Amarin Corp Plc (AMRN)

[Bouf]

Report on pre-trial conf just added to docket. All standard stuff RE trial prep. Trial dates set for 1/13-17, 1/21, and 1/27-31. Court will try to resolve motions in limine (to exclude certain evidence before trial) by 12/27. Most courts don’t decide these motions until trial, absent very clear grounds to exclude before trial.

One important point to remember here is that it is a high burden for a generic to challenge the validity of an issued patent. The standard of proof for this is clear and convincing, higher than the normal “preponderance of evidence” standard in civil cases, but lower than the “beyond a reasonable doubt standard” in criminal cases. These generics are challenging the patents on obviousness grounds, but given the science, it seems like a real big stretch that the generics could show by clear and convincing evidence that this drug invention was so obvious that the multiple Amarin held patents should not have issued. While I’m no patent lawyer, just an experienced commercial litigator, it’s clear the generics have a tall hill to climb to invalidate ant patents.

If all patent challenges fail, then the main question is whether Amarin can prove infringement by the generics’ sale of their products. That is also a question above my pay grade, but it is true that Amarin only has to prove its infringement claims by the lower “preponderance of evidence” standard. Also, to avoid infringing, the generics have to differentiate their products from Vascepa, but we all know that the whole reason they want to make a generic version is to grab sales from Vascepa. In other words, they have an inherent conflict between their legal position and their business objective. A very tough needle to thread in my experience.

All of this leads me to think that there will be a settlement, with Amarin pushing these guys to the wall to give up as little as possible of their patent protection, to avoid the modest but inescapable risk of any litigation. But in the end, there does not appear to be real peril in going to trial, as patent validity is solid. If the court finds no infringement, the patents are still good, and they only get to sell in a way that does not take away Amarin sales.