ITC Affirms Initial Determination, Finds Infringement of Five Align Technology Patents and Issues Cease-and-Desist Orders Against ClearCorrect US and ClearCorrect Pakistan
April 3, 2014 - SAN JOSE, CA
Align Technology, Inc. (NASDAQ: ALGN) announced today that it has received notice that the International Trade Commission (ITC) affirmed the Administrative Law Judge's (ALJ) Initial Determination that the ClearCorrect entities (ClearCorrect Operating, LLC, based in Houston, Texas and ClearCorrect Pakistan (Private) Ltd., based in Lahore, Pakistan) infringe five of the patents asserted by Align in its ITC investigation. The Commission ruled in Align's favor with regard to those patents, issued cease-and-desist orders directed to the ClearCorrect entities, and terminated the investigation. The Commission's opinion and the full cease-and-desist orders are not yet available to the public or the parties, and Align may have further comment after receiving and reviewing the Commission's reasoning.
"While we have not yet had the opportunity to review the opinion, we have been notified that the Commission found a violation of Section 337 based on the finding that the ClearCorrect entities infringe at least 18 claims of Align's patents," said Roger E. George, Align Technology vice president and general counsel. "The ITC has spoken, and it agrees with the ALJ, Align, and the ITC Staff Attorneys that these patent claims are valid, and that ClearCorrect infringes them. ClearCorrect can no longer use Align's patented process to generate infringing digital data and then simply import that data from Pakistan to print out molds used to make aligners in the US. We appreciate the ITC's assistance, and we will continue to vigorously defend our patents against infringement by domestic and foreign competitors."
The Commission's decision that Align's five patents and 18 claims are valid and infringed by ClearCorrect is now final, and accordingly, the Commission issued cease-and-desist orders against both ClearCorrect entities. The Commission, addressing an issue also followed by many outside of the dental industry, found that ClearCorrect's digital files were "articles" and that their electronic transmission constituted "importation" in violation of ITC statutes. The cease-and-desist orders should take effect in 60 days, unless the President of the United States exercises his rarely-used power to veto the decision. With the ITC process now resolved, Align will likely resume its federal court patent infringement case against ClearCorrect in order to recover monetary damages unavailable at the ITC.
Align initially filed an ITC complaint against ClearCorrect on March 1, 2012, asserting that ClearCorrect's aligners are made using digital data and treatment plans imported from Pakistan that infringe Align's patents. Align also has a patent infringement action pending against ClearCorrect in the United States District Court for the Southern District of Texas alleging infringement of nine Align patents, including four additional patents not included in the ITC litigation.
About Align Technology, Inc.
Align Technology is the leader in modern clear aligner orthodontics that designs, manufactures and markets the Invisalign system, which provides dental professionals with a range of treatment options for adults and teenagers. The Company also offers the iTero 3D digital scanning system and services for orthodontic and restorative dentistry. Align Technology was founded in March 1997 and received FDA clearance to market Invisalign in 1998. Visit www.aligntech.com for more information.