there is no further action to be taken to conclude the investigation.
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`B. Mootness and Vacatur
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`While Daewoong does not oppose rescission, Daewoong argues that the rescission moots
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`the appeals before the Federal Circuit and requests that the Commission vacate its final
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`12 The Commission agrees that good cause exists to limit service of the settlement agreements.
`As noted by the Settling Parties, “[t]he confidential portions of the Agreements reflect
`information that is not required to be disclosed publicly, or to Daewoong, in order to resolve this
`investigation, but disclosure of this limited set of terms would place the Settling Parties at a
`disadvantage, including in connection with potential future settlement negotiations or
`discussions.” See Service Mot. at 2.
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`6
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`determination. See Daewoong’s Pet. Resp. at 1-2, 6-11 (citing United States v. Munsingwear,
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`Inc., 340 U.S. 36 (1950)). Medytox disputes mootness of the appeals and argues that vacatur is
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`inappropriate. See Medytox’s Mot. Resp. at 1-3, 9-15.
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`The Commission does not address mootness here because a Commission opinion would
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`not determine the scope of Article III jurisdiction in the Federal Circuit. Any dispute
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`concerning mootness of the pending appeals is for the Federal Circuit to resolve.
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`As to vacatur, the Federal Circuit has allowed the Commission to have the first
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`opportunity to determine whether to vacate Commission determinations. See Ajinomoto Co. v.
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`ITC, Nos. 18-1590, 18-1629 (Fed. Cir. June 27, 2018); Sizewise Rentals LLC v. ITC, No. 17-
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`2334 (Fed. Cir. Dec. 26, 2017). The Commission agrees with Medytox that it would be
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`improper to vacate the Commission determination prior to a finding that the appeals are moot.
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`Medytox’s Mot. Resp. at 6-9. The Commission finds, however, that it is proper to indicate at
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`this stage that if the Federal Circuit dismisses the appeals as moot, the Commission will grant
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`Daewoong’s motion for vacatur. Cf. Fed. R. App. P. 12.1 (indicative rulings); Fed. R. Civ. P.
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`62.1 (same). The Commission further finds that providing an indicative ruling on vacatur may
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`assist the Federal Circuit in determining whether the appeals are justiciable, while preserving the
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`Commission’s role in determining whether its decisions should be vacated.
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`Vacatur is proper “‘when mootness [on appeal] results from unilateral action of the party
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`who prevailed below,’ . . . lest the losing party, denied an opportunity to appeal by its
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`adversary’s conduct, should later be subject to the judgment’s preclusive effect.” Hall v. CIA,
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`437 F.3d 94, 99-100 (D.C. Cir. 2006) (citing U.S. Bancorp Mortg. Co. v. Bonner Mall P’ship,
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`513 U.S. 18, 25 (1994); Munsingwear, 340 U.S. at 40). Thus, “[v]acatur ‘clears the path for
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`future relitigation of the issues between the parties and eliminates a judgment, review of which
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`7
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`was prevented through happenstance.’” U.S. Bancorp, 513 U.S. at 22-23 (quoting
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`Munsingwear, 340 U.S. at 40). The decision to vacate a judgment is committed to the discretion
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`of the courts and the Commission. See Senate Permanent Subcommittee on Investigations v.
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`Ferrer, 856 F.3d 1080, 1089 (D.C. Cir. 2017) (quoting to Sands v. NLRB, 825 F.3d 778, 785
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`(D.C. Cir. 2016) (itself quoting U.S. Bancorp, 513 U.S. at 25)); see also Certain L-Tryptophan,
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`L-Tryptophan Products, & their Methods of Production, Inv. No. 337-TA-1005, Comm’n Op.,
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`2020 WL 4500710, *2-3 (Mar. 5, 2020) (“Certain L-Tryptophan”); Certain Air Mattress Sys.,
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`Components Thereof, & Methods of Using the Same, Inv. No. 337-TA-971, Comm’n Op., 2020
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`WL 861520, *3 (Feb. 19, 2020) (“Certain Air Mattress Sys.”). In determining whether vacatur
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`is warranted, the tribunal must also consider the public interest. See U.S. Bancorp, 513 U.S. at
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`26. Indeed, as the Supreme Court held, “[j]udicial precedents are presumptively correct and
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`valuable to the legal community as a whole” and “[t]hey are not merely the property of private
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`litigants and should stand unless a court concludes that the public interest would be served by a
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`vacatur.” Id.
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`The Commission finds that, if the Federal Circuit finds that the pending appeals are moot,
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`vacatur is warranted here because appellate review has been prevented through happenstance.
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`Evolus, of course, was a settling party, but Daewoong was not. If appellate review for
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`Daewoong is prevented, it would be plainly through happenstance, and vacatur would be
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`warranted to prevent any preclusive effect of the final determination against Daewoong. See
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`Old Bridge Owners Co-op. Corp. v. Township of Old Bridge, 246 F.3d 310, 314 (3d Cir. 2001)
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`(finding vacatur warranted where settlement by one plaintiff mooted the appeal as to the other
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`8
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`plaintiff (FDIC) and where the FDIC had been deprived of review through no fault of its own).13
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`The potential for Medytox to use the Commission determination preclusively is exactly what
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`vacatur is meant to avoid where settlement by one party deprives another party of the right to
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`appeal. Indeed, vacatur exists to prevent even the speculative risk of preclusion.14 American
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`Family Life Assurance Co. of Columbus v. FCC, 129 F.3d 625, 631 (D.C. Cir. 1997).
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`However, vacatur does not mean that the Commission’s final determination will have no
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`persuasive effect in future investigations. A vacatur, which in this case would be due to
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`settlement and rescission of the remedial orders, would not prevent litigants from “rely[ing] on a
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`vacated Commission opinion not only before a district court, but also before the Commission
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`itself.” See Certain Air Mattress Sys., 2020 WL 861520 at *4; see also Certain L-Tryptophan,
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`2020 WL 4500710 at *4 n.2. Thus, the Commission has determined that if the Federal Circuit
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`dismisses the pending appeals as moot, the Commission will vacate its final determination upon
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`remand from the Federal Circuit.15
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`13 The public interest considerations against vacatur are based on the presumption that decisions
`are correct and beneficial to the legal community. To the extent that the public interest would
`favor non-vacatur, it is greatly outweighed by the potential harm to Daewoong from the
`preclusion (or risk of preclusion) that vacatur is meant to prevent.
`14 As Daewoong correctly recognizes, “tribunals generally