US_Bull
$AUPH Last distinctions compared to the Amarin v. Hikma case in my view is also that Amarin had previously lost and invalidated in separate district court litigation before the skinny label fight even peaked. None of this holds true for our 036' and 991' patents.
Finally, maybe the most important point as I see it Amarin lost at the Supreme Court because it relied on an "induced infringement". Amarin had to prove Hikma's website, generic "AB-equivalence" ratings, and generic promotion actively encouraged doctors to use it for the heart indication ('induced infringement').
In our case we would have direct infringement. If a doctor were to follow the FDA-mandated label instructions to adjust the generic dosage based on the patient's eGFR levels, they are directly executing our MOU. As I see it, because generics have to print those exact instructions to get FDA approval (due to kidney toxicity if not), in my view they are directly infringing on the claims not even induced infringement
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