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Legal Proceedings | 9 Months Ended
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Sep. 30, 2025
Legal Proceedings [Abstract] |
Legal Proceedings | Legal Proceedings Antitrust Class Actions On June 5, 2020, a dental practice, Simon and Simon, PC (doing business as City Smiles), brought an antitrust action in the U.S. District Court for the Northern District of California on behalf of itself and a putative class of similarly situated practices seeking treble monetary damages, interest, costs, attorneys’ fees and injunctive relief relating to our alleged market activities in alleged clear aligner and intraoral scanner markets. Plaintiff filed an amended complaint and added VIP Dental Spas as a plaintiff on August 14, 2020. On December 18, 2023, the court certified a class of persons or entities that purchased Invisalign directly from us between January 1, 2019 and March 31, 2022. The court denied Plaintiffs’ motion to certify a class of purchasers of scanners. On February 21, 2024, the court granted our motion for summary judgment on all claims brought by the plaintiffs. Plaintiffs have appealed the district court’s summary judgment ruling to the United States Court of Appeals for the Ninth Circuit. Oral argument was held on April 10, 2025. On May 3, 2021, an individual named Misty Snow brought an antitrust action in the U.S. District Court for the Northern District of California on behalf of herself and a putative class of similarly situated individuals seeking treble monetary damages, interest, costs, attorneys’ fees and injunctive relief relating to our alleged market activities in alleged clear aligner and intraoral scanner markets based on Section 2 of the Sherman Act. Plaintiffs have since filed several amended complaints adding new plaintiffs, various state law claims and allegations based on Section 1 of the Sherman Act. On November 29, 2023, the court certified a class of indirect purchasers of Invisalign between July 1, 2018 and December 31, 2023 and a class of indirect purchasers of Invisalign seeking injunctive relief. On February 21, 2024, the court granted our motion for summary judgment on the claims related to Section 2 allegations. The court entered judgment for the Section 2 and related state law claims on March 22, 2024. Plaintiffs have appealed the district court’s summary judgment ruling to the United States Court of Appeals for the Ninth Circuit. Oral argument was held on April 10, 2025. We are currently unable to predict the outcome of these lawsuits and therefore we cannot determine the likelihood of loss, if any, nor estimate a range of possible loss. In June 2024, we reached a settlement in principle with the Section 1 plaintiffs to resolve all remaining claims in the Section 1 lawsuit. In March 2025, Align and plaintiffs agreed to a revised settlement to resolve all Section 1 claims for a $31.75 million cash payment. On May 28, 2025, the court granted preliminary approval of the proposed settlement. The Final Approval/Fairness hearing has been set for November 20, 2025. We are unable to predict the timeline or outcome of the court’s final approval decision. We continue to believe that plaintiffs’ Section 1 claims are without merit and remain ready to vigorously defend ourselves against those claims. During the quarter ended September 30, 2025, Align issued a payment for the full settlement amount, $31.75 million, consisting of $27.5 million accrued as of December 31, 2024 and an additional loss accrual of $4.25 million in the first quarter of 2025, to an escrow agency in accordance with the court's preliminary approval. Straumann Litigation On April 11, 2024, we filed a lawsuit in the U.S. District Court for the Western District of Texas against ClearCorrect Operating, LLC, ClearCorrect Holdings., Inc. and Institut Straumann AG (collectively the “Defendants”). The complaint asserted claims of false advertising, unfair competition, civil conspiracy and infringement of our patents related to aligner material, treatment planning, and intraoral scanner technologies. Among other things, the complaint seeks relief enjoining Defendants’ infringement of multiple of our multilayer material patents through Defendants’ manufacture, sale and offer for sale of aligners made with Zendura FLX/ClearQuartz materials. On August 29, 2025 Align filed an amended complaint for damages and injunctive relief. On September 12, 2025, Defendants filed a motion to dismiss the amended complaint. That motion to dismiss remains pending. Defendants are also seeking to invalidate all of our asserted patents at the district court and United States Patent and Trial Appeal Board. On July 9, 2024, Defendants filed counterclaims against us alleging antitrust violations, false advertising, unfair competition and breach of contract. Among other things, the counterclaims seek injunctive relief and money damages. On August 29, 2025, Defendants filed amended counterclaims, which additionally allege that Align procured certain materials patents by fraud. On September 26, 2025, Align filed a motion to dismiss the amended counterclaims. That motion remains pending. On April 10, 12 and 14, 2025, the Defendants filed eight inter partes review (“IPR”) petitions with the United States Patent Trial and Appeal Board (“PTAB”), alleging that eight of the patents asserted by Align against the Defendants are unpatentable. On October 23, 2025, the PTAB issued decisions denying institution of two of Defendants eight IPRs. On October 23, 2025, the PTAB issued a decision instituting proceedings on one of the IPRs. Decisions on the remaining five IPRs are expected on or before November 8, 2025. We believe the petitions are without merit and intend to defend ourselves vigorously. We believe Defendants’ counterclaims are without merit and intend to vigorously defend ourselves. We are currently unable to predict the outcome of this lawsuit and cannot determine the likelihood of loss, if any, nor estimate a range of possible loss. Angelalign Technology, Inc. On August 15, 2025, we initiated two actions in the European Union Patent Court against Angelalign Technology, Inc.; Angelalign France Technology SASU; Europe Angelalign Technology B.V.; Angelalign Technology (Germany) GmbH; Italy Angelalign Technology S.R.L.; Shanghai EA Medical Instruments Co., Ltd. (collectively the “Defendants”) for infringing certain patens related to use interface and attachments. The Defendants responded in one action on October 23, 2025, and have yet to respond to the other. On August 18, 2025, we filed a lawsuit in the U.S. District Court for the Eastern District of Texas against Angelalign Technology Inc., Wuxi EA Medical Instruments Technologies Ltd., Wuxi EA Bio-Tech Co., Ltd., and Shanghai EA Medical Instruments Co., Ltd (collectively the “Defendants”). The complaint alleges that the Defendants infringed our patents related to multilayer materials, bite ramps, and power ridges. Defendants have not yet responded to the complaint. On August 18, 2025, we initiated two actions in the China Intermediate People’s Court against Shanghai Angelalign Medical Devices Co., Ltd., Wuxi Angelalign Medical Device Technology Co., Ltd., and Wuxi Angelalign Biotechnology Co., Ltd (collectively the “Chinese Defendants”) for infringing patents related to attachments and force-based treatment planning. On September 10, 2025, we filed another action against the Chinese Defendants alleging infringement of our patent related to extraction site closure. The Chinese Defendants have yet to respond to the complaints. On September 23, 2025, we filed a complaint at the U.S. International Trade Commission (“ITC”) against Angelalign Technology Inc., Wuxi EA Medical Instruments Technologies Ltd., Wuxi EA Bio-Tech Co., Ltd., Shanghai EA Medical Instruments Co., Ltd., and USA Angelalign Technology Corp. (collectively, “Respondents”). The complaint alleges that Respondents are violating 19 U.S.C. § 1337 (“Section 337”) through unlawful and unauthorized importation and sale of clear aligners that infringe claims of our patents related to multilayer materials, bite ramps, and power ridges. The complaint seeks an exclusion order blocking Respondents’ importation of the infringing clear aligners into the U.S., and a cease-and-desist order prohibiting Respondent from selling, marketing, and transferring the infringing clear aligners within the U.S. The ITC has yet to institute this investigation and has ceased regular operations during the government shutdown. Respondents have yet to appear. On August 22, 2025, Shanghai Angelalign Medical Devices Co., Ltd. and Wuxi Angelalign Medical Devices Technology Co., Ltd. filed a legal action against us in the Beijing Intellectual Property Court. The complaint alleges that we violate an Angelalign patent claim relating to undercut detection for mold manufacturing and seeks money damages and injunctive relief. We believe the case is without merit and intend to defend ourselves vigorously. We are currently unable to predict the outcome of these lawsuits or any future litigation, and therefore we cannot determine the likelihood of loss, if any, nor estimate a range of possible loss. In addition to the above, in the ordinary course of our operations, we are involved in a variety of claims, suits, investigations and proceedings, including actions with respect to intellectual property claims, patent infringement claims, government investigations, labor and employment claims, breach of contract claims, tax and other matters. Regardless of the outcome, these proceedings can have an adverse impact on us because of defense costs, diversion of management resources and other factors. Although the results of complex legal proceedings are difficult to predict and our view of these matters may change in the future as litigation and events related thereto unfold; we currently do not believe that these matters, individually or in the aggregate, will materially affect our financial position, results of operations or cash flows.

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