Align Technology and the U.S. International Trade Commission (ITC) will not appeal a 2015 federal court decision that determined the ITC does not have the authority to regulate data, according to a statement from ClearCorrect. While the decision reinforces that the ITC doesn't have jurisdiction over data, legal disputes between the two aligner creators are not over yet.
ClearCorrect noted that Align and the ITC did not file an appeal to potentially have the Supreme Court hear the case by the August 26 deadline. When asked to confirm, the ITC said it would not comment "on matters related to litigation." Align also declined to comment since "the ITC has not issued a statement regarding their decision to appeal or not appeal," a spokesperson wrote in an email to DrBicuspid.com.
Meanwhile, ClearCorrect claimed victory in its own press release.
"ClearCorrect is happy to announce that the ITC and Align have elected not to appeal that decision, solidifying the third victory in a row for ClearCorrect after several years of litigation," the company said. "Now that the ITC decision is finalized, Align's sole remaining lawsuit against ClearCorrect is expected to resume in Texas federal court."
Multiyear dispute over ITC jurisdiction
The heart of the ITC dispute is whether the commission has the authority to regulate the process by which ClearCorrect aligners are created. ClearCorrect, which is based in Texas, digitally sends scans of patients' mouths to ClearCorrect Pakistan. ClearCorrect Pakistan then creates treatment plans, which are sent electronically back to the U.S. and are used to create the physical orthodontic aligners. The company sends about half of its scans to Pakistan.
Align Technology first filed an ITC complaint against ClearCorrect in 2012, asserting that ClearCorrect's aligners infringed on Align's patents. However, in November 2015, the U.S. Court of Appeals for the Federal Circuit ruled that the ITC does not have the ability to regulate digital goods, including the data ClearCorrect imports from Pakistan to make its aligners.
After the appellate court ruling, Roger E. George, Align's vice president and general counsel, emphasized that the company will continue pursuing ClearCorrect for patent infringement.
"This is not a decision against Align, and it is not a decision about patent infringement -- it's about jurisdiction," he said in a statement. "And if it is determined that the ITC cannot enforce the previously determined finding of infringement of Align's patents, then we will pursue relief in a venue that can."
Returning to a 2011 lawsuit
Align is not done pursuing ClearCorrect for patent infringement. The company filed a 2011 lawsuit against ClearCorrect and related corporate entities, which was stayed indefinitely by the U.S. District Court for the Southern District of Texas during the ITC legal proceedings because of overlapping complaints.
In that lawsuit, Align alleged that ClearCorrect infringed on eight of its patents by making, offering to sell, and selling its clear-aligner therapy systems. ClearCorrect countersued in response, maintaining that it does not infringe upon any of Align's valid intellectual property.
Should the ITC not purse its litigation further, the district court lawsuit will resume, which ClearCorrect is optimistic will go its way.
"ClearCorrect anticipates that this final case will follow in the footsteps of the previous three [decisions] and demonstrate that ClearCorrect does not violate any valid patents held by Align," the company said.
Jarrett Pumphrey, ClearCorrect's CEO, told DrBicuspid.com by email that the decision by Align and the ITC not to pursue an appeal validates his company's position.
"This latest victory further validates the position we've held all along -- we do not violate any valid intellectual property," Pumphrey said. "We're looking forward to resolving the final case with similar results."