An administrative judge at the International Trade Commission (ITC) sided with AliveCor in its case against Apple, ruling that the tech giant has infringed the company's patented electrocardiogram technology.
The judge's ruling Monday sets up a vote by the full ITC and could lead to an import ban on Apple Watches into the U.S.
If affirmed by the full ITC, the administrative law judge's finding of a violation could lead to the issuance of a limited exclusion order barring the import of infringing Apple Watches.
The commission is expected to issue a final decision by Oct. 26.
Administrative Law Judge Cameron Elliot of the ITC ruled that Apple violated two of AliveCor's patents.
The U.S. president can veto an import ban, but does so rarely, Reuters reported. Parties can appeal a ban to the Federal Circuit after the presidential review period ends.
The company filed a lawsuit against Apple in December 2020 alleging that the Apple Watch Series 4, 5, and 6 infringed the same three patents, which all deal with the ability to monitor and track arrhythmia. That case has been paused based on the ITC proceedings, according to Reuters.
Four months later, AliveCor filed its complaint with the ITC accusing Apple of infringing three patents related to its KardiaBand, which monitors a user's heart rate, detects irregularities and performs an ECG to identify possible atrial fibrillation.
"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," said Priya Abani, CEO of AliveCor, in a statement. "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."
AliveCor also sued Apple last year in California federal court for allegedly monopolizing the U.S. market for Apple Watch heart rate monitoring apps. The company accused Apple of changing the heart rate algorithm for the Apple Watch to gain an "unfair competitive edge" over rivals and forced the developer to pull the product from the market over safety concerns.
Back in March, a federal judge advanced most of that lawsuit, but narrowed the suit and dismissed AliveCor's separate claim that Apple maintained an illegal monopoly over ECG-capable smart watches, Reuters reported.
In 2017, AliveCor gained clearance from the Food and Drug Administration (FDA) to sell a medical device accessory for Apple Watch. The regulatory nod covered AliveCor’s KardiaBand, a device that clips onto Apple’s smartwatch and performs ECG readings. It was the first FDA-cleared Apple Watch accessory.
A year later, Apple unveiled its Series 4 smartwatch that included an FDA-cleared ECG, officially classifying it as a medical device capable of alerting its user to abnormal heart rhythms.
In 2019, AliveCor secured FDA clearance for its mobile six-lead ECG device and also gained the agency's green light for its two-electrode device to spot bradycardia and tachycardia, two of the most common irregular heartbeats.
AliveCor scored a $65 million series E funding round last November to grow its remote monitoring platforms and also announced it had secured FDA clearance for its new generation of ECG-reading algorithms that spot a wider range of arrhythmias and potential heart conditions. The company has raised $154 million to date, according to Crunchbase.
The personal electrocardiogram maker also recently scored FDA clearance for its slimmest heart monitor yet, which is the size and shape of a credit card. The KardiaMobile Card offers a single-lead ECG reading within 30 seconds, providing medical-grade detection of six of the most common types of cardiac arrhythmia