Amarin Corp Plc (AMRN)

[Eagle2002]

Hi, I just wanted to add that Kura is also referenced in '715 patent, not just '728.

https://patentimages.storage.googleapis.com/a8/f7/57/0a377d21c2d3a2/US8318715.pdf

On the other hand the following language is accurate:

The prior art is either silent or teaches that there is no statistically significant change in Apo-B levels when patients with TG levels less than 150 mg/dl or between 150-499 mg/dl are treated with either 96% pure ethyl-EPA or a mixture of ethyl-EPA and DHA

Kura did not teach anything about EPA in mono therapy. If anything, Kura teaches the combination of EPA and estradiol. (Du makes an extrapolation about synergies and says that the Kura paper "suggests" there is no interaction; I find that unbelievable BTW). So Kura does not teach anything about mono therapy. (on top of this folks in this board have highlighted the fact that there is no stat significant change between groups).

So in essence there are 2 factual mistakes:
1) 715 patent - Kura paper is cited and therefore considered

while the Patent Office found that a decrease in Apo B was an unexpected benefit constituting a valid secondary consideration, the Patent Office’s examiner did not consider Kurabayashi. (pg 66) of ruling


2) Kura establishes there is no statistically significant difference between groups

The apolipoprotein B level in the eicosapentaenoic acid group was significantly lower at week 48 compared with the baseline level, but there was no significant difference between the groups