FDA Request for Justification Found to Provide a Mere Research Suggestion—Not Conception of Claimed Formulation

Author: Thomas J. Sullivan
Editor: Jeff T. Watson

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.

Observing that the FDA’s request amounted to at most a general research suggestion, the Federal Circuit held that a request to justify inclusion of one chelating agent is not the same as “definite and permanent idea” to eliminate the agent or to remove all chelating agents. The Court explained that “derivation is not proved by showing conception and communication of an idea different from the claimed invention even where that idea would make the claimed idea obvious.”  Accordingly, the Court found that Mylan did not show that the named inventor derived the invention from someone at the FDA.


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