The long-running battle between companies came to a head last week when Apple paused sales of two models of its smartwatch. This spat centers around light-based pulse oximetry technology used by the watches. Masimo develops a number of technologies that use pulse oximetry, including its recently FDA-cleared W1 smartwatch.
This followed an an October ruling in Masimo’s favor from the U.S. International Trade Commission (ITC). The ITC recommended a limited exclusion order for infringing Apple Watches with light-based pulse oximetry functionality. It found that Apple violated U.S. laws by incorporating this patented technology into its products.
ITC’s ruling was followed by a 60-day presidential review period that ended yesterday, Dec. 25. Apple took the Series 9 and Ultra 2 watches off the market to remain in compliance if President Biden’s administration failed to reverse the ITC ruling. With U.S. Trade Representative Katherine Tai allowing the ruling to stand, the ban went into effect today, Dec. 26.
“After careful consultations, Ambassador Tai decided not to reverse the ITC’s determination and the ITC’s decision became final on December 26, 2023,” Tai’s office said.
According to Reuters, Apple filed an appeal today, as expected once the decision went through. It also reportedly filed an emergency request for the U.S. Court of Appeals for the Federal Circuit to halt the ban.
Reuters says Apple asked the court to pause the ban until U.S. Customs and Border Protection determines if redesigned Apple Watches infringe the Masimo patents in question. The report says a decision should come in on Jan. 12.
More context around the Masimo-Apple patent battle
Masimo’s SET pulse oximetry technology uses include reducing blindness in neonatal ICU patients and monitoring post-surgical patients on opioids. It also offered remote patient monitoring for COVID-19.
In January 2020, Masimo accused Apple of poaching its employees and infringing 10 of its patents to improve the health monitoring functions of the Apple Watch. Earlier this year, a U.S. Administrative Law Judge in Washington, D.C. ruled in the company’s favor in a patent spat with Apple. The judge also ruled that Apple did not violate four other patents belonging to Masimo.
In May, a federal judge in California declared a mistrial after jurors could not come to a unanimous verdict. At the time, analysts said the mistrial “suggests Masimo will most likely not come away victorious” in its battle with Apple.
The tides turned for Masimo with the October ITC decision, though. Analysts viewed it as a “significant win.”
A similar spat over IP went on between AliveCor and Apple. It ended in February when the final determination rule favoring AliveCor cleared presidential review. A statement from an AliveCor spokesperson on the latest ruling against Apple reads:
“This is the second time in less than 12 months President Biden has allowed an International Trade Commission Limited Exclusion Order (LEO) to stand against imports of Apple Watches that violate the patents of small U.S. innovators. Earlier this year, AliveCor’s patent for its FDA-cleared personal electrocardiogram (ECG) technology was similarly affirmed and we share our support today for Masimo’s tenacity in its face off with Apple. Innovator companies and health consumers alike should be encouraged that industry giants are increasingly being held accountable for anticompetitive practices that would ultimately limit access to potentially life-saving technology.”
