What do you mean is the stat sig difference from baseline in the Apo B arm close enough?
That arm alone tells us nothing about EPA treatment effect at all. Not a little, not a small amount. It tells you zero.
For example - What if you asked 30 overweight individuals to fast and half were randomized to EPA and half were control. And both lost weight. Can you use the weight loss in the epa group to assess weight loss from epa? No.
The funny thing is that MARINE proved, in some sense, the ambiguity that exists in the Kurabayashi study.
Remember, Kurabayashi was 1.8 g / day. MARINE dosed two treatment groups: a 2 g and 4 g / day group.
There was no statistically significant reduction in ApoB in the 2g / day group in MARINE. In fact, the 2 g / day group saw an INCREASE in ApoB from baseline and a statistically insignificant decline relative to placebo. ANCHOR saw reductions that were marginally significant. If anything, the combination of MARINE/ANCHOR/Kurabayashi lead one to conclude, today, that 2 g / day of EPA has no impact on ApoB. It's the 4 g dosing that makes the big difference.
None of this is legally relevant, but it just points out that if Table 3 in Kurabayashi is enough to make the clear, statistically significant reduction in ApoB seen with 4g/day of EPA a "not unexpected success," we probably have too high a standard for patentability.
Now see the below from Kurabayashi’s conclusions (which is supported by the analysis of table-3). Let’s remember that the below is not an opinion, it is a basic conclusion of that paper (a fact), therefore a POSA would not be expected to read the paper and its conclusion in a different way. In my opinion what the judge says: “In light of the statistically-significant differential effects reported between the EPA and control groups” is just an incorrect interpretation of the facts.
Agree not simple but DU thinks she is qualified to give a complex decision when she clearly is not. She is an amateur in the field at best. Far to complex for a first time pharma patent case.