In Cumberland Pharmaceuticals, Inc.v. Mylan Institutioal LLC, [2016-1155, 2016-1259] (January 26, 2017) the Federal Circuit affirmed the district court holding that U.S. Patent No. 8,399,445, which describes and claims acetylcysteine compositions substantially free of chelating agents, was not derived from the FDA.

Mylan argued that the claimed invention was obvious from the FDA’s action on Cumberland’s petition to market the predecessor composition that contained a chelating agent.  The FDA asked Cumberland for data supporting the function of the chelating agent, which Mylan argued was proof that the FDA conceived of the idea of acetylcysteine free of chelating agents.

The district court found that Mylan proved neither (1) that anyone at the FDA conceived of the claimed invention before the patent named inventor nor (2) that there was a reasonable expectation that the claimed formulations, without any chelating agents, would succeed.  The Federal Circuit agreed, noting “[a] request for justification of the inclusion of EDTA, supported by data, is not the same as a suggestion to remove it, let alone to remove it and not replace it with another chelating agent.”  The Federal Circuit also rejected the argument that the FDA’s request for data to support the inclusion of EDTA required Cumberland to undertake research that would have inevitably led it to the invention, noting 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.