SCILEX PHARMACEUTICALS INC. v. AVEVA DRUG DELIVERY SYSTEMS, INC.

SCILEX PHARMACEUTICALS INC. v. AVEVA DRUG DELIVERY SYSTEMS, INC. The Federal Circuit affirmed the non-infringement judgment, holding that the claimed “dissolving agent” must both dissolve lidocaine and maintain it in a non-crystalline state in the finished patch. Under that construction, Aveva’s ANDA product did not infringe under the doctrine of equivalents. The decision underscores that specification examples and prosecution statements can meaningfully cabin a functional claim term even without a formal disclaimer. Affirmed. The asserted patents claim non-aqueous lidocaine patches with a dissolving agent consisting of an organic acid and a polyalcohol; representative dependent claims recited isostearic acid and dipropylene glycol. Scilex conceded no literal infringement and pursued only doctrine-of-equivalents infringement, arguing Aveva’s isostearic acid and oleyl alcohol were equivalent to the claimed two-component dissolving agent. The Federal Circuit agreed with the district court’s construction: in view of the claims, specification, and prosecution history, the “dissolving agent” must dissolve lidocaine, not merely prevent later crystallization. The prosecution history supported that construction because the applicant repeatedly stated that lidocaine is dissolved in the claimed organic acid/polyalcohol dissolving agent. Because Aveva used n-heptane to dissolve lidocaine, and n-heptane was not equivalent to the claimed dissolving agent, the court affirmed without reaching the district court’s alternative claim-vitiation and prosecution-history-estoppel rulings. claim construction infringement Hatch-Waxman / ANDA non-precedential claim construction infringement Hatch-Waxman / ANDA non-precedential claim construction infringement Hatch-Waxman / ANDA