New Patent Lawsuit Could See Apple Watches Banned in the United States

Only the Apple Watch SE would likely be exempt from such a ban.
Man wearing an Apple Watch Series 7 Credit: Ksenia Shestakova / Shutterstock
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A judge from the International Trade Commission has ruled that the Apple Watch possibly infringes on ECG technology patents owned by health technology company AliveCor. If upheld, the decision could ban the Apple watch from being sold in the United States.

AliveCor is perhaps best known for KardiaBand, an Apple Watch accessory capable of taking electrocardiogram (ECG) readings before the Apple Watch Series 4 came along and allegedly “Sherlocked” the idea.

Since the pre-Series 4 Apple Watch models didn’t support any ECG features, AliveCor stepped in with a Bluetooth-connected strap designed to communicate with its watchOS app to collect single-lead ECG readings and even monitor for irregular heart rhythms and atrial fibrillation.

AliveCor claims that its KardiaBand technology propelled the Apple Watch from simply being “a high-tech fashion accessory” into a life-saving health device.

However, when the Apple Watch Series 4 came along, the built-in ECG sensor rendered KardiaBand obsolete. Since then, AliveCor has been pursuing Apple on at least two fronts: a patent infringement complaint with the International Trade Commission (ITC) and an antitrust lawsuit accusing Apple of copying AliveCor’s ideas and sabotaging its apps and services.

Last month, a U.S. Federal Judge ruled that Apple must face AliveCor’s antitrust claims. An administrative law judge from the ITC has now made an even more serious decision regarding the company’s patented ECG technologies.

High Stakes for the Apple Watch

Unlike the antitrust lawsuit, where AliveCor will have the more difficult task of proving that Apple has an illegal monopoly for heart rate monitoring apps, the patent infringement claims are seemingly more black-and-white — and a preliminary decision has already been made.

Last month, U.S. District Judge Jeffrey White ruled only that the antitrust lawsuit could proceed. This means that Apple was unsuccessful in getting it thrown out; AliveCor will still have to prove its claims in court. Judge White also dismissed AliveCor’s complaint that Apple held an illegal monopoly over ECG-capable smartwatches, declaring that AliveCor had no legal grounds to make this claim as it “does not compete” in that market.

However, while this lawsuit may still take years to work its way through the courts, ITC judge Cameron Elliot has already made an initial determination that AliveCor has “proven infringement” of at least two U.S. patents.

It’s not a slam dunk for AliveCor, as Judge Elliot’s Notice of Initial Determination also notes that it failed to prove infringement of at least one patent. At the same time, Apple was also successful in establishing some claims against the two infringed patents were invalid.

Still, the decision is enough for the complaint to proceed to a full hearing, where a Final Determination will be made. According to a press release from AliveCor, this will occur on October 26, 2022.

If the full International Trade Commission upholds Judge Elliot’s initial determination, it could result in an order barring any infringing Apple Watch from being imported into the United States. Only the Apple Watch SE would likely be exempt from such a ban as it doesn’t include any ECG features.

In a press release, AliveCor’s CEO Priya Abani praised the ITC’s preliminary decision, saying, “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. Since the start, our focus has been on our customers and providing them with strong choices to help monitor their cardiac health, including KardiaBand, the first-ever FDA-cleared ECG device accessory for Apple Watch.”

The patents deemed to have been infringed are U.S. Patent 10,595,731, Methods and systems for arrhythmia tracking and scoring and U.S. Patent 10,683,941 — although we’re guessing this is a typo in Judge Elliot’s ruling, as that refers to an entirely unrelated patent. The ruling most likely refers to U.S. Patent 10,638,941, AliveCor’s patent for Discordance monitoring. This patent number is reflected in the final summary paragraph.

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