Friday, June 05, 2020 10:19:29 PM
Regarding Singer's brief: As expected, I think it's the strongest brief Amarin could have possibly hoped for. They got their money's worth. Singer captured the district court's errors of procedure and fact in an accessible, exceeding well-structured net of logic, and while I don't think it's necessarily checkmate, he's definitely got them on the run.
The plot definitely thickened today with the publishing of the JAMA paper addressing the statistical issues related to Mori. It would be wildly naive to think that paper is the result of a few docs standing around and saying, "Gee, it seems like maybe that Mori study was misinterpreted. Let's publish a paper."
The publishing of that paper is undoubtably a strategic move by Singer, and there is no way the findings of that paper will not make it into the appeal arguments. The prohibition of the introduction of new evidence on appeal is not the rigid restriction that some make it out to be. There are many, many ways new evidence makes it's way into an appeal, and Singer knows how to do that probably better than anyone in the world. Additionally, evidence that was not available at the time of the trial (which the JAMA paper purportes to disclose) is treated differently than known evidence that a party could have presented at trial but did not. Furthermore, parties are free to present new evidence in briefs or oral arguments on appeal. It's just up to the discretion of the panel of appellate judges to then apply, or not apply, any prohibition of new evidence. Application can also be made to the court to submit a post-deadline amicus brief, with the court having the option of allowing the late brief provided the opposing party is given adequate time to respond.
In any case, I think the JAMA paper, coming from such an unimpeachable source, and striking at the very heart of the district court's decision, is significant to the appeal case in ways we probably don't yet know. It certainly will weigh heavy on the generics as they plot their next moves.
I guess my bottom line is that, notwithstanding the traditional handicapping of chances of success on appeal, I'd much rather be in Amarin's shoes right now. And I do think there's more intrigue to come. Anyone who thinks Amarin management and counsel are sitting on their hands waiting for oral arguments would be very mistaken.
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