Certain Adalimumab, Processes for Manufacturing or Relating to Same, and Products Containing Same; Notice of Institution of Investigation
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Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 20 (Monday, January 31, 2022)</title>
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[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4912-4913]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. 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 <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) 205-2560.
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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