the question is when, why and how does it help the price of the stock? they have been filing and have been granted patents for years-the stock is at 6--how is this different?
This is great and I would love to see something from the company to explain how they plan to leverage the patent in the US. I think this is great for the EU if granted, protects V for another 10 years but the big money is restoring the US rights. Does this do it? Or, do we have to wait for it to hit the Orange Book?
This suggests a plasma level test between V and gV could be done quickly and show that gv isn't (or isn't likely to be) equivalent to V in therapeutic affect. Then what? While the clinical evidence would be there and a pretty strong theoretical basis, how does one get the FDA to use this knowledge and disallow gV or at least Hikma's gV for Vasepa indication?
1. A method of reducing triglyceride levels in a subject on statin therapy and HAVING ATRIAL FIBRILLATION and triglycerides of greater than 500 mg/dl, the method comprising administering to the subject about 4 g of per day of ethyl eicosapentaenoate.
It only covers patients having atrial fibrillation. How many is that? How does Amarin use this claim to stop generics from treating the vast majority of Vascepa patients who do not have atrial fibrillation?
Excellent Job tying this all together. I was working on this exact project when I read your review. For my own edification, I'll finish what I was doing anyway. :) Thanks
So does management need to test the generic product? It seems like we are ultimately going to need the FDA's help even if the generic product is inferior because the generics will just play dumb and insist they are not seeking the REDUCE-IT indication but just going after the MARINE indication.
Not sure I've seen those words on Tmax before in older patents very similar to this one - I find reading patents give me a headache so I never get all the way thru, that text could have existed prior to this one - but in any case, it doesn't nothing to protect AMRN in the US market, no new patents do.