Par Pharmaceuticals v. Roxanne Laboratories (CAFC 2007-1093, 1134) non-precedential

In In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), this court set forth eight factors relevant to the enablement analysis:

(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.

In this case, Par sought extremely broad claims in a field of art that it acknowledged was highly unpredictable, therefore, Par has set a high burden that its patent disclosure must meet to satisfy the requisite quid pro quo of patent enablement. See Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1380 (Fed. Cir. 2007) (“The motto, ‘beware of what one asks for,’ might be applicable here.”). The scintilla of evidence put forward by Par to suggest that the claims are enabled, most of which actually conflicts with the intrinsic evidence in this case, does not raise a genuine issue of material fact. See Anderson, 477 U.S. at 252 (“The mere existence of a scintilla of evidence in support of the plaintiff’s position will be insufficient [to overcome summary judgment].”).

The '318 and '320 disclosures discussed the unpredictability of the formulations, and Par's expert witness testified to it. Par's own experiments "within the scope of the claims" were unsuccessful in numerous attempts.

As to claim breadth:

The claims allow the choice of any surfactant in any concentration. The language of the claims and the specification both suggest that the claims encompass hundreds of possible surfactants. Par admitted as much in oral argument.

Par's spec had only three working examples, using only one new surfactant.

Given the highly unpredictable nature of the invention and the extremely broad scope of the claims, these three working examples do not provide an enabling disclosure commensurate with the entire scope of the claims.