Friday, May 22, 2020 4:32:16 PM
(2) Ascertain the differences between the claimed invention and the prior art;
For our case, the difference is TG population. After reading this, https://drive.google.com/drive/folders/1W5Z3OnsQqyEqAlGTuiYF17jIapWGCLf1, do you think the generics took up the burden to explain why the two TG population should behave the same as far as LDL-C is concerned? Or did Du put the burden on Amarin despite there is an easy to understand explanation, i.e., Friedewald Equation:
LDL = TC(total cholesterol)- HDL-C(high density lipoprotein cholesterol) -Trigs/5
For SHTG (TG>500), a POSA should expect TG reduction to be above 30% for using DHA/EPA
For HTG, a POSA should know the TG reduction is about 10-20% for using DHA/EPA
Therefore, the greater the %TG reduction, i.e. SHTG population, a POSA should expect a greater rise in LDL-C. So a POSA looking at Mori and saw EPA raised LDL-C for even a marginally above average TG population, he should stay as far away from EPA as possible for SHTG population. That's why experts said increased LDL-C was inevitable for SHTG lowering therapy and that's why there was such a long unmet need after Mori until the discovery of Vascepa. Only hindsight could force Mori to be a valid prior art.
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