[Insights] Apple Watch Faces Allegations of Blood Oxygen Monitoring Patent Infringement, Resolution or Redesign Incurs Substantial Costs

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In late December 2023, Apple faced sales suspension of certain Apple Watch models in the United States due to concerns over patent infringement with Masimo’s blood oxygen detection technology.

Despite Apple’s appeal for reinstatement, regulatory authorities will review updated designs presented in mid-January 2024 to determine whether sales suspension persists. The potential financial and time costs associated with settlement or redesign may prompt Apple to reassess the necessity of incorporating blood oxygen detection.

TrendForce’s insight:       

Apple and Masimo’s Prolonged Legal Battle Set to Conclude in Mid-January 2024, Verdict on Blood Oxygen Monitoring Patent Infringement

Since the introduction of the S6 in 2020, Apple Watch has featured blood oxygen monitoring technology, addressing the demand for detecting hidden hypoxia and hypoxemia, particularly in the context of the COVID-19 pandemic. Many smartwatches released during the same period also incorporated this functionality.

The blood oxygen monitoring technology in Apple Watch utilizes traditional pulse oximetry. The built-in sensor consists of red, green, infrared LEDs, and a photodiode sensors that converts light into electric current.

In essence, the technology relies on shining light onto wrist blood vessels to capture data on the difference between oxygenated and deoxygenated blood. Algorithms are then employed to determine the blood oxygen content.

Hence, this technology involves not only software-related analytical applications but also hardware configurations and usage considerations.

In fact, the infringement dispute between Apple and Masimo has been ongoing. Since 2020, Masimo has accused Apple of patent infringement. The legal battle continued until October 2023 when the U.S. International Trade Commission (ITC) ruled in favor of Masimo, determining that Apple had indeed infringed. Consequently, in late 2023, a sales ban was imposed on certain models of Apple watches.

Despite Apple’s appeal allowing them to resume sales, regulatory authorities will reassess Apple’s redesigned models in mid-January 2024 to determine if improvements have been made.

Currently, the most severe impact of the ban is on models with blood oxygen functionality from the S6 onwards, including the S8, while only the SE series, without this feature, remains unaffected.

Diminished Need for Blood Oxygen Monitoring in Temporal Context – Apple May Reconsider Necessity

Given the current situation, there are several possible developments. Firstly, Apple may reapply for approval of a redesigned model by regulatory authorities, allowing them to resume sales after making necessary adjustments.

However, this approach involves not only software modifications but also hardware changes, encompassing testing, review processes, and relaunching, which could take several months. Considering Apple’s usual product release schedule in September each year, the company faces significant time pressure.

Secondly, Apple may opt for a settlement with Masimo. In the past, Apple has resolved disputes over chip technology and intentional slowdown of older devices with Qualcomm and in collective lawsuits with users.

However, settlement amounts were substantial, approximately $4.5 billion with Qualcomm and potentially up to $500 million in the case of collective user lawsuits. Compared to Apple Watch’s annual revenue in 2023, which may not have reached $20 billion, such outcomes may be less favorable for Apple.

If Apple cannot bypass Masimo’s patent through updates, settlement and payment of ongoing patent fees may become a necessary consideration. However, this to some extent may prompt Apple to reevaluate the necessity of the blood oxygen monitoring feature.

After all, for smartwatches equipped with blood oxygen monitoring is intended for health, not medical purposes. Besides Withings’ products, most smartwatches with this feature have not obtained approval from the U.S. Food and Drug Administration (FDA). In other words, they cannot be used for medical purposes.

While having more features at the same price would enhance the product value for consumers, the current context of the post-pandemic era and Apple’s user loyalty suggest that the demand for additional functionalities may vary.

If Apple does not intend to further integrate blood oxygen data with other physiological data, there might be room to reconsider the necessity of redeveloping the technology and the continued existence of the blood oxygen monitoring feature in future Apple Watches. The value of incorporating such functionality may be subject to greater flexibility in this scenario.

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(Photo credit: Apple)