A Lesson in "Be Careful What You Wish For"

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.

Claim one reads as follows:

A method for treating ADD or ADHD comprising administering a dosage form comprising methylphenidate that provides a release of methylphenidate at an ascending release rate over an extended period of time.

This claim raises two important issues: (1) does the claim encompass non-osmotic dosage forms, and if so (2) does the specification enable a claim encompassing non-osmotic dosage forms? If claim one encompasses non-osmotic dosage forms but the specification does not enable them, then the claim must be held invalid.

At the Markman hearing Alza made the fateful decision to argue that claim one does in fact encompass non-osmotic dosage forms, successfully overcoming Andrx's attempt to limit the scope of claim one to osmotic dosage forms. The District Court construed the phrases "pharmaceutically acceptable composition" and "dosage form" to mean "a pharmaceutical composition that includes a dose of methylphenidate, [including non-osmotic dosage forms]."[1] However, at trial the District Court found that the inclusion of non-osmotic dosage forms within the scope of claim one renders the claim invalid for lack of enablement. Applying the In re Wands test, the District Court held that developing a non-osmotic dosage form as claimed would require undue experimentation, and therefore the specification fails to enable claim one.[2]

On appeal, Alza argued that the specification is enabling in part because non-osmotic dosage forms are well known in the art, and that while some trial-and-error experimentation would be necessary, it would only require a routine effort. Essentially, Alza argued that non-osmotic dosage forms are much easier to manipulate than the osmotic type, and therefore require far less description to enable "an ascending release rate over an extended period of time." Alza's reasoning was that the ordinary skill in the art makes up for the specification's terse description of non-osmotic dosage forms.

The Federal Circuit's response was to point out that "the rule that a specification need not disclose what is well known in the art is "merely a rule of supplementation, not a substitute for a basic enabling disclosure."[3] The Court went on to say that in order to satisfy the plain language of Section 112 ¶ 1 Alza must supply an "adequate enabling disclosure" and cannot merely rely on the ordinary skill in the art to fill in the gaps.[4] Accordingly, the Federal Circuit affirmed the District Court ruling holding claim one and the relevant dependent claims of the '373 patent invalid for lack of enablement.