The U.S. Court of Appeals for the Federal Circuit has upheld a ruling invalidating AliveCor’s electrocardiogram (EKG) patents, effectively ending the prospect of an International Trade Commission (ITC) import ban on Apple Watches equipped with heart-rate monitoring technology. This decision marks a pivotal victory for Apple in a multi-year legal battle that threatened to disrupt sales of one of its flagship products. The ruling underscores the fragility of patent claims in fast-evolving tech sectors and reinforces Apple’s ability to integrate critical health features into its wearables without licensing constraints.
Background of the AliveCor-Apple Patent Dispute
The conflict between AliveCor and Apple originated in 2021 when AliveCor, a pioneer in FDA-cleared personal EKG devices, accused Apple of infringing three patents related to arrhythmia detection and heart-rate monitoring. These patents were central to AliveCor’s KardiaBand, an Apple Watch accessory that provided advanced cardiac insights before Apple introduced native EKG capabilities in its Series 4 watches. AliveCor argued that Apple’s incorporation of similar technology into its wearables—coupled with changes to watchOS that restricted third-party access to heart-rate data—constituted anticompetitive behavior and patent infringement.
AliveCor’s legal strategy mirrored that of Masimo, another medical device firm that secured an ITC import ban against Apple in 2023 over blood oxygen sensor patents. However, the outcomes diverged due to differences in patent validity challenges. While Masimo’s patents withstood scrutiny, AliveCor’s claims were invalidated by the Patent Trial and Appeal Board (PTAB) in December 2022, a decision now affirmed by the Federal Circuit.
Legal Proceedings and Key Rulings
PTAB’s Invalidation of AliveCor’s Patents
The PTAB determined that AliveCor’s patents (U.S. Patent Nos. 10,638,941 and 10,595,731) were unpatentable due to “obviousness” based on prior art and existing technologies. This ruling hinged on evidence that AliveCor’s innovations lacked sufficient novelty, as methods for analyzing cardiac signals using wearable devices had been documented in earlier research. Apple’s legal team successfully argued that AliveCor’s patents merely repackaged known techniques, a stance the Federal Circuit found convincing.
ITC’s Conditional Import Ban
In June 2022, the ITC initially ruled that Apple infringed AliveCor’s patents and recommended a limited exclusion order to block imports of EKG-enabled Apple Watches. However, this ban was contingent on the patents’ validity, which the PTAB’s subsequent invalidation nullified. The ITC’s enforcement mechanisms were suspended pending appellate review, a process that concluded with the Federal Circuit’s March 7, 2025, decision to uphold the PTAB’s findings.
Federal Circuit’s Final Judgment
The Federal Circuit’s ruling emphasized the PTAB’s authority to reassess patent validity independently of ITC infringement determinations. By affirming that AliveCor’s patents were unpatentable, the court vacated the ITC’s exclusion order, ensuring uninterrupted sales of Apple Watches in the U.S. AliveCor has expressed dismay over the outcome, alleging that the court overlooked “secondary considerations” such as commercial success and industry praise for its innovations. The company plans to pursue further appeals, though legal experts consider the prospects slim given the Federal Circuit’s definitive stance.
Comparative Analysis: AliveCor vs. Masimo
The divergent outcomes of AliveCor’s and Masimo’s patent disputes illustrate the critical role of patent robustness in ITC litigation. Masimo’s blood oxygen sensor patents survived validity challenges, leading to a 2023 import ban that forced Apple to disable the feature in U.S.-sold watches. In contrast, AliveCor’s EKG patents were vulnerable to invalidation, enabling Apple to circumvent the ban through technical redesigns validated by U.S. Customs in 2024.
This discrepancy highlights Apple’s strategic prioritization of feature-specific legal defenses. While the company could re-engineer its EKG algorithms to avoid AliveCor’s claims, Masimo’s pulse oximetry technology proved harder to decouple from hardware components, necessitating feature removal.
Corporate Responses and Market Implications
AliveCor’s Position
AliveCor CEO Priya Abani condemned the ruling as a blow to innovation, vowing to “explore all legal avenues” to protect the company’s intellectual property. The firm’s antitrust lawsuit against Apple, alleging monopolistic practices in the heart-rate app market, remains pending in Northern California but faces uncertainty following a 2024 dismissal of related claims.
Apple’s Commitment to Health Tech
Apple reaffirmed its dedication to advancing health features, with spokesperson Fred Sainz stating, “Our teams have worked tirelessly to create industry-leading health tools that impact users’ lives.” The decision solidifies Apple’s ability to integrate EKG capabilities—a key differentiator for the Apple Watch—without licensing fees or design constraints.
Industry-Wide Ramifications
The case underscores the risks for smaller medtech firms relying on patent litigation to compete with tech giants. AliveCor’s inability to enforce its patents despite initial ITC support may deter similar claims, emboldening companies like Apple to aggressively challenge patent validity preemptively. Conversely, the ruling may accelerate innovation in wearable health tech by clarifying the boundaries of patentable inventions.
Technical and Legal Strategy Breakdown
Patent Invalidity and Prior Art
The Federal Circuit’s decision rested on substantial evidence that AliveCor’s patents described obvious advancements over existing technologies. Prior research in wearable EKGs, including academic papers and earlier products, provided a foundation for the PTAB’s conclusion that AliveCor’s claims lacked inventiveness. This precedent reinforces the importance of robust prior art analysis in patent drafting, particularly in crowded fields like digital health.
Redesign as a Legal Tactic
Apple’s successful redesign of its EKG software—certified by U.S. Customs as non-infringing—demonstrates a pragmatic approach to sidestepping import bans. By contrast, hardware-dependent features like Masimo’s blood oxygen sensor required more drastic measures, highlighting the interplay between software adaptability and legal liability.
Conclusion: The Future of Wearable Health Tech
The Federal Circuit’s ruling removes a significant legal hurdle for Apple, allowing it to consolidate its dominance in the smartwatch market. However, the decision raises questions about the adequacy of patent protections for incremental innovations in fast-moving industries. As AliveCor weighs further appeals and Apple continues to face scrutiny over its health tech practices, the case serves as a cautionary tale for firms navigating the intersection of intellectual property and consumer electronics.
For the broader wearable industry, the outcome signals that patent validity challenges will remain a cornerstone of legal strategy, often outweighing infringement claims. Companies must prioritize rigorous patent drafting and anticipate validity reviews when litigating against deep-pocketed rivals. As Apple forges ahead with new health features, the balance between innovation, competition, and intellectual property rights will continue to shape the trajectory of wearable technology.