P. 14 of the Amarin brief concedes that the increase in LDL in the DHA arm of the Mori study was statistically significant, while the the increase in the EPA arm was not. This must have been the state of the evidence presented to the trial court.
It seems pretty clear to me that Amarin did not raise this argument of no statistically significant difference between the EPA and DHA arms of the Mori study to the court.
Not good news.
Having said that, the evidence showed that the increases in LDL in the two arms were not that different, 3.5% for EPA and 8% for DHA. So there is an issue imbedded in the case about whether this study showed by “clear and convincing” evidence that EPA would not increase LDL in the severe HGL patient population. The CTA judges will be focused on this because the trial judge relied so heavily on Mori.
Singer in my view is savvy enough to get the question of statistical significant difference into the Reply Brief so he can argue it to the court. I don’t have a feel for how well known is the principal of statistics relied on by Bhatt & co. The more well know, the easier it is to argue it should have been known to the trial judge, even though it was not argued to her directly. No matter what, they have to figure out a way to get this before the CTA, as it shows just how much the Mori study is of so little value on obviousness in this case.
