ITC Closes Apple Watch Import Ban Case, Rejecting Masimo’s Bid to Reinstate Exclusion Order

知財ニュースバナー IP News

The U.S. International Trade Commission (ITC) on April 19, 2026, rejected Masimo Corporation’s request to reinstate an import ban on the Apple Watch, upholding an Administrative Law Judge’s (ALJ) initial determination issued on March 18, 2026. The ALJ found that Apple’s redesigned Apple Watch does not infringe the asserted claims of Masimo’s patents, and the full Commission declined to review that ruling. The decision effectively closes the ITC proceeding that began in 2022.

The dispute arose from ITC Investigation No. 337-TA-1276, in which Masimo alleged that the blood-oxygen monitoring feature in the Apple Watch Series 9 and Ultra 2 infringed its patents related to pulse oximetry technology, including U.S. Patent No. 10,945,648. Masimo filed the ITC complaint in 2022, seeking an exclusion order that would bar importation of infringing Apple Watch models.

In October 2023, the ALJ issued an initial determination finding infringement of two Masimo patents. The full ITC Commission affirmed that finding in December 2023. The Biden administration declined to exercise presidential veto authority, and Apple suspended U.S. sales of the affected models starting in January 2024 while developing a redesign.

Apple subsequently removed the blood-oxygen measurement feature from U.S.-market Apple Watch units and later reintroduced a modified version in August 2024 — one that displays blood-oxygen data on associated Apple devices such as the iPhone rather than on the watch itself. U.S. Customs and Border Protection (CBP) determined that this redesigned version fell outside the scope of the existing exclusion order.

Masimo contested that determination and sought further ITC review, arguing the redesigned watch continued to infringe. The ALJ concluded in the March 2026 initial determination that Apple’s engineering workaround successfully avoided the asserted patent claims. The Commission’s April 19 decision upholding that ruling, as reported by 9to5Mac and MacTech, removes any immediate risk of import disruption for the Apple Watch.

Masimo retains the right to appeal the ITC decision to the U.S. Court of Appeals for the Federal Circuit. However, absent a successful appeal, the ITC chapter of this dispute is concluded.

A separate action in the Central District of California continues independently. A federal jury awarded Masimo $634 million in damages in 2024, and the appeal of that verdict remains pending. The ITC’s April 2026 ruling does not directly affect the California litigation.

This case illustrates the strategic value and limits of ITC Section 337 proceedings as an enforcement tool against large-scale infringers. The exclusion order secured by Masimo in 2023 forced Apple to redesign its product, representing a significant tactical victory. However, once Apple demonstrated that the redesign did not infringe the asserted claims, the ITC’s enforcement mechanism could not be extended to cover the modified product. Companies facing ITC exclusion orders can effectively neutralize those orders through design-arounds, though at potentially significant cost in terms of product functionality.

The central unresolved question in the Apple-Masimo dispute now shifts to the federal court litigation, where the $634 million jury verdict is under appellate review. Whether that award is upheld, reduced, or overturned will determine the ultimate financial impact of this multi-year patent conflict on both companies.

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