[Federal Register Volume 90, Number 32 (Wednesday, February 19, 2025)]
[Notices]
[Pages 9910-9913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02759]
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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 a Commission Determination To Review a Final
Initial Determination Finding a Violation of Section 337; Request for
Written Submissions on Remedy, the Public Interest, and Bonding
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
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SUMMARY: Notice is hereby given that the U.S. International Trade
Commission (``Commission'') has determined to review a final initial
determination (``FID'') issued by the presiding Chief Administrative
Law Judge (``Chief ALJ''), finding a violation of section 337 of the
Tariff Act of 1930, as amended. The Commission requests written
submissions from the parties, interested government agencies, and other
interested persons on the issues of remedy, the public interest, and
bonding, under the schedule set forth below.
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
[[Page 9911]]
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, by
way of the importation, sale for importation, or sale in the United
States after importation 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 as
respondents: Ascletis Pharma Inc. of Hangzhou, Zhejiang Province,
China; Ascletis Pharmaceuticals Co. of Shaoxing, Zhejiang Province,
China; Ascletis Bioscience Co. of Hangzhou, Zhejiang Province, China;
Gannex Pharma Co. of Shanghai, China; and Jinzi Jason 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).
The Chief ALJ held an evidentiary hearing from November 13 to 16,
2023.
On October 3, 2024, the Chief ALJ issued the 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. 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)
jointly and severally.
The ALJ's recommended determination (``RD'') recommends, should the
Commission find a violation of section 337, that the Commission issue:
(1) a seven-year limited exclusion order 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 cease and desist order against each
of Respondents. The RD also recommends that the Commission impose a 100
percent bond against accused articles imported 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 8, 2024, Respondents, Rimon PC (Respondents' former
counsel), 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 request 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 petitions
for Commission review of the sanctions order against Respondents and
their former counsel. Additionally, OUII petitions 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 petitions 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 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).
Having reviewed the record of the investigation, including the
final ID, the parties' submissions to the Chief ALJ, and the parties'
submissions to the Commission, the Commission has determined to review
the FID in its entirety.
In connection with the final disposition of this investigation, the
statute authorizes issuance of, inter alia, (1) an exclusion order that
could result in the exclusion of the subject articles from entry into
the United States; and/or (2) cease and desist orders that could result
in the respondents 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, Comm'n Op.
at 7-10 (Dec. 1994).
The statute requires the Commission to consider the effects of that
remedy upon the public interest. The public interest factors the
Commission will consider include the effect that an exclusion order and
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.\1\ In particular, there is interest in responses
to the following public interest questions:
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\1\ Commissioner Johanson does not join Commission questions 2
and 3 to the extent they seek briefing related to the FDA ``safe
harbor'' provision of 35 U.S.C. 271(e)(1) because it is not the
basis of the alleged violation in this investigation.
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1. Please address with support from the evidentiary record to what
extent do the statutory public interest factors set forth in 19 U.S.C.
1337(c), especially that related to public health and welfare, weigh
against the issuance of an exclusion order for a violation under 19
U.S.C. 1337(a)(1)(A) directed to the accused drug candidates in this
investigation. In answering this question, identify how many people in
the United States have been diagnosed with non-alcoholic
steatohepatitis
[[Page 9912]]
(``NASH''), the health implications of NASH (including the extent to
which that condition can be life-threatening or raise other serious
health concerns), and available treatment options.
2. Please explain with support from the evidentiary record if and
how the Commission can tailor its remedy to minimize harm to the public
interest. In particular, address whether the importation of accused
products found in violation of 19 U.S.C. 1337(a)(1)(A) should
nonetheless be permitted for purposes of ongoing or planned clinical
trials. Cf. 35 U.S.C. 271(e)(1); Amgen Inc. v. Int'l Trade Comm'n, 565
F.3d 846, 848 (Fed. Cir. 2009). If an exemption is made to allow
importation for purposes of clinical trials, please propose specific
language in the Commission's remedial orders reflecting such an
exemption and the scope/duration of such exception.
3. Please address how a finding of violation based on the alleged
trade secret misappropriation in this case might raise different public
interest issues than the policy considerations underlying the FDA
``safe harbor'' provision of 35 U.S.C. 271(e)(1).
4. Please address with support from the evidentiary record the
extent to which Madrigal Pharmaceuticals' resmetirom product, which has
been approved by the FDA for treatment of NASH, is effective for the
treatment of NASH and the extent to which Viking's VK2809 drug
candidate or Ascletis's ASC41 and ASC43F drug candidates (the accused
products) are likely to offer more effective treatment for NASH. In
answering this question, explain the extent to which the patient
population undergoing treatment for NASH with resmetirom overlaps with
the potential patient populations for Viking's VK2809 drug candidate or
Ascletis's ASC41 and ASC43F drug candidates.
5. Please address the extent to which resmetirom is available to
meet demand for treatment of NASH. Please address the extent to which
resmetirom together with Viking's VK2809 drug candidate if approved
would be available to meet demand for treatment of NASH. Would there be
a shortfall in the availability to meet demand if Ascletis's ASC41 and
ASC43F drug candidates are excluded?
6. Please address with support from the evidentiary record how many
patients in the United States are currently enrolled in or are expected
to be enrolled in clinical trials for Viking's VK2809 drug candidate
during the next seven years. Please identify the current status of each
clinical trial involving Viking's VK2809 drug candidate, including when
each clinical trial began (or is expected to begin), how many patients
are enrolled in each trial, and when each clinical trial will end (or
is expected to end). Would this answer change depending on whether
Ascletis's products are excluded?
7. Please address with support from the evidentiary record how many
patients in the United States are currently enrolled in or are expected
to be enrolled in clinical trials for Ascletis's ASC41 and ASC43F drug
candidates during the next seven years assuming the absence of an
exclusion order? Please identify the current status of each clinical
trial involving Ascletis's ASC41 and ASC43F drug candidates, including
when each clinical trial began (or is expected to begin), how many
patients are enrolled in each trial, and when each clinical trial will
end (or is expected to end).
8. Please address with support from the evidentiary record what
impact an exclusion of the accused products will have on patients with
NASH that are currently or later enrolled in clinical trials involving
Ascletis's ASC41 and ASC43F drug candidates. Explain the extent to
which patients currently or later enrolled in clinical trials involving
Ascletis's ASC41 and ASC43F drug candidates can switch to Viking's
VK2809 drug candidate, resmetirom, or any other clinical treatment for
NASH.
9. To the extent the information requested above does not exist in
the evidentiary record or emerged after the close of the evidentiary
record, please provide such information with a citation to the source
of that information.
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: 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 address the recommended
determination by the Chief ALJ on remedy, bonding, and the public
interest.
In its initial submission, Complainant is also requested to
identify the remedy sought and Complainant and OUII are requested to
submit proposed remedial orders for the Commission's consideration.
Complainant is further requested to provide the HTSUS subheadings under
which the accused products are imported, and to supply the
identification information for all known importers of the products at
issue in this investigation. The initial written submissions and
proposed remedial orders must be filed no later than close of business
on February 28, 2025. Reply submissions must be filed no later than the
close of business on March 7, 2025. No further submissions on 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 (Mar. 19, 2020). Submissions should refer to the
investigation number (Inv. No. 337-TA-1352) 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 by marking each document
with a header indicating that the document contains confidential
information. This marking will be deemed to satisfy the request
procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b)
& 210.5(e)(2)). Documents for which confidential treatment by the
Commission is properly sought will be treated accordingly. Any non-
party wishing to submit comments containing confidential information
must serve those comments on the parties to the investigation pursuant
to the applicable Administrative Protective Order. A redacted non-
confidential version of the document must also be filed with the
Commission and served on any parties to the investigation within two
business days of any confidential filing. 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
[[Page 9913]]
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, solely for
cybersecurity purposes. All contract personnel will sign appropriate
nondisclosure agreements. All nonconfidential written submissions will
be available for public inspection on EDIS.
The Commission vote for this determination took place on February
12, 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: February 12, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025-02759 Filed 2-18-25; 8:45 am]
BILLING CODE 7020-02-P