By Katy Gasper

AliveCor, self-proclaimed “global leader in FDA-cleared personal electrocardiogram (ECG) technology and services,” has recently filed a complaint with the U.S. International Trade Commission (ITC) against Apple Inc. stating infringement on three of their patents in the production and sale of the Apple Watch.

AliveCor Background:

Since 2011, AliveCor has invested largely in the technology of allowing individuals to utilize AI-driven cardiological detection services. Through these investments and research, groundbreaking products have been created including KardiaMobile, the most medically approved personal ECG in the world, KardiaMobile 6L, the only six-lead personal ECG, the KardiaBand, the first ever FDA-cleared medical accessory for Apple Watches, and SmartRhythm, which utilizes AI to constantly evaluate heart beats for signs of arrhythmias and tachycardia (the two most common forms of irregular heartbeat

The Complaint:

In December, 2020, AliveCor, a Mountain View, California-based company in December sued Apple for patent infringement in U.S. District Court for the Western District of Texas, stating Apple was aware of AliveCor’s existing patents that protected “methods of using specialized sensors in a wearable device to improve upon existing cardiac monitoring technology” patents when they created the Series 4, 5 and 6 Apple Watches. According to the press release announcing the complaint, the complaint is “one step, among others, AliveCor is taking to obtain relief for Apple’s intentional copying of AliveCor’s patented technology.”

AliveCor alleges that Apple pilfered its technologies that analyze an individual’s heart rate and to take an ECG reading on devices such as the Apple Watch.  In this suit, they allege that Apple is engaging in monopolistic conduct in an attempt to eliminate AliveCor as a competitor in the heart rate analysis marketplace.  In April 2021, AliveCor asked the U.S. International Trade Commission to ban imports of Apple Watches pending the outcome of the litigation.  Then, the following month, AliveCor sued Apple for antitrust in U.S. District Court for the Northern District of California alleging violations of the Sherman Antitrust Act by attempting to monopolize heart-rate technologies. 

It is crucial to note that in 2017, AliveCor had gained clearance from the FDA to sell a medical accessory made for the Apple Watch; this was the first FDA cleared Apple Watch accessory to exist. This adornment took the form of a small piece of technology that would attach to an Apple Watch to take ECG readings. Only a year later, the Apple Watch Series 4 was revealed and included an FDA-approved built-in medical ECG that was able to monitor heart rates and alert the consumer of irregularities.  “As it has done multiple times over the years in other markets, Apple decided that it would not accept competition on the merits,” AliveCor said.

What Could Happen:

If the infringements are proven to be true, and this multi-state, multi-pronged litigation against Apple is successful, U.S. sales of Apple Watches could be banned.  AliveCor is also seeking unspecified triple damages in the latest court filing, citing Apple’s alleged “willful” effort to create a monopoly.

The latest case is AliveCor Inc v Apple Inc, U.S. District Court, Northern District of California, No. 21-03958.  AliveCor is represented by Quinn Emanuel Urquhart & Sullivan.

Katharine Gaspar is a Los Angeles native currently studying Music Business and Legal Studies as a Junior at Belmont University in Nashville, Tennessee. She is an active member of several student organizations on campus including Grammy U, Service Corps, Belmont University Pre-Law Society, Young Entertainment Society, Belmont University Copyright Society and Women in Entertainment and is currently interning with Shrum Hicks & Associates PC, as well as with Quay Entertainment. With passions in the fields of entertainment law and live events, she looks forward to starting a career in the entertainment industry.

Resources:

https://9to5mac.com/2021/04/21/apple-watch-ecg-patent-infringement-claim/

https://www.fiercehealthcare.com/tech/alivecor-seeks-to-bar-u-s-sales-apple-watch-alleging-ecg-patent-infringement