Allergan, Inc. v. Sandoz, Inc.

A patent claim is invalid for obviousness where prior art suggests the efficacy of the chemical combination found in the claim and where the prior art provides a motivation to make the combination.

Opinion (Prost): Allergan, Inc. ("Allergan") sued Sandoz, Inc. and several other generic drug manufactures (Sandoz) following the generic manufactures' filing of Abbreviated New Drug Applications seeking approval to sell generic versions of an Allergan Glaucoma drug that is covered by four patents. After claim construction, but before a bench trial, the district court granted summary judgment of non-infringement for three claims from one of the patents, and the parties stipulated to infringement of the other claims. In the district court, the generic manufactures argued that the remaining patent claims were invalid. The district court rejected the generic manufactures' argument, finding that although prior art suggested the efficacy of the combinations found in the remaining claims; there was no motivation to create the combination, some prior art taught away from making the combination, the result was unpredictable, and existing secondary considerations meant the claims were not invalid for obviousness. The generic manufactures appealed. A finding of obviousness is a legal conclusion based on underlying facts. The underlying factual considerations include the scope and content of the prior art, the differences between the prior art and the claimed invention, the level of ordinary skill in the art, and any relevant secondary considerations. The factual findings of a district court are reviewed for clear error and its legal conclusions are reviewed de novo. Two of the chemicals used in Allergan's drug were independently recognized as effective in the treatment of Glaucoma and one patent in the prior art suggested the combination would have benefits beyond what could be achieved by either alone and provided a motivation to combine the two. Because of the prior art and the existing motivation to make the combination, the Federal Circuit Court found the district court committed clear error when it found the claims non-obvious. Accordingly the Federal Circuit Court REVERSED the district court's judgment.