Words are Not Enough to Describe Stomach Acid Inhibition
In Nuvo Pharm. V. Dr. Reddy’s Lab the Fed. Cir. reversed the D.N.J.’s holding of nonobviousness, enablement and adequate written description. Patentee claimed a pharm comp comprising an acid inhibitor, at least a portion of which is not enterically coated and an enterically coated NSAID, coordinated to release in a single tablet. The acid inhibitor prevents release of the NSAID below a determined pH, but the acid inhibitor must be protected from destruction by stomach acid. Patentee’s argument for non-obviousness that PHOSITA would not have expected uncoated acid inhibitor to be effective to raise the pH paved the way to attack patentee’s written description that an uncoated acid inhibitor would be effective at raising the pH. While acknowledging that experimental data, a theory or explanation or actual reduction to practice are not necessary to written description, the record reflected that PHOSITA would not have expected uncoated acid inhibitor to be effective. Patentee’s argument as to enablement was insufficient to satisfy the broader requirement of a written description providing notice of the scope of the claimed invention and to show possession.