Otezla’s ‘Unexpected’ Success Mulled in Appeal Over Generics

A Federal Circuit panel pressed generic manufacturers Sandoz Inc. and Zydus Pharmaceuticals USA Inc. on why a patented aspect of Amgen Inc.'s psoriasis treatment Otezla should be ineligible for protection despite producing a drug of “unexpected” strength and efficacy.

Judge Alan David Lourie seemed dissatisfied when he pushed the manufacturers’ counsel to explain “where is the dividing line” between unexpected results that render an improvement worthy of patent protection on its own, and a mere difference in degree that might invalidate the patent as obvious.

“If it’s an unexpected difference in degree, I guess that would be—" said Maureen L. ...