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Press Release

Dec 01, 2015

Align Technology Provides Update Regarding Patent Review Request Filed by ClearCorrect

SAN JOSE, CA -- (Marketwired) -- 12/01/15 -- Align Technology, Inc. (NASDAQ: ALGN) today announced that ClearCorrect Operating, LLC filed a petition for inter partes review ("IPR") of one of Align's patents with the United States Patent and Trademark Office ("USPTO"). The Petition requests that the USPTO institute an IPR to review the validity of one of the fourteen patents asserted in Align's federal district court action against SmileCareClub LLC in California. The challenged patent is not among the patents the International Trade Commission ("ITC") previously found to be valid and infringed by ClearCorrect, nor is it among the patents Align asserted in the pending federal district court action in Texas. Specifically, the Petition requests review and cancellation of certain claims of U.S. Patent No. 6,699,037 ("the '037 patent").

"This Petition is merely another chapter in ClearCorrect's ongoing attempts to avoid responsibility for its knowing and continued infringement of Align's valid patents," said Roger E. George, Align Technology vice president and general counsel. "Despite all of ClearCorrect's efforts, it has failed to achieve cancellation or a finding of invalidity regarding even a single claim out of over 200 claims involved in the Houston and ITC cases and hundreds more at issue in the SmileCareClub action. Just as the ITC rejected all of ClearCorrect's invalidity arguments, and just as all previous reexaminations of Align's patents by the USPTO have resulted in the patents being confirmed, we expect that Align will similarly be successful here. Most importantly, the Petition does not affect Align's ability to continue to aggressively pursue ClearCorrect's patent infringement in federal district court in Texas or in any appeal of the Federal Circuit's recent opinion in the International Trade Commission Action."

Align will have approximately three months to submit a preliminary response to the Petition and the USPTO will have three months from Align's response date to determine whether to institute inter partes review. If review is instituted, a panel of three Administrative Law Judges will review evidence presented by Align and ClearCorrect to determine whether ClearCorrect has carried its burden of invalidity. A final ruling would be issued within one year of the institution date.

In July 2015, ClearCorrect filed petitions for ex parte reexamination of certain of Align's patents. These proceedings differ from petitions for inter partes review in that ClearCorrect is not permitted to participate in the ongoing reexamination proceedings (it is entirely between the USPTO and Align). The ex parte reexamination process for these patents is still in the preliminary stage based on arguments provided only by ClearCorrect and no final decision has been made by the USPTO. Align recently presented rebuttal arguments for U.S. Patent No. 6,217,325. Align will respond and present its rebuttal arguments and evidence to the remaining reexamination requests as necessary. ClearCorrect previously challenged the validity of four of these patents subject to ex parte reexamination (U.S. Patent Nos. 6,217,325; 6,722,880; 8,070,487; 6,626,666) during the ITC investigation. Both the experienced ITC Administrative Law Judge and the International Trade Commission itself, after extensive additional briefing by ClearCorrect, rejected the invalidity challenges raised by ClearCorrect, specifically finding that these same patents were NOT invalid. The ALJ and the Commission also found that ClearCorrect infringed each of these patents.

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. Align also offers the iTero® 3D digital scanning system and services for orthodontic and restorative dentistry. Align was founded in March 1997 and received FDA clearance to market the Invisalign system in 1998. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign provider in your area, please visit www.invisalign.com. For additional information about the iTero 3D digital scanning system, please visit www.itero.com.

Source: Align Technology

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