The Federal Circuit Court of Appeals (CAFC) on April 26, 2010 rendered an opinion affirming a Delaware District Court decision holding claim one of Alza, Inc.’s patent (US Pat. No. 6,919,373) invalid for lack of enablement.
The technology in this case relates to time-released methylphenidate (the active ingredient in Ritalin®) tablets for the treatment of ADD or ADHD. Specifically, Alza invented a tablet capable of releasing methylphenidate at an increasing rate over time. Most of Alza’s development effort, and in fact its product embodying the invention (Concerta®), involved osmotic dosage forms; consequently, the ‘373 patent goes into great detail with regard to such dosage forms. However, the specification also vaguely mentions non-osmotic dosage forms in very general terms, and does so in the space of a mere 10 lines.
