Certain Botulinum Toxin Products, Processes for Manufacturing or Relating to Same and Certain Products Containing Same Commission Decision To Review in Part a Final Initial Determination Finding a Violation of Section 337; Schedule for Filing Written Submissions, 60489-60490 [2020-21158]

Download as PDF Federal Register / Vol. 85, No. 187 / Friday, September 25, 2020 / Notices 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 Decision To Review in Part a Final Initial Determination Finding a Violation of Section 337; Schedule for Filing Written Submissions U.S. International Trade Commission. ACTION: Notice. AGENCY: Notice is hereby given that the U.S. International Trade Commission has determined to review in part a final initial determination (‘‘FID’’) of the presiding administrative law judge (‘‘ALJ’’) finding a violation of section 337 of the Tariff Act of 1930, as amended. The Commission also requests written submissions, under the schedule set forth below, on remedy, the public interest, and bonding. 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; Allergan plc of Dublin, Ireland; and Allergan, Inc. of 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 into the United States, the sale for importation, and the sale within the United States after importation of certain botulinum toxin products, khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:25 Sep 24, 2020 Jkt 250001 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’’) is also a party to the investigation. See id. On July 6, 2020, the ALJ issued the FID finding a violation of section 337 based on the importation into the United States, the sale for importation, or the sale within the United States after importation of certain 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 FID also includes a recommended determination (‘‘RD’’) recommending that, if a violation is found, the Commission issue: (1) A limited exclusion order barring entry of certain botulinum toxin products that are imported, sold for importation, and/or sold after importation by respondents Daewoong and Evolus; and (2) a cease and desist order against Evolus. The RD also recommends that the Commission impose a bond based on price differential during the period of Presidential review. On July 20, 2020, Respondents filed a petition for Commission review of the FID. On July 28, 2020, Complainants and OUII filed responses to Respondents’ petition. On September 18, 2020, Respondents filed a motion for leave to file a notice of new factual development. The Commission has determined to accept Respondents’ filing. The Commission has determined to review the FID in part. Specifically, the Commission has 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. The Commission has determined not to review the remainder of the FID. The Commission has also determined to allow Complainants to respond to Respondents’ notice of new factual development in their written submissions to the Commission pursuant to the present notice. PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 60489 In connection with its review, the Commission requests that the parties brief their positions with reference to the applicable law and the evidentiary record regarding the following questions: 1. Describe the differences between the Medytox strain and other Hall Ahyper strains and explain the relevance of those differences to Complainants’ trade secrets misappropriation claim. 2. Discuss the availability in the marketplace of Hall A-hyper strains since Dr. Hall’s discovery in the 1920s and the U.S. Army’s development in the 1940s (i.e., not just during the 2009– 2010 timeframe and thereafter). 3. For the alleged domestic industry costs regarding activities related to regulatory approvals and compliance (including costs for activities such as relevant research and development or testing): (A) Which of those regulatory activities are of a nature that can only be performed in the United States (for either legal or practical reasons), and which could have been carried out in another country; and (B) does the record permit allocation of costs between those two categories? 4. What is the federal legal standard for determining what constitutes a misappropriation of trade secrets sufficient to establish an ‘‘unfair method of competition’’ under Section 337? 5. Is injury to the complainant an element of a federal trade secret misappropriation cause of action that is necessary to establish an ‘‘unfair method of competition’’ under Section 337(a)(1)(A) (distinct from the ‘‘threat or effect’’ requirements of Section 337(a)(1)(A)(i)–(iii))? 6. Please explain whether, consistent with the federal common law, the injury requirement discussed in the FID (see FID at 45 (‘‘(4) that the respondent has used or disclosed the trade secret causing injury to the complainant.’’) (emphasis added)) refers to injury within the meaning of section 337(a)(1)(A)(i)–(iii) (i.e., ‘‘threat or effect’’ subsections) and not a separate ‘‘injury’’ requirement for establishing trade secret misappropriation. In seeking briefing on these issues, the Commission has not determined to excuse any party’s noncompliance with Commission rules and the ALJ’s procedural requirements, including requirements to present issues in submissions to the ALJ and in petitions for Commission review. The Commission may, for example, decline to disturb certain findings in the FID upon finding that issue was not presented in a timely manner to the ALJ or to the Commission. E:\FR\FM\25SEN1.SGM 25SEN1 khammond on DSKJM1Z7X2PROD with NOTICES 60490 Federal Register / Vol. 85, No. 187 / Friday, September 25, 2020 / Notices In addition, in connection with the final disposition of this investigation, the Commission may (1) issue an order that could result in the exclusion of the subject articles from entry into the United States, and/or (2) issue one or more cease and desist orders that could result in the respondent(s) being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see Certain Devices for Connecting Computers via Telephone Lines, Inv. No. 337–TA–360, USITC Pub. No. 2843 (Dec. 1994) (Comm’n Op.). If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order and/or cease and desist orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation. If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve, disapprove, or take no action on the Commission’s determination. See Presidential Memorandum of July 21, 2005, 70 FR 43251 (July 26, 2005). During this period, the subject articles would be entitled to enter the United States under bond, in an amount determined by the Commission and prescribed by the Secretary of the Treasury. The Commission is therefore interested in receiving submissions concerning the amount of the bond that should be imposed if a remedy is ordered. Written Submissions: The parties to the investigation are requested to file written submissions on the questions identified in this notice. Parties to the investigation, interested government agencies, and any other interested VerDate Sep<11>2014 18:25 Sep 24, 2020 Jkt 250001 parties are encouraged to file written submissions on the issues of remedy, the public interest, and bonding. Such submissions should also address the recommended determination by the ALJ on remedy and bonding. Complainants and the Commission Investigative Attorney are also requested to submit proposed remedial orders for the Commission’s consideration. Complainants are further requested to provide the HTSUS numbers under which the accused products are imported, and to supply the names of known importers of the products at issue in this investigation. Written submissions and proposed remedial orders must be filed no later than close of business on October 9, 2020. Reply submissions must be filed no later than the close of business on October 16, 2020. Initial written submissions may not exceed 60 pages in length, exclusive of any exhibits, while reply submissions may not exceed 30 pages in length, exclusive of any exhibits. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission. Persons filing written submissions must file the original document electronically on or before the deadlines stated above. The Commission’s paper filing requirements in 19 CFR 210.4(f) are currently waived. 85 FR 15798 (March 19, 2020). Submissions should refer to the investigation number (‘‘Inv. No. 337–TA–1145’’) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, https:// www.usitc.gov/documents/handbook_ on_filing_procedures.pdf). Persons with questions regarding filing should contact the Secretary (202–205–2000). Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel,1 solely for cybersecurity purposes. All non-confidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS. The Commission’s vote on this determination took place on September 21, 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: September 21, 2020. Lisa Barton, Secretary to the Commission. [FR Doc. 2020–21158 Filed 9–24–20; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE [OMB Number 1140–0080] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension Without Change of a Currently Approved Collection; Notification of Change of Mailing or Premise Address Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice. ACTION: 60-Day notice. AGENCY: The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection (IC) is also being published to obtain comments from the public and affected agencies. DATES: Comments are encouraged and will be accepted for 60 days until November 24, 2020. FOR FURTHER INFORMATION CONTACT: If you have additional comments, regarding the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please contact: SUMMARY: 1 All contract personnel will sign appropriate nondisclosure agreements. E:\FR\FM\25SEN1.SGM 25SEN1

Agencies

[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Notices]
[Pages 60489-60490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21158]



[[Page 60489]]

=======================================================================
-----------------------------------------------------------------------

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 
Decision To Review in Part a Final Initial Determination Finding a 
Violation of Section 337; Schedule for Filing Written Submissions

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has determined to review in part a final initial 
determination (``FID'') of the presiding administrative law judge 
(``ALJ'') finding a violation of section 337 of the Tariff Act of 1930, 
as amended. The Commission also requests written submissions, under the 
schedule set forth below, on remedy, the public interest, and bonding.

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 plc of Dublin, Ireland; 
and Allergan, Inc. of 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 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'') is also a party to the 
investigation. See id.
    On July 6, 2020, the ALJ issued the FID finding a violation of 
section 337 based on the importation into the United States, the sale 
for importation, or the sale within the United States after importation 
of certain 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 FID also includes a recommended determination (``RD'') 
recommending that, if a violation is found, the Commission issue: (1) A 
limited exclusion order barring entry of certain botulinum toxin 
products that are imported, sold for importation, and/or sold after 
importation by respondents Daewoong and Evolus; and (2) a cease and 
desist order against Evolus. The RD also recommends that the Commission 
impose a bond based on price differential during the period of 
Presidential review.
    On July 20, 2020, Respondents filed a petition for Commission 
review of the FID. On July 28, 2020, Complainants and OUII filed 
responses to Respondents' petition. On September 18, 2020, Respondents 
filed a motion for leave to file a notice of new factual development. 
The Commission has determined to accept Respondents' filing.
    The Commission has determined to review the FID in part. 
Specifically, the Commission has 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. The Commission has determined not to review 
the remainder of the FID. The Commission has also determined to allow 
Complainants to respond to Respondents' notice of new factual 
development in their written submissions to the Commission pursuant to 
the present notice.
    In connection with its review, the Commission requests that the 
parties brief their positions with reference to the applicable law and 
the evidentiary record regarding the following questions:
    1. Describe the differences between the Medytox strain and other 
Hall A-hyper strains and explain the relevance of those differences to 
Complainants' trade secrets misappropriation claim.
    2. Discuss the availability in the marketplace of Hall A-hyper 
strains since Dr. Hall's discovery in the 1920s and the U.S. Army's 
development in the 1940s (i.e., not just during the 2009-2010 timeframe 
and thereafter).
    3. For the alleged domestic industry costs regarding activities 
related to regulatory approvals and compliance (including costs for 
activities such as relevant research and development or testing): (A) 
Which of those regulatory activities are of a nature that can only be 
performed in the United States (for either legal or practical reasons), 
and which could have been carried out in another country; and (B) does 
the record permit allocation of costs between those two categories?
    4. What is the federal legal standard for determining what 
constitutes a misappropriation of trade secrets sufficient to establish 
an ``unfair method of competition'' under Section 337?
    5. Is injury to the complainant an element of a federal trade 
secret misappropriation cause of action that is necessary to establish 
an ``unfair method of competition'' under Section 337(a)(1)(A) 
(distinct from the ``threat or effect'' requirements of Section 
337(a)(1)(A)(i)-(iii))?
    6. Please explain whether, consistent with the federal common law, 
the injury requirement discussed in the FID (see FID at 45 (``(4) that 
the respondent has used or disclosed the trade secret causing injury to 
the complainant.'') (emphasis added)) refers to injury within the 
meaning of section 337(a)(1)(A)(i)-(iii) (i.e., ``threat or effect'' 
subsections) and not a separate ``injury'' requirement for establishing 
trade secret misappropriation.
    In seeking briefing on these issues, the Commission has not 
determined to excuse any party's noncompliance with Commission rules 
and the ALJ's procedural requirements, including requirements to 
present issues in submissions to the ALJ and in petitions for 
Commission review. The Commission may, for example, decline to disturb 
certain findings in the FID upon finding that issue was not presented 
in a timely manner to the ALJ or to the Commission.

[[Page 60490]]

    In addition, in connection with the final disposition of this 
investigation, the Commission may (1) issue an order that could result 
in the exclusion of the subject articles from entry into the United 
States, and/or (2) issue one or more cease and desist orders that could 
result in the respondent(s) being required to cease and desist from 
engaging in unfair acts in the importation and sale of such articles. 
Accordingly, the Commission is interested in receiving written 
submissions that address the form of remedy, if any, that should be 
ordered. If a party seeks exclusion of an article from entry into the 
United States for purposes other than entry for consumption, the party 
should so indicate and provide information establishing that activities 
involving other types of entry either are adversely affecting it or 
likely to do so. For background, see Certain Devices for Connecting 
Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843 
(Dec. 1994) (Comm'n Op.).
    If the Commission contemplates some form of remedy, it must 
consider the effects of that remedy upon the public interest. The 
factors the Commission will consider include the effect that an 
exclusion order and/or cease and desist orders would have on (1) the 
public health and welfare, (2) competitive conditions in the U.S. 
economy, (3) U.S. production of articles that are like or directly 
competitive with those that are subject to investigation, and (4) U.S. 
consumers. The Commission is therefore interested in receiving written 
submissions that address the aforementioned public interest factors in 
the context of this investigation.
    If the Commission orders some form of remedy, the U.S. Trade 
Representative, as delegated by the President, has 60 days to approve, 
disapprove, or take no action on the Commission's determination. See 
Presidential Memorandum of July 21, 2005, 70 FR 43251 (July 26, 2005). 
During this period, the subject articles would be entitled to enter the 
United States under bond, in an amount determined by the Commission and 
prescribed by the Secretary of the Treasury. The Commission is 
therefore interested in receiving submissions concerning the amount of 
the bond that should be imposed if a remedy is ordered.
    Written Submissions: The parties to the investigation are requested 
to file written submissions on the questions identified in this notice. 
Parties to the investigation, interested government agencies, and any 
other interested parties are encouraged to file written submissions on 
the issues of remedy, the public interest, and bonding. Such 
submissions should also address the recommended determination by the 
ALJ on remedy and bonding. Complainants and the Commission 
Investigative Attorney are also requested to submit proposed remedial 
orders for the Commission's consideration. Complainants are further 
requested to provide the HTSUS numbers under which the accused products 
are imported, and to supply the names of known importers of the 
products at issue in this investigation.
    Written submissions and proposed remedial orders must be filed no 
later than close of business on October 9, 2020. Reply submissions must 
be filed no later than the close of business on October 16, 2020. 
Initial written submissions may not exceed 60 pages in length, 
exclusive of any exhibits, while reply submissions may not exceed 30 
pages in length, exclusive of any exhibits. No further submissions on 
any of these issues will be permitted unless otherwise ordered by the 
Commission.
    Persons filing written submissions must file the original document 
electronically on or before the deadlines stated above. The 
Commission's paper filing requirements in 19 CFR 210.4(f) are currently 
waived. 85 FR 15798 (March 19, 2020). Submissions should refer to the 
investigation number (``Inv. No. 337-TA-1145'') in a prominent place on 
the cover page and/or the first page. (See Handbook for Electronic 
Filing Procedures, https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf). Persons with questions regarding 
filing should contact the Secretary (202-205-2000).
    Any person desiring to submit a document to the Commission in 
confidence must request confidential treatment. All such requests 
should be directed to the Secretary to the Commission and must include 
a full statement of the reasons why the Commission should grant such 
treatment. See 19 CFR 201.6. Documents for which confidential treatment 
by the Commission is properly sought will be treated accordingly. All 
information, including confidential business information and documents 
for which confidential treatment is properly sought, submitted to the 
Commission for purposes of this Investigation may be disclosed to and 
used: (i) By the Commission, its employees and Offices, and contract 
personnel (a) for developing or maintaining the records of this or a 
related proceeding, or (b) in internal investigations, audits, reviews, 
and evaluations relating to the programs, personnel, and operations of 
the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. 
government employees and contract personnel,\1\ solely for 
cybersecurity purposes. All non-confidential written submissions will 
be available for public inspection at the Office of the Secretary and 
on EDIS.
---------------------------------------------------------------------------

    \1\ All contract personnel will sign appropriate nondisclosure 
agreements.
---------------------------------------------------------------------------

    The Commission's vote on this determination took place on September 
21, 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: September 21, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020-21158 Filed 9-24-20; 8:45 am]
BILLING CODE 7020-02-P