After a recent ruling from the United States International Trade Commission (ITC), Apple will be barred from importing certain “Apple Watch” products into the United States starting on December 26, 2023. Masimo, a California-based medical technology company, filed its ITC Complaint against Apple in August 2021. The Complaint alleged that Apple was importing into the U.S. “certain light-based physiological measurement devices and components”[1] that infringed five Masimo patents. Last week, the ITC ruled in Masimo’s favor, holding that certain components of the Apple Watch infringe two of Masimo’s patents related to pulse oximetry. Along with the infringement holding, the ITC issued a limited exclusion order, prohibiting the unlicensed entry of infringing Apple Watches into the United States. Notably, the exclusion order applies to the Watch’s pulse oximetry features, not the Watch itself.
The ITC
The ITC is a governmental agency based in Washington D.C. that enforces acts of unfair competition, including patent infringement, under Section 337(a) of the Tariff Act. Unlike U.S. District Courts, which may order monetary relief to a patent owner in an infringement action, the ITC possesses an arguably harsher power: if it determines that imported products infringe a valid and enforceable U.S. Patent, it can issue an exclusion order, banning the importation of those products into the U.S.[2] Before issuing an exclusion order, the ITC considers the effect of the product’s exclusion on public health and welfare.[3] Additionally, the President may veto an exclusion order within sixty days of the ITC’s determination.[4]
What is Next for Apple?
As of now, U.S. Customs and Border Protection will begin enforcing the ITC’s exclusion order on December 26, 2023. The ITC ruling does not mean that the Apple Watch is altogether banned from U.S. entry. Rather, the ITC order is applicable specifically to the pulse oximetry features. As such, Apple may continue to import Watches without those features.
Additionally, President Biden has until December 26th to reverse the exclusion order; however, a Presidential ban seems unlikely. Yet, President Obama vetoed an ITC exclusion order in 2013 which would have otherwise halted imports of the iPhone and iPad (there were likely strong public policy reasons to issue the veto in that instance).
Next, Apple can appeal the ban to the U.S. Court of Appeals for the Federal Circuit and indicated that it intends to do so—an appeal, however, cannot be filed until after the sixty-day Presidential review period. Further, an appeal to the Federal Circuit does not provide Apple with immediate relief. It could take well over a year for the Federal Circuit to issue a decision, and whether the ITC’s exclusion order is stayed during Federal Circuit review is not guaranteed.
[1] Certain Light-Based Physiological Measurement Devices and Components Thereof, Inv. No. 337-TA-1276 (Oct. 26, 2023) (Final).
[2] 28 U.S.C. 1337(d)(1).
[3] Id.
[4] Id. at (j)(2).
