The appellate ruling concludes a legal battle that began in June 2022, when Scilex initially challenged Aveva’s Abbreviated New Drug Application. After a July 2024 bench trial in the Southern District of Florida found no infringement, the case moved to the Federal Circuit. Judges determined that Aveva’s product avoids violating U.S. Patent Nos. 9,283,174, 9,925,264, and 9,931,403 under both literal interpretation and the doctrine of equivalents.
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Aveva Wins ZTlido Patent Appeal, Clears Path for Generic Launch
The U.S. Court of Appeals for the Federal Circuit has ruled in favor of Aveva Drug Delivery Systems, affirming a lower court decision that its generic lidocaine topical system does not infringe on Scilex Pharmaceuticals' ZTlido patents. The decision removes the final legal hurdle for the company's market entry.
With the court’s affirmance, Aveva is now positioned to initiate a commercial launch of its generic 1.8% lidocaine topical system. The company is set to benefit from 180 days of market exclusivity. Represented by Joseph Thomas Jaros of Rakoczy Molino Mazzochi Siwik LLP, the Miramar-based manufacturer prepares to scale its operations at its 210,000-square-foot facility to meet the anticipated demand for the product.
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