Amarin Corp Plc (AMRN)

[HinduKush]

MARKMAN BLOG LATEST DISCUSSION BY ZILBERSHER

Other comments have suggested that it does not seem fair that incontrovertible evidence that comes to light only once the case is on appeal cannot be used to show that the lower court’s ruling was based on a study (Mori) that, it turns out, is wrong. This is not, however, how the Federal Circuit will consider Dr. Bhatt’s article. First, the types of instances where new evidence can be introduced on appeal includes scenarios where, for example, a third-party confesses to a crime while a defendant’s conviction is on appeal, or the author of a prior art reference used to invalidate a patent confesses he or she falsified the data. The touchstone is that the evidence was not previously available and was impossible of otherwise procuring. Here, Dr. Bhatt’s analysis was previously available to anyone who though to do it. The fact that he happened to publish now is irrelevant.

Dr. Bhatt concedes that the level of technical analysis in the article is available to those with ordinary knowledge in statistics. Dr. Bhatt’s contribution was not to prove that the Mori study itself, and the data within it, was somehow wrong or inaccurate. Rather, his article suggests that the Mori study lacked a certain comparison that, in his view, was necessary for Judge Du’s obviousness conclusion to be correct.Fifteen minutes goes by very quickly. The risk for Amarin from trying to inject Dr. Bhatt’s article at this late stage is that, given all the evidentiary and admissibility issues, it muddies Amarin’s narrative, liquidates Amarin’s credibility (given the argument is likely waived) and may be a distraction from what remains Amarin’s principle argument—namely, that Mori addressed the wrong patient population. As discussed above in our original post, Amarin’s opening brief was a clear and focused on three main arguments. To put this another way, when you are arguing an appeal, you don’t have the judges' limitless attention, and raising a new argument that is potentially waived could be a distraction that does more damage than good.
Yet, Amarin was at liberty to do this analysis while the trial was still pending. For whatever reason, it didn’t do it. Or if it did, it doesn’t appear to have raised it at trial.

Federal Circuit will not simply accede to that request on the basis that Dr. Bhatt’s analysis is presumed to be incontrovertible. Instead, it will have to give the generics an opportunity to respond. They will argue that Dr. Bhatt’s conclusions are not, in fact, incontrovertible. On the contrary, they will point out that their own expert, Dr. Heinecke, testified that the data in Mori—including the comparisons to baseline without the differential analysis between EPA and DHA—was sufficient to show that the patents, in combination with other art, were obvious. The generics will also point out that, although Amarin attempted to distinguish Mori on numerous grounds, it did not challenge Dr. Heinecke’s opinion on the grounds that Mori lacked the differential analysis that Dr. Bhatt now highlights as so critical. Having failed to mount that challenge at trial, the generics will argue that Amarin waived the right to do so on appeal. The generics will also argue that they have not had the opportunity to conduct discovery around Dr. Bhatt’s article, including potentially deposing its authors, but at the very least having the opportunity to provide their own expert’s opinion on Dr. Bhatt’s analysis. They will also point out that as a potentially interested party, Amarin’s introduction of Dr. Bhatt’s article is self-serving.