The Defendants did enter the entire Kurabayashi study into the record earlier in the trial, including the complete table. That is helpful for Amarin on appeal, as it can’t be claimed that Judge Du did not have access to the full table with the legend explaining the two different p values.
From the language of Judge Du’s findings regarding Kurabayashi, which was a virtual duplication of Defendant’s Kurabayashi arguments, and which lacked any counter-arguments from Amarin, it’s pretty clear she just copied and pasted the Defendants post-trial Findings of Fact Kurabayashi argument, and it’s doubtful that she went back into the record and read the full study, including Table 3 in its entirety. On appeal, it can be argued that her failure to do so led to her mistakenly claiming in the decision that there was a significant difference in Apo B level changes between the two groups. Table 3 clearly shows that there was not a difference between the two groups. It’s also in the record that Dr. Toth testified that there was no significant difference between the two Kurabayashi groups. Based on the multiple references in the record to the correct interpretation of the Kurabayashi findings, Amarin should not face any issues with respect to their ability, on appeal, to direct the appeals court’s attention to Judge Du’s critical error of fact regarding Kurabayashi.
That error of fact was the basis for Judge Du’s elimination of “unexpected benefit” from the secondary considerations for Vascepa, and as such, it’s very likely that it was also the basis for her invalidation of the patents.
It’s also significant that, despite multiple references in the trial record to the USPTO having considered Kurabayashi in its prosecution of the Amarin patents in question, Judge Du mistakenly claimed, in incontrovertible language, that the USPTO had not considered Kurabayashi. While it’s true that this additional error of fact could be less significant given the latitude that the district court has to essentially overrule a USPTO finding in the event the USPTO did consider Kurabayashi but still found the patents non-obvious, such an argument falls apart when the district court, as it did here, commits a fatal error of fact in interpreting the prior art in question.
