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Tuesday, January 05, 2021 4:37:54 PM
Hikma takes the expected party line which is "there is no case here, carving out indications is an essential part of industry/precedent, and that's all we are doing. The only way we could do anything wrong is if we were actively encouraging the use of vascepa for non-MARINE patients, and we don't do that at all. This is an easy dismissal".
The only really interesting part is where they pre-emptively bring up GSK v. Teva, and essentially say that "while not a part of the complaint, we suspect Amarin is going to rely on this case, and while we don't ultimately know what will happen (i.e. could get overturned en banc or go to supreme court), the case is very distinguishable from this one, and hence not applicable". However, the section where they actually try to distinguish it is probably the weakest part of the brief in my mind (a bit of smokescreen around the launches being different, and then differing direct evidence on press release and AB rating disclosure)... That portion sure doesn't seem dispositive to me, and seems like the case should survive motion to dismiss. And then I guess we will see what happens with the GSK v. Teva case, and whether the court(s) want to take up this clearly broken "carve-out" issue or not!
Amarin litigation is definitely a hail mary, so good chance it gets dismissed. Frankly if the GSK v. Teva case didn't exist, I think it would be almost a certainty that this complaint gets dismissed.... the carve-out section is total BS, but at this point it is generally accepted precedent and barring reform from congress, it's just the way it goes. The GSK case breathes new life into the Amarin situation in my mind, and I think makes the chances of an outright dismissal much lower... frankly I kind of expect the judge here to stretch this case out, as he waits to see how GSK appeal/en banc goes. A en banc reversal probably gives him cover to end this case farther down the line. But an upheld decision (unlikely, but possible) would mean that the AMRN case is pretty legit, so he'd look a little foolish if he had already dismissed it (especially with prejudice... so don't see that happening at least). So I ultimately think this one survives motion to dismiss and then is in slow/waiting mode while people wait to see what happens in GSK.
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