The Biden administration has let stand a ban imposed by the US International Trade Commission (ITC) on imports of the latest Apple Watch models stemming from a patent dispute over the devices’ no blood oxygen monitoring technology.
The ban, which went into effect on Tuesday, bars imports of the Apple Watch Series 9 and Apple Watch and Ultra 2 models. It follows an October ruling by the ITC that claims that Apple infringed on patented technology belonging to medical device maker Masimo Corp.
Masimo had complained to the agency in mid-2021 that the watches’ ability to measure blood oxygen levels violated its patents. The commission agreed in a decision in October and ordered Apple to halt all imports of the Series 9 and Ultra 2.
On Tuesday, the Office of the U.S. Trade Representative said in a statement that after “careful consideration,” the Biden administration had “decided not to reverse the ITC’s determination.”
The statement means that the administration essentially declined to veto the trade agency’s import ban, allowing it to take effect as scheduled. While presidents have 60 days to review such bans, reversals are rare.
Apple Will Continue to Fight the ITC’s Decision
In a parallel statement Tuesday, Apple said:
“We strongly disagree with the USITC decision and resulting exclusion order, and are taking all measures to return Apple Watch Series 9 and Apple Watch Ultra 2 to customers in the US as soon as possible”.
Apple (AAPL) has appealed the patent ruling with a federal appeals court while still complying with the ban. It has already stopped all direct sales of the watches in the United States but said that customers could still buy previously imported stock from third-party retailers for now.
Apple has also asked the appeals court to pause the ITC’s ban as the case proceeds on the argument that the restrictions are causing “irreparable harm” to the firm’s product line and finances.
Masimo did not immediately respond to requests for comment on the Biden administration’s decision Tuesday.
The legal battle stems from Masimo’s allegations, made in a 2020 lawsuit, that Apple stole trade secrets and violated its patents in developing a pulse oximeter for the Apple Watch – a technology that measures a user’s blood oxygen levels and that Masimo said it pioneered.
Apple has denied stealing any secrets. In counter lawsuits filed last year, Apple alleged that Masimo’s own wearable device infringes Apple patents and that Masimo is using litigation to try to clear its own smartwatch path.
The Ban Applies Only to the Latest Apple Watch Iterations
While the import restriction is now in effect, it does not bar all Apple Watches – only the latest models including Series 9 and Ultra 2 watches which use the pulse oximeter sensor technology.
Other models, like the more budget-conscious Apple Watch SE, do not support the blood oxygen monitoring feature targeted by Masimo’s complaints. Apple said it will continue selling those devices in the United States.
The ban also does not impact customers who previously purchased a Series 9 or Ultra 2 in the country either, Apple has confirmed.
Pulse Oximeter at Issue in Dispute Over Patent Infringement
At the heart of the dispute is the question of who has rights to foundational patents covering the use of light-based sensors to measure blood oxygen saturation.
Masimo is a medical device company that specializes in signal-processing technology and patient monitoring devices used in hospital settings. It has accused Apple of stealing trade secrets related to its innovative pulse oximetry technology, which uses light beams to measure oxygen levels in blood and can detect health problems like sleep apnea.
In its 2021 complaint to the ITC, Masimo said that it invested billions to develop this technology and accused Apple of copying its innovative approach in 2020 when it unveiled blood oxygen measurement in the Apple Watch Series 6.
Masimo argued that Apple infringed 10 of its patents and claimed that confidential information was illegally transferred by former Masimo employees who were hired by Apple to work on the Apple Watch.
Apple has denied stealing these secrets or infringing any patents. Apple said it independently developed the Apple Watch blood oxygen app and that Masimo’s patents are invalid. It called Masimo’s legal actions an effort to push aside the Apple Watch in the market to make room for its own smartwatch copied from Apple’s designs.
The Legal Fight and Uncertain Path Ahead
Masimo first sued Apple separately in 2020 in federal court in California, accusing Apple of poaching employees and stealing trade secrets related to its blood oxygen monitoring technology in order to incorporate this feature into the Apple Watch. That case ended in a mistrial in May after jurors failed to reach a unanimous verdict.
Masimo also brought complaints against Apple over patent infringement to the US International Trade Commission in 2021, arguing that Apple should be barred from importing watches that use its proprietary technology.
An ITC judge sided with Masimo in January 2022, finding that Apple infringed on the patents. The commission reviewed the dispute before issuing its own ruling in October agreeing that Apple’s watches violate Masimo patents and should be banned.
Apple appealed that decision days later and filed an emergency motion earlier this month asking an appeals court to pause the ban as it fights the case. With the Biden administration declining to veto the ITC’s import ban, Apple is also submitting redesigned watches to customs officials that it believes no longer violate Masimo’s patents in hopes of resuming sales as soon as possible.
However, the path forward remains uncertain for Apple while the legal battle plays out. To comply with the import ban, Apple halted sales ahead of the restriction that went into effect on Tuesday. The company still disagrees strongly with the trade agency’s finding that its technology infringes Masimo patents.
Further complicating the matter, Apple filed its own patent lawsuits against Masimo last year. Apple alleges that Masimo’s wrist-worn pulse oximeter product violates patents on Apple Watch design and functionality.
With both companies now fighting heated legal battles against one another over who controls foundational smartwatch and blood oxygen monitoring patents, the tech giants appear headed for a showdown that will likely take months if not years to be resolved in various courts.