US Customs sued by Masimo over approval of Apple Watch imports with blood oxygen feature

[Apple Store at 5th Ave in Manhattan, New York City]
ozgurdonmaz/iStock Unreleased via Getty Images

Masimo (NASDAQ:MASI [https://seekingalpha.com/symbol/MASI]) filed a lawsuit against U.S. Customs and Border Protection over a decision that allowed Apple (NASDAQ:AAPL [https://seekingalpha.com/symbol/AAPL]) to import Apple Watches with blood-oxygen feature technology during a patent dispute between the companies.

The lawsuit said [https://storage.courtlistener.com/recap/gov.uscourts.dcd.283918/gov.uscourts.dcd.283918.1.0.pdf] the action challenges an August 2025 ruling by U.S. Customs and Border Protection, or CBP, allowing Apple to bypass an order from the U.S. International Trade Commission, or ITC, that prohibits the importation of Apple Watch products that infringe Masimo's patents.

Masimo said in the lawsuit that Customs improperly decided that Apple can import watches with pulse oximetry technology, reversing its own ruling from last year without notifying Masimo.

Apple, Masimo and U.S. Customs and Border Protection did not immediately respond to a request for comment from Seeking Alpha.

The lawsuit said that in October 2023 the ITC determined that Apple’s watches infringed multiple claims of Masimo’s patents related to light-based pulse oximetry technology. The ITC accordingly issued an order prohibiting the importation of Apple’s alleged infringing products.

The lawsuit added that in January 2024 CBP conducted a thorough adversarial proceeding, with participation from Apple and Masimo, and determined that Apple’s redesigned watches could be imported only to the extent the infringing functionality was completely disabled.

"It has now come to light that CBP thereafter reversed itself without any meaningful justification, without any material change in circumstances, and without any notice to Masimo, let alone an opportunity for Masimo to be heard," said the lawsuit.

Last week, Apple said [https://seekingalpha.com/news/4485408-apple-bringing-blood-oxygen-feature-to-more-watches-in-us] it was introducing a redesigned blood oxygen feature for some Apple Watch Series 9, Series 10, and Apple Watch Ultra 2 users through an iPhone and Apple Watch software update. The U.S. tech giant had noted that the update was enabled by a recent U.S. Customs ruling.

Masimo's lawsuit noted that CBP’s function is to enforce ITC exclusion orders, not to create loopholes that render them ineffective.

"By issuing its August 2025 ruling through an ex parte process and applying a self-imposed rule against considering indirect infringement theories, CBP has acted unlawfully and deprived Masimo of the protections of its patents," said the lawsuit.

Masimo has asked the Washington court to halt the agency's ruling.

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