84 FR 8112 - Certain Botulinum Toxin Products, Processes for Manufacturing or Relating to Same and Certain Products Containing Same; Institution of Investigation

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on January 30, 2019, under section 337 of the Tariff Act of 1930, as amended, on behalf of Medytox Inc. of South Korea; Allergan plc of Ireland; Allergan, Inc., Irvine, California. Supplements to the complaint were filed on February 12, 2019, February 13, 2019, and February 14, 2019. 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 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. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Pages 8112-8113]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2019-03987]


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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; 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 January 30, 2019, under section 
337 of the Tariff Act of 1930, as amended, on behalf of Medytox Inc. of 
South Korea; Allergan plc of Ireland; Allergan, Inc., Irvine, 
California. Supplements to the complaint were filed on February 12, 
2019, February 13, 2019, and February 14, 2019. 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 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.
    The complainants request that the Commission institute an 
investigation and, after the investigation, issue a limited exclusion 
order and cease and desist orders.

ADDRESSES: The complaint, except for any confidential information 
contained therein, is available for inspection during official business 
hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. 
International Trade Commission, 500 E Street SW, Room 112, Washington, 
DC 20436, telephone (202) 205-2000. 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. The 
public record for this investigation may be viewed on the Commission's 
electronic docket (EDIS) at https://edis.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 section 210.10 of the Commission's Rules of 
Practice and Procedure, 19 CFR 210.10 (2018).
    Scope of Investigation: Having considered the complaint, the U.S. 
International Trade Commission, on February 28, 2019, ordered that--
    (1) Pursuant to section 337 of the Tariff Act of 1930, as amended, 
an investigation be instituted to determine whether there is a 
violation of subsection (a)(1)(A) 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 misappropriation of trade secrets, the 
threat or effect of which is to destroy or substantially injure a 
domestic industry in the United States;
    (2) Pursuant to section 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 botulinum neurotoxin 
products manufactured by Daewoong Pharmaceuticals Co., Ltd., 
specifically: (1) DWP-450 (prabotulinumtoxinA), variously marketed 
under the brand names Nabota[supreg], JeuveauTM and other 
brand names; (2) products containing or derived from DWP-450; and (3) 
products containing or derived from the BTX strain assigned the high-
risk pathogen control number 4-029-CBB-IS-001 by the Korean Centers for 
Disease Control and Prevention or the manufacturing process used to 
manufacture DWP-450;
    (3) 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: Medytox Inc., 626 Tehran Road, Gangnam, 
Seoul, South Korea; Allergan plc, Clonshaugh Business and Technology 
Park, Coolock, Dublin, D17 E400, Irland; Allergan, Inc., 2525 Dupont 
Drive, Irvine, CA 92612.
    (b) The respondents are the following entities alleged to be in 
violation of section 337, and are the parties upon which the complaint 
is to be served: Daewoong Pharmaceuticals Co., Ltd., Bongeunsaro 114-
gil 12, Gangnam, Seoul, 06170; South Korea; Evolus, Inc., 17901 Von 
Karman Avenue, Suite 150, Irvine, CA 92614.
    (c) The Office of Unfair Import Investigations, U.S. International 
Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
    (4) 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 respondents in accordance with section 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), such responses will be 
considered by the Commission if received not later than 20 days after 
the date of service by the Commission 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 a respondent to file a timely response to each 
allegation in the complaint and in this notice may be

[[Page 8113]]

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: February 28, 2019.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2019-03987 Filed 3-5-19; 8:45 am]
 BILLING CODE 7020-02-P