Masimo’s latest lawsuit against U.S. Customs and Border Protection (CBP) faces a direct challenge. The medical device company accused the agency of unlawfully allowing Apple to resume selling Apple Watch models with the blood oxygen feature enabled. Now, CBP has filed a motion to dismiss, arguing the case does not belong in federal district court.
The dispute stems from Masimo’s long-running patent battle with Apple. In December 2023, the International Trade Commission imposed an import ban on Apple Watch models with the blood oxygen feature, ruling that the technology infringed Masimo patents. Apple briefly halted sales but soon returned with modified versions of the Series 9 and Ultra 2. The hardware remained intact, but the feature was disabled through software.
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Earlier this year, Apple reintroduced the blood oxygen tool with a software redesign that shifts calculations to the iPhone. Masimo challenged the move, claiming Customs improperly approved the workaround without due process.
In its filing, Masimo argued that the agency “reversed itself without any meaningful justification” and issued an ex parte ruling that allowed Apple to bypass the exclusion order.
Customs’ Argument
CBP responded with a motion to dismiss, pointing to established precedent. According to Bloomberg Law, the agency argued that Congress bars federal district courts from reviewing Customs’ implementation of exclusion orders. It cited the Supreme Court’s ruling in Thunder Basin Coal Co. v. Reich, which held that when Congress provides a specific review process, disputes must follow that path.
The government maintains that Masimo must first take its objections to the International Trade Commission. If the ITC rules against Masimo, the company can appeal to the Federal Circuit. Customs said Masimo cannot sidestep this process by filing directly in district court.
In its filing, CBP concluded that Masimo remains free to raise the same arguments before the Commission and even request reconsideration of its August 2025 ruling. But it insisted that district court jurisdiction does not apply. The agency closed by asking the court to dismiss the case for lack of subject-matter jurisdiction.
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