[Federal Register Volume 90, Number 106 (Wednesday, June 4, 2025)]
[Notices]
[Pages 23709-23711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10122]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1352]
Certain Selective Thyroid Hormone Receptor-Beta Agonists,
Processes for Manufacturing or Relating to Same, and Products
Containing Same; Notice of Commission Final Determination Finding a
Violation of Section 337; Issuance of a Limited Exclusion Order and
Cease and Desist Orders; Termination of the Investigation
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
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SUMMARY: Notice is hereby given that the U.S. International Trade
Commission has found a violation of section 337 of the Tariff Act of
1930, as amended, in the above-captioned investigation by respondents
Ascletis Pharma Inc. of Hangzhou, Zhejiang Province, China; Ascletis
Pharmaceuticals Co. Ltd. of Shaoxing, Zhejiang Province, China;
Ascletis Bioscience Co., Ltd. of Hangzhou, Zhejiang Province, China;
and Gannex Pharma Co., Ltd. of Shanghai, China (collectively,
``Corporate Respondents''), based on their misappropriation of certain
asserted trade secrets. The
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Commission has determined to issue a seven-year limited exclusion order
(``LEO'') prohibiting the unlicensed entry into the United States of
certain selective thyroid hormone receptor-beta agonists, processes for
manufacturing or relating to same, and products containing same,
imported by or on behalf of the Corporate Respondents, and a cease and
desist order (``CDO'') against each of the Corporate Respondents. The
investigation is terminated.
FOR FURTHER INFORMATION CONTACT: Houda Morad, Esq., 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: The Commission instituted this investigation
on February 9, 2023, based on a complaint, as supplemented, filed by
Viking Therapeutics, Inc. (``Viking'' or ``Complainant'') of San Diego,
California. 88 FR 8455-56 (Feb. 9, 2023). The complaint alleges a
violation of section 337 the Tariff Act, as amended, 19 U.S.C. 1337
(``section 337''), by way of the importation into the United States of
certain selective thyroid hormone receptor-beta agonists, processes for
manufacturing or relating to same, and 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 or
prevent the establishment of a domestic industry. Id. The notice of
investigation named the following respondents: (1) the Corporate
Respondents; and (2) Jinzi Jason Wu (``Dr. Wu'') of Seattle, Washington
(collectively, ``Respondents''). Id. The Office of Unfair Import
Investigation (``OUII'') is also participating in the investigation.
Id.
On September 22, 2023, the Commission granted a motion to intervene
filed by Foster, Murphy, Altman & Nickel, PC for the ``limited purpose
of defending Foster Murphy and its attorneys' interests in response to
Complainant Viking Therapeutics, Inc.'s Omnibus Motion for Sanctions.''
See Order No. 37 (Aug. 28, 2023), unreviewed by Comm'n Notice (Sept.
22, 2023). Respondents' former counsel, Rimon PC, also filed a motion
to intervene on February 7, 2024, and the Chief Administrative Law
Judge (``Chief ALJ'') granted that motion in part, allowing Rimon PC to
participate as an intervenor to address the Chief ALJ's sanctions
decisions.
The Chief ALJ held an evidentiary hearing from November 13 to 16,
2023.
On October 3, 2024, the Chief ALJ issued a final initial
determination (``FID'') finding a violation of section 337.
Specifically, the FID finds that: (1) the Commission has statutory
authority to conduct this investigation; (2) the asserted trade secrets
are protectable; (3) Respondents misappropriated the asserted trade
secrets; (4) Complainant has demonstrated both that a domestic industry
exists and is in the process of being established; and (5) Respondents'
unfair acts have caused actual and threatened injury to Viking's
domestic industry and prevented the establishment of an industry. The
FID also grants Complainant's motion for sanctions under Commission
Rule 210.33 (19 CFR 210.33) and imposes certain non-monetary and
monetary sanctions against Respondents and/or their former counsel,
Rimon PC.
The Chief ALJ also issued a recommended determination (``RD'')
recommending, should the Commission find a violation of section 337,
that the Commission issue: (1) a seven-year LEO against certain
selective thyroid hormone receptor-beta agonists, processes for
manufacturing or relating to same, and products containing same that
are imported by or on behalf of Respondents; and (2) a CDO against each
of the Respondents. The RD also recommends that the Commission impose a
one hundred percent (100%) bond against covered articles imported by or
on behalf of the Respondents during the period of Presidential review.
Regarding the public interest, the RD finds that the statutory public
interest factors do not weigh against the issuance of remedial orders.
On November 4, 2024, Complainant filed a statement on the public
interest pursuant to Commission Rule 210.50 (19 CFR 210.50).
Respondents did not submit a statement on the public interest pursuant
to Commission Rule 210.50. In addition, the Commission did not receive
any submissions from the public in response to its post-RD Federal
Register notice. See 89 FR 82256-57 (Oct. 10, 2024).
On November 8, 2024, Respondents, Rimon PC, and OUII petitioned for
Commission review of the FID. On the same day, Complainant filed a
contingent petition for review of the FID. More specifically,
Respondents requested Commission review of the FID's findings with
respect to: (1) the Commission's statutory authority over Dr. Wu, who
is the Chief Executive Officer or President of each of the Corporate
Respondents; (2) sanctions against Respondents and their former
counsel, Rimon PC; (3) misappropriation of trade secrets; and (4)
injury to a domestic industry. Rimon PC also petitioned for Commission
review of the sanctions order against Respondents and their former
counsel. Additionally, OUII petitioned for review of: (1) the Chief
ALJ's failure to issue an ID at the conclusion of the 100-day
proceeding; (2) the FID's findings regarding the existence and
misappropriation of trade secrets; and (3) the FID's findings regarding
the existence and injury to a domestic industry. Lastly, Complainant
contingently petitioned for review of the FID's findings with respect
to: (1) misappropriation of trade secrets; (2) existence of a domestic
industry and injury thereto; and (3) sanctions against Respondents and
their former counsel. On November 27, 2024, the parties filed responses
to the petitions.
On February 12, 2025, the Commission issued a notice determining to
review the FID in its entirety. See 90 FR 9910-13 (Feb. 19, 2025)
(``the WTR Notice''). The WTR Notice also requested written submissions
from the parties, interested government agencies, and any other
interested parties on issues of remedy, the public interest, and
bonding. See id. Additionally, the notice requested responses to
certain public interest questions. See id. As directed in the WTR
Notice, the parties filed written submissions concerning the issues of
remedy, the public interest, and bonding on February 28, 2025, and
replies thereto on March 7, 2025. The Commission did not receive any
submissions from the public in response to the WTR Notice.
On April 3, 2025, the Commission issued a notice requesting
supplemental briefing on whether the alleged unfair acts have caused
substantial actual or threatened injury to Complainant's domestic
industry and/or prevented the establishment of such an industry
(``Supplemental Notice''). As directed in the Supplemental Notice, the
parties filed initial submissions on April 11, 2025, and replies
thereto on April 18, 2025.
Having examined the record of this investigation, including the
FID, the RD,
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and the parties' submissions, the Commission has determined to affirm
in part and reverse in part the FID's finding of a violation of section
337. Specifically, as explained in the Commission Opinion issued
concurrently herewith, the Commission affirms with modification the
FID's finding of a violation of section 337 by the Corporate
Respondents and adopts the Chief ALJ's sanctions order against those
respondents and their former counsel, Rimon PC. As to Dr. Wu, the
Commission reverses the FID's finding of a violation of section 337 and
vacates the sanctions order against him. More specifically, the
Commission: (1) finds that it has statutory authority over this
investigation including with respect to Dr. Wu, but finds insufficient
evidence to establish liability by Dr. Wu in his personal capacity; (2)
affirms with modification the FID's findings as to misappropriation of
trade secrets by the Corporate Respondents; and (3) affirms with
modification the FID's findings as to the domestic industry requirement
and threat of injury thereto. The Commission takes no position on the
FID's findings that Respondents' unfair acts have caused actual injury
to Viking's domestic industry or prevented the establishment of such an
industry. The Commission affirms all other findings in the FID that are
not inconsistent with its opinion.
The Commission has determined that the appropriate remedy is a
seven-year LEO prohibiting the unlicensed entry into the United States
of certain selective thyroid hormone receptor-beta agonists, processes
for manufacturing or relating to same, and products containing same,
imported by or on behalf of the Corporate Respondents, and a CDO
against each of the Corporate Respondents. The Commission has also
determined that the public interest factors enumerated in subsections
337(d)(1) and (f)(1) (19 U.S.C. 1337(d)(1), (f)(1)) do not preclude the
issuance of the LEO and CDOs. The Commission has further determined to
set a bond during the period of Presidential review (19 U.S.C. 1337(j))
in the amount of one hundred percent (100%) of the entered value of the
covered articles.
Accordingly, the investigation is terminated with a finding of a
violation of section 337 by the Corporate Respondents.
The Commission's orders and opinion were delivered to the President
and to the United States Trade Representative on the day of their
issuance.
The Commission vote for this determination took place on May 29,
2025.
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 29, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025-10122 Filed 6-3-25; 8:45 am]
BILLING CODE 7020-02-P