OREXO AB, OREXO US INC., v. ACTAVIS ELIZABETH LLC

Before Newman, Hughes, and Stoll. Appeal from the United States District Court for the District of Delaware

Summary: Objective indicia of nonobviousness cannot be dismissed merely because all the ingredients in a formulation were generally known and nothing prevented a skilled artisan from combining them.

Actavis filed an Abbreviated New Drug Application for a generic version of a drug sold by Orexo. Orexo sued for patent infringement under the Hatch-Waxman Act, and Actavis challenged the validity of Orexo’s asserted patent. Orexo argued that the prior art did not disclose or suggest the claimed formulation or the unexpected benefits associated with the claimed formulation, including enhanced bioavailability and decreased potential for abuse. However, the district court held the claims were obvious because the ingredients were generally known and the combination of ingredients would have been obvious. Orexo appealed.

The Federal Circuit reversed. The court emphasized that “consideration of the objective indica is part of the whole obviousness analysis, not just an afterthought.” The Federal Circuit explained that the particular structure as claimed and the associated benefits were not taught or suggested in any reference. Furthermore, the court found that the claimed invention “is achieved solely upon the hindsight knowledge” of the structure and benefits disclosed in challenged patent. Therefore, the Federal Circuit held that Actavis did not sufficiently establish that the challenged claims were obvious. The court reversed and remanded for further proceedings.