On September 23, 2016, in Certain Digital Models, Digital Data, and Treatment Plans For Use in Making Incremental Dental Positioning Adjustment Appliances, the Appliances Made Therefrom, and Methods Of Making the Same, Inv. No. 337-TA-833, the Commission issued a notice rescinding the previously issued cease and desist orders and terminating the Investigation with a finding of no violation of Section 337.

The Case

The Investigation was instituted on April 5, 2012, based upon a complaint filed by Align Technology, Inc. that alleged violations of Section 337 in the sale for importation, importation, or sale within the United States after importation of certain digital models, digital data, and treatment plans for use in making incremental dental positioning adjustment appliances, the appliances made therefrom, and methods of making the same by reason of infringement of certain claims of U.S. Patent Nos. 6,217,325, 6,471,511, 6,626,666, 6,705,863, 6,722,880, 7,134,874, and 8,070,487. The named respondents in the Investigation were ClearCorrect Pakistan (Private), Ltd. and ClearCorrect Operating, LLC.

On May 6, 2013, the presiding ALJ issued his final initial determination, finding a violation of Section 337 with respect to the ‘325 patent, the ‘880 patent, the ‘487 patent, the ‘511 patent, the ‘863 patent, and the ‘874 patent. He found no violation as to the ‘666 patent. On review, the Commission found a violation of Section 337 with respect to claims 1 and 4-8 of the ‘863 patent; claims 1, 3, 7, and 9 of the ‘666 patent; claims 1, 3, and 5 of the ‘487 patent; claims 21, 30, 31 and 32 of the ‘325 patent; and claim 1 of the ’880 patent and issued a limited exclusion order and cease and desist orders against respondents.

ClearCorrect and Align each took appeals of the Commission’s determination to the U.S. Court of Appeals for the Federal Circuit. In ClearCorrect’s appeal, the Federal Circuit reversed the Commission’s decision that the electronic transmission of the digital models could constitute an imported “article” within the meaning of 19 U.S.C. § 1337, and remanded the case to the Commission. ClearCorrect Operating, LLC v. ITC, 810 F.3d 1283 (Fed. Cir. 2015), reh’g en banc denied, 819 F.3d 1334 (2016). The Commission did not file a petition for certiorari with the Supreme Court. In Align’s appeal, the Federal Circuit vacated and remanded the case to the Commission “for further proceedings in light of” the ClearCorrect decision. Align Tech., Inc. v. ITC, 622 F. App’x 910 (Fed. Cir. 2015).

In view of the Federal Circuit’s findings with respect to the scope of Section 337, the Commission determined to rescind the cease and desist orders and terminate the Investigation with a finding of no violation of Section 337.


The Commission’s notice brings the landmark ClearCorrect case to an end. The Federal Circuit’s holding, which was not appealed to the Supreme Court, takes the electronic transmission of digital data outside the scope of Section 337. Absent intervention by Congress, the ITC is likely unable to protect U.S. industry from electronic transmissions originating in foreign countries that infringe intellectual property rights.