Certain Antibody Drug Conjugates and Components Thereof and Products Containing the Same; Institution of Investigation
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Issuing agencies
Abstract
Notice is hereby given that a complaint filed with the U.S. International Trade Commission on November 18, 2025, under section 337 of the Tariff Act of 1930, as amended, on behalf of AbbVie Inc. of North Chicago, Illinois; ImmunoGen, Inc. of Waltham, Massachusetts; and ImmunoGen Switzerland GmbH. A letter supplementing the complaint was filed on December 10, 2025. The complaint alleges violations of section 337 based upon the importation into the United States of certain antibody drug conjugates and components thereof and products containing the 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 or to prevent the establishment of an industry in the United States. The complainants request 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.
Full Text
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<title>Federal Register, Volume 90 Issue 243 (Monday, December 22, 2025)</title>
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[Federal Register Volume 90, Number 243 (Monday, December 22, 2025)]
[Notices]
[Pages 59867-59868]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23515]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1466]
Certain Antibody Drug Conjugates and Components Thereof and
Products Containing the Same; Institution of Investigation
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
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SUMMARY: Notice is hereby given that a complaint filed with the U.S.
International Trade Commission on November 18, 2025, under section 337
of the Tariff Act of 1930, as amended, on behalf of AbbVie Inc. of
North Chicago, Illinois; ImmunoGen, Inc. of Waltham, Massachusetts; and
ImmunoGen Switzerland GmbH. A letter supplementing the complaint was
filed on December 10, 2025. The complaint alleges violations of section
337 based upon the importation into the United States of certain
antibody drug conjugates and components thereof and products containing
the 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 or to prevent the
[[Page 59868]]
establishment of an industry in the United States.
The complainants request 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 <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. For help accessing EDIS, please email
<a href="/cdn-cgi/l/email-protection#8acfcec3d9b9c2efe6facafff9e3fee9a4ede5fc"><span class="__cf_email__" data-cfemail="d590919c86e69db0b9a595a0a6bca1b6fbb2baa3">[email protected]</span></a>. 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 <a href="https://www.usitc.gov">https://www.usitc.gov</a>.
FOR FURTHER INFORMATION CONTACT: Pathenia M. Proctor, The Office of
Unfair Import Investigations., 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 (2025).
Scope of Investigation: Having considered the complaint, the U.S.
International Trade Commission, on December 17, 2025, 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 an
industry in the United States or to 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 ``certain antibody
drug conjugates called Rina-S (also known as ``rinatabart sesutecan,''
``PRO1184,'' or ``GEN1184''), certain components thereof (i.e.,
fragments of the fully intact Rina-S ADC that include the linker as
part of the molecular structure, including (1) the linker itself; (2)
the linker combined with (bonded to) the antibody; or (3) the linker
combined with (bonded to) the drug payload), and products containing
them used in treating ovarian cancer'';
(3) 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);
(4) 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 complainants are:
AbbVie Inc., 1 North Waukegan Road, North Chicago, IL 60064
ImmunoGen, Inc., 830 Winter Street, Waltham, MA 02451-1477
ImmunoGen Switzerland GmbH, Gotthardstrasse 26, 6300 ZUG, Switzerland
(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:
ProfoundBio US Co., 401 Terry Avenue N, Seattle, WA 98109
ProfoundBio (Suzhou) Co., Ltd., No. 1 Xinze Road, Suzhou Industrial
Park, Suzhou, China 215021
Genmab A/S, Carl Jacobsens Vej 30, 2500 Valby, Denmark
Genmab B.V., Yalelaan 60, Utrecht, Utrecht, 3584 CM, Netherlands
Genmab US, Inc., 777 Scudders Mill Road, Plainsboro, NJ 08536
(c) The Office of Unfair Import Investigations, U.S. International
Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
(4) 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), such responses will be
considered by the Commission if received not later than 20 days after
the date of service by the Commission 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.
Issued: December 17, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025-23515 Filed 12-19-25; 8:45 am]
BILLING CODE 7020-02-P
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