Apple Watch Import Bar? ITC Ruling Against Apple Over ECG Patent Violations

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A phone screen shows a chart of descending time spent in atrial fibrillation. An Apple Watch shows text alert showing a person shows signs of the arrhythmia 4% of the time last week


AliveCor previously sold an ECG accessory to Apple Watch. When the latter incorporated arrhythmia detection capabilities into the device, AliveCor pulled its products from the market in 2019. Jump forward to 2021, AliveCor filed a complaint against Apple with the International Trade Commission (ITC).

A judge with the ITC found that Apple infringed AliveCor’s patents, which could lead to complications for Apple, including the prohibition of importing their smartwatches into the United States.

When analyzing the complaint, the judge found that AliveCor has successfully proven that Apple infringed two of its patents. While it’s early to tell, affirming this ruling by the full commission could lead to barring Apple smartwatches from entering the U.S.

This article will detail the ruling of this lawsuit to give the audience insight into the potential outcome of Apple Watches.

The ruling of the ITC against Apple

In 2017, AliveCor became the first company to get the Food and Drug Administration (FDA) clearance for an accessory in Apple Watch. 

The KardiaBand is the system developed by AliveCor, which takes a single-lead ECG. Before asking the wearer to take the ECG, it assesses whether their heart rate and physical activity are synchronized. 

By late 2018, Apple decided to remove the ECG accessory from their system. At the same time, they included an ECG app that sends notifications about irregular heart rhythm in their Apple Watch Series 4.

To make people distinguish KardiaBand, AliveCor decided to stop selling its products. This happened a few months after introducing the ECG app of Apple.

In 2021, AliveCor decided to seek a legal resolution to their problem. Consequently, they filed a complaint with the ITC in April. They followed up on this with an anti-competition complaint in May. Before releasing the final determination in October, AliveCor published the initial ruling, which was in their favor. However, Apple won a few counts.

The CEO of AliveCor, Priya Abani, stated that “today’s ruling is a strong validation of our IP and underscores that patents matter and even an influential company like Apple cannot simply violate them to stifle innovation.” 

As of the writing of this article, Apple did not comment on this issue.

Patient violations by Apple

Analyzing the ruling of the ITC shows that the latter found Apple guilty of infringing several claims against the two patents. As for the third patent, the ITC found that AliveCor failed to prove its infringement. On the other hand, Apple managed to prove that some of the infringed claims were invalid. 

In the first quarter of 2022, Apple shipped more than 32 million wearables. On their website, the Series 7 Apple Watch retails for $399 a piece. It is now the only watch on sale that comes with an ECG function. Similar to AliveCor’s accessory, the watch comes with a single-leading ECG.

According to the International Data Corporation, Apple holds around a third of the global wearable market.

If this ruling is upheld, Apple risks the barring of all infringing Watches into the U.S.

Takeaway message

The ruling in favor of AliveCor could have a serious impact on Apple’s imports of smartwatches. With millions of wearables sold every year, this could lead to a big economic loss for the company.

Hopefully, this article managed to explain the ordeal between Apple and AliveCor and their dispute over the patents of the ECG accessory.

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