ITC Issues Final Determination in Align’s Patent Infringement Case Against 3Shape

Dentistry Today


The International Trade Commission (ITC) has issued a notice of final determination in an investigation initiated by Align Technology against 3Shape A/S, 3Shape TRIOS A/S, and 3Shape Inc.

The determination modifies and reverses parts of the initial determination of the Administrative Law Judge (ALJ) finding that 3Shape infringed two of Align’s patents as well as a violation of Section 337 of the Tariff Act of 1930.

The ALJ recommended an exclusion order and a cease and desist order be entered against 3Shape’s unlawful importation, Align said.

In its notice of final determination, the ITC said it found that there was no violation of Section 337. While the ITC found that 3Shape had infringed certain Align patent claims, it also found those claims invalid.

Further, the ITC did not disturb the ALJ’s findings that two other Align patents were valid. Instead, it reversed the ALJ’s finding that 3Shape had indirectly infringed those patents.

“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,” said Julie Coletti, Align Technology senior vice president, chief legal and regulatory officer.

“We remain steadfast in our commitment to protecting our patented inventions and are proud of our history of innovation, our over $2 billion in investments in technology, and the benefit that our innovations bring to patients and doctors,” Coletti said.

“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 six US District Court cases, where we are seeking damages and injunctive relief for 3Shape’s infringement,” said Coletti.

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