I like the article until I got to the end - he makes a critical mistake - R-IT results will only apply to pure EPA drugs, and AMRN IP will prevent anyone else from marketing Rx versions for CV protection (DS might take advantage though):
And we also remain skeptical on another point: the question of whether Amarin itself will really benefit from winning the case in the long run.
Amarin has already invested in the outcomes trial (REDUCE-IT), and is still likely to complete it by the end of 2017. If the trial fails, the company will be obliged to abandon the off-label campaign – as even the Manhattan court would agree that promoting a CV benefit in the face of a failed trial would qualify as misleading. And who knows what additional fallout may come in that event.
But what if the trial succeeds? Amarin will then have conducted a definitive and expensive study to win a landmark claim that its product improved CV outcomes. And the company will also have established the legal principle that anyone else selling fish oil can make a similar claim without paying for the trial.
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