ITC Opens 337 Investigation on Lidocaine Patches (Patent Infringement)

Content

ACTION:

Notice.

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 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.

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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