The International Trade Commission has issued a Limited Exclusion order (LEO) and a cease and desist order against Apple, ruling that the company’s Apple Watch design infringes on AliveCor’s personal electrocardiogram (ECG) technology.

Since 2020, AliveCor has said that the Apple Watch's built-in heart-monitoring technology has similar features to the sensors used in the former’s KardiaBand solutions, a watch band and connected app that, when paired with the Apple Watch, monitors heartbeats and makes diagnoses.

KardiaBand was cleared by the FDA in 2017, but Apple also gained clearance for its built-in ECG technology a year later, making KardiaBand no longer necessary for use with the Apple Watch.

The LEO prohibits Apple from exporting the watches. Additionally, the ITC has set a bond of $2 per unit on any Apple Watches that are imported or sold, potentially impacting the sales of millions of its watches. President Joseph Biden will review the ruling over a 60-day period and issue a final determination.

"The ruling underscores the importance of upholding intellectual property rights for companies like AliveCor and scores of others whose innovations are at risk of being suppressed by a Goliath like Apple," said Priya Abani, CEO of AliveCor, in a statement.

The ITC decision affirms the initial determination issued in June by Administrative Law Judge Cameron Elliot of the ITC, who ruled that Apple had indeed violated two of the patents.

The ITC verdict follows an early December determination made by the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB). In contrast to the ITC, the PTAB deemed all three of AliveCor’s claims against Apple for patent infringement “unpatentable," reasoning that a person “of ordinary skill in the art” of making heart-monitoring technologies could construct the same solutions, making AliveCor’s claims too obvious to be patented.

AliveCor is appealing the PTAB's decision, and the ITC has suspended enforcement of its orders pending the resolution of that appeal.

AliveCor has also filed a suit against Apple for anticompetitive behavior in the Northern District of California. The case is expected to go to trial in early 2024.

In response, Apple filed its own lawsuit in early December against AliveCor, accusing it of infringing on its own patents for innovations in its heart-rate sensing, health data collection and other connected health tools. It says that some of its technologies were developed as far back as 2008 before AliveCor was founded in 2011.

AliveCor has called this “a desperate last-ditch effort by Apple to bully AliveCor into submission just days before the ITC decision.”

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