Nuvo Pharmaceuticals, Inc. v. Dr. Reddy’s Laboratories, Inc. is an interesting case, recently decided by the Federal Circuit. The claims at issue were directed to a pharmaceutical composition of a non-steroidal anti-inflammatory drug (NSAID) coated with a proton pump inhibitor (PPI). The aim of the invention was to provide a formulation of a NSAID which did not provoke bleeding in the stomach.
The focal issue of the court was whether there was enough written description to support the efficacy claimed. While the court agreed that there is no requirement for experimental data and for an explanation of how or why a claimed composition will be effective, the court also rejected Nuvo’s argument that the written description is satisfied when the specification teaches how to make and use the claimed invention, because this argument pertains to the enablement requirement, and not to the written description.
Thus, if the claim language appears “ipsis verbis” in the specification, this might not be enough to support a claim of sufficient written description, which requires that the specification notifies the public of the boundaries and scope of the claimed invention. The problem here was that the background of the invention describes how prior attempts to use PPI to protect the GI tract against the NSAID have failed. The specification did not provide enough data to prove the opposite, thus, based upon the background and the specification, one skilled in the art would not have expected that the claimed formulation would have worked.
The holding of the case was that if the specification teaches nothing more than that the invention might, surprisingly, or unexpectedly work, it does not demonstrate that the inventor(s) possessed more than a mere wish or hope that the invention would work, and thus it does not demonstrate the actual possession of the invention claimed.
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Silvia Salvadori, PhD