FDA Request For Justification Found To Provide A Mere Research Suggestion—Not Conception Of Claimed Formulation

In Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC, Nos. 16-1115, -1259 (Fed. Cir. Jan. 26, 2017), the Federal Circuit affirmed the lower court's holding that a patent covering a chelating-agent-free drug formulation was not derived from someone at the FDA.

Mylan's derivation argument centered around communications between the inventor and the FDA regarding Cumberland's application to market a pharmaceutical formulation that included the chelating agent EDTA. Specifically, the FDA requested that Cumberland provide justification for including EDTA in the formulation. Mylan argued that the FDA request (along with other exchanges) established conception of the claimed chelating-agent-free formulation by the FDA.