Sydnexis v. Eyenovia: Federal Circuit Affirms Patent Unpatentable
Sydnexis, Inc. appealed a patentability ruling over US10940145B2, covering an ophthalmic composition, against rival Eyenovia, Inc. The Federal Circuit affirmed the underlying invalidity finding, extinguishing Sydnexis’s patent rights after a 600-day appellate proceeding spanning September 2023 to May 2025.
Federal Circuit seals fate of Sydnexis ophthalmic composition patent
Sydnexis, Inc. filed Appeal No. 23-2402 at the U.S. Court of Appeals for the Federal Circuit on 20 September 2023, challenging a prior ruling that US10940145B2 — a patent covering an ophthalmic composition — was unpatentable. The dispute pitted Sydnexis against Eyenovia, Inc., a competing ophthalmology company, in a proceeding centered on the validity of Sydnexis’s formulation claims. Wilson Sonsini Goodrich & Rosati represented the appellant; Mintz Levin acted for Eyenovia.
The Federal Circuit issued its affirmance on 12 May 2025, upholding the original unpatentability determination without finding reversible error in the proceedings below. With a basis of termination recorded as ‘Unpatentable,’ the patent claims are effectively cancelled, stripping Sydnexis of enforceable IP protection over the covered ophthalmic composition. Eyenovia is thereby free to operate within the scope of those now-invalidated claims without risk of infringement liability from this patent.
The 600-day duration of the appellate proceeding suggests a substantive briefing and review process, consistent with technically complex patentability disputes in the pharmaceutical formulation space. The public record does not disclose the precise grounds of unpatentability affirmed — whether obviousness, anticipation, or another basis — nor any financial terms or licensing arrangements between the parties. What remains commercially significant is that Eyenovia emerges with cleared freedom to operate, while Sydnexis must now look to its remaining portfolio to protect its ophthalmic product pipeline.
Filing to Unpatentable in 600 days
600-day appellate proceeding — above the Federal Circuit median for patent validity appeals
Federal Circuit affirms: what the unpatentability ruling means for both parties
Affirmance means the lower unpatentability finding stands
When the Federal Circuit ‘affirms,’ it finds no reversible error in the decision under review. Here, the court upheld the underlying ruling that US10940145B2’s claims are unpatentable. The appellate panel applied its standard of review — deferential to factual findings, de novo on legal questions of patentability — and concluded the original determination was correct. The patent is cancelled with finality at this appellate level.
No reversible error foundSydnexis loses enforceable rights to US10940145B2
With the Federal Circuit affirming unpatentability, Sydnexis can no longer assert US10940145B2 against any party. The affirmance forecloses further appeal at this level, and a petition for certiorari to the Supreme Court — statistically unlikely to succeed in a patent validity matter — would be the only remaining avenue. Sydnexis’s commercial protection for this ophthalmic composition now depends entirely on any other patents in its portfolio.
Patent rights extinguishedEyenovia secures freedom to operate in the affirmed claim scope
Eyenovia prevails at the appellate level, confirming that the challenged claims cannot be enforced against it or any other party. The affirmance strengthens Eyenovia’s freedom to operate within the technical scope of US10940145B2’s cancelled claims. This outcome also raises the bar for Sydnexis to reassert similar protection — a new application covering substantially the same subject matter would face heightened scrutiny in light of this unpatentability finding.
Freedom to operate confirmedOphthalmic formulation space loses a patent barrier post-affirmance
The cancellation of a pharmaceutical formulation patent following Federal Circuit affirmance typically signals a cleared competitive landscape for rival developers. Companies active in ophthalmic drug delivery — particularly micro-dose or topical formulation platforms — may now operate within the former scope of US10940145B2 without licence obligations to Sydnexis. Competitors and investors should monitor whether Sydnexis pursues continuation or divisional applications covering related subject matter.
Sector barrier removedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Sydnexis, Inc. | Company | Ophthalmology drug developer — holder of US10940145B2, ophthalmic composition patentSearch in Eureka ↗ |
| Defendant | Eyenovia, Inc. | Company | Eyenovia, Inc. — ophthalmology company and challenger to Sydnexis’s formulation patentSearch in Eureka ↗ |
| Plaintiff counsel | Jad Allen Mills | Attorney | Counsel for Sydnexis, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Kelsey Catina | Attorney | Counsel for Sydnexis, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Michael T. Rosato | Attorney | Counsel for Sydnexis, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Richard Torczon | Attorney | Counsel for Sydnexis, Inc.Search in Eureka ↗ |
| Plaintiff law firm | WilsonSonsini Goodrich & Rosati LLP | Law Firm | Representing Sydnexis, Inc.Search in Eureka ↗ |
| Defendant counsel | Peter Cuomo | Attorney | Counsel for Eyenovia, Inc.Search in Eureka ↗ |
| Defendant counsel | Thomas H. Wintner | Attorney | Counsel for Eyenovia, Inc.Search in Eureka ↗ |
| Defendant counsel | Williams Dixon | Attorney | Counsel for Eyenovia, Inc.Search in Eureka ↗ |
| Defendant law firm | Mintz, Levin, Cohn, Ferris, Glovsky & Popeo PC | Law Firm | Representing Eyenovia, Inc.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 one-word disposition — AFFIRMED — confirms that the panel found no reversible error in the underlying unpatentability determination concerning US10940145B2. At the appellate level, factual findings from the tribunal below are reviewed for substantial evidence, while legal conclusions on patentability are reviewed de novo. An affirmance on both standards simultaneously forecloses Sydnexis’s strongest arguments and leaves the cancelled claims with no avenue for reinstatement short of Supreme Court review, which is granted only rarely in patent validity matters.
US10940145B2 — ophthalmic composition formulation patent
US10940145B2, filed under application number US16/785418, protects an ophthalmic composition — broadly, a formulated preparation designed for ocular administration. Ophthalmic composition patents in this class typically cover aspects of active ingredient concentration, excipient selection, pH buffering, or delivery vehicle characteristics that collectively define a clinically viable eye drop or instillation product. The patent’s technical domain sits within pharmaceutical formulation science, at the intersection of ophthalmology and drug delivery engineering.
For competing ophthalmic drug developers, US10940145B2 represented a potential barrier to formulation design around Sydnexis’s claimed composition parameters. Its cancellation following Federal Circuit affirmance removes that barrier, but the underlying technical disclosure remains part of the prior art record — which may itself affect the patentability of overlapping claims filed by any party. Companies developing micro-dose ophthalmic platforms, preservative-free formulations, or novel delivery vehicles should assess how the affirmed unpatentability grounds interact with their own prosecution strategies.
Should you run an FTO analysis referencing US10940145B2?
R&D and regulatory teams developing ophthalmic compositions — including topical eye drops, ocular gels, or instillation devices — should note that US10940145B2’s claims have been cancelled and affirmed as unpatentable at the Federal Circuit. While this specific patent no longer poses an infringement risk, the Sydnexis portfolio may include related continuation or divisional patents with overlapping subject matter. A targeted FTO search should confirm whether any surviving Sydnexis applications cover your product’s formulation parameters.
PatSnap Eureka’s FTO Search Agent can map the cancelled claims of US10940145B2 against your formulation specifications, identify live Sydnexis family members and continuation applications, and flag any third-party patents in the ophthalmic composition space that may present residual risk. For product teams approaching regulatory submission or commercial launch in ocular drug delivery, a structured FTO review anchored to this case’s invalidation record is a commercially sound step.
Run a freedom-to-operate analysis on US10940145B2 to assess your product’s exposure
Run FTO in Eureka →Similar Federal Circuit ophthalmic and pharmaceutical formulation patent appeals
Cases involving Federal Circuit affirmance of unpatentability in ophthalmic and pharmaceutical formulation patent disputes, relevant to US10940145B2 claim cancellation analysis.
What this case signals for the ophthalmic IP landscape
The Federal Circuit’s affirmance reshapes the competitive dynamics around ophthalmic formulation patents and raises practical questions for any company in the space.
Unpatentability affirmance clears the claim scope for all competitors
A Federal Circuit affirmance of unpatentability is not party-limited — the cancelled claims of US10940145B2 cannot be asserted against anyone. Ophthalmic formulation developers should review whether their products previously carried infringement risk under this patent and update their FTO assessments accordingly.
Sydnexis’s portfolio depth now determines its competitive moat
With US10940145B2 cancelled, Sydnexis’s ability to protect its ophthalmic composition products hinges on continuation patents, divisionals, or other portfolio assets. Companies licensing or partnering with Sydnexis should conduct diligence on the remaining scope of its IP estate before committing to long-term agreements.
Sydnexis v Eyenovia — key questions answered
The Federal Circuit affirmed the unpatentability of US10940145B2, Sydnexis’s ophthalmic composition patent, in a decision issued 12 May 2025. The court found no reversible error in the underlying invalidity determination, effectively cancelling the patent’s claims and confirming Eyenovia’s freedom to operate within their scope.
No. The Federal Circuit’s affirmance of the unpatentability finding means the claims of US10940145B2 are cancelled and unenforceable against any party. Sydnexis cannot assert this patent in infringement proceedings. The only theoretical remaining avenue would be a petition for certiorari to the U.S. Supreme Court, which is statistically rare in patent validity cases.
A ‘basis of termination: Unpatentable’ indicates the patent’s claims failed a validity challenge — most commonly at an inter partes review or similar proceeding — and that finding was upheld on appeal. For the ophthalmic formulation sector, it clears the competitive landscape of this particular patent barrier and may influence how examiners and tribunals assess similar claims in pending or future applications.
The appeal ran for approximately 600 days, from filing on 20 September 2023 to closure on 12 May 2025. This duration is consistent with a fully briefed Federal Circuit patent appeal involving substantive patentability arguments, and is above the court’s median disposition time for patent cases, suggesting the matter received detailed judicial consideration.
Sydnexis was represented by Wilson Sonsini Goodrich & Rosati LLP, with attorneys Jad Allen Mills, Kelsey Catina, Michael T. Rosato, and Richard Torczon on record. Eyenovia was represented by Mintz, Levin, Cohn, Ferris, Glovsky & Popeo PC, with Peter Cuomo, Thomas H. Wintner, and Williams Dixon appearing for the defendant-appellee.
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