Ban on Apple Watches with pulse oximetry renews in US

Apple has once again been prevented from selling two of its Apple Watch models in the US, in the latest phase of its patent dispute with health wearable company Masimo.

The tech giant stopped selling and importing versions of its Series 9 and Ultra 2 Apple Watches towards the end of last year over a complaint that the devices violated Masimo patents on the use of pulse oximetry sensors in wearables to measure blood oxygen levels.

It resumed sales as 2023 drew to a close after filing an emergency appeal against the ban, ordered by the International Trade Commission (ITC) in October, but a federal court has now ruled that the infringing devices must be taken off the market until the patent litigation reaches a conclusion.

Other Apple Watches are not affected by the orders, nor are devices sold outside the US or devices previously sold with the sensors.

In response, Apple has used a software tweak to disable the pulse oximetry sensors in existing supplies of the two models to allow sales to continue and said those versions will be available from today. It’s not immediately clear if that will satisfy the terms of the ban or if the software change could be circumvented by users, however, newly-manufactured devices will have the sensors removed altogether.

Analysts have suggested that it could take a year or more for the patent litigation to play out and there is no guarantee that Apple will win. The company said it “strongly disagreed” with the federal court judgment, but would comply with the ban.

The ongoing lawsuit follows a federal trial over the IP in which Masimo sought $1.85 billion in damages, but ended in a hung jury. The health wearables company has also accused Apple of poaching its staff and appropriating its pulse oximeter technology.

Pulse oximetry is increasingly being used for remote and self-monitoring of blood oxygen in wearables, and Masimo sells a range of devices for patient monitoring purposes, including a recently approved baby monitoring system and the watch-based Masimo W1.

The company has annual revenues of around $2 billion a year, compared to Apple’s revenues of almost $400 billion.

Masimo’s founder and chief executive, Joe Kiani, said the federal court ruling “affirms that even the largest and most powerful companies must respect the intellectual rights of American inventors and must deal with the consequences when they are caught infringing others’ patents.”

The Apple Watch dominates the smartwatch market, with around 50 million units sold last year, taking the total sold since it launched in 2015 to around 230 million. Apple has included a pulse oximeter feature in smartwatches since its Series 6 Apple Watch in 2020.

“Apple’s appeal is ongoing, and we believe the US Court of Appeals for the Federal Circuit should reverse the […] ITC’s decision,” the company said in its statement. “We strongly disagree with the […] ITC decision and resulting orders.”