By: Peter Rozewicz

Masimo, a global medical technology company organized under the laws of Delaware engaged Apple, a global technology company incorporated in California, in a patent dispute involving the Apple Watch Series 6.[1] Specifically, the complaint alleges Apple violated Masimo’s patents for using light sensors to measure blood oxygen by including the technology on its Series 6 watch.[2] Masimo brought the dispute in front of the United States International Trade Commission (“ITC”), which resolves patent disputes far differently than the district courts.[3]

By litigating in the ITC, the parties can resolve the dispute much more quickly than in the district court, and a decision in Masimo’s favor could block infringing watches from entering the US.[4]  Such a decision would be the second major hit endured by Apple of this kind in a short period of time.[5] On February 21, 2023, the ITC’s final determination in a patent dispute between Apple and AliveCor over Apple Watch electrocardiogram technology cleared presidential review, meaning the ITC’s limited exclusion order will stand.[6] The AliveCor case is the first time the ITC imposed a limited exclusion order against Apple that cleared presidential review.[7]

Presidential review of these patent cases is a procedure unique to ITC Section 337 litigation.[8] Section 337 cases have many of the same procedures as district court cases and some procedures unique to the ITC, but with an average length of eighteen months, the procedures are expedited.[9] The timeline of investigations under 337 consists of around fourteen steps starting with filing a complaint and ending with presidential review.[10] The petitioner serves the complaint and a copy is published in the Federal Register, and then the ITC decides whether to pursue the investigation.[11] Next, the respondents respond to the complaint, a schedule for the investigation is set, and discovery begins.[12] After that, there is a pre-hearing to set forth arguments to be heard at the hearing, followed by the hearing where the parties present their case and a post-hearing briefing where the parties address the issued raised in the hearing.[13] Lastly, the administrative law judge (“ALJ”) will make an initial determination, the commission reviews the initial determination and makes their own determination, which is subject to presidential review.[14]

In Apple’s dispute with Masimo, Masimo claims Apple violated five of its patents related to pulse oximetry, and an ALJ determined that Apple violated one of the patents twice with the Apple Watch Series 6.[15] The case is now undergoing review by the full commission, whose ruling could ban the import of infringing Apple Watch devices until they cease to violate Masimo’s intellectual property rights.[16] As the case moves into its final stages of review, Masimo requested that the ITC ban the importation of infringing devices into the United States, that Apple cease to violate the patents, and that a bond be set at the value of the infringing products during presidential review.[17]

Given the seeming similarities to the AliveCor case and the outcome in that dispute, Apple will likely be on the receiving end of yet another exclusion order.[18] AliveCor’s victory against Apple is indicative of the ITC’s successes in protecting inventors’ intellectual property and protecting domestic industry.[19] Section 337 litigation is not new, and Apple is no stranger to it, but the grave impact violations of Section 337 can have on a company, even one as large as Apple, should set off alarms for those looking to innovate, motivating them to ensure the technology they are using reflects their own intellectual property or intellectual property they have permission to use.[20] When violating Section 337 and placing themselves in a position to have their goods banned from entry into the US, companies are risking the same loss of business opportunities, reputational damage, depletion of goodwill, and barriers to successful business operation that they inflicted on the opposing party.[21]

[1] See SEC, Restated Articles of Incorporation of Apple Inc. (1988), https://www.sec.gov/Archives/edgar/data/320193/000119312509153165/dex31.htm; SEC, Restated Articles of Incorporation of Masimo Corporation (1996), https://www.sec.gov/Archives/edgar/data/937556/000119312507123994/dex32.htm; Eric Revell, Apple Watch faces potential import ban over patent dispute with Masimo, yahoo!finance (Feb. 19, 2023) [hereinafter dispute with Masimo], https://finance.yahoo.com/news/apple-watch-faces-potential-import-201330855.html?guccounter=1&guce_referrer=aHR0cHM6Ly9uZXdzLmdvb2dsZS5jb20v&guce_referrer_sig=AQAAANwvv5KbRnUyJehInCGbsMk7wSBkV1Bgf9dpiFb73iHtiR3c02nCGuJIoPdPPLemHb2q7cqhpy4Ggkk_ddQODp4X_tfIJ3utAEMUU2oeyb1kpBmYC21T825VyhVIPu2tMtTH1GYS9eqCA4pJrDBte3ygxaW706By5lvIOU1MaBhs.

[2] Revell, dispute with Masimo, supra note 1.

[3] Revell, dispute with Masimo, supra note 1; About Section 337, USITC [hereinafter USITC 337], https://www.usitc.gov/intellectual_property/about_section_337.htm (last visited Feb. 21, 2023).

[4] See Revell, dispute with Masimo, supra note 1; USITC 337, supra note 3; ITC Section 337, Finnegan, https://www.finnegan.com/en/work/practices/patent-litigation/itc-section-337.html (last visited Feb. 21, 2023).

[5] See Eric Revell, Biden admin declines to overrule trade court’s import ban on Apple Watch, Fox Business (Feb. 21, 2023, 8:30 PM) [hereinafter Biden admin declines], https://www.foxbusiness.com/markets/biden-admin-declines-overrule-trade-courts-import-ban-apple-watch.

[6] See Revell, Biden admin declines, supra note 5; AliveCor, AliveCor Announces the ITC’s Limited Exclusion Order Against Apple Clears Presidential Review, Cision: PR Newswire (Feb. 21, 2023, 12:00 PM), https://www.prnewswire.com/news-releases/alivecor-announces-the-itcs-limited-exclusion-order-against-apple-clears-presidential-review-301751962.html; Bradley Roush, et al., Navigating The Range Of Remedial Orders At The ITC, Foley & Lardner LLP (July 26, 2022), https://www.foley.com/en/insights/publications/2022/07/navigating-range-remedial-orders-itc#:~:text=Exclusion%20Orders,-An%20exclusion%20order&text=If%20the%20ITC%20finds%20a,the%20underlying%20Section%20337%20investigation (defining a limited exclusion order as a bar on the import of infringing articles, specifically import by the respondent in the case).

[7] AliveCor, supra note 6.

[8] See Gwendolyn Tawresey and Frank D. Liu, Overview of a Section 337 Investigation at the U.S. International Trade Commission, Troutman Pepper, 6 https://www.troutman.com/images/content/3/2/v3/324000/ITC_FAQ_Section337-Investigation_092722.pdf (last visited Feb. 21, 2023).

[9] See Tawresey, supra note 8, at 3-6.

[10] See Tawresey, supra note 8, at 3-6.

[11] See Tawresey, supra note 8, at 3.

[12] See Tawresey, supra note 8, at 4-5.

[13] See Tawresey, supra note 8, at 5.

[14] See Tawresey, supra note 8, at 5-6.

[15] See Revell, dispute with Masimo, supra note 1 (noting no violations of the other four patents).

[16] See Revell, dispute with Masimo, supra note 1.

[17] See Revell, dispute with Masimo, supra note 1; Tawresey, supra note 8, at 6 (noting the respondent may pay the bond and continue to import infringing products during presidential review).

[18] See Revell, Biden admin declines, supra note 5; Heather Landi, Judge rules Apple Watch infringed AliveCor’s ECG patent, setting up potential U.S. import ban, Fierce Healthcare (June 29, 2022, 7:47 AM), https://www.fiercehealthcare.com/digital-health/judge-finds-apple-violated-alivecors-patent-rights-setting-potential-us-apple-watch.

[19] See Revell, Biden admin declines, supra note 5; Tawresey, supra note 8, at 2-3.

[20] See Revell, dispute with Masimo, supra note 1; See Revell, Biden admin declines, supra note 5.

[21] See Talkin’ Trade: Enforcement of Section 337 Exclusion Orders at U.S. Customs and Border Protection, Ropes & Gray (Apr. 7, 2022), https://www.ropesgray.com/en/newsroom/podcasts/2022/april/podcast-talkin-trade-enforcement-section-337-exclusion-orders-us-customs-border-protection.

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