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Press Release

Mar 31, 2016

Align Technology Provides Update on Federal Circuit's Denial of En Banc Review of Its November 2015 Ruling on the ITC's Jurisdiction

SAN JOSE, CA -- (Marketwired) -- 03/31/16 -- Align Technology, Inc.(NASDAQ: ALGN) today provided an update on the Federal Circuit's denial of the International Trade Commission's (ITC) and Align's requests for en banc review of its November 2015 ruling regarding the ITC's final determination issued against the ClearCorrect entities (ClearCorrect Operating, LLC, based in Houston, Texas and ClearCorrect Pakistan (Private) Ltd., based in Lahore, Pakistan). The Federal Circuit's November 2015 decision stated that the Commission's jurisdiction does not extend to transmissions of digital data and it is instead limited to importation of tangible goods.

"This is not a decision against Align and it is not a decision about the substance or compelling evidence of ClearCorrect's patent infringement -- this decision remains solely about the ITC's jurisdiction," said Roger E. George, Align Technology vice president and general counsel. "The panel's decision today has no bearing on Align's patents or position against ClearCorrect. As Judge Newman's dissenting opinion today noted, 'it is not disputed that the digital data sets and digital models for teeth alignment, produced in Pakistan and imported into the United States, infringe the patents of Align Technology.'"

Mr. George went on to say, "This case has raised precedent-setting issues regarding the limits of what the ITC can and cannot enforce regarding the patent rights of U.S. companies, but for Align this remains a basic case of our right to defend our patents against infringement. The Federal Circuit panel's opinion in November that ClearCorrect's transmission of infringing digital data falls outside the scope of the ITC's jurisdiction, even if it ultimately stands, in no way contradicts the administrative law judge's and Commission's substantive findings that the ClearCorrect entities infringe Align's valid patents. We are conferring with the Commission regarding appropriate next steps, including the possibility of seeking review from the Supreme Court. In the event no further review is sought, Align welcomes the opportunity to return to federal court in Houston and obtain its full array of remedies against ClearCorrect's proven patent infringement."

Align initially filed an ITC complaint against ClearCorrect in 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. The District Court action has been stayed pending resolution of the ITC proceeding. In the event the ITC and Align decide not to seek Supreme Court review, Align will then be free to re-commence the federal court patent infringement action in Houston and seek all available remedies against ClearCorrect for the patent infringement identified by the administrative law judge and confirmed by the ITC. 

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.

Investor Relations Contact
Shirley Stacy
Align Technology, Inc.
(408) 470-1150
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Shannon Mangum Henderson
Ethos Communication, Inc.
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Source: Align Technology

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