The patent-at-issue claimed a pharmaceutical composition comprising asenapine or pharmaceutical salt thereof, as well as a method for treating “excitation, anxiety, and psychotic” disorders by sublingual or buccal administration of asenapine. Following a bench trial, the district court held that the asserted claims were valid and nonobvious but that two of the defendants (generic drug manufacturers) did not infringe the method claim. All the defendants appealed the validity finding, and the plaintiff appealed the non-infringement finding.
The Federal Circuit vacated the district court’s judgment of non-obviousness. The district court had erred by failing to make an express finding as to whether compliance concerns with patients who have trouble swallowing would provide a motivation to combine asenapine in a sublingual or buccal form. The Federal Circuit remanded for consideration of this limited question and its impact on the obviousness analysis.
The Federal Circuit also vacated the district court’s judgment that two of the defendants did not infringe the method claim. The defendants’ proposed generic products were indicated for the treatment of bipolar disorder symptoms. The district court’s construction of the method claim erred by improperly construing “excitation” as a separate disorder and not a symptom, thereby carving out bipolar disorder from the claim. The Federal Circuit construed “excitation” to refer to a symptom, not a separate disorder, and remanded for considering the issue of infringement under this revised construction.