Today, the medical device company AliveCor said that President Biden has upheld an ITC decision that would result in a potential import restriction on the Apple Watch due to its ECG capability.
We applaud President Biden for upholding the ITC’s ruling and holding Apple accountable for infringing the patents that underpin our industry-leading EKG technology
AliveCor CEO
The ITC declared in December that Apple had violated AliveCor’s wearable EKG technology patents. For Apple Watch models having ECG functionality, the ITC suggested a limited exclusion order and a cease-and-desist order in the decision. If put into effect, Apple would no longer be permitted to import Apple Watches with ECG features for sale into the US.
Hannah Smith, an Apple spokesman, said that the company would take the ITC’s ruling to the Federal Circuit for review.
The Series 4 through the Apple Watch Ultra, with the exception of the two iterations of the SE, will not all be discontinued as a result of Biden’s decision. According to Apple’s Smith, the ITC decision isn’t currently having a significant effect.
Because the Patent Trial and Appeal Board recently concluded that AliveCor’s ECG technology isn’t technically patentable, any prospective ban would need to be upheld by AliveCor on appeal.
Yet, AliveCor is not the only provider of medical technology requesting an ITC import restriction on the Apple Watch. Apple was also accused of violating five of Masimo’s patents related to pulse oximetry. A judge for the ITC ruled in favour of Masimo last month and will decide in May if an import ban is necessary.
If so, any Apple Watch with a SpO2 sensor would be affected by that import ban (i.e., the Series 6 or later, excluding the SE.)
Patent disputes are nothing new. Given the widespread use of the Apple Watch and the size of Apple’s bank account, it will be unexpected if an import ban is implemented. It’s more plausible that AliveCor, Masimo, and other businesses on a comparable path are vying for Apple’s patent use in exchange for a sizable licencing price.
Nonetheless, that might establish a legal standard with far-reaching effects on how wearable technology manufacturers approach future health tech features, such as blood pressure and blood glucose monitoring. Due to FDA clearance requirements, developing these functionalities already takes a lot of time and resources. Battles for licences and patents would add another level of complexity to the situation.
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