A few days ago, Masimo sued US customs over the decision that it could enable blood oxygen and reopen Apple, which sells its US Apple Watch. The agency is currently responding with a motion to dismiss the lawsuit. Details are here.
A brief summary
When Apple released blood oxygen functionality on its Apple Watch, medical device manufacturer Masimo sued on suspicion of patent infringement.
For many years, the lawsuit was dragged into my head in December 2023 with an import ban.
Since then, after halting sales for several days, Apple had been selling the Apple Watch Series 9 and Apple Watch Ultra 2 without blood oxygen, but the hardware was not removed. Instead, this feature was disabled via software.
Last month, Apple announced it would resume sales of its fully-enabled Apple Watch in the US. It uses a “redesigned blood oxygen function” that calculates blood oxygen in your iPhone rather than a clock.
At the time, Masimo sued US Customs and Border Protection (CBP) claiming that the agency violated a legitimate process when Apple allowed it to restore functionality.
From Masimo submission:
“Now it has become clear that CBP has reversed itself, not to mention the opportunity for Masimo to hear, without meaningful legitimacy, a serious change in the situation, or without notice to Masimo. CBP has repositioned Apple’s Watch-Plus-Iphone. The iPhone already in the US performed the same function that ITC discovered that infringed Masimo’s patent.
US Customs responds
As reported by Bloomberg MethodCPB filed an motion to dismiss Masimo’s case in a previous lawsuit, alleging that “Congress has prevented the district court from reviewing the issue of customs issues in the implementation of the Commission’s exclusion order.”
In other words, the CBP says that the federal district courts do not have jurisdiction to hear Masimo’s challenge. Previous cases, especially Thunder Basin Coal Co.v. Reich A lawsuit that finds that when Congress sets up a specific review process, it must first pass the process, rather than go straight to federal district court.
CBP argues that Masimo must challenge the International Trade Commission in a supplementary lawsuit, and that Apple’s workaround has not yet cleared the exclusion order. Only then can Masimo appeal to the Federal Circuit, rather than trying to bypass the process in a district court case.
From submission:
In short, Masimo can make all the same tolerance arguments he intends to bring here about customs rulings when discussing with the Commission (or, if necessary, the Federal Circuit) that the Commission’s Limited Exclusion Order should cover a redesigned smartwatch. (…) It is also free to reconsider the August 2025 ruling directly from customs. (…) But it cannot avoid the prescribed path to the challenges of Congress. It was first successful in the committee and then the Federal Circuit. ”
The submission ends with CBP’s appeal to dismiss the case based on “lack of jurisdiction over the subject.”
