Sleven,
I appreciate your response and it is clear that I am not doing a good job explaining myself. I understand that we had patent protection for both SHTG and CVD with FDA approval. Hikma decides to launch for SHTG so we sue them for patent infringement and lose. The FDA approves their product for SHTG. They launch and purposely advertise beyond the SHTG level in their initial launch. It looks like they are on their way and nothing we can do about it. In the months after they launch, we lose the appeals on the patent infringement so then sue them for infringement through their launch and advertisement as infringing. It doesn't look like there is a hope in hell. Fortunately they do all the infringement BEFORE the Teva GSK case becomes reversed. Now they have issues! With the reversal ruling, they back track quickly taking down the infringement publications and change their tune. During their launch they should only get 10% of the market since 90% is for CVD indication. The generics are eating up about 50% of all scripts if not a little more (well find out in the next CC). We've got hope again with the lawsuit moving forward to discovery. This could be incredibly life changing for Amarin if this can go to trial and win. I know it is a long ways from this miracle happening but it is still possible. What I was trying to say and I believe Ramfan too (although I don't want to speak for him) is if we go to a jury trial, AND we have launched generic V with it being used 50% of the time for the CVD indication just like the other generics but it is simply labeled for SHTG like the generics but not mentioning use as CVD indication (since the patents no longer are in effect for the SHTG but they still are in effect for the CVD) what keeps the defense from saying, "Wait a minute, you guys are suing us for our generic product being used in the same method and ways as your generic product is being used for and your label also is approved only for SHTG also and says nothing about being used for CVD indication! How can we be guilty when you are doing the exact same thing we are doing? We aren't asking the PBMs to use it for the other indication. We are no more guilty of forcing the insurance companies, pbms and pharmacists switching to this as you are!" I understand this isn't exactly the case because they advertised beyond SHTG and also included the CVD in their financial records. What I am saying is this argument is mute if what North said is true. If the authorized generic is also protected by all the patent protection which the brand is, then the authorized generic is not only approved for the SHTG (which patents are no longer enforceable) but also is approved for the CVD indication which ARE still enforceable! This a what I am trying to find out by North. Is the authorized generic also protected by all the patent protection (patent office) that of the brand and will it's label be exactly the same as brand (FDA)? If so, then when such an argument comes up, the response to the jury is simple. "Yes, the AG is being used 50% for the CVD indication but we have exactly the same label as brand V (SHTG and CVD) and also have the appropriate patents to use for this since we are the patent holders." Maybe this is a non issue but if the label is identical to the brand, I would feel much more comfortable if we have launched a AG when this trial moves toward a hearing (hopefully). Hope this clarifies a little more why I have asked North concerning the legality of the patents carrying over as well as the label. Thanks for all your input. You are a great asset to the board. Once again, from my understanding, Italian government has approved V for reimbursement but with more restrictions. I'm not for sure why Amarin has not announced anything. I don't know if there are further negotiations occurring for a wider reimbursement or not. This is very strange.
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