Case Explained: SCILEX PHARMACEUTICALS INC v. AVEVA DRUG DELIVERY SYSTEMS, INC

Court: United States Court of Appeals for the Federal Circuit Filed: 2026-08-04 The Federal Circuit affirmed the district court’s judgment of non-infringement in a patent infringement case involving U.S. Patent Nos. 9,283,174, 9,931,403, and 9,925,264 directed to non-aqueous lidocaine patch compositions. The court held that the district court correctly construed the claim term “dissolving agent” to require a substance that both dissolves the lidocaine and maintains it in a non-crystalline state. Applying the clear-error standard of review, the Federal Circuit determined that the patent specification and prosecution history unambiguously supported this construction, noting that the applicant repeatedly represented during prosecution that the lidocaine was dissolved in the claimed organic acid and polyalcohol combination. Because Aveva’s generic product used a single solvent, n-heptane, rather than the claimed two-component dissolving agent, it did not infringe under either literal infringement or the doctrine of equivalents. The practical consequence is that the final judgment of non-infringement stands, allowing Aveva to proceed with its Abbreviated New Drug Application for a generic version of ZTlido® without liability for patent infringement. Do It For The Case Law is a news reporting service. Nothing in this episode constitutes legal advice.