A PRIOR ART REFERENCE MUST BE ENABLING

Impax Laboratories, Inc. v. Aventis Pharmaceuticals Inc., [2007-1513] (October 3, 2008) [RADER, Schall, Zobel] The Federal Circuit affirmed the district court’s determination that U.S. Patent No. 5,236,940 does not qualify as an enabling prior art reference and thus does not anticipate claims 1-5 of U.S. Patent No. 5,527,814.
DISCUSSION: In order to anticipate a claimed invention, a prior art reference must enable one of ordinary skill in the art to make the invention without undue experimentation. In other words, the prior art must enable the claimed invention. The Wands factors are used to determine when experimention is “undue”: The “undue experimentation” component of that equation examines (1) the quantity of experimentation; (2) the amount of direction or guidance present; (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.
LOF: Whether a prior art reference is enabling presents a question of law based upon underlying factual findings. The Federal Circuit held that the burden to show non-enablement of the prior art was properly shifted to the patentee, and that the district court did not commit error in determining that the burden had been met.