Masimo tells CAFC that CBP Ruling for Apple Removes Danger of Irreparable Harm

Masimo’s legal team told the U.S. Court of Appeals for the Federal Circuit (CAFC) in a January 15 filing that the Exclusion Order Enforcement Branch (EOE) of U.S. Customs and Border Protection has cleared a redesigned version of the Apple watches that were banned by the International Trade Commission (ITC) in late October. The CBP’s decision has not been made public.

According to the filing, the redesigned watches do not contain pulse oximetry technology, which was the subject of the ITC exclusion order. The decision, which has not been made public, removes any danger of irreparable harm alleged by Apple, according to the filing.

The ITC issued a limited exclusion order (LEO) and cease and desist order against Apple on October 26, 2023, barring import of certain Apple Watches that infringed on two Masimo patents covering technology related to reading blood-oxygen levels.

In December, Apple announced that it would halt sales of the relevant watches following the ruling, but in late December, the CAFC stayed the ITC’s order following Apple’s filing of an emergency motion for immediate interim stay of the order pending its appeal to the CAFC.

On January 10, the ITC responded to Apple’s motion, arguing that “Apple presents a weak and unconvincing case” that “amount[s] to little more than an indisputably adjudicated infringer requesting permission to continue infringing the asserted patents.” The ITC’s response in opposition to Apple also said that Apple’s irreparable harm claims are “speculative, at least because Apple provided no affidavit to support its assertions of irreparable harm to its goodwill and reputation, instead relying on a declaration presented to the Commission that (inadequately) addressed its public interest argument.”

In Masimo’s initial complaint to the ITC, 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 complaint also claimed that 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. Masimo also said Apple’s blood oxygen measurements were not reliable and therefore the public would not be harmed by any ban.

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.”

Various media reports today have quoted Masimo representatives as saying the removal of pulse oximetry technology from the redesigned watches is a positive step that suggests Apple may be acknowledging accountability.

Image Source: Deposit Photos
Author: tonellophotography
Image ID: 438950404