I am not a judge or a lawyer...and I don't like having to go back and digging through the Amarin Ihub posts...I believe I have heard from this site and others that the Appeals process might not place too much emphasis on Judge Du's factual errors and they (the appellate judges) may place more attention on unintended consequences..And other factors we lay people just don't understand.. I am trying to come with a solution that will allow Amarin to keep the R-I indication and not have to depend on the court reversing Judge Du..
But all I get is flack that I am rewriting the law..Which is not the case. And I do not get anyone offering a better solution..Which I would welcome..It is very difficult to imagine that our current situation is much better than it was at the time of the Du trial..IMO Amarin seemed to have presented the better case..But the judge ruled against Amarin and this does not make me extremely confident that Amarin will prevail in the appeal...
So please if any of you have a better idea than mine which is allow Amarin to keep its Vascepa patents. This allows Amarin to keep its patents for the SNDA (the REDUCE -IT indication) which the court agreed were valid...And Amarin would give the Generics the net profits from the Marine High trig indication which the judge opined the patents were invalid and the generics were free to pursue.. Judges Du's judgement was the generics would be allowed sell Vascepa for the MARINE indication because the MARINE patents were invalid..She made no such claim regarding the R-I patents..
The single greatest problem with the judge Du's decision to allow the Generics to sell the Marine indication..Is that in the real world of drugs..You can not by any measure prevent doctors from prescribing off label (including for the sNDA patent protected indication) nor is there an obvious way to stop drug plans from substituting the cheaper drug of the two ( Brand Vascepa vs Gen Vascepa)..So Judge Du's decision actually does much more than grant the generics the Marine indication, it also gives the generics the R-I indication via off labeling...And this violates Amarins R-I patents..
Please understand I am looking for the best solution for this very important problem..And posting that I am ignoring the law is not a better solution..I'm not breaking the law..I am not a judge..I am asking the Appellate Court to vacate Judge Du's decision to give the generics the Marine label because if the generics get it. Amarin is going to be very unlikely to survive..And that is their reward for doing all the work for developing the drug..Wasting hundreds of millions of dollars and ten years of their lives... If anyone has a better idea..I would love to hear it because I want Amarin to survive and I am a shareholder..What I don't want are flip statements trying to be cute. or sound educated..It doesn't help anyone
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