Certain Selective Thyroid Hormone Receptor-Beta Agonists, Processes for Manufacturing or Relating to Same, and Products Containing Same; Institution of Investigation, 8455-8457 [2023-02725]

Agencies

• INTERNATIONAL TRADE COMMISSION

[Federal Register Volume 88, Number 27 (Thursday, February 9, 2023)]
[Notices]
[Pages 8455-8457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02725]


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

INTERNATIONAL TRADE COMMISSION

[Inv. No. 337-TA-1352]


Certain Selective Thyroid Hormone Receptor-Beta Agonists, 
Processes for Manufacturing or Relating to Same, and Products 
Containing Same; Institution of Investigation

AGENCY: International Trade Commission.

ACTION: Notice.

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

SUMMARY: Notice is hereby given that a complaint was filed with the 
U.S. International Trade Commission on December 29, 2022, under section 
337 of the Tariff Act of 1930, as amended, on behalf of Viking 
Therapeutics, Inc. of San Diego, California. A supplement was filed on 
January 13, 2023. The complaint, as supplemented, alleges violations of 
section 337 based upon the importation into the United States of 
certain selective thyroid hormone

[[Page 8456]]

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. 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 
[email protected]. 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: Pathenia M. Proctor, The Office of 
Unfair Import Investigations, U.S. International Trade Commission, 
telephone (202) 205-2560.

SUPPLEMENTARY INFORMATION: 
    Scope of Investigation: Having considered the complaint, the U.S. 
International Trade Commission, on February 3, 2023, 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)(A) of section 337 in the 
importation into the United States of certain products identified in 
paragraph (2) 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 or prevent the establishment of 
an industry in the United States;
    (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 ``drug products and 
drug substances that are selective thyroid hormone receptor-beta 
agonists for the treatment of metabolic disorders and liver diseases'';
    (3) Pursuant to section 210.10(b)(3) of the Commission's Rules of 
Practice and Procedure, 19 CFR 210.10(b)(3), the presiding 
Administrative Law Judge shall hold an early evidentiary hearing, find 
facts, and issue an early decision, within 100 days of institution 
except for good cause shown, as to whether complainant can show that 
the threat or effect of the alleged unfair acts is to (i) to destroy or 
substantially injure an industry in the United States, or (ii) to 
prevent the establishment of such an industry. Notwithstanding any 
Commission Rules to the contrary, which are hereby waived, any such 
decision should be issued in the form of an initial determination (ID) 
under Commission Rule 210.42(a)(3), 19 CFR 210.42(a)(3). The ID will 
become the Commission's final determination 30 days after the date of 
service of the ID unless the Commission determines to review the ID. 
Any such review will be conducted in accordance with Commission Rules 
210.43, 210.44, and 210.45, 19 CFR 210.43, 210.44, and 210.45. The 
issuance of an early ID finding that complainant failed to demonstrate 
that the threat or effect of the alleged unfair acts is (i) to destroy 
or substantially injure an industry in the United States, or (ii) to 
prevent the establishment of such an industry shall stay the 
investigation unless the Commission orders otherwise; any other 
decision shall not stay the investigation or delay the issuance of a 
final ID covering the other issues of the investigation. Commissioner 
Schmidtlein does not support the use of a 100-day proceeding in this 
investigation. See concurrently filed Memorandum No. C086-VV-002 
(February 3, 2023);
    (4) Pursuant to Commission Rule 210.50(b)(l), 19 CFR 210.50(b)(1), 
the presiding administrative law judge shall take evidence or other 
information and hear arguments from the parties or other interested 
persons with respect to the public interest in this investigation, as 
appropriate, and provide the Commission with findings of fact and a 
recommended determination on this issue, which shall be limited to the 
statutory public interest factors set forth in 19 U.S.C. 1337(d)(l), 
(f)(1), (g)(1);
    (5) 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:

Viking Therapeutics, Inc., 9920 Pacific Heights Blvd., Suite 350, San 
Diego, CA 92121

    (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:

Ascletis Pharma Inc., 12/F, Building D, 198 Qidi Road, HIPARK, Xiaoshan 
District, Hangzhou, Zhejiang Province, China 312000
Ascletis Pharmaceuticals Co. Ltd., No.1, Yunhai Road, Lihai Town, 
Binhai New Town, Shaoxing, Zhejiang Province, China 312000
Ascletis Bioscience Co., Ltd., 12F, Building D, 198 Qidi Road, HIPARK, 
Xiaoshan District, Hangzhou, Zhejiang Province, China 311200
Gannex Pharma Co., Ltd., 3F, No. 665 Zhangjiang Road, Pilot Free Trade 
Zone, Shanghai, China 200000
Jinzi Jason Wu, 3413 E. Pine Street, Seattle, WA 98122

    (c) The Office of Unfair Import Investigations, U.S. International 
Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
    (6) For the investigation so instituted, the Chief Administrative 
Law Judge, U.S. International Trade Commission, shall designate the 
presiding Administrative Law Judge.
    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 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.
    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.

[[Page 8457]]

1337, and in section 210.10 of the Commission's Rules of Practice and 
Procedure, 19 CFR 210.10 (2022).

    Issued: February 3, 2023.
Katherine Hiner,
Acting Secretary to the Commission.
[FR Doc. 2023-02725 Filed 2-8-23; 8:45 am]
BILLING CODE 7020-02-P