Sydnexis v. Eyenovia: Federal Circuit Affirms Unpatentability of Ophthalmic Composition Patent
Sydnexis, Inc. appealed a patentability ruling against Eyenovia, Inc. over US10842787B2, a patent covering ophthalmic compositions. The Federal Circuit affirmed the invalidity finding in a Rule 36 judgment — issuing no written opinion — closing the dispute after 598 days.
Federal Circuit summarily affirms ophthalmic patent cancellation against Sydnexis
Sydnexis, Inc., holder of US10842787B2 — a patent directed to ophthalmic compositions, likely covering topical drug formulations for eye conditions — appealed a patentability decision to the United States Court of Appeals for the Federal Circuit (Case No. 23-2411). The appeal was filed on 22 September 2023 and opposed by Eyenovia, Inc., a competing ophthalmic drug delivery company represented by Mintz Levin. The underlying proceedings had resulted in a finding that the claimed invention was unpatentable.
On 12 May 2025, the Federal Circuit issued an affirmance under Federal Circuit Rule 36 — a summary disposition that carries the same legal force as a full opinion but provides no written reasoning. The court found no reversible error in the lower tribunal’s unpatentability determination, leaving the cancellation of US10842787B2 intact. Sydnexis’s patent is effectively extinguished as an enforceable IP right, while Eyenovia avoids any infringement exposure tied to that claim scope.
The 598-day duration reflects typical Federal Circuit appellate timelines for patent validity contests. The Rule 36 affirmance — used when the panel finds the result clearly correct and no precedential value warrants a written opinion — forecloses any further elaboration on why the claims failed. The precise invalidity grounds (anticipation, obviousness, or written description deficiency) remain unexplained in the public record, limiting the precedential utility of this outcome for third-party observers.
Filing to Unpatentable in 598 days
598 days from filing to Federal Circuit affirmance — above the median for ex parte patent appeals
Federal Circuit affirms: what the Rule 36 judgment means for both parties
A Rule 36 affirmance: full effect, no written reasoning
Federal Circuit Rule 36 allows a panel to affirm a lower decision without a written opinion when the result is clearly correct. The judgment carries identical legal weight to a fully reasoned opinion — the unpatentability finding stands — but provides no guidance on which statutory grounds prevailed or how the claims were construed. Practitioners cannot mine the ruling for claim-scope signals.
No written opinion issuedUS10842787B2 is cancelled — Sydnexis loses its ophthalmic IP right
The affirmance confirms that the claims of US10842787B2 are unpatentable. Sydnexis cannot enforce this patent against Eyenovia or any other party. Any licensing programme or exclusivity strategy built around this asset must be reconsidered. Because the Federal Circuit was the final appellate step, further review would require a petition for certiorari to the Supreme Court — a high bar rarely granted for patent validity disputes.
Patent extinguishedEyenovia’s invalidity win is locked in at appellate level
Eyenovia secured cancellation of the asserted patent and has now seen that result affirmed by the Federal Circuit, the highest specialist patent court. The company faces no residual infringement exposure from US10842787B2. The Rule 36 disposition also means Sydnexis has no written reasoning to leverage in any parallel or follow-on proceeding. Eyenovia’s freedom to operate in the claim space covered by the cancelled patent is significantly strengthened.
FTO substantially clearedOphthalmic formulation competitors gain clearer freedom in this claim space
The cancellation of US10842787B2 removes a potential blocking patent from the ophthalmic topical drug formulation landscape. Competitors and product developers working in adjacent eye-drop composition spaces should assess how the cancelled claims overlapped with their pipelines. The absence of a written opinion limits guidance, but the outcome signals that the originally granted claims were vulnerable — consistent with heightened scrutiny of formulation patents at the USPTO and PTAB.
Formulation IP risk reducedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Sydnexis, Inc. | Company | Ophthalmic drug development company — holder of US10842787B2Search in Eureka ↗ |
| Defendant | Eyenovia, Inc. | Company | Eyenovia, Inc. — ophthalmic drug delivery company specialising in microdose eye-drop technologySearch in Eureka ↗ |
| Plaintiff counsel | Michael T. Rosato | 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 | 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 order — ‘AFFIRMED. See Fed. Cir. R. 36’ — is the court’s most compressed form of disposition. It confirms that the panel found no reversible error in the underlying unpatentability determination but issues no written opinion explaining its reasoning. At the appellate level, affirmance under Rule 36 means the panel applied the applicable standard of review (typically substantial evidence for factual findings, de novo for legal conclusions) and found the lower tribunal’s result clearly supportable. The absence of a written opinion is not an indication of a close call — it typically signals the opposite. No grounds exist to challenge the outcome within the Federal Circuit; Supreme Court certiorari is the only remaining avenue.
US10842787B2 — Ophthalmic Composition (Topical Eye-Drop Formulation)
US10842787B2, filed under application number US15/568381, protects an ophthalmic composition — broadly, a formulated product designed for topical ocular administration. Ophthalmic composition patents in this space typically cover combinations of active pharmaceutical ingredients, excipients, pH buffers, or preservative systems optimised for corneal penetration, stability, or patient tolerability. The patent’s grant date and claim scope placed it squarely in the competitive landscape for eye-drop drug delivery technologies.
Ophthalmic formulation patents occupy a strategically important but legally contested niche. Regulatory exclusivity and IP protection often converge in eye-drop products, making formulation claims a primary competitive tool. The cancellation of US10842787B2 — confirmed by the Federal Circuit — is consistent with broader scrutiny of formulation patents where prior art discloses similar compositions with overlapping parameters. Companies building product exclusivity on single formulation patents face meaningful validity risk, particularly at the PTAB, where inter partes review success rates for pharmaceutical formulation claims remain significant.
Should you run an FTO analysis against US10842787B2?
Product teams and R&D leaders developing topical ophthalmic drug formulations — including eye-drop compositions, ocular drug delivery systems, or related pharmaceutical preparations — should note that US10842787B2 has been confirmed unpatentable. The patent no longer presents an infringement risk. However, related applications, continuations, or divisional patents within the same family (application US15/568381) may extend protection to overlapping subject matter and warrant independent FTO review.
PatSnap Eureka’s FTO Search Agent can map the full patent family around US15/568381, identify any surviving continuations or related grants, and cross-reference your product’s formulation parameters against live claim scopes. For ophthalmic composition developers, this analysis surfaces both cleared claim space and residual risk from related IP — enabling confident product development decisions without manual prior art trawls.
Run a freedom-to-operate analysis on US10842787B2 to assess your product’s exposure
Run FTO in Eureka →Similar Federal Circuit appeals on ophthalmic and pharmaceutical formulation patents
Federal Circuit cases affirming PTAB unpatentability findings in ophthalmic drug formulation and topical pharmaceutical composition disputes — relevant to US10842787B2 and Case 23-2411.
What this case signals for the ophthalmic drug formulation IP landscape
A Rule 36 affirmance of unpatentability sends a quiet but significant signal to patent holders and challengers in the ophthalmic drug delivery sector.
Rule 36 dispositions offer no claim-scope guidance — plan accordingly
When the Federal Circuit issues a Rule 36 affirmance, it confirms the outcome but leaves the legal reasoning opaque. Patent holders in adjacent ophthalmic formulation spaces cannot rely on this ruling to understand where the claim boundaries failed. An independent claim landscape and validity analysis remains essential before asserting or licensing related patents.
Cancelled ophthalmic formulation claims create freedom-to-operate opportunities
The confirmed cancellation of US10842787B2 opens space in the ophthalmic composition claim landscape. R&D teams and product managers developing topical eye-drop formulations should map the cancelled claim scope against their product pipelines. If the cancelled claims previously created a design-around burden, that constraint may now be removed.
Sydnexis v Eyenovia — key questions answered
A Rule 36 affirmance means the Federal Circuit upheld the unpatentability of US10842787B2 without issuing a written opinion. The ruling has full legal force — the patent is cancelled — but provides no written reasoning explaining which invalidity grounds prevailed or how the claims were construed.
No. The Federal Circuit’s affirmance on 12 May 2025 confirms that US10842787B2 is unpatentable. Sydnexis cannot enforce this patent against Eyenovia or any third party. The only remaining avenue for Sydnexis would be a petition for certiorari to the Supreme Court, which is rarely granted in patent validity cases.
The patent at issue was US10842787B2, filed under application number US15/568381. The patent covered an ophthalmic composition — a topical eye-drop drug formulation. The underlying patentability challenge resulted in a finding of unpatentability, which the Federal Circuit affirmed.
The basis of termination is recorded as ‘Unpatentable,’ indicating that the claims of US10842787B2 were found to lack the statutory requirements for a valid patent — typically anticipation by prior art or obviousness. The Federal Circuit affirmed this determination, confirming the claims do not meet patentability standards under US patent law.
The cancellation of US10842787B2 removes that patent as a potential infringement risk for ophthalmic composition developers. However, related continuation or divisional applications within family US15/568381 may remain active. FTO analysis should confirm whether any surviving related patents cover overlapping claim scope before relying on this outcome as a full clearance.
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