Apple Watch faces another possible sales ban in Masimo pulse oximetry patent fight

For the second time in the last year, the U.S. International Trade Commission (ITC) has determined that Apple violated a competitor’s patents in a health-tracking feature of its popular smartwatch, setting up the devices for a potential ban in the U.S.

This time around, the dispute concerned the pulse oximetry feature that Apple began adding to its wearables in 2020, starting with the Apple Watch Series 6—and which Masimo has claimed infringes its own light-based pulse oximetry technology.

An ITC administrative law judge ruled in Masimo’s favor in an initial determination at the start of this year, and, in a formal vote this week, the commission opted to uphold that ruling, issuing a limited exclusion order and a cease-and-desist order to Apple, according to documents (PDF) filed Thursday.

If enacted, the limited exclusion order would ban Apple from manufacturing or importing Apple Watches that include the disputed light-based pulse oximeters. The ITC’s ruling now goes to President Joe Biden, who has 60 days to decide whether to uphold the ruling, allowing the sales ban to take effect, or veto it and allow Apple to continue selling its smartwatches as usual.

In a company release Thursday, Masimo founder and CEO Joe Kiani said, “Today’s ruling by the USITC sends a powerful message that even the world’s largest company is not above the law. This important determination is a strong validation of our efforts to hold Apple accountable for unlawfully misappropriating our patented technology.”

Masimo highlighted the many comments of support that had been sent to the ITC on its behalf, citing one in particular from the Consumer Federation of America: “There is no greater offense to both the antitrust and intellectual property law than when a dominant firm infringes the patent of a smaller rival, who is an actual or potential competitor. In this case, as in the other cases involving Apple’s egregious abuse of market power, the harms far outweigh the benefit. In fact, because competition will swiftly replace any services or products that Apple is no longer able to deliver because of the remedy, there will be little harm and a great deal of benefit for consumers and the economy.”

In a statement of its own sent to Fierce Medtech, Apple said, “Our teams work tirelessly to create products and services that empower users with industry-leading health, wellness and safety features. Masimo has wrongly attempted to use the ITC to keep a potentially lifesaving product from millions of U.S. consumers while making way for their own watch that copies Apple. While today’s decision has no immediate impact on sale of Apple Watch, we believe it should be reversed, and will continue our efforts to appeal.”

That appeal will go to the Federal Circuit, and, in the meantime, U.S. Trade Representative Katherine Tai will also have the option to veto the ITC ruling, according to Apple.

The tech giant asserted that a sales ban on its device would negatively impact U.S. consumers and patients as well as public health overall, and accused Masimo of starting the patent war purely to help clear a space in the market for its own smartwatch—which Apple has claimed bears more than a little similarity to Apple-made predecessors. It’s currently pursuing those claims in two ongoing patent infringement lawsuits against Masimo, while another previously filed by Masimo resulted in a hung jury earlier this year, though Masimo promised to retry the case.

The back-and-forth between Apple and Masimo may spark a sense of deja vu, since it was less than a year ago that the ITC issued another limited exclusion order to Apple in a patent infringement case, once again setting up a possible sales ban for the Apple Watch over a different feature.

In that case, the electrocardiogram technology embedded into recent models of the Apple Watch took center stage, as AliveCor accused Apple of violating its patents for similar portable ECG sensors.

Following the ITC’s late December order, the Biden administration opted not to veto the exclusion order, though sales of the smartwatch have yet to be halted as related patent challenges between Apple and AliveCor drag on in court.