Replies to post #429731 on Amarin Corp Plc (AMRN)

[rosemountbomber]

Ram you raise an interesting question that I have not ever seen mentioned here (but I could have missed the discussion). I know that for typical generics an ANDA application has to be made to the FDA and if the patent has expired and other exclusivities are over and the drug meets some bioequivalence testing, then the FDA grants its permission. BUT does the same procedure apply to an authorized generic? I assume it would be but I really need to be educated on this. So like you say would it have to be an AG for VHTG and then just play the game that all the Generics play? Can't see how this could help them in their infringement cases as I would assume the defendants could bring this up. Funny if both litigants could be found guilty of breaking the law!

[Birdbrain Ideas]

Very good points!

[north40000]

Amarin’s launch of its generic would be for both indications like present Vascepa. Why do you think it odd that such a generic would “infringe” its patents? Following the observations of the 3-member CAFC panel in Amarin v. Hikma et al, Hikma’s product has NOT been FDA-approved for CVD indications, nor has it been shown to be therapeutically equivalent to Vascepa. The rub might be that a different dose or “container/capsule” environment might also require clinical trial testing by Amarin for both indications.