By Eric Schweibenz
On March 1, 2012, Align Technology, Inc. of San Jose, California (“Align”) filed a complaint requesting that the ITC commence an investigation pursuant to Section 337.

The complaint alleges that ClearCorrect Pakistan (Private), Ltd. of Pakistan (“ClearCorrect Pakistan”) and ClearCorrect Operating, LLC of Houston, Texas (collectively, “ClearCorrect”) unlawfully import into the U.S., sell for importation, and/or sell within the U.S. after importation certain digital models, digital data, or treatment plans for use in making incremental dental positioning adjustment appliances that infringe—or are made, produced, or processed by means of a process that infringes—one or more claims of U.S. Patent Nos. 6,217,325 (the ‘325 patent), 6,705,863 (the ‘863 patent), 6,626,666 (the ‘666 patent), 8,070,487 (the ‘487 patent), 6,471,511 (the ‘511 patent), 6,722,880 (the ‘880 patent), and 7,134,874 (the ‘874 patent) (collectively, the “asserted patents”).

According to the complaint, the asserted patents generally relate to novel methods of straightening teeth.  In particular, the ‘325 patent relates to methods for facilitating tooth repositioning treatment and fabricating tooth repositioning appliances.  The ‘511 patent relates to, among other things, a computer-implemented orthodontic treatment plan.  The ‘666 patent relates to methods for producing a plurality of digital data sets representing tooth arrangements.  The ‘863 patent relates to a method for producing digital models for use in fabricating incremental dental positioning appliances.  The ‘880 patent relates to methods of using digital data sets representing tooth arrangements to fabricate aligners.  Lastly, the ‘874 and ‘487 patents relate to computer-implemented methods of creating treatment plans.

In the complaint, Align states that ClearCorrect imports and sells products that infringe the asserted patents.  The complaint specifically names the ClearCorrect System and ClearCorrect appliances that are used with the ClearCorrect System as infringing products.

Regarding domestic industry, Align states that the asserted patents cover and relate to its Invisalign System, which encompasses proprietary software programs, sophisticated design parameters and tools, extensive know-how, advanced production processes, and ultimately, customized aligners and computerized interfaces used to treat patients.  As to the economic prong, Align refers to its 122,350 square-foot headquarters in San Jose, California.  Align states that this facility is home to Align’s senior executive officers, as well as the marketing and sales, customer care, research and development, software engineering, and administrative functions of the company.  Align states that it has over 2,500 employees, approximately 600 of whom are in the U.S.  Align further states that it has spent over $240 million in research and development of the Invisalign System.

As to related litigation, Align states that it has instituted civil litigation against ClearCorrect in the U.S. District Court for the Southern District of Texas based in part on some of the acts of patent infringement asserted in the instant ITC complaint.  Align further states that in January 2005, it filed an ITC complaint against an entity known as OrthoClear alleging trade secret misappropriation and infringement of many of the same patents asserted in the instant ITC complaint.  According to the instant complaint, on October 13, 2006, Align and OrthoClear entered into a Consent Order whereby OrthoClear and its officers, directors, agents, servants, employees, successors, and assigns agreed (1) to not import articles infringing any of the patents-in-suit, and (2) to not sell, import, sell after importation, or aid/abet/encourage/participate in, or induce the sale for importation of the articles at issue.  The instant complaint states that, in spite of this Consent Order, former OrthoClear managers, directors, and operators are now infringing Align’s patents under the auspices of ClearCorrect Pakistan.  Accordingly, Align further states that contemporaneously with the filing of the instant ITC complaint, it is also requesting the initiation of an ITC enforcement action to address the former OrthoClear employees’ violation of the Consent Order through their work in managing, owning, operating, and/or working for ClearCorrect Pakistan.

With respect to potential remedy, Align requests that the Commission issue permanent cease and desist orders directed at ClearCorrect.