The contentious patent battle between Apple and Masimo has been in the news as of late. Generally, patent litigation isn’t at the forefront of most people’s minds, so why is this one? In this particular instance, potential customers of the Apple Watch (especially around the busiest shopping season of the year!!) have been affected. This article explores the center of the dispute — the technology behind the “pulse oximeter” and the outcome of the legal battle between two bona fide competitors in the health technology space.
Pulse Oximeter – what is it?
A “pulse oximeter” is a device that noninvasively measures and/or monitors a person’s blood oxygen saturation level(s) (and more specifically, the oxygen saturation of blood in pulsating vessels[1]) and is at the center of the patent dispute between Apple and Masimo.
Interestingly, in the patent specification for the Masimo patent,[2][3] the term “pulse oximeter” is used only once; however, the device and its written description support undeniably show Masimo’s possession of the pulse oximeter device long before Apple’s alleged infringing use of the same. (See footnote 3, below).
Background of the Dispute
The legal battle between Apple and Masimo is predated by Masimo’s victory over True Wearables. In 2018, Masimo filed suit against True Wearables and it’s CEO Marcelo Lamego on multiple causes of action, including breach of contract, trade secret misappropriation, and patent infringement.[4] Masimo’s suit alleged that while Lamego was an employee at Masimo, and was subject to an Employee Confidentiality agreement, he was exposed to numerous technological processes that were “restricted to a only a very small number of Masimo’s trusted engineers.”[5] More specifically, the suit alleges that Lamego was a senior member of a team that developed a variety of non-invasive parameters for its wearable monitoring solutions and was “personally involved” in “strategic discussions on both the marketing and product plans for the wireless sensors and wearable monitors . . . [and] these plans were not generally known.”[6] Ultimately, Masimo prevailed in its suit against True Wearables and Lamego, and the District Court issued a permanent injunction against the sale of the infringing True Wearables device in December 2022.[7]
It is important to note that Lamego worked at both Apple and Masimo, and Masimo has essentially that alleged that Apple has integrated its pulse oximetry technology (including both the device and the method of use) into the Apple Watch – specifically the Watch Series 9 and Watch Ultra 2.
The ITC Limited Exclusion Order
The International Trade Commission (ITC) is an agency of the United States that, in part, analyzes and investigates the extent to which an unfair trade practice harms U.S. businesses. The ITC has the authority to issue import bans of products that infringe U.S. patents. The legal mechanism for this import ban comes from § 337 of the Tariff Act of 1930 (codified in 19 U.S.C. § 1337).
In the present case, the ITC found a § 337 violation and issued a limited exclusion order (LEO) prohibiting the unlicensed entry into the United States of the “infringing wearable electronic devices with light-based pulse oximetry functionality and components” covered by the Masimo patent (that is, a ban on importing the Watch Series 9 and Watch Ultra 2 absent a licensing agreement between Apple and Masimo). Additionally, the ITC issued a Cease and Desist Order (CDO) against Apple (and issued an exemption to the remedial orders for service, repair, or replacement of products purchased under terms of a warranty).
What to Watch (no pun intended) out for
To be in immediate compliance with the LEO, Apple would have to enter into a licensing agreement with Masimo.[8] The obvious benefit to entering into such a licensing agreement would be a continuity in sales of the Apple Watch (Series 9 and Ultra 2 specifically); however, Apple has chosen a different route. In an apparent attempt to work around the LEO, Apple filed Remedial Order (a request) with the Exclusion Order Enforcement Branch of the U.S. Customs and Border Protection hoping to get a favorable ruling that essentially contradicts the LEO. Instead, the Exclusion Order Branch stated that “Apple’s redesigned products are not subject to the Remedial Orders.”[9]
In late December 2023, Apple re-started sales of the Apple Watch with the Blood Oxygen app effectively removed. While this move places Apple in compliance with the LEO, I suspect that Apple’s appeal of the LEO and its continued fight against other related Masimo patents[10] is part of a larger licensing negotiation. I will keep an eye on these fascinating developments and provide updates as necessary.
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[1] URL: [https://www.oed.com/search/dictionary/?scope=Entries&q=pulse+oximeter]
[2] The “Masimo patent” refers to US Patent Nos. 10,912,502 or 10,945,648 (as stated in the Summary of the ITC’s final determination finding a § 337 violation) [https://www.usitc.gov/system/files?file=secretary/fed_reg_notices/337/337_1276_notice10262023sgl.pdf]
[3] Claim 1 of the Masimo patent is reproduced below for the reader’s convenience:
“A user-worn device configured to non-invasively measure a physiological parameter of a user . . . comprising:
a first set of light emitting diodes (LEDs), the first set of LEDs comprising at least an LED configured to emit light at a first wavelength and an LED configured to emit light at a second wavelength;
a second set of LEDs spaced apart from the first set of LEDs, the second set of LEDs comprising at least an LED configured to emit light at the first wavelength and an LED configured to emit light at the second wavelength;
four photodiodes arranged on an interior surface of the user-worn device and configured to receive light after attenuation by tissue of the user;
a protrusion comprising:
a convex surface extending over the interior surface,
a plurality of openings in the convex surface extending through the protrusion and aligned with the four photodiodes, each opening defined by an opaque surface, and
a plurality of windows, each of the windows extending across a different one of the openings; and
one or more processors configured to receive . . . signals from at least one of the photodiodes and calculate a measurement of the physiological parameter of the user” (emphasis added).
[4] See complaint: [https://www.documentcloud.org/documents/24245189-masimo-vs-true-wearables?responsive=1&title=1]; Patent that was allegedly infringed was US Pat. Nos. 8,983,564, 8,886,271, 7,295,866 and 7,186,966
[5] Id. at page 9, paragraph 26
[6] Id. at pages 9 and 10, paragraph 27
[7] The Verge: “Why Masimo thought it could take on Apple” [https://www.theverge.com/2023/12/28/24016913/apple-patent-dispute-masimo-lagemo-true-wearables]
[8] Presumably, this licensing agreement would have to meet the requirements of the Fair, Reasonable and Non-Discriminatory (FRAND) requirements.
[9] Patentlyo: “Apple Watch Stays on US Market, But Pulse-Ox Disabled Pending Appeal” [https://patentlyo.com/patent/2024/01/market-disabled-pending.html]
[10] Apple has instituted multiple Inter Partes Review (IPRs) against Masimo’s method of use patents on the basis of multiple prior art references claiming that these references render Masimo’s claimed methods as “obvious” (and therefore not meeting the statutory patentability requirements).