Today's decisions are a huge positive for Amarin. The decisions on the summary motions have the effect of boiling the entire case down to one simple question: If a patient walks into a doctors office and that doctor determines that the patient is a good candidate for generic Vascepa, is it at all likely that the doc will write a script for 12 weeks or more based on the MARINE label. If the answer is yes, then the generics lose. It's that simple. In my view, there is NO WAY the generics will take this to trial given the fact that the court has narrowed the trial to this one test for inducement infringement. The court also tipped its hand on this one issue, should it go to trial, when stating:
"Plaintiffs persuasively argue that no treating physician would view the labeling in a vacuum - rather, they would bring their own knowledge and experience to bear on the labeling in deciding the duration of treatment."
"Plaintiffs also make the related argument that doctors know severe hypertriglyceridemia is a chronic condition requiring indefinite treatment;", and " doctors would understand the labelling as requiring treatment for more than 12 weeks".
"The Court finds this argument intuitively persuasive - chronic conditions require indefinite treatment."
Tonight the generic companies are reading the above language from the court knowing that the court has now thrown out their last remaining argument for the invalidity of Amarin's patents (written description), and that they've conceded all other invalidity arguments (anticipation; enablement; indefiniteness). With no remaining invalidity defenses available to them, all they are left with is the inducement infringement theory, and the court has made it quite clear how it views that issue.
I believe today's decisions put Amarin very much in the driver's seat with regard to a settlement, as the likelihood of a generic win at trial is vanishingly small. Before today's decisions, the generics' leverage was increasing with every day leading up to the trial date. After today's decisions, I think that dynamic has been flipped. The offers to settle, from Amarin,, will only get smaller by the day. I think that was telegraphed in the update this evening to the Amarin website where they stated, "In Amarin's view, the summary judgement process and today's court ruling have strengthened Amarin's position in the litigation by eliminating from the case several potential lines of generic argument. As such, the ruling strengthens Amarin's position should it determine that case settlement is in the company's best interest."
I would now expect a settlement sooner than later.
