Masimo Corporation, a medical technology firm, is embroiled in a legal dispute with U.S. Customs and Border Protection (CBP) concerning the importation of Apple Watch models equipped with blood oxygen monitoring features. This contention arises from Masimo’s assertion that Apple has infringed upon its patented pulse oximetry technology.
Background of the Dispute
The conflict traces back to December 2023 when the International Trade Commission (ITC) determined that Apple’s inclusion of blood oxygen sensors in its Apple Watch Series 9 and Ultra 2 models violated Masimo’s patents. Consequently, the ITC imposed an import ban on these devices. In response, Apple temporarily halted sales but soon resumed by offering modified versions with the blood oxygen feature disabled via software.
In early 2025, Apple reintroduced the blood oxygen functionality through a software update that shifted the processing of oxygen-level calculations from the watch to a paired iPhone. Masimo contested this move, alleging that CBP improperly approved Apple’s workaround without adhering to due process. The company argued that CBP reversed itself without any meaningful justification and issued an ex parte ruling that permitted Apple to circumvent the exclusion order.
CBP’s Motion to Dismiss
In response to Masimo’s lawsuit, CBP filed a motion to dismiss, contending that the case does not fall within the jurisdiction of federal district courts. The agency referenced the Supreme Court’s decision in Thunder Basin Coal Co. v. Reich, which stipulates that when Congress provides a specific review process, disputes must follow that designated path. CBP asserted that Masimo should first present its objections to the ITC and, if necessary, appeal to the Federal Circuit, rather than seeking resolution through the district court.
CBP emphasized that Masimo retains the right to raise the same arguments before the ITC and request reconsideration of its August 2025 ruling. However, the agency maintained that the district court lacks subject-matter jurisdiction over the case and requested its dismissal on these grounds.
Implications and Broader Context
This legal confrontation is part of a broader series of disputes between Masimo and Apple. In 2021, Masimo accused Apple of misappropriating its technology and poaching key employees to develop the blood oxygen feature in the Apple Watch Series 6. The ITC’s 2023 ruling in favor of Masimo led to the initial import ban, prompting Apple to seek alternative solutions to maintain the feature’s availability in the U.S. market.
The outcome of CBP’s motion to dismiss will significantly influence the trajectory of this ongoing legal battle. If the motion is granted, Masimo will need to pursue its claims through the ITC’s established review process, potentially prolonging the resolution of the dispute. Conversely, if the motion is denied, the case will proceed in federal district court, potentially expediting a judicial determination on the matter.
This case underscores the complexities inherent in patent enforcement and the challenges companies face when navigating the intersection of intellectual property rights and regulatory compliance. As the legal proceedings unfold, stakeholders in the technology and medical device industries will be closely monitoring the implications for innovation, competition, and consumer access to health-monitoring technologies.
