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Re: ggwpq post# 197330

Wednesday, 06/19/2019 7:54:08 AM

Wednesday, June 19, 2019 7:54:08 AM

Post# of 425927

For those worry about patents, don't worry. Amarin's patents are novel and non-obvious as JT explained below.-ggwpq

“patenting the use of highly pure eicosapentaenoic acid for the treatment of patients who had triglyceride levels greater than 500 resulting in triglyceride reduction without increasing cholesterol and that's unique from the perspective that even if you put patients with very high triglycerides and diet. Their cholesterol tends to go up. Lovaza, in that population, the cholesterol went up by 49% and consistently, it seem -- cholesterol go up in that population. So being able to show something different for that was deemed to be unique..”



I would still be very much worried if I had a significant amount of capital exposed to AMRN while these litigations are going on. We found it amusing that apparently the investigators of MARINE were coaxed into specifically writing about how “unexpected” this was, to see no increase in LDL-C. Actually it isn’t at all true. To a person of ordinary skill in the art, not seeing a significant increase in LDL-C from 4 g/d of EPA-only was wholly expected. We go into much detail on this point in our greater report, highlighting data from ~30 different studies proving just that. And there is a problem in the label we highlight, drawing from multiple examples in case law. In fact the claim itself is highly problematic. It may not even need be invalidated, as ANDA filers are by our reading not infringing on that point of the claims anyway.

The IP for Vascepa is very weak. There is a reason insiders have been dumping their holdings; there is a reason no buyout has occurred; there is a reason a delay in filing in the EU; there is a reason no partnering for EU. And they all converge on two issues: marketing approval is dubious, and proving ANDA filers will be infringing upon the patent claims covering Vascepa is highly dubious.




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