Last week, Dr. Dipak Bhatt, Amarin’s (NASDAQ:AMRN) lead investigator for the Reduce-IT trial, published a report, along with other authors, on factual errors present in the recent judgment by Judge Miranda Du. The report discussed a single critical error - “As we will show, a key piece of the prior art, which was central to this case, included an incorrect conclusion based on a common statistical error.”
This key piece of prior art is the Mori report.
The Bhatt report is extremely clear and lucid in its statements, and even a lay reader can quickly grasp its import. This report is described here.
According to its authors, the key question before the Court was whether it could be obvious to those skilled in the art that EPA and DHA had differential effect on LDL cholesterol levels.
Note this question carefully. The question does not ask: does DHA have a statistically significant effect on LDL-C from baseline to post-intervention? (it does, in Mori). The question does not ask: does EPA have a statistically significant effect on LDL-C from baseline to post-intervention? (It does not, in Mori). Instead, the question asks: is the difference between the EPA and the DHA effect on LDL-C from baseline to post-intervention statistically significant?
It is obvious that in Mori et al, there is a differential effect between EPA and DHA. But unless it is statistically significant, Mori does not make this effect globally obvious. Unless it is statistically significant, a POSA cannot claim, from looking at Mori, that one could observe the same effect in every other trial under the same circumstances. Mori provides no data on that statistical significance - therefore while someone could draw a conclusion - a hint - from Mori as to the differential effect of EPA vs DHA, such a conclusion would not be conclusive, i.e., obvious. As Dr. Bhatt and his co-authors say, Mori was a hypothesis-generating trial, not a conclusive
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