ITC finding that Apple watch infringes Masimo blood oxygen patents affirmed by Federal Circuit

The Federal Circuit [said] that the ITC permissibly treated the Masimo Watch as the domestic industry article and reasonably

By: :  Linda John
Update: 2026-03-23 02:00 GMT


ITC finding that Apple watch infringes Masimo blood oxygen patents affirmed by Federal Circuit

The Federal Circuit [said] that the ITC permissibly treated the Masimo Watch as the domestic industry article and reasonably viewed the prototype units as physical articles practicing the asserted claims

The U.S. Court of Appeals for the Federal Circuit (CAFC) has issued a decision in Apple Inc. v. International Trade Commission, affirming a final determination that Apple violated Section 337 of the Tariff Act of 1930. The United States International Trade Commission (ITC) correctly concluded that Masimo Corporation and Cercacor Laboratories, Inc., proved that Apple violated Section 337 through the sale and import of certain Apple Watch models, ultimately “finding no error in the Commission’s domestic industry determination, its validity rulings, or its infringement findings”; the CAFC determined.

U.S. patents relate to wearable technology that measures physiological metrics using optical emitters and photodetection. The patents cover devices which use light-emitting diodes to emit light into tissue and photodetectors to measure the returned intensity of optical emissions to determine a physiological parameter. Masimo in 1995 introduced its motion- and low-perfusion-tolerant technology to address inaccurate readings from conventional non-invasive pulse oximeters, especially in clinical settings. Apple in September 2020 launched the Apple Watch Series 6, which included a feature that could estimate the wearer’s blood oxygenation level. Masimo in June 2021 filed a complaint with the ITC, alleging that the importation and sale of the Apple Watch Series 6 infringed several patents covering wearable blood oxygen measurement devices. A five-day hearing was held by an administrative law judge who issued an opinion finding a violation of Section 337. A final determination affirming the violation was issued by the ITC which also issued a limited exclusion order barring the importation of the infringing products.

Judge Stark writing for the CAFC found that the ITC properly relied on the Masimo Watch as the domestic industry article. The ITC was required to limit its technical-prong analysis to specific physical models produced during discovery, Apple argued. The Federal Circuit disagreed and stated that the ITC permissibly treated the Masimo Watch as the domestic industry article and reasonably viewed the prototype units as physical articles practicing the asserted claims. The court noted that circumstantial evidence is acceptable and not second-class to direct evidence and that substantial evidence supported the finding that the prototypes were user-worn and measured blood oxygen levels at the time of the complaint.

The ITC erred in crediting investments in prototypes that did not practice the asserted claims; Apple also argued. This argument was rejected by the Federal Circuit which explained that Section 337 allows for significant investments in aspects of production other than the patent-practicing article itself to count toward meeting the economic prong. Investments in earlier-generation prototypes qualify when directed to significant components specifically tailored for use in the patent-practicing article; the court clarified. The court found substantial evidence that the investments in the earlier sensors were made as part of an iterative design process which led to specifically tailored technical features of the patent-practicing articles.

The Federal Circuit noted that the plain and ordinary meaning of ‘over’ and ‘above’ relates to positions of the equipment’s components relative to other components without any further restriction on the orientation of the device. While Apple argued that the asserted claims were invalid for lack of adequate written description, the Federal Circuit disagreed finding that the specification expressly states that features of different embodiments can be combined.

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By: - Linda John

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