`
`NOS. 2023-1509, 2023-1553 (XAP)
`United States Court of Appeals
`for the Federal Circuit
`ALIVECOR, INC.,
`v.
`INTERNATIONAL TRADE COMMISSION,
`Appellee,
`
`Appellant,
`
`APPLE INC.,
`Intervenor.
`_____________________________________
`APPLE INC.,
`v.
`INTERNATIONAL TRADE COMMISSION,
`Appellee,
`
`Appellant,
`
`ALIVECOR, INC.,
`
`Intervenor.
`
`On Appeal from the United States International Trade Commission
`Inv. No. 337-TA-1266
`_____________________________________________________________________________________________________________________
`BRIEF OF DR. HUGH CALKINS AS AMICUS CURIAE IN SUPPORT OF
`APPLE INC. AND REVERSAL-IN-PART
`
`ADAM P. SEITZ
`ERISE IP, P.A.
`7015 College Blvd., Suite 700
`Overland Park, KS 66211
`(913) 777-5600
`adam.seitz@eriseip.com
`
`ABRAN J. KEAN
`ERISE IP, P.A.
`5299 DTC Blvd., Suite 1340
`Greenwood Village, CO 80111
`(720) 689-5440
`abran.kean@eriseip.com
`
`Counsel for Amicus Curiae Dr. Hugh Calkins
`
`
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`Case: 23-1509 Document: 41 Page: 2 Filed: 08/14/2023
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`FORM 9. Certificate of Interest
`
`Form 9 (p. 1)
`Marc.h 2023
`
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`CERTIFICATE OF INTEREST
`
`Case Number 23-1509 23-1553
`'
`Alivecor, Inc. v International Trade Commission, Apple, Inc.
`Short Case Caption
`Filing Party/Entity Dr. Hugh Calkins
`
`~~~~~~~~~~~~~~~~~~~~~~~-
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`~~~~~~~~~~~~~~~~~~~~~~~-
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`Instru ctions:
`
`1. Complete each section of the form and select none or NIA if appropriate.
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`2. Please enter only one item per box; attach additional pages as needed, and
`check the box to indicate such pages are attached.
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`3. In answering Sections 2 and 3, be specific as to which represented entities
`the answers apply; lack of specificity may result in non-compliance.
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`4. Please do not duplicate entries within Section 5.
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`5. Counsel must file an amended Certificate of Interest within seven days after
`any information on this form changes. Fed. Cir. R. 47.4(c).
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`I certify the following information and any attached sheets are accurate and
`complete to the best of my knowledge.
`
`Date: 0811412023
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`Signature:
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`Isl Abran J. Kean
`
`Name:
`
`Abran J . Kean
`
`
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`Case: 23-1509 Document: 41 Page: 3 Filed: 08/14/2023
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`FORM 9. Certificate of Interest
`
`Form 9 (p. 2)
`Marc.h 2023
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`1. Represent ed
`Entities.
`Fed. Cir. R. 47.4(a)(l).
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`2. Real Part y in
`Interest.
`Fed. Cir. R. 47.4(a)(2).
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`3. P arent Corporations
`an d Stockh olders.
`Fed. Cir. R. 47.4(a)(3).
`
`Provide the full names of
`all entities represented by
`undersigned counsel 1n
`this case.
`
`Provide t he full names of
`all real parties in interest
`for the entities. Do not list
`the real parties if they are
`the same as the entities.
`
`Dr. Hugh Calkins
`
`0 None/Not Applicable
`
`Provide the full names of
`all parent corporations for
`t h e
`entities
`and
`all
`publicly held compames
`that own 10% or more
`stock in t he entities.
`0 None/Not Applicable
`
`D
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`Additional pages attached
`
`
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`Case: 23-1509 Document: 41 Page: 4 Filed: 08/14/2023
`
`FORM 9. Certificate of Interest
`
`Form 9 (p. 3)
`Marc.h 2023
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`4. Legal Re presenta t ives.
`List all law firms, partners, and associates that (a)
`appeared for the entities in the originating cou rt or agency or (b) are expected to
`appear in this court for t he e ntities . Do not include t hose who h ave already entered
`an appearance in t his court. Fed. Cir. R. 47.4(a)(4).
`D
`D
`
`Additional pages attached
`
`None/Not Applicable
`
`Abran J. Kean
`Ei-ise IP, P.A.
`
`Adam P. Seitz
`Erise IP, P.A.
`
`5. Related Cases. Other than t h e originating case(s) for this case, are there
`related or prior cases t hat meet the criteria under Fed. Cir. R. 47.5(a)?
`D Yes (file separate notice; see below) Cl No
`IZI NIA (amicu s/m ovant)
`If yes, concurrently file a separate Notice of Related Case Information that complies
`with Fed. Cir. R. 47.5(b). P lease do not duplica te information . This sep arate
`Notice must only be filed with the first Cer tificate of In terest or, subsequently, if
`information changes during the pendency of the appeal. Fed. Cir. R. 47.5(b).
`
`6. Organizat ional Victims and Ba nkruptcy Cases. Provide any information
`required under Fed. R. App. P. 26.l(b) (organizational victims in criminal cases)
`and 26.l(c) (bankruptcy case debtors and trustees). Fed. Cir. R. 47.4(a)(6).
`D
`
`Additional pages attached
`
`[Z]
`
`None/Not Applicable
`
`
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`Case: 23-1509 Document: 41 Page: 5 Filed: 08/14/2023
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`TABLE OF CONTENTS
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`Page:
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`CERTIFICATE OF INTEREST
`TABLE OF CONTENTS ............................................................................. i
`TABLE OF AUTHORITIES ....................................................................... ii
`STATEMENT OF INTEREST OF AMICUS CURIAE ............................. 1
`ARGUMENT ............................................................................................... 4
`CONCLUSION ........................................................................................... 9
`CERTIFICATE OF COMPLIANCE ........................................................ 10
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`Case: 23-1509 Document: 41 Page: 6 Filed: 08/14/2023
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`TABLE OF AUTHORITIES
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`Page(s):
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`Other Authorities:
`Agnieszka Kotalczyk, Gregory YH Lip, & Hugh Calkins,
`The 2020 ESC Guidelines on the Diagnosis and
`Management of Atrial Fibrillation,
` 10(2) ARRHYTHMIA & ELECTROPHYSIOLOGY REV. (2021) ....................... 7
`Ben Freedman et al., Screening for Atrial Fibrillation:
`A Report of the AF-SCREEN International Collaboration,
` 135 CIRCULATION (2017) ..................................................................... 6-7
`Camm, A. John et al., The Year in Cardiology: Arrhythmias and
`Pacing: The Year in Cardiology 2019, CARDIOLOGIA CROATICA,
` May/June 2020 ....................................................................................... 5
`David O. Arner, Management of asymptomatic arrhythmias: a
`European Heart Rhythm Association (EHRA) consensus document,
`endorsed by the Heart Failure Association (HFA), Heart Rhythm
`Society (HRS), Asia Pacific Heart Rhythm Society (APHRS),
`Cardiac Arrhythmia Society of Southern Africa (CASSA), and
`Latin America Heart Rhythm Society (LAHRS)
` EUROPEAN SOCIETY OF CARDIOLOGY, March 18, 2019 .......................... 5
`Hugh Calkins, New Supraventricular Tachycardia Initiative
`Seeks to Help Patients Find the Best Possible Care and Support,
` 7(1) EUROPEAN J. OF ARRHYTHMIA
` & ELECTROPHYSIOLOGY 2 (2021) ............................................................. 5
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`ii
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`Case: 23-1509 Document: 41 Page: 7 Filed: 08/14/2023
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`Kadire, Siri R et al., Anticoagulation after
`Ablation for Atrial Fibrillation
` THE NEW ENGLAND JOURNAL OF MEDICINE, July 29, 2021 ................... 5
`Ritu Yadav et al., Sex-Based Differences in Safety and
`Efficacy of Catheter Ablation for Atrial Fibrillation, J.
` CARDIOVASCULAR ELECTROPHYSIOLOGY (2023) ....................................... 6
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`iii
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`Case: 23-1509 Document: 41 Page: 8 Filed: 08/14/2023
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`STATEMENT OF INTEREST OF AMICUS CURIAE
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`Dr. Hugh Calkins respectfully submits this brief as an amicus
`
`curiae pursuant to Federal Rule of Appellate Procedure 29 and Federal
`
`Circuit Rule 29.1 Dr. Calkins is a Professor of Cardiology and Director of
`
`the Electrophysiology Laboratory and Arrhythmia Service at Johns
`
`Hopkins Hospital. This case is of interest to Dr. Calkins because of his
`
`longstanding and ongoing work in the area of cardiology, especially work
`
`and research involving cardiac arrhythmias, and because of his concern
`
`for preserving public access to devices that include important health
`
`features. Dr. Calkins writes to emphasize public health considerations
`
`that the Court should be aware of when deciding the case.
`
`Dr. Calkins is the Catherine Ellen Poindexter Professor of
`
`Cardiology and Director of the Electrophysiology Laboratory and
`
`Arrhythmia Service at the Johns Hopkins Hospital. He is an
`
`internationally recognized expert on catheter ablation, atrial fibrillation,
`
`syncope, arrhythmogenic right ventricular dysplasia (ARVD) and
`
`arrhythmia management.
`
`
`
`1 No person other than the amicus or their counsel authored this brief or
`contributed money intended to fund its preparation or filing.
`
`
`
`1
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`
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`Case: 23-1509 Document: 41 Page: 9 Filed: 08/14/2023
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`Dr. Calkins attended Williams College and Harvard Medical School
`
`before training in medicine at Massachusetts General Hospital. He
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`received his cardiology training at Johns Hopkins. His first faculty
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`position was at the University of Michigan, where he directed the
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`Pacemaker Service, and he returned to Johns Hopkins as director of the
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`Arrhythmia Service in 1992.
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`Dr. Calkins is an Associate Editor of the Journal of Cardiovascular
`
`Electrophysiology and is on the editorial board of many other cardiology
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`journals. He is a former member of the American Board of Internal
`
`Medicine Electrophysiology Boards Test Writing Committee. Dr. Calkins is
`
`a fellow of the American College of Cardiology, the American Heart
`
`Association and the Heart Rhythm Society. He led a 44-member
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`international task force whose 2012 Expert Consensus Statement gave
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`recommendations for treatment and research of atrial fibrillation. Dr
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`Calkins is a past president of the Heart Rhythm Society and was elected to
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`be a member of the Miler Coulsen Academy of Clinical Excellence in 2014.
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`Dr. Calkins has published more than 500 articles and book chapters
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`on a large variety of cardiac arrhythmias. His research has focused
`
`predominantly on catheter ablation, atrial fibrillation, syncope, and
`
`
`
`2
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`
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`Case: 23-1509 Document: 41 Page: 10 Filed: 08/14/2023
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`arrhythmogenic right ventricular dysplasia. Dr. Calkins has also written
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`extensively on most aspects of heart rhythm disorders and their
`
`treatment. As can be seen from the above, Dr. Calkins has devoted his
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`professional career to understanding cardiovascular health and helping
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`treat and cure patients that suffer from heart problems.
`
`
`
`
`
`
`
`3
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`Case: 23-1509 Document: 41 Page: 11 Filed: 08/14/2023
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`ARGUMENT
`
`Since its introduction to the market in 2015, the Apple Watch has
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`become an important tool that serves the public health interests of
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`United States citizens. In particular, the availability of heart monitoring
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`software,
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`including High Heart Rate Notifications, and cardiac
`
`arrhythmia focused software such as the electrocardiography (ECG) App
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`and Irregular Rhythm Notifications on the Apple Watch help patients
`
`and doctors understand typical heart rates and potential issues with
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`heart health.
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`First, these sensors and software in the Apple Watch provide
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`significant benefit to patients by alerting them to possible arrhythmias
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`such as atrial fibrillation, which is a common cardiac arrhythmia
`
`affecting millions of people in the United States and a common cause for
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`stroke. Importantly, the risk for stroke can be mitigated through
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`treatment if the atrial fibrillation is discovered in a patient. The Apple
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`Watch significantly aids in diagnosis of conditions such as atrial
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`fibrillation and positions patients to receive a diagnosis and to receive
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`treatment earlier than they otherwise would without this information
`
`
`
`4
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`Case: 23-1509 Document: 41 Page: 12 Filed: 08/14/2023
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`from the Apple Watch. See Appx1408 (Dr. Calkins Letter).2 This early
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`warning of heart problems is critical in successful treatment and
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`avoiding what could otherwise become emergency situations. If the Apple
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`Watch and this functionality were to no longer be available, millions of
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`people would no longer have advanced warning of atrial fibrillation. This
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`could lead to countless numbers of citizens being placed at a heightened
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`risk for severe health complications, including death.
`
`
`
`2 See also Kadire, Siri R et al., Anticoagulation after Ablation for Atrial
`Fibrillation, THE NEW ENGLAND JOURNAL OF MEDICINE, July 29, 2021, at
`468 (suggesting an Apple Watch equipped with electrocardiographic
`monitoring for patients suffering from atrial fibrillation); Camm, A. John
`et al., The Year in Cardiology: Arrhythmias and Pacing: The Year in
`Cardiology 2019, CARDIOLOGIA CROATICA, May/June 2020, at 134
`(referencing an Apple Watch study investigating if a smartwatch based
`irregular pulse notification algorithm
`identified possible atrial
`fibrillation); Hugh Calkins, New Supraventricular Tachycardia Initiative
`Seeks to Help Patients Find the Best Possible Care and Support, 7(1)
`EUROPEAN J. OF ARRHYTHMIA & ELECTROPHYSIOLOGY 2 (2021) (explaining
`how use of mobile devices, such as Apple Watches, improved the
`diagnosis of SVT (an elevated heart rate condition) during the COVID-19
`pandemic); David O. Arner, Management of asymptomatic arrhythmias:
`a European Heart Rhythm Association (EHRA) consensus document,
`endorsed by the Heart Failure Association (HFA), Heart Rhythm Society
`(HRS), Asia Pacific Heart Rhythm Society (APHRS), Cardiac Arrhythmia
`Society of Southern Africa (CASSA), and Latin America Heart Rhythm
`Society (LAHRS), EUROPEAN SOCIETY OF CARDIOLOGY, March 18, 2019 at
`845 (explaining how devices like the Apple Watch can measure pulse
`rates for patients with heart rhythm irregularities).
`
`
`
`5
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`Case: 23-1509 Document: 41 Page: 13 Filed: 08/14/2023
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`Second, the data generated by the Apple Watch and its sensors and
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`software is also useful to doctors. Traditionally, lacking specialized
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`equipment, patients were required to go to the hospital to undergo an
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`ECG. Many patients were unable to make it to the hospital before their
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`symptoms resolved, making it difficult for doctors to gather data that
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`showed an arrhythmia and complicating further treatment. Other
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`patients did not have access to a care provider that was able to quickly
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`perform an ECG. Many other patients suffer from a fear of doctors and
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`simply refuse to go to a care provider to have their symptoms examined.
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`The Apple Watch has alleviated many of these problems by providing
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`patients with a way to gather a more robust data set about their heart
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`health without stepping foot into a provider’s office. The data gathered
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`and stored by the Apple Watch and its sensors and software can be useful
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`to doctors in understanding a patient’s heart health, can help doctors
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`diagnose potential issues, and can lead to a more thorough treatment
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`plan.. See Appx1408 (Dr. Calkins Letter). 3 The advanced atrial
`
`
`
`3 See also Ritu Yadav et al., Sex-Based Differences in Safety and Efficacy
`of Catheter Ablation for Atrial Fibrillation, J. CARDIOVASCULAR
`ELECTROPHYSIOLOGY (2023) (describing how Apple Watches were used for
`arrhythmia recurrence monitoring to gather data related a medical
`procedure’s effectiveness); Ben Freedman et al., Screening for Atrial
`
`
`
`6
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`
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`Case: 23-1509 Document: 41 Page: 14 Filed: 08/14/2023
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`fibrillation warning systems of the Apple Watch also can provide the
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`necessary “push” for patients to receive treatment who otherwise would
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`not visit a doctor’s office.
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`Third, the Apple Watch and its sensors and software are currently
`
`being used in clinical arrhythmia research. Thus, not only does the
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`availability of the Apple Watch help direct consumers and their doctors,
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`but also the public at large stands to gain from this research. This clinical
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`arrhythmia research using the Apple Watch will lead to advancements
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`in science and heart health saving many more Americans from serious
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`illness or death. Indeed, many clinically-impactful research studies in the
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`United States depend on the use of the Apple Watch to make meaningful
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`discoveries that will serve the health interests of the overall population.
`
`See Appx1408 (Dr. Calkins Letter).4
`
`
`
`Fibrillation: A Report of the AF-SCREEN International Collaboration,
`135 CIRCULATION 1851–67 (2017) (explaining that ongoing monitoring
`detects atrial fibrillation more effectively than repeated patient-activated
`devices and that noninvasive devices can accomplish continuous
`monitoring).
`
` 4
`
` See also Agnieszka Kotalczyk, Gregory YH Lip, & Hugh Calkins, The
`2020 ESC Guidelines on the Diagnosis and Management of Atrial
`Fibrillation, 10(2) ARRHYTHMIA & ELECTROPHYSIOLOGY REV. 65-67 (2021)
`(“[i]ncreasing data on the identification and monitoring of AF are
`available for the use of wearable technology or implantable loop recorders
`
`
`
`7
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`Case: 23-1509 Document: 41 Page: 15 Filed: 08/14/2023
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`I understand
`
`the
`
`International Trade Commission has
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`recommended an injunction on sales of the Apple Watch in the United
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`States. As a practicing physician who has devoted his career to studying
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`cardiology and treating heart problems, it is my opinion that removing
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`the Apple Watch and its heart health functionality from the marketplace
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`has the potential to create a public health crisis. Millions of citizens
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`would lose access to a device that includes functionality for detecting
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`potential heart problems. Without this early detection, millions of
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`citizens who are suffering from heart problems would then miss the
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`crucial early treatment that helps doctors and emergency providers save
`
`lives. This injunction would compromise ongoing projects that will lead
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`to further advancements in medical science, which has the potential to
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`cause significant setbacks to future treatments. Any injunctive remedy
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`that disrupts the availability of the Apple Watch and its heart health
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`functionality would be detrimental to the public health interest of United
`
`
`
`to detect and record AF episodes . . . . [n]ovel tools and technologies for
`digital ECG analysis, in the form of wearables, machine learning and
`artificial intelligence, have brought potentially significant opportunities
`for the detection and diagnosis of [atrial fibrillation] and may be used for
`long-term [atrial fibrillation] screening, especially in high-risk cohorts.”).
`
`
`
`8
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`Case: 23-1509 Document: 41 Page: 16 Filed: 08/14/2023
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`States citizens and to the advancement of the science by medical
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`professionals across the nation. See Appx1408 (Dr. Calkins Letter).
`
`CONCLUSION
`
`The Court should consider the public health consequences of
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`injunctive relief when deciding this appeal.
`
`
`
`Dated: August 14, 2023
`
`
`
`
`
`
`
`/s/ Adam P. Seitz
`ADAM P. SEITZ
`ERISE IP, P.A.
`7015 College Blvd., Suite 700
`Overland Park, KS 66211
`(913) 777-5600
`adam.seitz@eriseip.com
`
`
`
`9
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`Case: 23-1509 Document: 41 Page: 17 Filed: 08/14/2023
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`CERTIFICATE OF COMPLIANCE WITH TYPE-VOLUME
`LIMITATION, TYPEFACE AND TYPE STYLE REQUIREMENTS
`1.
`This brief complies with the type-volume limitation of Federal
`
`Rule of Appellate Procedure 32(a)(7)(B) or Federal Rule of Appellate
`
`Procedure 28.1(e). The brief contains 1,562 words, excluding the parts of
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`the brief exempted by Federal Rule of Appellate Procedure
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`32(a)(7)(B)(iii).
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`2.
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`This brief complies with the typeface requirements of Federal
`
`Rule of Appellate Procedure 32(a)(5) or Federal Rule of Appellate
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`Procedure 28.1(e) and the type style requirements of Federal Rule of
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`Appellate Procedure 32(a)(6). The brief has been prepared in a
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`proportionally spaced typeface using Microsoft Word for Mac in Century
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`Schoolbook, 14 point font.
`
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`Dated: August 14, 2023
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`
`
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`
`
`
`/s/ Adam P. Seitz
`ADAM P. SEITZ
`ERISE IP, P.A.
`7015 College Blvd., Suite 700
`Overland Park, KS 66211
`(913) 777-5600
`adam.seitz@eriseip.com
`
`
`
`10
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