If all of this information is new to you and words like Masimo and pulse oximetry are confusing, don’t worry. A lot has happened in a short span of time, and many are struggling to keep up with the entire saga, allow us to break it down for you.
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What is Masimo?
The entire dispute goes as far back as 2013, two years before the first-ever Apple Watch was released. According to a report by the Wall Street Journal, this was the time when Apple became interested in a health technology company called Masimo Corporation. Founded in 1989, Masimo is a public venture headquartered in Irvine, California. The company primarily manufactures patient monitoring devices and technologies, including non-invasive sensors using optical technology, patient management, and telehealth platforms.
The company founder, chairman, and CEO Joe Kiani started the venture and was later joined by Mohamed Diab, a senior research scientist who is at the core of the company’s scientific innovation. In the later years, Michael O’Reilly, Masimo’s then-chief medical officer also played a crucial role in developing the company’s Signal Extraction Technology (SET) pulse oximetry, which became the bone of contention between Apple and Masimo.
What is pulse oximetry?
During the COVID-19 pandemic, we have all become familiar with the term ‘blood oxygen level’. It is the amount of oxygen in your blood. For normal functioning, doctors recommend that it should be at or above 95 percent. It is only when a respiratory disorder or a genetic condition affects us, that it goes down, potentially causing a life-threatening situation for people.
For most people, there is no need to monitor blood oxygen as the body maintains it autonomously. However, in situations like COVID-19 or critical congenital heart disease (CCHD), it becomes important to keep track of it. Masimo developed a noninvasive method to check blood oxygen levels using two light-emitting diodes (LEDs), one red and one infrared. It measures the absorption of light and translates that into the percentage of hemoglobin molecules that are bound to oxygen, which is called arterial oxygen saturation (SpO2).
This method also became popular as it could only detect arterial oxygen and ignore venous blood using filters.
The Masimo patent dispute
After this background check, we go back to 2013, when Apple was developing an interest in Masimo. In particular, the SpO2 technology they owned. Apple was interested in integrating that technology in its Apple Watch which was still in the research and development phase. Senior folks from Masimo even had meetings with the Cupertino-based tech giant and as per reports, the feeling in the Masimo camp was of excitement.
However, later that year, Apple began hiring some of the key employees of Masimo, including O’Reilly. Reports claimed that they were offered big salaries and other perks to move. Soon, it became clear to Masimo that Apple never intended to form a partnership, but wanted a way to do it all by itself.
Kiani later told the WSJ, “When Apple takes an interest in a company, it’s the kiss of death. First, you get all excited. Then you realize that the long-term plan is to do it themselves and take it all”.
While this was tragic and unethical, no legal terms were broken yet. And they won’t be for the next 7 years. In the fall of 2020, as the COVID-19 pandemic was in full effect, Apple launched the Apple Watch 6, with a new feature that lets users measure their SpO2 levels without needing a medical device.
Masimo saw this coming. It became aware of the developments occurring at Apple and sued the company even before the product was launched for stealing its trade secrets and infringing upon its pulse oximetry patents.
ITC enters the scene
Patent litigation is a slow process, which revolves around scrutinizing technicalities. Looking for an immediate result, Masimo looked towards the International Trade Commission (ITC) in 2021, while it continued dragging the in-court litigation. This turned out to be a genius move because, in May 2023, the lawsuit was declared a mistrial.
However, things went bad for Apple as the ITC ruled in favor of Masimo in October 2023, after finding that Apple had infringed upon Masimo’s technology.
As a result, ITC banned the sale of every single Apple Watch in the US that contained this technology. This would be every single smartwatch by the company from the Apple Watch 6 all the way to Apple Watch Series 9 and Apple Watch Ultra 2. The Apple Watch SE was the only exception since it did not feature SpO2 monitoring.
The ban came into effect on December 26 and Apple had pulled the latest generation smartwatches from both its online and retail stores. It also shelved the refurbished Apple Watch 7 and 8, which were still in circulation.
This brings us to the present, where Apple has now received a temporary halt in the ban by an appellate court. It now remains to be seen how exactly the iPhone maker navigates from here and whether it is able to do a software-based upgrade to undo the hardware that is causing the patent infringement.
Source: tech.hindustantimes.com