Notice2021-23866
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 2, 2021
Issuing agencies
International Trade Commission
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 209 (Tuesday, November 2, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 209 (Tuesday, November 2, 2021)]
[Notices]
[Pages 60469-60470]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. For help accessing EDIS, please email
<a href="/cdn-cgi/l/email-protection#1356575a40205b767f635366607a67703d747c65"><span class="__cf_email__" data-cfemail="afeaebe6fc9ce7cac3dfefdadcc6dbcc81c8c0d9">[email protected]</span></a>. General information concerning the Commission may
also be obtained by accessing its internet server at <a href="https://www.usitc.gov">https://www.usitc.gov</a>. 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on November 2, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.