Apple may evade import ban by nixing pulse ox sensor from Apple Watch, Masimo says

In an attempt to avoid another pause on sales of its smartwatches equipped with blood oxygen sensors—which are the subject of a patent infringement case brought by Masimo—Apple in late December submitted to U.S. Customs and Border Protection a redesign of those Apple Watches that could exempt them from an import ban imposed by the U.S. International Trade Commission

The plan has reportedly worked: Though CBP has yet to publicly release its Jan. 12 ruling on the matter because it contains information designated by Apple as confidential, a court filing from Masimo this week claims that the department has concluded that the redesigned Apple Watches fall “outside the scope” of the ITC’s order.

They do so by completely removing the devices’ pulse oximetry technology, according to the document, a letter from Masimo’s attorney that was filed in federal appeals court Monday.

In a statement sent to Fierce Medtech, a spokesperson for Masimo said, “Apple’s claim that its redesigned watch does not contain pulse oximetry is a positive step toward accountability. It is especially important that one of the world’s largest and most powerful companies respects the intellectual property rights of smaller companies and complies with ITC orders when it is caught infringing.”

The import ban affects only domestic sales of the Series 9 and Ultra 2 models of the Apple Watch, which Apple briefly stopped selling in the U.S. for a few days in December before the import ban took effect.

Though the company confirmed in a court filing of its own on Monday that CBP did approve a redesign, it has yet to confirm whether the submitted designs do indeed remove the blood oxygen sensors from the devices, nor has it announced any plans to sell pulse ox-less versions of the smartwatches.

For now, both models are still available for sale with the sensors still in place, an Apple spokesperson confirmed to Fierce Medtech.

The ITC levied the import ban in October, siding with Masimo in its claims that the Apple Watch’s built-in blood oxygen sensor infringes on Masimo’s own light-based pulse oximetry technology. The ban took effect in late December, following a 60-day presidential review period during which the Biden administration opted not to veto the ban.

The ban is currently on hold, however, as Apple was granted an emergency pause while it fights for a longer stay that would remain in place while it appeals the ITC decision. Apple has argued that being unable to sell the affected models of its smartwatch while the appeal plays out—a process that it says could take a year or more—would cause “irreparable harm” to its business.

Masimo has pushed back on that claim, suggesting that Apple can stay afloat on sales of its other Apple Watch models and wide array of other products, and adding in its letter this week that potential sales of the newly redesigned devices “would eliminate any irreparable harm alleged by Apple.” For its part, Apple argued in its Monday filing that the still-confidential changes made in the redesign “[mean] Apple will continue to suffer reputational harm from being unable to provide consumers with a fully-featured Apple Watch product.”

The federal appeals court could issue its ruling on the requested stay pending appeal as early as today, Jan. 16, per Apple.