`
`
`
`Chairman David S. Johanson
`United States International Trade Commission
`500 E Street SW
`Washington, DC 20436
`
`Commissioner Jason E. Kearns
`United States International Trade Commission
`500 E Street SW
`Washington, DC 20436
`
`Commissioner Amy A. Karpel
`United States International Trade Commission
`500 E Street SW
`Washington, DC 20436
`
`
`October 14, 2022
`
`Commissioner Rhonda K. Schmidtlein
`United States International Trade Commission
`500 E Street SW
`Washington, DC 20436
`
`Commissioner Randolph J. Stayin
`United States International Trade Commission
`500 E Street SW
`Washington, DC 20436
`
`Re: Inv. No. 337-TA-1266: Certain Wearable Electronic Devices With ECG Functionality and Components
`Thereof
`
`Dear Chairman Johanson and Commissioners Schmidtlein, Kearns, Stayin, and Karpel:
`
`We write today to highlight public interest concerns if the initial International Trade Commission (ITC)
`determination is upheld during your independent review. Failure to overturn this initial determination, which may
`include an exclusion order to ban the importation of all Apple wearable devices across the United States, could
`result in severe negative impacts to businesses and millions of Americans.
`
`Currently, the ITC is considering a dispute between AliveCor, Inc. and Apple, Inc., under Section 337 of the
`Tariff Act of 1930 (Tariff Act).1 Enforcement provisions under Section 337 include the complete importation ban
`of a foreign product that infringes upon a domestic patent.2 AliveCor’s complaint alleges patent violations of its
`heart-health monitoring components within Apple’s wearable devices that were previously imported and sold
`across the United States. In June, an ITC Administrative Law Judge (ALJ) issued an initial determination
`recommending the ITC find that Apple infringed upon two of three AliveCor’s patents. The review of this initial
`determination is now before the ITC Commissioners.
`
`In your review, the Tariff Act requires consideration of “public interest” factors before issuing an exclusion order.
`Public interest factors include: 1) public health and welfare; 2) competitive conditions in the United States
`economy; 3) the production of like or directly competitive articles in the United States; and 4) the effect on United
`States consumers.3
`
`While we take no position on the underlying merits of the patent dispute between the parties in this litigation, we
`are concerned that issuing an exclusion order against Apple’s wearable devices would present a significant
`
`1 Inv. No. 337-TA-1266
`2 19 U.S.C. § 1337(a)
`3 19 U.S.C. § 1337(c)
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`detriment to American consumers. We ask that our concerns be included as part of the record under consideration
`by the ITC Commissioners who will soon finalize its review of the ALJ’s initial determination.
`
`Speaking directly to the public health and welfare standard, an exclusion order would immediately limit access
`to Apple’s heart-health monitoring wearable devices which are already widely available to the public. A complete
`restriction would add significant barriers to health and wellness features such as atrial fibrillation, or Afib
`monitors, which promptly alert users to previously undetected heart conditions. Heart-health information is also
`provided to valuable organizations such as the American Heart Association, Mayo Clinic, Northwestern
`University, and the National Institutes of Health (NIH) to conduct lifesaving research on serious conditions like
`reducing the risk of stroke and other cardiovascular conditions.4
`
`Concurrently with this ITC investigation, the Patent Trial and Appeal Board of the United States Patent and
`Trademark Office (PTAB) is undertaking an inter partes review (IPR) to determine the patentability of AliveCor’s
`asserted patents. As you may be aware, the purpose of the PTAB is to adjudicate the patentability of issued patents
`challenged by third parties. While PTAB judges continue to assess the patentability of these claims, their final
`determinations may add insight into the proceedings before the ITC.
`
`We recognize the unique challenges facing the ITC in protecting American consumers from unfair trade practices
`and infringements on intellectual property rights, including as an adjudicator of claims between domestic and
`foreign entities. Leading up to the ITC’s final determination in this case, we encourage close consideration of the
`public health benefits which Apple’s heart-health monitoring devices bring to the American consumer.
`Additionally, we recommend allowing the PTAB to finalize its own written decision stemming from the
`patentability dispute between AliveCor and Apple before making any final determination on the merits of this
`claim.
`
`We look forward to your prompt attention to this matter and appreciate your dedication towards an equitable
`outcome that benefits American consumers.
`
`Sincerely,
`
`
`
`
`
`
`
`
`4 See, e.g., Can Apple Watch reduce patients’ reliance on blood thinners?, Northwestern University, Aug. 29, 2022, available at,
`https://news.northwestern.edu/stories/2022/08/30m-grant-to-study-wearables-stroke-prevention-in-patients-with-atrial-fibrillation/
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`(Mids 7. SytienD
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`Linda T. Sanchez
`Memberof Congress
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`
`
`
`y Fanetta
`mber of Congress
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`