ITC ruling sets clock ticking on possible Apple Watch ban

The Apple Watch is facing the threat of a US import ban in the wake of an International Trade Commission (ITC) ruling that it violated patents held by Masimo on the use of wearables to measure blood oxygen levels.

The decision marks the second time in a year that the ITC has ruled against Apple over a feature of the device and – unless vetoed by President Joe Biden in the next 60 days – could, in principle, result in a ban on Apple Watch imports into the US.

The limited exclusion order concludes that the Apple Watch infringes a pair of patents on the use of light-based pulse oximetry, namely US patent numbers 10,912,502 or 10,945,648, attributed to Masimo and Cercacor Labs, so should not be imported unless Apple negotiates a license to the intellectual property.

It upholds an earlier ITC decision in January, and also follows a federal trial over the IP in which Masimo sought $1.85 billion in damages but ended in a hung jury.

Industry observers have suggested that Biden is unlikely to veto the decision, and Apple will take the dispute to appeal, buying more time and – potentially at least – a licensing deal.

The pulse oximetry sensor was added to the Apple Watch in Series 6, which was first introduced in the US in March 2020 and has been present on some versions of the device ever since then.

Apple has just started taking pre-orders for the Series 9, which will also include a pulse oximetry sensor, although the feature has not been present on its entry-level SE devices.

In a statement, Masimo chief executive and founder Joe Kiani said the ruling “sends a powerful message that even the world’s largest company is not above the law” and is a “strong validation of our efforts to hold Apple accountable for unlawfully misappropriating our patented technology.”

Pulse oximetry is sometimes referred to as the fifth vital sign, and is increasingly being used for remote and self-monitoring of blood oxygen from home, gaining traction during the COVID-19 pandemic, as well as for continuous wireless monitoring of patients in hospital wards.

Masimo’s action has been supported by the Consumer Federation of America, which commented that “there is no greater offence to both the antitrust and intellectual property law than when a dominant firm infringes the patent of a smaller rival, who is an actual or potential competitor.”

Masimo sells a range of pulse oximetry devices based on its Singal Extraction Technology (SET), which solved some of the reliability issues associated with the approach, including a watch-like device, the Masimo W1, for patient monitoring.

In a statement, Apple claimed that Masimo “has wrongly attempted to use the ITC to keep a potentially life-saving product from millions of US consumers, while making way for their own watch that copies Apple.”