ITC Issues Final Decision on Patent Infringement Case Involving 3Shape and Align Technology

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In its final ruling, the U.S. International Trade Commission finds that 3Shape has not infringed any valid Align patents, and thus, 3Shape has not committed any unfair acts as alleged by Align.

In the back and forth patent infringement case between 3Shape and Align Technology, a final ruling this week from the U.S. International Trade Commission (ITC) states that 3Shape has not infringed any valid Align patents. Shortly after the ITC ruling, both sides issued press releases and not surprisingly, offer differing views of the ruling.

On Wednesday, 3Shape announced that the company has received a favorable final ruling from the ITC in the third patent infringement complaint Align Technology has filed at the ITC against 3Shape since November 2017. Two days earlier, the ITC had issued a final decision regarding Administrative Law Judge (ALJ) MaryJoan McNamara’s opinion in Investigation No. 1144 from April 30, 2020.

In this final ruling, the ITC found that 3Shape has not infringed any valid Align patents, and thus, 3Shape has not committed any unfair acts as alleged by Align. According to 3Shape, this marks the third time the ITC has provided a favorable outcome for the company, which develops 3D scanners and CAD/CAM software solutions for the dental industry.

Last November, the ITC affirmed ALJ Cheney’s initial determination finding 3Shape had not committed any unfair act and terminated in its entirety Investigation No. 1091. Prior to that, ALJ Dee Lord also ruled in 3Shape’s favor in Investigation No. 1090, finding that 3Shape did not infringe any valid Align patents.

In a press release on Wednesday, Align announced that it was not in agreement with the lastest ruling from the ITC.


"We respectfully disagree with the Commission’s reversal of the Administrative Law Judge’s determination and are evaluating our next steps in this matter, including possible reconsideration by the full Commission and/or an appeal to the Federal Circuit,” Julie Coletti, Align Technology senior vice president, chief legal and regulatory officer, says in the press release. “We remain steadfast in our commitment to protecting our patented inventions and are proud of our history of innovation, our over two billion dollars in investments in technology and the benefit that our innovations bring to patients and doctors. The ITC is a venue where domestic industry seeks exclusion orders prohibiting importation of infringing goods. We have also asserted more than 25 patents across 6 U.S. District Court cases, where we are seeking damages and injunctive relief for 3Shape’s infringement.”

“We are pleased that the Commission has found no violation by 3Shape. Following 3Shape’s favorable outcomes in all three ITC Investigations Align initiated, this is yet another victory for 3Shape, innovation, and dental professionals,” says

Jakob Just-Bomholt, CEO of 3Shape, says the company is pleased that the Commission did not find any violations by 3Shape. He a statement released by 3Shape, he says: “Align has attempted to use ITC investigations to block 3Shape’s innovative products in the intraoral scanner market and has now completely failed in its attempt.”

In addition to defending against Align’s infringement claims in the ITC and the District Court of Delaware, 3Shape has filed its own patent infringement claims against Align in the District Court of Delaware to address Align’s infringement of a number of 3Shape patents, 24 petitions for IPRs with the United States Patent and Trademark Office (USPTO) to address the invalidity of a number of Align patents, and an antitrust lawsuit in the District Court of Delaware to address Align’s abuse of monopoly power.

The initial determination of the Administrative Law Judge (ALJ) had found 3Shape infringed two of Align’s patents and found a violation of Section 337 of the Tariff Act of 1930. The ALJ recommended an exclusion order and cease and desist order be entered against 3Shape’s unlawful importation, but this ruling came prior to this week’s announced reversal.

The Commission now has found that there was no violation of Section 337. The Commission found that 3Shape had infringed certain Align patent claims, but found those claims invalid. The Commission further did not disturb the ALJ’s findings that two other Align patents were valid, but reversed the ALJ’s finding that 3Shape had indirectly infringed those patents.

Align Technology’s iTero intraoral scanners are designed to deliver speed, reliability, intuitive operations, and optimal visualization capabilities for general practitioners or orthodontists. The company is a leading provider of clear aligner solutions with the Invisalign system.