Defendant's Reply Brief - No Game Changing Surprises*
As expected, the defendant's filed their Reply brief yesterday. The brief became available a few hours ago and I just completed my first review of the 65 page document, which I paste at the end of this post. Upon my initial review, I didn't find anything surprising enough to change my viewpoint on this appeal. Going into this event, and after my review of the brief, my viewpoint remains that AMRN has roughly a 25%-33% chance of winning the appeal. I am most eagerly awaiting the future assignment of the panel of 3 appellate judges in this case because our research suggests that at least some of the judges have a bias toward or against validity in similar secondary consideration cases, and that could be a big factor affecting Amarin's chance of victory in this case. In my view this is because the facts and obviousness legal analysis in this case could go either for or against Amarin, and thus can turn on a judge's subjective bias.
If you want more details on why I reach the conclusion that as expected, this defendant reply brief doesn't change AMRN's odds of success, here's more detail: The case is a classic battle of split legal analysis/Fed Cir. panel bias and battle of each side's experts. The defendant's presented numerous prior Federal Circuit cases that support the District Court's legal analysis, to counter the cases that the plaintiff presented to support the analysis that gives them a better chance. The defendant's brief does not dwell much (I don't recall even a mention) on a split in the court regarding obviousness analysis, which is an issue that Amarin focused on a lot in their brief. Rather, the defendants provided cites for many cases where the Federal Circuit held patents obvious despite some evidence of secondary factors/objective indicia. Furthermore, the defendant's stress that the district court judge did not reach a conclusion that the patents were obvious before considering secondary factors, but rather only reached a prima facie conclusion, and analyzed secondary factors even before that. And even if she did, the result would be the same. In my view, if a Federal Circuit wants to overturn the obviousness ruling, they could for example attack the balancing of secondary factors that the district court seemed to do, despite the defendant's arguments otherwise.
Regarding the battle of experts, the defendant's acknowledge the battle of experts at play here, but correctly conclude that the district court adopted the vast majority of facts consistent with their expert's testimony. The defendant's made their arguments as to why the district court was correct in her conclusion that a skilled artisan would have expected that EPA would reduce triglycerides but not LDL-Cs in patients with triglycerides of at least 500 mg/dL. This was a key important factual finding that AMRN wants the Federal Circuit to reverse the district court judge. The defendants repeatedly mentioned the significance as relied on by the judge of the fact that there is nothing fundamentally different about a subject with triglycerides at 499 mg/dL and a patient at 500 mg/dL.
On other notes, the defendant's argued that the district court should not have ruled that the secondary factor of commercial success was established because most of the sales of Vascepa are not for the severely elevated triglyceride patients. I was a little surprised by the emphasis on this because maybe it could come back to hurt the defendants in a possible future litigation where AMRN brings its Reduce-It patents against the defendants outside of the ANDA context. The defendants again attacked AMRN's "invention" stressing the fact that AMRN had no data in this patent application, but rather relied on prior art cited in this litigation, such as Mori and the JELIS study, to list a number of potential advantages of purified EPA in their patent application that led to the asserted patents, such as the claimed elements of reducing triglycerides in patients with at least 500 mg/dL without increases LDL-Cs. And that it wasn't until years after the patent filing that AMRN actually had clinical data on patients with severe hypertriglycidemia. Finally, the defendant's spend some time reiterating the district court judge's conclusion that the prior data on EPA not increasing LDL-Cs did not have to be scientifically perfect, just strong enough to give a skilled artisan a reasonable expectation of success, in case AMRN focuses more in their final brief on reiterating their arguments on the weakness of Mori's analysis. Finally, I was a little surprised by the defendants' arguments regarding non-infringement because our research indicated that the Federal Circuit has clarified that in the current litigation posture, defendants could not yet appeal the infringement ruling, and therefore we did not expect them to mention it.
In summary, defendant's arguments were not surprising and do not affect AMRN or defendant's chance of success in my view. We do not plan to change our Amarin position tomorrow. I feel that Amarin's chance of success remains around 25% to 33%.
**Here's a copy of the defendant's brief:
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