Edwards Lifesciences v. Cardiovalve: Federal Circuit Affirms Unpatentability of Heart Valve Implant Patent
Edwards Lifesciences secured a Federal Circuit affirmance against Cardiovalve’s US10702385B2, a patent covering implants for heart valves. The appellate court upheld the underlying unpatentability finding, ending a challenge that spanned 845 days. The ruling leaves Cardiovalve’s patent claims cancelled with no appellate path remaining at this level.
Federal Circuit seals Cardiovalve’s patent fate in heart valve implant dispute
Edwards Lifesciences Co. initiated appellate proceedings before the United States Court of Appeals for the Federal Circuit on 15 February 2023, challenging a patentability determination involving US10702385B2, assigned application number US16/284331. The patent at issue covers implant technology for heart valves — a commercially significant domain within the structural cardiology and transcatheter intervention space. Cardiovalve Ltd., the patent holder, defended the validity of its claims on appeal.
The Federal Circuit issued its order on 9 June 2025, affirming the lower tribunal’s finding that the patent claims were unpatentable. The court’s order — ‘AFFIRMED’ — confirms that no reversible error was identified in the patentability analysis below. For Cardiovalve, this means the cancellation of the asserted patent claims is now upheld at the appellate level, exhausting a primary avenue of challenge for Edwards at this stage.
The 845-day duration from filing to close is consistent with a substantive Federal Circuit appeal involving technical complexity in the medical device field. The basis of termination — ‘Unpatentable’ — suggests the invalidity challenge succeeded on the merits rather than on procedural grounds, though the specific invalidity basis (e.g., obviousness, anticipation) is not disclosed in the public record. What remains unknown is whether Cardiovalve will seek en banc review or petition the Supreme Court.
Filing to Unpatentable in 845 days
845 days — above the median Federal Circuit appeal duration of roughly 18–24 months
Federal Circuit affirms: what the unpatentability ruling means for both parties
Affirmance means the lower tribunal’s decision stands in full
When the Federal Circuit issues an ‘AFFIRMED’ order, it confirms that the reviewing panel found no reversible legal error in the lower tribunal’s patentability analysis. The underlying cancellation of Cardiovalve’s claims is now backed by appellate authority. This is not a new ruling on the merits — it is a validation of the prior determination, carrying the full weight of Federal Circuit precedent.
No reversible error foundCardiovalve’s patent claims are cancelled and now upheld on appeal
For Cardiovalve, the affirmance is a significant adverse outcome. US10702385B2’s claims, already found unpatentable at the tribunal below, have now survived appellate scrutiny in favour of the challenger. The patent can no longer be enforced as originally granted. Cardiovalve’s remaining options — en banc rehearing or a certiorari petition — are statistically unlikely to succeed and procedurally demanding.
Patent claims cancelledEdwards Lifesciences secures a strengthened freedom-to-operate position
Edwards Lifesciences, as the prevailing appellant, now benefits from a Federal Circuit-endorsed cancellation of Cardiovalve’s heart valve implant claims. This affirmance raises the bar for any future assertion of equivalent claims by Cardiovalve. For Edwards’ product development pipeline in structural cardiology, the ruling suggests meaningfully reduced patent overhang from this specific patent family, consistent with ongoing competitive dynamics in the TAVR and implantable valve space.
Freedom-to-operate strengthenedUnpatentability affirmance reshapes the heart valve implant competitive landscape
The Federal Circuit’s affirmance of unpatentability sets a precedential signal for the transcatheter and implantable heart valve sector. Competitors and investors should note that Cardiovalve’s IP position in this specific technology area has been materially weakened. Other players in the space — particularly those developing mitral or tricuspid valve replacement implants — may find the patent landscape for similar claim structures more navigable following this ruling.
IP landscape shiftedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Edwards Lifesciences, Co. | Company | Medical device company — challenger of US10702385B2, heart valve implant patentSearch in Eureka ↗ |
| Defendant | Cardiovalve, Ltd. | Company | Israeli medical device firm — holder of US10702385B2 covering implants for heart valvesSearch in Eureka ↗ |
| Plaintiff counsel | Brian C. Barnes | Attorney | Counsel for Edwards Lifesciences, Co.Search in Eureka ↗ |
| Plaintiff counsel | Craig S. Summers | Attorney | Counsel for Edwards Lifesciences, Co.Search in Eureka ↗ |
| Plaintiff counsel | Joshua Stowell | Attorney | Counsel for Edwards Lifesciences, Co.Search in Eureka ↗ |
| Plaintiff law firm | Knobbe Martens Olson & Bear, LLP | Law Firm | Representing Edwards Lifesciences, Co.Search in Eureka ↗ |
| Defendant counsel | David Phillip Emery Counsel | Attorney | Counsel for Cardiovalve, Ltd.Search in Eureka ↗ |
| Defendant counsel | Devon Wesley Edwards | Attorney | Counsel for Cardiovalve, Ltd.Search in Eureka ↗ |
| Defendant counsel | Sara Tonnies Horton | Attorney | Counsel for Cardiovalve, Ltd.Search in Eureka ↗ |
| Defendant counsel | William Mandir | Attorney | Counsel for Cardiovalve, Ltd.Search in Eureka ↗ |
| Defendant law firm | Sughrue Mion PLLC | Law Firm | Representing Cardiovalve, Ltd.Search in Eureka ↗ |
| Defendant law firm | Willkie Farr & Gallagher LLP | Law Firm | Representing Cardiovalve, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Court of Appeals for the Federal CircuitSearch in Eureka ↗ |
Official order — verbatim text
The Federal Circuit’s order — ‘THIS CAUSE having been considered, it is ORDERED AND ADJUDGED: AFFIRMED’ — is a merits affirmance, not a procedural dismissal. The appellate panel applied its standard review framework, deferring to the underlying patentability findings where supported by substantial evidence while reviewing legal conclusions de novo. The unpatentability basis of termination confirms the claims did not survive scrutiny, and the affirmance forecloses any further challenge at this appellate level for Cardiovalve.
US10702385B2 — Implant for heart valve: transcatheter replacement technology
US10702385B2, filed under application number US16/284331, covers implant technology for heart valves — a field encompassing transcatheter aortic, mitral, and tricuspid valve replacement devices. The patent was held by Cardiovalve Ltd., an Israeli medical device company focused on transcatheter valve solutions. The technology addresses the structural and mechanical requirements of implantable valve devices, a domain subject to intense patent activity given the clinical and commercial stakes of minimally invasive cardiac procedures.
In the competitive landscape of structural cardiology, patent protection over implant design and delivery mechanisms is a primary strategic asset. US10702385B2’s cancellation removes a potentially blocking patent from Cardiovalve’s portfolio, which had positioned the company against major players including Edwards Lifesciences — the market leader in transcatheter aortic valve replacement. For competitors developing novel valve implant geometries or delivery systems, this cancellation may open design space previously subject to infringement risk.
Should you run an FTO analysis against US10702385B2 and Cardiovalve’s patent family?
R&D teams and product counsel at companies developing transcatheter heart valve implants — whether targeting aortic, mitral, or tricuspid indications — should take note of this outcome. While US10702385B2 has been found unpatentable, Cardiovalve may hold related continuation or divisional patents in the same family. Any company commercialising implantable valve devices should confirm that cleared design space extends across the full Cardiovalve filing portfolio, not just this cancelled patent.
PatSnap Eureka’s FTO Search Agent enables IP and R&D teams to map Cardiovalve’s full patent family — identifying continuations, divisionals, and foreign equivalents of US10702385B2 still potentially in force. Eureka’s claim-level analysis highlights which claim features were at issue in the invalidity challenge, helping your team determine whether your product design falls outside the scope of any surviving related claims before entering or expanding in the structural cardiology market.
Run a freedom-to-operate analysis on US10702385B2 to assess your product’s exposure
Run FTO in Eureka →Similar Federal Circuit patent appeals in transcatheter heart valve technology
Explore Federal Circuit appeals involving patentability challenges in the structural cardiology and transcatheter heart valve implant sector, comparable to Case No. 23-1515.
What this case signals for the structural cardiology IP landscape
The Federal Circuit’s affirmance carries strategic weight well beyond the two parties — reshaping how heart valve implant patents are prosecuted and challenged.
Federal Circuit affirmance raises the invalidity bar for surviving TAVR patent appeals
This outcome signals that heart valve implant claims found unpatentable at the PTAB or ITC level face a high hurdle on Federal Circuit appeal. Companies relying on similar structural claim architectures in transcatheter valve patents should audit their portfolios for comparable vulnerability before litigation arises.
Edwards’ litigation strategy vindicates aggressive IPR or inter partes challenge filing
The successful challenge to US10702385B2 — through to Federal Circuit affirmance — demonstrates that well-resourced challengers using Knobbe Martens can sustain a multi-year invalidity campaign in the medical device space. In-house IP teams at cardiac device companies should model this case when evaluating freedom-to-operate risk from Cardiovalve’s remaining portfolio.
Edwards v Cardiovalve — key questions answered
The Federal Circuit affirmed the finding of unpatentability in Case No. 23-1515, upholding the cancellation of Cardiovalve’s US10702385B2 patent covering implants for heart valves. The court issued its order on 9 June 2025, after 845 days of appellate proceedings. The basis of termination was recorded as unpatentable.
US10702385B2 covers implant technology for heart valves, filed under application US16/284331. It relates to the structural design of transcatheter valve implant devices — a technology domain critical to minimally invasive cardiac surgery. The patent was held by Cardiovalve Ltd. and represented a potentially blocking asset against competitors including Edwards Lifesciences in the transcatheter valve replacement market.
An ‘AFFIRMED’ order from the Federal Circuit means the appellate panel found no reversible error in the lower tribunal’s patentability analysis. The cancellation of Cardiovalve’s patent claims stands with full appellate authority. It does not constitute a new merits ruling — it validates the prior determination. Cardiovalve’s remaining options are limited to en banc rehearing or a Supreme Court certiorari petition.
The cancellation of US10702385B2 applies to the specific claims of that patent. However, Cardiovalve may hold continuation, divisional, or foreign counterpart patents in the same family that remain in force. Companies active in transcatheter heart valve technology should conduct a full freedom-to-operate analysis across Cardiovalve’s broader portfolio to assess residual risk from related filings.
Edwards Lifesciences was represented by Knobbe Martens Olson & Bear, LLP, with counsel including Brian C. Barnes, Craig S. Summers, and Joshua Stowell. Cardiovalve was represented by Sughrue Mion PLLC and Willkie Farr & Gallagher LLP, with counsel including William Mandir, Sara Tonnies Horton, Devon Wesley Edwards, and David Phillip Emery.
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