Otherside, Thank you this was a very instructive read..interesting how we see for the defendants (generics Sun and Caraco pharma) Charles B Klein (suprise, surpise). I agree:
Lets hope the CAFC sees this again with Amrn's Appeal case. Clearly the CAFC including Judges Prost Newman Dyk felt that just because a determination of prima facie obviousness is made, doesn't mean you then set that decision in stone and wall it off by negating or ignoring or weighing against each other, the secondary objective criteria. These secondary objective criteria are (1) Objective and (2) Secondary only in sequence of consideration not in importance for final obviousness determination. They are the watchmen, the yeomen that guard againgst hindsight bias. One doesn't just throw away the secondary consideration of wearing a seat belt for road safety, just because one made a prior primary obviousness determination of "low safety risk" based on driving a low traffic road on a sunny day. ...Hindsight bias is a poison and the court must avoid it. The skillfull presentation of marginal trivia (that too of dubious scientific quality) as a cumulative evidence of obviousness to combine in the prior art, was the mess that Du got herself into.
I found this part encouraging from the opinion of these CAFC judges:
One thing in the Novo case I find in favor of Amarin is where the Novo Judges say they didn't believe one side "intentionally left out evidence to bolster their case" as though that would be grounds for the case being overturned - see below. That IS a point Singer will make in that the material used by the Generics was intentionally cropped to mislead Judge Du.
"Dr. Sturis was accused of failing to notify the PTO that the original test plan did not include his data calculations at 120 minutes. The Federal Circuit found it to be a nonmaterial omission because it did not qualify as “but-for” material. The Court explained that this was not a case in which adverse results were hidden in favor of more positive data, nor did the omission undermine the opinion stated in the declaration."