notice Published 2025-12-29

Certain Clear Aligners and Components Thereof; Institution of Investigation

📌 ETDETA brief — importer impact summary (educational)

Brief takeaway: The ITC has opened a Section 337 patent-infringement investigation into imported clear aligners, which could eventually lead to import restrictions on affected products.

What changed: According to the notice, the ITC instituted an investigation based on a complaint filed by Align Technology, Inc. alleging that certain clear aligners and components are imported and sold in violation of Section 337 by infringing six named U.S. patents. The notice states the complainant asked the Commission to issue a limited exclusion order and cease and desist orders, but no such orders have been issued at this stage.

Who's affected: The notice names "certain clear aligners and components thereof" as the products at issue. It cites U.S. Patents Nos. 11,766,313; 11,766,314; 8,899,977; 12,059,321; 10,980,616; and 11,490,996. Countries of origin and HTS codes are not specified in the notice.

What to review:
- Review whether your imported products fall within the "clear aligners and components thereof" category described in the notice.
- Confirm with your broker or counsel whether any of the six named patents may be relevant to the goods you import.
- Check the ITC docket for the assigned investigation number and any respondents named as the proceeding develops.
- Review whether a potential future exclusion or cease and desist order could affect your supply chain, and discuss contingency options with counsel.

This is general information, not legal advice and not a compliance determination — confirm specifics with a licensed customs broker or trade counsel.

Official notice

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on September 23, 2025, under section 337 of the Tariff Act of 1930, as amended, on behalf of Align Technology, Inc. of Tempe, Arizona. A letter supplementing the complaint was filed on November 20, 2025. 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 clear aligners and components thereof by reason of the infringement of certain claims of U.S. Patent No. 11,766,313 ("the '313 patent"); U.S. Patent No. 11,766,314 ("the '314 patent"); U.S. Patent No. 8,899,977 ("the '977 patent"); U.S. Patent No. 12,059,321 ("the '321 patent"); U.S. Patent No. 10,980,616 ("the '616 patent"); and U.S. Patent No. 11,490,996 ("the '996 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.

Source: Federal Register · International Trade Commission · Read the official notice ↗

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This update is a general educational summary based on public CBP CSMS / Federal Register information. It is not legal advice, customs broker advice, a final classification, duty determination, entry instruction, or compliance determination. Importers should confirm applicability, effective dates, HTSUS/Chapter 99 reporting, rates, refunds, PSC procedures, and filing instructions with their licensed customs broker, trade counsel, and/or CBP.