Certain Over-the-Counter Topical Lidocaine Patches; Notice of Institution of Investigation
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Issuing agencies
Abstract
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on March 10, 2026, under section 337 of the Tariff Act of 1930, as amended, on behalf of J.A.R. Laboratories LLC of Lake Forest, Illinois. Supplements to the complaint were filed on March 23, 2026 and March 30, 2026. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain over-the- counter topical lidocaine patches by reason of the infringement of certain claims of U.S. Patent No. 12,109,181 ("the '181 patent"). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. 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 91 Issue 71 (Tuesday, April 14, 2026)</title>
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[Federal Register Volume 91, Number 71 (Tuesday, April 14, 2026)]
[Notices]
[Page 19203]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07145]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1498]
Certain Over-the-Counter Topical Lidocaine Patches; 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 March 10, 2026, under section
337 of the Tariff Act of 1930, as amended, on behalf of J.A.R.
Laboratories LLC of Lake Forest, Illinois. Supplements to the complaint
were filed on March 23, 2026 and March 30, 2026. The complaint, as
supplemented, alleges violations of section 337 based upon the
importation into the United States, the sale for importation, and the
sale within the United States after importation of certain over-the-
counter topical lidocaine patches by reason of the infringement of
certain claims of U.S. Patent No. 12,109,181 (``the '181 patent''). The
complaint further alleges that an industry in the United States exists
as required by the applicable Federal Statute. 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#7732333e24443f121b073702041e031459101801"><span class="__cf_email__" data-cfemail="d194959882e299b4bda191a4a2b8a5b2ffb6bea7">[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: Susan Orndoff, The Office of the
Secretary, Docket Services Division, 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 April 9, 2026, 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)(B) of section 337 in the
importation into the United States, the sale for importation, or the
sale within the United States after importation of certain products
identified in paragraph (2) by reason of infringement of one or more of
claims 1 and 5 of the '181 patent, and whether an industry in the
United States exists as required by subsection (a)(2) of section 337;
(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 ``over-the-counter
topical lidocaine patches'';
(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 complainant is:
J.A.R. Laboratories LLC, 13777 Laurel Avenue, Lake Forest, Illinois
60045
(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:
Veridian Healthcare LLC, 1175 Lakeside Drive, Gurnee, Illinois 60031
Perrigo Company plc, The Sharp Building, 10-12 Hogan Place, Dublin 2,
Ireland
Perrigo Company, 515 Eastern Avenue, Allergan, Michigan 49010
Perrigo Direct, Inc., 725 Highway 74 South, Peachtree City, Georgia
30269
Opella Healthcare Group SAS, 157 Avenue Charles DeGaulle, 92200
Neuilly-sur-Seine, France
Opella North America, 21 South Street, Morristown, New Jersey 07960
Chattem, Inc., 1715 West 38th Street, Chattanooga, Tennessee 37409
Hisamitsu Pharmaceutical Co., Inc. 408, Tashirodaikan-machi Tosu, Saga
Japan 841-0017
Hisamitsu U.S., Inc., 100 Campus Drive, Suite 117, Florham, New Jersey
07932
Hisamitsu America, Inc., 100 Campus Drive, Suite 203, Florham, New
Jersey 07932
Reckitt Benckiser Group PL, 103-105 Bath Road, Slough, Berkshire, SL1
3UH, United Kingdom
Reckitt Benckiser LLC, 399 Interspace Parkway, Parsippany, New Jersey
07054
RB Health LLC, 399 Interspace Parkway, Parsippany, New Jersey 07054
(4) For the investigation so instituted, the Chief Administrative
Law Judge, U.S. International Trade Commission, shall designate the
presiding Administrative Law Judge.
The Office of Unfair Import Investigations will not participate as
a party in this investigation.
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: April 9, 2026.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2026-07145 Filed 4-13-26; 8:45 am]
BILLING CODE 7020-02-P
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