My point with respect to USPTO and FDA relates to the Defendants’ obviousness arguments. The USPTO found Amarin’s invention non-obvious in the context of Amarin’s patent applications, and the FDA, with the input of multiple experts in the field, found prior art so non-obvious as to require Amarin to complete extensive studies before approving Vascepa. For Defendants’ theories of non-obviousness to be valid, one would have to accept that both agencies failed to discern the obviousness of Vascepa’s efficacy. From the perspective of the court, it would appear that the outlier among the facts is the Defendants’ non-obviousness argument (which are by definition selfishly motivated), versus the experience, knowledge and resources of two federal agencies.
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