I don't think infringement applies to side effects.
From a judge perspective, adding a side effect on a generic is not supposed to help for sales. And sanctioning a generic for disclosing a side effect may have harmful consequences in the future, as an incentive not to do so...
To me this GSK/Teva trial outcome does not change anything for Amarin. Vascepa generics will just be more careful to avoid promoting the Reduce-it indication.
The positives comes more from the awareness it creates around skinny labels and this unfair system where a generic can easily steal market shares and jeopardise innovation. Let's hope there will be more to come but it will likely be a long long way...
Just because A-fib risk was found during R-IT doesn't mean it's not a valid finding that should be on GV's label - could have discovered this from doing an analysis of existing V patients - FDA should make GV put it on their label but that doesn't mean anything as far as R-IT indication goes.
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