In an interview with Ian Lopez of Bloomberg Law, St. Louis patent litigator Doug Robinson discusses the Federal Circuit’s decision to uphold the invalidating as obvious of two patent claims directed to the ulcerative colitis drug Apriso.
Dr. Falk Pharma GmbH owns the patent behind Apriso and licenses it to Salix Pharmaceuticals. When Mylan Pharmaceuticals sought to make a generic version of the drug, both Salix and Dr. Falk filed suit for patent infringement.
Mylan responded with a challenge at the PTAB, where the board found that a claim defining remission as having a Disease Activity Index score of “0 or 1” based on a set of four subscores — which is the normal number of subscores — is obvious over the prior art. Dr. Falk argued at appeal that his score was based on two subscores. but the Federal Circuit noted that the patent’s own specification defined the DAI score as having four subscores.
The Federal Circuit therefore upheld the PTAB and rendered news concurrent patent infringement suit in district court as moot.
Robinson finds the ruling notable for two reasons. First, “it marks another example of the Federal Circuit being pretty deferential to PTAB obviousness findings.”
Second, “Always be mindful of the definitions that you include in the specification. It takes a lot of effort to overcome a definition you yourself put in the specification, so make sure you have them right.”