[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4912-4913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01917]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1296]


Certain Adalimumab, Processes for Manufacturing or Relating to 
Same, and Products Containing Same; Notice of Institution of 
Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that a complaint was filed with the 
U.S. International Trade Commission on December 17, 2021, under section 
337 of the Tariff Act of 1930, as amended, on behalf of AbbVie Inc. of 
Chicago, Illinois; AbbVie Biotechnology Ltd. of Bermuda; and AbbVie 
Operations Singapore Pte. Ltd. of Singapore. A supplement to the 
complaint was filed on January 4, 2022. The complaint, as supplemented, 
alleges violations of section 337 based upon the importation into the 
United States and the sale of certain adalimumab, processes for 
manufacturing or relating to same, and products containing same by 
reason of the misappropriation of trade secrets and tortious 
interference with contractual relations, the threat or effect of which 
is to destroy or substantially injure an industry in the United States. 
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 
<a href="/cdn-cgi/l/email-protection#4a0f0e031979022f263a0a3f39233e29642d253c"><span class="__cf_email__" data-cfemail="d095949983e398b5bca090a5a3b9a4b3feb7bfa6">[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 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: 
    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 (2021).
    Scope of Investigation: Having considered the complaint, the U.S. 
International Trade Commission, on January 25, 2022, 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 or in the sale of certain products 
identified in paragraph (2) by reason of the misappropriation of trade 
secrets and tortious interference with contractual relations, the 
threat or effect of which is to destroy or substantially injure 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 ``adalimumab (drug 
substance and drug product), vials, prefilled syringes, autoinjectors 
or other presentations containing same, and the methods of 
manufacturing and processes for making the same'';
    (3) 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 Rd., North Chicago, IL 60064
AbbVie Biotechnology Ltd, Harbour Fiduciary Services Limited, Thistle 
House, 4 Burnaby Street, Hamilton HM11, Bermuda
AbbVie Operations Singapore Pte. Ltd., 23 Tuas South Avenue 6, 
Singapore 637022

    (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:

Alvotech hf., S[aelig]mundargata 15-19, 101 Reykjavik, Iceland
Alvotech Germany GmbH, Karl-Heinz-Beckurts-Str. 13, 52428, J[uuml]lich, 
Nordrhein-Westfalen, Germany
Alvotech Swiss AG, Thurgauerstrasse 54 Z[uuml]rich, 8050 Switzerland
Alvotech USA Inc., 1201 Wilson Blvd., Ste 2130, Arlington, VA, 22209
Ivers-Lee AG, Kirchbergstrasse 160, Burgdorf, Bern, 3400 Switzerland
Teva Pharmaceutical Industries Ltd., 5 Basel Street, Petach Tikva, 
49131 Israel
Teva Pharmaceuticals USA Inc., 1090 Horsham Road, North Wales, PA 19454

    (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), 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 
complainants 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/the respondents 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

[[Page 4913]]

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: January 26, 2022.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2022-01917 Filed 1-28-22; 8:45 am]
BILLING CODE 7020-02-P


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