Postes, like you say, it is a good deal for everyone. Wish I knew what was going on between the ears of those Generic companies because a win is really a loss for them or at least it is not a win for a blockbuster drug as sales will be piddling.
What I am not clear on, is that Raf indicates it would be year head start whereas you and Kiwi indicate 6 months. A year sounds better to me if I was the Generics.
Postes ...try arguing it from Hikma's side. Hikma is the only generic with an approved ANDA ? ...ie could do an "at risk " launch if they wanted to. Is Dr R's ANDA approved yet ?
So assume you are Hikma with a FDA ok to launch......but you wait for the appeal decision in Jan.
Right now AMRN is committed to marketing Vascepa . Apparently DTC will start to run and 800 sales reps are on the payroll . If Hikma wins the appeal they can simply wait to see what AMRN does re marketing. AMRN may decide to keep marketing UNTIL Hikma actually launches . So Hikma can launch at a time of their choosing.....which I would guess will be sometime in 2022.....assuming AMRN keeps its current marketing spend thru 2021.
So if Hikma thinks they have a 50% chance of prevailing in the appeal .....would you give up a 50% chance of the scenario above ......simply to be able to launch 6 mths earlier than Apotex / Teva in 2028 ?
Rose. Apotex and Teva can not launch until the 6 mth exclusivity is up for Hikma ...which I believe starts when Hikma launches ...my recollection. ....if they win the appeal.
Not if generics want to roll the dice to have a case they can point to as precedent for tons of future patent cases.
The have a coin flip appeal to possibly establish new case law that helps them on much bigger opportunities. Why would they settle and give that up, when they got the brass ring against all odds? (unless they truly feel they will lose appeal and that it's not a coin flip).
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