Align Technology, best known for its Invisalign clear aligner orthodontics filed a 2014 complaint against ClearCorrect for patent infringement. The complaint alleged that ClearCorrect had made a total of 18 infringements on five of its product patents. This was the third time that Invisalign legally cited patent issues concerning ClearCorrect’s use of similar products and digital imaging processes. This third complaint went before the International Trade Commission (ITC) which set an extended target date of April 2014 to complete its review of this issue.
ClearCorrect And OrthoClear
ClearCorrect was started in 2006 by Dr. Willis Pumphrey in Houston, Texas. Some five years prior, Pumphrey had been using Invisalign products in the treatment of his patients. The switch to a competing company called OrthoClear was soon made by Pumphrey due to their more efficient manufacturing process and reduced lab fees.
While Invisalign was initially founded by two graduates of Stanford University, Kelsey Wirth and Zia Chisti, Chisti soon opted to leave this business and founded OrthoClear. In 2006, an agreement was struck between OrthoClear and Invisalign such that OrthoClear would no longer manufacture or offer the same clear aligners that were first innovated under the Invisalign brand. During this time, Pumphrey had several patients who were using the OrthoClear brand and thus, he decided to start ClearCorrect rather than revert back to using Invisalign.
ClearCorrect Patent Infringements
This company has two primary headquarters. The first of these is home to Dr. Pumphrey in Texas, while the other is located in Pakistan. Infringing digital data has been produced by the Pakistan headquarters for the treatment of patients and then imported into the US to the Texas office. The resulting computer images are then manipulated by the treating orthodontist in order to provide an ideal match for the patient’s teeth. This entire process is made possible by a special program that creates a three-dimensional model of the patient’s teeth from impressions that are made in-office. Although one part of this process is performed off of U.S. soils, the overall manufacturing of the companies products closely mirrors that of Invisalign.
How Clear Aligners Work
There are a number of benefits in using these devices to improve smile aesthetics that have made them extremely popular among consumers over the past decade. They are a discreet and non-invasive way for adults to reshape and enhance the smile. Unlike conventional or wire braces, aligners can be removed when the patients brushes or eats. They are minimally invasive and are constructed to provide a custom and comfortable fit. Patients also have the option of seeing a 3D viewing of their new devices before the production process is complete. Best of all, these products can be used in treatments for those who have metal allergies and are therefore unable to use wire braces for improving smile aesthetics.
An initial set of aligners is worn by a patient for several weeks. During this time, some pressure will be felt as the teeth are encouraged to gradually shift into a more ideal positioning. Once this transition has been made and the initial devices become incapable of producing further improvements, new digital images will be created and new aligners will then be furnished based upon these images. Thus, the treating doctor will have a continued need for the products that a company produces once care has been started. For Pumphrey, the agreement for OrthoClear to stop its production of aligners meant that he must find an alternative solution in order to complete treatments currently in progress. Pumphrey apparently felt that starting his own brand of aligners was the most practical or advantageous solution. Complaints made against this effort essentially allege that there are no marked differences from the products that his companies produces and the products that were first patented.
As the sole producer of these devices, Invisalign held initial dominance of this market and had sufficient patents on its products and the methods for creating them to limit likely competitors. When ClearCorrect arrived on the scene, Pumphrey appeared driven to model his business after that of OrthoClear in that he strove to maintain a more efficient production process and to limit the related lab costs. This meant that his company could offer virtually the same treatments at a notably reduced cost.
Although other competitors soon arrived on the scene boasting products that had marked differences from those produced by original patent holder on clear aligners, their imaging and production processes were not in violation of existing patents, nor were their devices. Among these are Simpli5 and Insignia.
The ITC Ruling
On April 3, 2014 the ITC announced that ClearCorrect was in clear violation of the patents concerning Align Technology. They ordered an immediate cease and decease on the production of these products and on the digital imaging processes that were being used in Pakistan. This was the first victory for the company after having made two prior and unsuccessful attempts to cite and address patent violations.
The first complaint concerning patent infringement was made by the makers of Align technology in March of 2012. Thus, it took nearly two years for ITC researchers to conclude that these were valid charges that had been leveled. Following the issue of the cease and desist order, the investigation has been closed by the ITC. 18 total violations concerning five Align technology patents were determined, as per the third complete that was filed concerning this matter. For Dr. Pumphrey, this will likely mean having to find alternative methods of completing treatments for patients whose cosmetic corrections are still in progress.