EU antitrust investigation puts spotlight on life science bundling

The European Commission has launched an investigation into Align Technology as it looks to explore whether the Invisalign manufacture has breached EU competition rules.

The investigation will examine whether Align may have breached EU competition rules by tying its iTero intra-oral scanners to its Invisalign clear aligners in the EEA following a complaint from a competitor.

But Alex Stratakis, a competition law expert with Pinsent Masons, said the case would likely draw attention beyond the dental sector as it touches on a growing concern over commercial integration of products.

“The Align investigation is significant because it brings a traditional ‘tying’ theory of harm into the medical devices sector,” he explained.

“While integrated product offerings often deliver important benefits for customers, competition authorities are increasingly examining whether links between complementary products may have the effect of making it more difficult for rivals to compete.

"As healthcare products become increasingly connected through technology, data and digital workflows, competition law questions that were once associated primarily with the technology sector are becoming more relevant in medical devices and life sciences markets."

The Commission said it was concerned the company may have “unfairly leveraged” its aligners by effectively forcing the dental industry to use them, by refusing to approve competing scanners for automated submissions for Invisalign orders since 2017, and by refusing to accept dental professionals’ scan submissions from scanners other than their own iTero device.

Align denied it had acted in an anti-competitive way, saying in a statement: “Align is confident that any review of Align’s scanner and scan acceptance policies will reflect the robust and dynamic nature of the teeth-straightening market and believes its practices comply with applicable competition laws.

“We will cooperate fully and engage constructively with the Commission through the appropriate channels.”

The case comes just weeks after Italian competition investigators opened an inquiry into whether medical firm Biogen had used access to one of its diagnostic tools to protect sales of its multiple sclerosis treatment against rival firms.

Stratakis said both cases reflected the increasingly complex healthcare markets – where interconnected devices and services are often supplied by the same companies, meaning competition authorities were putting the commercial arrangements for those products under increased scrutiny.

"Both the Align and Biogen investigations are likely to be closely watched across the healthcare and life sciences sectors,” said Stratakis.

“They highlight the willingness of European competition authorities to scrutinise how complementary products are supplied and marketed, while also demonstrating the importance of considering potential efficiency, quality, interoperability and patient safety justifications that businesses may advance in support of integrated offerings.”