Amarin Corp Plc (AMRN)

[Bill B]

Post from cmm3rd on investor village

Two of Amarin's legal options

Here are a few preliminary thoughts about some of Amarin's legal options.

Amarin has the right to move for a new trial, which if they do, I would expect this same judge would deny. If they do this, I would expect their purpose would be simply to extend (at most a few months) the legal timeline and thus potentially delay the generics’ ultimate ability to launch a generic product.

They also have the right to appeal the judgment to the US Court of Appeals for the Federal Circuit (CAFC), which hears appeals from US district court judgments in patent cases. It’s a near certainty imo that Amarin will do this. If they do, I would expect the generics to cross-appeal their having lost the infringement part of the case, as, if the trial court’s determination of obviousness is overturned, the generics could still salvage a win by also getting the court’s infringement finding reversed (to no infringement).

The above rights to appeal are absolute. CAFC would have to hear those appeals.

I have not completed my research, but I am pretty sure that, at least as of 2016 (the year a good law review article on the subject was published), the standard of review on appeal from the obviousness finding is “de novo,” which basically means that CAFC (3 judge panel) does not defer much to the trial court’s findings that underlie the ultimate obviousness decision. Instead, CAFC would rule on the case based on the evidence of record, giving the trial court's decision little or no presumption of correctness, reviewing the evidence as a trial court would, and reviewing underlying factual determinations, for “clear error.” This standard of review (if it applies, and so far I think it does, but I have not finished my research) would favor Amarin (vs other standards of review) because the reviewing court essentially puts themselves in the shoes of the trial court when reviewing the evidence, and if at least 2 of the 3 members of the panel think the trial judge committed “clear error” in her review of/findings from the evidence and which led to an improper result, they should reverse the decision. I think this avenue will be viewed by Amarin as one of its primary levers to pull.

The losing party at the CAFC panel then has a right to petition for review by the panel and for review by the entire en banc CAFC. Most such petitions are denied. Those that are granted rarely result in a major change in the panel's opinion, but such a change does occasionally occur.