ITC Finds Violation Of Section 337 And Issues Cease And Desist Orders In Certain Digital Models, Digital Data, And Treatment Plans For Use, In Making Incremental Dental Positioning Adjustment Appliances Made Therefrom (337-TA-833)

On April 3, 2014, the International Trade Commission (the “Commission”) issued a notice 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).  In the notice, the Commission determined to affirm-in-part, modify-in-part, and reverse-in-part the Initial Determination (“ID”) issued by former ALJ Robert K. Rogers, Jr. on May 6, 2013.  In addition, the Commission found a violation of Section 337, issued cease and desist orders, and terminated the investigation.

By way of background, the Commission instituted this investigation on March 30, 2012 based on a complaint filed by Align Technology, Inc. (“Align”).  In the Complaint, Align alleged that Respondents ClearCorrect Operating, LLC and ClearCorrect Pakistan (Private), Ltd. (collectively, “Respondents”) violated Section 337 in the importation into the U.S. and sale of certain digital models, digital data, or treatment plans for use in making incremental dental positioning adjustment appliances that infringe—or are made, produced, or processed by means of a process that infringes—one or more claims of U.S. Patent Nos. 6,217,325 (the ‘325 patent); 6,705,863 (the ‘863 patent); 6,626,666 (the ‘666 patent); 8,070,487 (the ‘487 patent); 6,471,511 (the ‘511 patent); 6,722,880 (the ‘880 patent); and 7,134,874 (the ‘874 patent).  See our March 2, 2012 and April 6, 2012 posts for more details on the complaint and Notice of Investigation, respectively.

On May 6, 2013, ALJ Rogers issued the ID.  In the ID, the ALJ found that Respondents had violated Section 337 with respect to the ‘325, ‘880, ‘487, ‘511, ‘863, and ‘874 patents.  However, the ALJ found no violation with respect to the ‘666 patent.  ALJ Rogers also recommended the issuance of cease and desist orders directed to Respondents.  See our June 24, 2013 post for more details on the ID.

On July 25, 2013, the Commission determined to review the ID in its entirety and requested briefing on the issues on review and on remedy, the public interest, and bond.  The Commission then extended the target date for completion of the investigation on four separate occasions, first to November 1, 2013, then to January 17, 2014, then to March 21, 2014, and finally to April 3, 2014.  As part of the third such extension, the Commission requested additional briefing from the parties and the public.  See our January 27, 2014 post for more details.

According to the April 3 notice, after considering the ID, the relevant portions of the record, and the submissions of the parties and the public, the Commission determined to affirm-in-part, modify-in-part, and reverse-in-part the ID and to find a violation of Section 337.  In particular, the Commission affirmed the ALJ’s conclusion that the accused products are “articles” within the meaning of Section 337(a)(1)(B) and that the mode of bringing the accused products into the U.S. constitutes importation of the accused products into the U.S. pursuant to Section 337(a)(1)(B).  The Commission further determined to find a violation of Section 337 with respect to (i) claims 1 and 4-8 of the ‘863 patent; (ii) claims 1, 3, 7, and 9 of the ‘666 patent; (iii) claims 1, 3, and 5 of the ‘487 patent; (iv) claims 21, 30, 31, and 32 of the ‘325 patent; and (v) claim 1 of the ‘880 patent.  The Commission also issued cease and desist orders directed to the Respondents, with an exemption for activities related to treatment of existing patients in the U.S.  Lastly, the Commission terminated the investigation.

The notice states that the Commission issued an opinion setting forth the reasons for its determination.  According to the notice, Commissioner Johanson dissented and filed a dissenting opinion.  We will provide additional information once the public version of the Commission opinion and dissenting opinion issue.

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