Align Technology Files ITC Section 337 Complaints Against ClearCorrect Operating LLC and ClearCorrect Pakistan

Complaints Seek International Trade Commission Investigation, Cease and Desist Order to Stop Utilization of Imported Infringing Products, and Enforcement of Prior Consent Order


SAN JOSE, Calif., March 1, 2012 (GLOBE NEWSWIRE) -- Align Technology, Inc. (Nasdaq:ALGN) today announced that it has filed two complaints with the United States International Trade Commission (ITC) against both ClearCorrect Operating, LLC, based in Houston, Texas, and ClearCorrect Pakistan (Private) Ltd., based in Lahore, Pakistan. Both complaints seek relief based on infringement of Align patents.

In the first complaint, Align asserts that ClearCorrect infringes seven Align patents, comprised of 280 claims, related to methods for planning and implementing orthodontic treatment using aligners (the "Infringement Complaint"). The complaint alleges that treatment planning for ClearCorrect's products is performed by ClearCorrect Pakistan at a facility in Lahore, Pakistan. The Infringement Complaint requests the ITC institute an immediate investigation and ultimately issue a cease and desist order prohibiting ClearCorrect from using the digital data representing orthodontic treatment that is imported into the U.S. and infringes Align's patents, and prohibiting ClearCorrect from selling aligners manufactured using such treatment plans. After Align files the Infringement Complaint, the ITC has 30 days to determine whether or not it will institute a formal Section 337 investigation.

The second complaint seeks enforcement of a prior Consent Order granted by the ITC on October 27, 2006 in the OrthoClear ITC action (the "Enforcement Complaint"). The Enforcement Complaint seeks to remedy the continuing infringement of Align's patents by ClearCorrect USA, ClearCorrect Pakistan, and certain former OrthoClear employees who now own, manage, and are employed by ClearCorrect Pakistan in Lahore, Pakistan. These individuals, previously directors and managers of OrthoClear's operations in Pakistan, are currently violating the Consent Order issued in the OrthoClear matter by continuing to engage in infringing activities, only now on behalf of ClearCorrect Pakistan.

Align became aware of ClearCorrect's operations in Pakistan during the discovery process in the Company's federal patent infringement case against ClearCorrect filed last year. Previously, ClearCorrect had not publicly acknowledged that its aligner treatment planning work is done in Pakistan or that it works with former OrthoClear employees there. Align is not aware of any former OrthoClear founders involved with ClearCorrect.

Align's existing federal court patent infringement action against ClearCorrect in the Southern District of Texas, which alleges infringement of some of the same patents at issue in the ITC action, will continue unless stayed by the Court. In the federal court action, Align seeks monetary damages and an injunction in addition to the relief available from the ITC.

"Align has invested millions of dollars in developing its technology and intellectual property and we will use every legal tool available to defend and protect that investment against infringement," said Roger E. George, Align's vice president, legal affairs and general counsel. "Align chose to seek an investigation and remedy through the ITC because of the Commission's experience in investigating and addressing importation of infringing products and because of the expedited treatment of complaints filed under Section 337."

The patents-in-suit include those listed below and cover a wide range of Align's processes, including those related to digital models and orthodontic treatment planning for aligner therapy:

  • U.S. Patent No. 6,217,325 ("the '325 patent")
  • U.S. Patent No. 6,705,863 ("the '863 patent")
  • U.S. Patent No. 6,626,666 ("the '666 patent")
  • U.S. Patent No. 8,070,487 ("the '487 patent")
  • U.S. Patent No. 6,471,511 ("the '511 patent")
  • U.S. Patent No. 6,722,880 ("the '880 patent")
  • U.S. Patent No. 7,134,874 ("the '874 patent")

About Align Technology, Inc.

Align Technology designs, manufactures and markets Invisalign, a proprietary method for treating malocclusion, or the misalignment of teeth. Invisalign corrects malocclusion using a series of clear, nearly invisible, removable appliances that gently move teeth to a desired final position. Because it does not rely on the use of metal or ceramic brackets and wires, Invisalign significantly reduces the aesthetic and other limitations associated with braces. Invisalign is appropriate for treating adults and teens. Align Technology was founded in March 1997 and received FDA clearance to market Invisalign in 1998. The Invisalign product family includes Invisalign, Invisalign Teen, Invisalign Assist, Invisalign Express 10, Invisalign Express 5, and Vivera Retainers. To learn more about Invisalign or to find an Invisalign trained doctor in your area, please visit www.invisalign.com.

Cadent Holdings, Inc. is a subsidiary of Align Technology and is a leading provider of 3D digital scanning solutions for orthodontics and dentistry. The Cadent family of products includes iTero and iOC scanning systems, OrthoCAD iCast, OrthoCAD iQ and OrthoCAD iRecord. For additional information, please visit www.itero.com


            

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