Claimed Efficacy Benchmarks are not Inherent to Method Using Generic Formulation

In Galderma Labs. v. Teva Pharm. the Fed. Cir. reversed the D Ct’s finding of invalidity for anticipation.  The D Ct found the claimed rosacea treatment method by topically applying a composition comprising 1% ivermectin and a pharmaceutically acceptable carrier, obtaining significant reduction in lesion count, to be anticipated by McDaniel which disclosed treating rosacea by once-daily application of a topical formulation comprising 1-5% ivermectin.  While the parties stipulated that Manetta enabled the claimed formulation, Teva’s expert testified that 1) 1% ivermectin could be formulated in thousands of ways and 2) variations in formulation will undoubtedly affect the results achieved.  It was noted that Teva did not present any demonstration that any of the generic formulations inevitably resulted in the claimed efficacies.  Citing In re Gleave an anticipatory reference must disclose each and every limitation and enable subject matter falling within the scope of the claims.