Law360: Brian Trinque and Giulio DeConti on 2013 Providing Few Small-Molecule Decisions


For pharmaceutical patent practitioners, the 2012 ruling Otsuka Pharmaceutical Co. v. Sandoz further solidified the Federal Circuit’s two-part test that it regularly applies when considering small-molecule pharmaceutical obviousness. Under the court’s approach, a determination of obviousness for a small-molecule pharmaceutical generally requires both the identification of a “lead” compound (often a compound of similar structure having activity in the same therapeutic area) as well as a motivation in the prior art to modify that lead in the manner necessary to arrive at the compound at issue (for example, replacing one functional group with another). Read more ...