Live WebinarPeriodontitis: A crash course in the context of the new World Workshop Classification, from diagnosis to treatment and maintenance
08 Mar 2021, 12:00 PM EST (New York)
Jonathan Du Toit MSc (Dent), MChD (OMP), FCD(SA) OMP, PhD
The conflict officially began back in November 2017, when Align filed six patent infringement lawsuits regarding 3Shape’s TRIOS intra-oral scanner and Dental System software. Four of the complaints were lodged in the District Court for Delaware, while the other two—Section 337 complaints that alleged that 3Shape was violating US trade laws by selling these patent-infringing products—were lodged with the US International Trade Commission (ITC).
In December 2018, Align filed an additional Section 337 complaint with the ITC, as well as two more separate complaints with the District Court for Delaware, as it sought cease-and-desist and exclusion orders that would prevent 3Shape from importing its TRIOS scanning system, among other products, into the US. These three lawsuits were filed even though the original six lawsuits were still pending resolution.
“The continued nature of 3Shape’s infringing activities forced Align’s further enforcement of its deep patent portfolio,” Roger George, then Align Technology’s senior vice president and chief legal and regulatory officer, said at the time. “We will not allow competitors to take advantage of our significant investments into research and development by continuing to implement product features that infringe our patents.”
3Shape was quick to defend itself against these claims of frequent patent infringement, stating in a November 2017 press release that the original lawsuits were “completely unfounded and without merit”. In May and June 2018, the Danish company filed two patent infringement complaints against Align, followed in August of the same year by an anti-trust lawsuit alleging, among other claims, that Align was attempting to block the sale of competing scanners that could be used for orthodontic treatment.
“Align is illegally holding on to their monopoly of clear aligners after expiry of many of their patents, by effectively forcing dental professionals to buy Align’s intra-oral scanner which, with regard to clear aligners and for most practical purposes, is only used for Align’s own clear aligner product Invisalign,” said Wendelynne Newton, counsel for 3Shape, at the time.
In 2019, multiple judgments were handed down regarding the investigations of the patent infringements filed by Align that, by and large, resulted favourably for 3Shape. The ITC issued notices of initial determination in March and April that found that, in relation to the original Section 337 claims filed in November 2017, no violation of Align’s patent rights had been committed by 3Shape. These results were confirmed by final rulings later in the year, prompting then 3Shape co-CEO Tais Clausen to declare it as “yet another victory for 3Shape, innovation, and dental professionals”.
In May 2020, an ITC notice of initial determination related to the Section 337 complaint from December 2018 complicated the situation somewhat by finding that 3Shape had, in fact, infringed seven of nine patent claims asserted in the case by Align. However, the patents asserted against 3Shape’s TRIOS intra-oral scanner were found not to have been infringed upon, leading both companies to declare a victory of sorts in the immediate aftermath. A final determination, signalling the completion of the investigation, is scheduled to be released on 2 November.
As it stands, there are currently seven separate patent infringement lawsuits that have been filed by Align against 3Shape in US courts relating to over 30 patents. Meanwhile, 3Shape’s anti-trust lawsuit and one of its patent infringement cases against Align are currently pending in the District Court for Delaware.