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Expert Analysis

2013 Provided Few Small-Molecule Decisions

Law360, New York ( January 6, 2014, 11:59 AM EST) -- 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)....

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