Commission opens antitrust investigation into Align Technology's conduct regarding Invisalign clear aligners and intra-oral scanners

The European Commission has opened a formal antitrust investigation to assess whether Align Technology has breached EU competition rules by tying its intra-oral scanners to its dental clear aligners branded as Invisalign in the European Economic Area ('EEA'). This investigation, which follows a complaint by a competitor, is the first formal antitrust investigation in the medical devices sector.

Align Technology, headquartered in the US, is a global medical device company specialising in two flagship products. First, clear aligners sold under the Invisalign brand, which are customised removable dental aligners made of clear plastic designed to treat teeth misalignment. Until 2017, Invisalign held a near monopoly in clear aligners due to patent protection. Second, Align Technology also markets intra-oral scanners, branded as iTero, used by dental professionals to generate a 3D digital scan of a patient's teeth and jaws.

Intra-oral scanners are the digital entry-point into the clear aligner market. Digital scans generated by these scanners are used for orthodontic treatments, such as clear aligners, and restorative treatments, such as crowns and implants. Practically, they are used by dental professionals to order clear aligners.

The Commission is concerned that Align Technology may have unfairly leveraged its market-leading Invisalign clear aligners, by effectively forcing dental professionals to purchase the iTero scanner if they wish to order Invisalign for their patients.

The investigation focuses on Align Technology's restrictive interoperability strategy, implemented through two key measures:

• a refusal to approve competing state-of-the-art scanners for the automated submission to Align of digital scans for Invisalign orders since 2017.
• a refusal to accept dental professionals' submissions of scans generated by other intra-oral scanners, despite those being based on industry-standard files.

This creates a closed ecosystem around Invisalign. By limiting the possibility to order Invisalign clear aligners using competing intra-oral scanners, Align Technology may be shielding its iTero scanners from competition while protecting its possible dominance in the clear aligner market.

If proven, the practices under investigation may breach EU competition rules that prohibit the abuse of a dominant position (Article 102 of the Treaty on the Functioning of the European Union ('TFEU')) and Article 54 of the European Economic Area ('EEA') Agreement.

The Commission will now carry out its in-depth investigation as a matter of priority. The opening of a formal investigation does not prejudge its outcome.

Background

Article 102 TFEU and Article 54 of the EEA Agreement prohibit the abuse of a dominant position that may affect trade and prevent or restrict competition within the Single Market. The implementation of Article 102 TFEU is defined in Regulation 1/2003.

Article 11(6) of Regulation 1/2003 provides that the opening of proceedings by the Commission relieves the competition authorities of the Member States of their competence to apply EU competition rules to the practices concerned. Article 16(1) further provides that national courts must avoid adopting decisions which would conflict with a decision contemplated by the Commission in proceedings it has initiated.

There is no legal deadline for bringing an antitrust investigation to an end. The duration of an antitrust investigation depends on a number of factors, including the complexity of the case, the extent to which the companies concerned cooperate with the Commission and the parties' exercise of the rights of defense.

For more information

More information on the investigation will be available on the Commission's competition website, in the public case register under the case number AT.40900. For more information on the Commission's competition law enforcement in pharmaceutical and health service markets, see here.