ITC Import Rules for Medical Devices: How Apple Can Shut Down the Ratchet? The Case of Apple and AliveCor

This import ban isn’t the only one Apple is facing. In February, the Biden administration also declined to veto another ITC import ban and cease-and-desist order stemming from a dispute with AliveCor over the Apple Watch’s EKG features. Like Masimo, AliveCor argued that Apple stole its tech to develop the wearable EKG feature, thereby infringing on its patents. The result of one case doesn’t speak to how the other will play out

There was a dispute between the medical tech company Masimo and the suspension. As Engadget reports, Masimo sued Apple in 2021. The company alleged that Apple had infringed on one of its patents related to light-based blood-oxygen monitoring. A judge ruled that Apple had infringed on the patents, and the ITC upheld that ruling in October. The 60-day presidential review period ends on December 25. Apple is taking steps preemptively to comply.

Earlier this year, the US International Trade Commission (ITC) ruled that Apple had infringed on two patents from medical device maker Masimo. The ITC will ban the entry of Apple Watches Series 9 and Ultra 2 on December 26th. It was hard to believe that this would happen when Apple gets sued all the time, and even when it loses, how frequently do it face dramatic consequences?

That was 10 years ago and Apple pulled the rabbit out of the hat. Levi says it is very unlikely for them to do that again.

Can the Apple Watch SpO2 Sleep Apnea Detector Be Disapproved by the International Trade Commission? Dr. Iancu’s View

You can take a spot check on the Apple Watch, which periodically takes SpO2 readings, if you so choose. Apple doesn’t use these metrics very often. It’s not like how the watch uses its EKG capabilities to detect atrial fibrillation. SpO2 features on consumer devices have no medical use cases. They’re essentially for “entertainment” purposes, and we’ve repeatedly reported that you should never, ever use them as any sort of replacement for traditional pulse oximeters.

To get a veto, a company usually has to show a public interest or health policy basis. “It’s unlikely that the import exclusion order will be disapproved by the USTR and the president,” says Smith Brittingham, partner at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. “The only real answer would be, ‘Well, it’s Apple.’”

“It is extraordinarily rare for the President to overturn a decision from the International Trade Commission and in my view, [it’s] unlikely in this particular case,” says Andrei Iancu, co-chair of the Council for Innovation Promotion (C4IP) and partner at Sullivan & Cromwell LLP, who was also the director of the US Patent and Trademark Office from 2018 to 2021.

If the rumor that Apple is working on a sleep apnea detection is correct, it would be a real blow for the company. Losing the sensors in that instance would make developing this feature harder. However, that feature would require a lengthy FDA clearance process. That means more advanced health features like sleep apnea detection are more of a medium to long-term concern — and it’s very possible that Apple will have a workaround by the time such features are ready for consumers.

It is not a colorable difference if Apple makes a change that is significant enough to avoid the patent. Minor changes will not be sufficient,” Iancu says.

Basically, Apple can’t simply make a small tweak to the code and call it a day. While Masimo claims the patents are hardware related, disabling the sensor can’t be done without a patent. Apple could remove it entirely from the design, but that would require mucking around with Apple’s meticulous supply chain and could take some time.

The options would cost Apple some money. Apple could sit down with Masimo and hammer out a licensing deal for the infringed patents. Masimo CEO Joe Kiani told the New York Times that Apple hadn’t been involved in licensing negotiations. It is an easy fix, so why not do it? For starters, both parties have to want to settle.

Levi says that every case is different. “Different complainants who bring up a case have got their own businesses, their own products, and those implicate a whole different set of facts.”

Iancu claims that everything is working as it should. The system is working as intended. If Apple wants to have products imported into the US, it should make sure that it comes up with its original inventions and does not infringe on other people’s patented technology.”