We have received several follow-up questions, both online and offline, regarding some of our earlier posts – especially on the topics of Kurabayashi and prospective settlement. This post will attempt to collect further thoughts on Kurabayashi. This post gets deeper into the weeds than most of our earlier posts, but it is in response to thoughtful questions and comments that investors clearly looking for areas of weakness in the district court’s opinion. We will follow up shortly on another post discussing dynamics of a potential settlement.

The post mortem of the district court’s decision invalidating Amarin’s ($AMRN) Marine patents continues. We received questions regarding a finding of fact related to the prior art reference, Kurabayashi. The Honorable Miranda M. Du from the District of Nevada found that Kurabayashi was not considered during prosecution of the patents and that Kurabayashi suggested that pure EPA would reduce Apo-B. Are these findings accurate? If not, are they a basis to reverse Judge Du’s decision on appeal?

We previously blogged about the upcoming litigation trial between Amarin Pharmaceuticals ($AMRN) and Dr. Reddy’s and Hikma, which are two prospective generics for Amarin’s Vascepa®.  While that blog post provided a general overview of the issues to be litigated at the upcoming trial, there are numerous other issues and questions around the upcoming trial.  This post will focus on how the REDUCE-IT trial may impact Amarin’s fight with the existing generics, if at all.

Amarin Pharmaceuticals ($AMRN) will be going to trial soon to protect Vascepa® against generic competition.  Amarin has asserted 15 claims from six patents against ANDAs filed by Hikma, Dr. Reddy’s and Teva.  What are the issues to be addressed at trial?