Amarin Corp Plc (AMRN)

[Mocha Loca]

Montana - During discovery the judge said she found Amarin's argument "intuitively persuasive" that chronic conditions required indefinite treatment, then commented on Amarin's expert testimony making the case even stronger. So, inducement is a win for Amarin unless the defense has some miracles up their sleeve.

Obviousness seems to be included because of the Hayashi study mainly. In fact, none of the studies the defense cites were known to have anyone with triglycerides over 500 mg/dl; however, that might not have been true because the Hayashi study had parameters of 300 + or - 233 mg/dl, so it was possible some of the 28 patients were over 500, although notes on the study seem to indicate no one was over 430. That's it, that's their argument. Hayashi was a tiny study and there is no confirmation the exact composition of what was claimed to be EPA. The patent examiner initially denied the application from Amarin, but reconsidered when a Dr. Lavin verified no one in the study was over 450 mg/dl. The examiner was still concerned and took the data to his supervisors who together agreed on the patent. Having patents denied initially happens all the time and resubmissions are accepted often when new information is introduced like in this case. That doesn't mean if the examiner had decided the parameters of Hayashi suggested it possibly had some patients over 500 mg/dl that Amarin would have stopped there. They probably would have confirmed the composition of the molecule was impossible to determine and then received their patent. On top of that the examiner said there were secondary considerations, including the fact there was no triglyceride reducing agent currently available that didn't raise bad cholesterol. To deny the application; therefore, would possibly be to the detriment of the populace. Adding in another issue like REDUCE-IT is something Amarin is using as a back up. Amarin has the best lawyering team in all of biotech and they have taken these issues with dead seriousness from day one. If the judge rules against Amarin, it'll be a huge surprise, but then they'll appeal. Manufacturing and composition patents are something the generics are going to have a hard time with if they get by this step.