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, 60469-60470 [2021-23866]
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Federal Register / Vol. 86, No. 209 / Tuesday, November 2, 2021 / Notices
of the Tariff Act of 1930, as amended,
on behalf of Easton Diamond Sports,
LLC of Thousand Oaks, California.
Supplements to the complaint were
filed on October 13 and October 18,
2021. The complaint, as supplemented,
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 composite
baseball and softball bats and
components thereof by reason of
infringement of certain claims of U.S.
Patent No. 6,997,826 (‘‘the ’826 Patent’’).
The complaint further alleges that an
industry in the United States exists as
required by the applicable Federal
Statute.
The complainant requests 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, may be viewed on the
Commission’s electronic docket (EDIS)
at https://edis.usitc.gov. For help
accessing EDIS, please email
EDIS3Help@usitc.gov. 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.
FOR FURTHER INFORMATION CONTACT:
Katherine Hiner, Office of Docket
Services, U.S. International Trade
Commission, telephone (202) 205–1802.
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 (2020).
Scope of Investigation: Having
considered the complaint, the U.S.
International Trade Commission, on
October 26, 2021, ordered that—
(1) Pursuant to subsection (b) of
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)(B) 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
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17:42 Nov 01, 2021
Jkt 256001
identified in paragraph (2) by reason of
infringement of one or more of claims
1–5, 9–12, 14–15, and 18–19 of the ’826
Patent, and whether an industry in the
United States exists as required by
subsection (a)(2) of section 337;
(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 ‘‘composite baseball
and softball bats having a barrel formed
by more than one cylindrical layer of
material’’;
(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 complainant is:
Easton Diamond Sports, LLC, 3500
Willow Lane, Thousand Oaks, CA
91361
(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:
Juno Athletics LLC, 1000 Williams
Boulevard, Unit 2703, Aventura, FL
33160
Monsta Athletics LLC, 1090 5th Street,
Suite 115, Calimesa, CA 92320
Proton Sports Inc., 7904 East Chaparral
Road, Suite A110, Scottsdale, AZ
85250
(4) For the investigation so instituted,
the Chief Administrative Law Judge,
U.S. International Trade Commission,
shall designate the presiding
Administrative Law Judge.
The Office of Unfair Import
Investigations will not participate as a
party to this investigation.
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), as
amended in 85 FR 15798 (March 19,
2020), such responses will be
considered by the Commission if
received not later than 20 days after the
date of service by the complainant 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
deemed to constitute a waiver of the
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60469
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: October 27, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021–23824 Filed 11–1–21; 8:45 am]
BILLING CODE 7020–02–P
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
U.S. International Trade
Commission.
ACTION: Notice.
AGENCY:
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
EDIS3Help@usitc.gov. 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
SUMMARY:
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jspears on DSK121TN23PROD with NOTICES1
60470
Federal Register / Vol. 86, No. 209 / Tuesday, November 2, 2021 / Notices
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
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17:42 Nov 01, 2021
Jkt 256001
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
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Fmt 4703
Sfmt 4703
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
DEPARTMENT OF JUSTICE
[OMB Number 1110–0058]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Extension of
an Approved Collection; National
Incident-Based Reporting System
(NIBRS)
Federal Bureau of Investigation
(FBI), Department of Justice (DOJ).
ACTION: 60-Day notice and request for
comments.
AGENCY:
The Criminal Justice
Information Services (CJIS) Division,
FBI, DOJ, will be submitting the
following information collection request
to the Office of Management and Budget
for review and approval in accordance
with the Paperwork Reduction Act
(PRA) of 1995.
DATES: Comments are encouraged and
will be accepted for 60 days until
January 3, 2022.
FOR FURTHER INFORMATION CONTACT: All
comments, suggestions, or questions
regarding additional information, to
include obtaining a copy of the
proposed information collection
instrument with instructions, should be
directed to the Crime and Law
Enforcement Statistics (formerly the
Crime Statistics Management) Unit
Chief, Amy C. Blasher, FBI, CJIS
Division, Module D–1 1000 Custer
Hollow Road, Clarksburg, West Virginia,
26306.
SUMMARY:
E:\FR\FM\02NON1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
