CAFC Panel Splits on Reasonable Expectation of Success Analysis

In a precedential decision authored by Judge Lourie, the U.S. Court of Appeals for the Federal Circuit affirmed a district court’s final judgment that certain claims of several patents owned by Salix Pharmaceuticals for a drug used to treat irritable bowel syndrome (IBS) and other ailments were invalid as obvious. The CAFC also affirmed an order of the district court that instructed the Food and Drug Administration (FDA) that the effective approval date of generic company Norwich’s Abbreviated New Drug Application (ANDA) may not precede the expiration dates of the claims of three other Salix patents that were found to be valid and infringed by Norwich. Norwich cross-appealed from that order and also from the denial of its motion to modify the district court’s final judgment.

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