U.S. International Trade Commission Starts Investigation on Clear Aligners

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The U.S. International Trade Commission has started an investigation into certain clear aligners and parts used to make them.

A complaint was filed on September 23, 2025, by Align Technology, Inc. from Tempe, Arizona. They said that clear plastic aligners and their parts, including the tri-layer material for the aligners, are being imported and sold in the U.S. without their permission. The complaint was updated on November 20, 2025.

Align Technology claims that some companies are using their inventions covered by these U.S. patents:

  • Patent No. 11,766,313
  • Patent No. 11,766,314
  • Patent No. 8,899,977
  • Patent No. 12,059,321
  • Patent No. 10,980,616
  • Patent No. 11,490,996

The focus will be on these claims:

  • Claims 1 and 16 of the ‘313 patent
  • Claims 1, 11, and 21 of the ‘314 patent
  • Claims 1 and 9 of the ‘977 patent
  • Claim 1 of the ‘321 patent
  • Claims 1, 12, and 20 of the ‘616 patent
  • Claims 1, 17, and 21 of the ‘996 patent

The accused companies in the investigation are:

  • Angelalign Technology Inc., Shanghai, China
  • Wuxi EA Medical Instruments Technologies Co., Ltd., Wuxi, China
  • Wuxi EA Bio-Tech Co., Ltd., Wuxi, China
  • Shanghai EA Medical Instruments Co., Ltd., Shanghai, China
  • USA Angelalign Technology Corp., Newark, Delaware

The Commission will look to see if there is a violation of section 337 of the Tariff Act of 1930. This section is about importing goods that infringe U.S. patents. If the companies are found to have broken the rules, the Commission may stop imports or sales, and issue cease and desist orders.

The investigation started on December 19, 2025. The main products being looked at are clear plastic aligners for treating misaligned teeth and bites, along with key parts used to make them.

Respondents must answer the complaint within 20 days of being served. If they do not respond in time, they may lose their right to defend themselves. The Commission and an Administrative Law Judge can then decide the case based on the claims. This may lead to orders stopping the import or sale of the accused products.

The Office of Unfair Import Investigations will not be a party to this investigation.

Anyone can view the public version of the complaint online at https://edis.usitc.gov.

The notice was issued by Lisa Barton, Secretary to the Commission, on December 19, 2025.


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