FDA Did Not Conceive of Claimed Invention Through Regulatory Comments to Inventors

February 2017

Cumberland Pharmaceuticals, Inc. v. Mylan Institutional LLC, No. 2016-1155 (Fed. Cir. Jan. 26, 2017)

 

In Cumberland v. Mylan, the Federal Circuit affirmed a district court holding that Cumberland’s patented drug formulation was not derived from another inventor in view of FDA comments that supposedly conceived of the invention.

Cumberland sought FDA approval for a conventional formulation of the drug acetylcysteine. During the approval process, the agency asked Cumberland to provide scientific and regulatory justification for including EDTA, a chelator, in the formulation. Cumberland responded that EDTAwas included to stabilize the drug. However, the question prompted the Cumberland inventor to consider if the drug could be stable in the absence of EDTA or any other chelator. Cumberland tested the drug without chelator and surprisingly found that it was stable. Cumberland then obtained a patent to the chelator-free drug formulation.

Mylan filed an abbreviated new drug application for a generic EDTA-free acetylcystine product. In response, Cumberland sued Mylan for infringement.  Mylan defended, in part, on the basis that the invention was derived from someone at the FDA because it was that person, and not the inventor, who had the idea to remove EDTA from the prior art formulation.

The Federal Circuit found that the FDA employee did not conceive of the chelator-free formulation. A request for justification of the inclusion of EDTA is not the same as a suggestion to remove it. Conception of an invention requires a definite and permanent idea. A bare hope, a general goal, or a research plan is not enough. Even if the FDA employee had requested a chelator-free study, as Mylan proposed, the FDA’s communications were too high level, and left too much room for a skilled artisan to choose the specific manner with which to proceed.

Key takeaway: A regulatory communication which does little more than pose a question, without suggesting or testing a solution, cannot constitute conception of an invention.