Apple faces lawsuit over oxygen monitoring patents

Shortly before the lights went out in 2023, Apple found itself in turmoil over the patents for the blood oxygen saturation monitoring technology in its Watch Series 9 and Watch Ultra 2 smartwatches. The ITC, the US federal agency that deals with international trade disputes, identified that a feature of the Apple Watch models for reading blood oxygen levels infringed the pulse oximetry patents of Masimo, a California-based medical device manufacturer.

Based on these arguments, Masimo has filed a lawsuit against Apple on the grounds of patent infringement. Because of this legal dispute, Apple would be prohibited from importing and selling the Watch Series 9 and Watch Ultra 2 models. However, a US appeals court granted Apple an injunction on Wednesday, December 28, suspending the ban on sales of the wearables in the United States.

This is just a pause in the sales ban, not the end of the dispute in the courts. The date for the next chapter in the confrontation is January 12, when it will be decided whether the software changes made to the Apple smart watches in question will be enough to resolve the issue. Masimo claims that this is about the main hardware, and not something that can be fixed in the software.

How did it all start?

This soap opera began about a decade ago, when Tim Cook, Apple’s CEO, received an email from an engineer claiming that they could develop a new technology that would take the company to the forefront of the medical and fitness device markets.

According to an article in Bloomberg, the Brazilian engineer had previously been technical director of Cercacor Laboratories, Masimo’s sister company, which in turn is the company suing Apple for infringing patents on blood oxygen saturation monitoring technologies. While Apple denies any wrongdoing, Masimo cites employee theft as part of its allegations.

The engineer in question joined Masimo in 2003 as a research scientist before becoming Cercacor’s chief technology officer in 2006, according to Bloomberg. Cercacor is a subsidiary of Masimo, and both are run by CEO Joe Kiani, who helped invent much of the technology cited in the lawsuits.

On the Masimo website, you can find, among other products, the Masimo W1 watch model capable of pulse oximetry and thus monitoring health parameters such as saturation, heart rate and pulse in real time.

Last November, the Masimo W1 was authorized by the FDA for use with or without a doctor’s prescription, and was cited by the company as the first watch approved by the entity to provide continuous measurements of oxygen saturation and pulse rate in real time.

According to Masimo, this FDA authorization expands the Masimo W1’s indications in the United States as a medical device for use by adults in hospitals, clinics, long-term care facilities and at home. The manufacturer emphasizes that the power of the Masimo W1 lies in the integrated Masimo MW-1 sensor, hardware and software module that precisely incorporate more than 30 years of pulse oximetry expertise into a single wearable module.

This MW-1 module uses Masimo’s proprietary signal processing algorithms to produce high-resolution oxygen saturation, pulse rate and heart rate information.

The ITC’s decisions do not affect the Apple Watch SE, the lowest-priced model that does not have pulse oximetry features, but they do not specifically point out which models with this technology are affected. Masimo argues that all Apple Watch models with the aforementioned technology infringe its patents.