First, all of the primary prior art references relied upon by the generics were previously before the Examiner or discussed by the Examiner during prosecution of the patents. That, in itself, is not determinative that the district court will side with Amarin. There is precedent of courts invalidating patents based upon prior art previously considered during prosecution. Nevertheless, it does not help the generics, and adds an extra weight to their load.
Second, the burden of proving obviousness is on the generics, and it is a relatively high one. The generics must show that the patents are invalid based upon a “clear-and-convincing-evidence” standard. In short, if the case really comes down to a close call, and the court correctly applies the standard, that suggests that the court should in theory rule against invalidating the patents.
i was under the misconception this case was about just how soon generics could sell icosapent ethyl, not about whether or not amarin's patents are actually valid? settling this case is secondary in importance only to the reduce-it label!
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