Apple Loses ITC Battle to Masimo Over Pulse Oximeter Technology

The U.S. International Trade Commission on Tuesday issued a Notice of Final Initial Determination (FID) finding that Apple violated Section 337 of the Tariff Act of 1930 by importing and selling in the United States Apple Watches with light-based pulse oximetry technology that infringed claims 24 and 30 of Masimo’s U.S. Patent No. 10,945,648.

According to a Masimo press release, Apple first started selling the Apple Watch with a pulse oximeter sensor in 2020 and has continued to use it in subsequent versions of the product since then. The ITC Notice said it found no violation of the asserted claims of four other patents named in Masimo’s complaint.

The ITC will issue its recommendation on whether to implement an Exclusion Order or other remedy within 14 days of the FID.

“Today’s decision should help restore fairness in the market,” said Masimo CEO, Joe Kiani, in a statement. “Apple has similarly infringed on other companies’ technologies, and we believe today’s ruling exposes Apple as a company that takes other companies’ innovations and repackages them.”

In Masimo’s complaint filed June 29, 2021, the company claimed that Apple first met with Masimo in 2013 about integrating Masimo’s technology into the Apple Watch and subsequently “began hiring Masimo employees, starting with Masimo’s Chief Medical Officer. In the Fall of 2020, Apple introduced the Series 6, manufactured in Asia.” The sale and importation of the devices infringed Masimo’s patents as well as incorporated Masimo’s trade secrets, which the parties are litigating separately, according to the complaint.

Further, Masimo argued the Apple Watch would not harm public health or welfare because the Apple Watch blood oxygen measurements are actually not reliable and “[s]ome have even observed that the inaccurate physiological measurements of the Series 6 watch endanger public health.”

A Notice published January 6 indicated that the Commission will not review the administrative law judge’s initial determination extending the target date for completion of the investigation, which is May 10, 2023.

Pulse oximeters became popular during the COVID-19 pandemic as a way of remotely monitoring patients’ blood oxygen levels. Masimo has also released its own wearable device, the Masimo W1™, which it says is “the first wearable device on the market to provide consumers with accurate, continuous health data, including oxygen level, hydration index, and pulse, heart, and respiration rates.”