On August 20, 2012, ALJ Robert K. Rogers, Jr. issued Order No. 44 granting Complainant Align Technology’s (“Align”) motion to strike Respondents ClearCorrect Operating, LLC (“ClearCorrect USA”), ClearCorrect Pakistan (Private), Ltd., Mudassar Rathore, Waqas Wahab, Nadeem Arif, and Asim Waheed’s (collectively, “Respondents”) affirmative defenses related to invalidity or unenforceability in Certain Incremental Dental Positioning Adjustment Appliances and Methods of Producing Same (Inv. No. 337-TA-562).

According to the Order, Align argued that the Consent Order at issue in the enforcement action expressly prohibits parties bound thereto from challenging the validity or enforceability of the relevant patents, and that if any of the Respondents is found not to be bound by the Consent Order, then that respondent would no longer be a party to the investigation.  The Commission Investigative Staff (“OUII”) was also of the view that invalidity and unenforceability defenses cannot be raised in an enforcement action as a matter of law because they are precluded by the Commission Rules and typical consent order provisions.  The OUII further contended that the question of whether the Consent Order binds Respondents, who have different names than the original respondents, does not affect whether invalidity and unenforceability arguments are proper.  ClearCorrect USA countered that it was never a party to the Consent Order and is not bound by its terms, and also argued that “several of Align’s patent claims, including one of the patents at issue in the underlying investigation” were invalidated by the Federal Circuit in Ormco Corp. v. Align Technology, Inc., 463 F.3d 1299 (Fed. Cir. 2006) and Ormco Corp. v. Align Technology, Inc., 498 F.3d 1307 (Fed. Cir. 2007).

ALJ Rogers agreed with Align and the OUII that respondents who enter into consent orders cannot challenge the validity and enforceability of the patents at issue, and also noted that ClearCorrect USA failed to identify any claims at issue in the enforcement proceeding as having been reviewed and invalidated by the Federal Circuit.  Accordingly, the ALJ ruled that Respondents’ Second, Third and Sixth Affirmative defenses relating to unclean hands, invalidity and unenforceability, respectively, should be stricken.