Thursday, January 02, 2020 2:15:48 PM
https://www.markmanadvisors.com/blog/2019/12/3/can-amarins-patents-protect-vascepa-from-generics
However, that article includes this:
The generics rely upon Mori 2000 to show that, allegedly, DHA was responsible for increased LDL-C levels, rather than EPA. Mori 2000 discloses a study in which three groups of approximately 20 men were administered EPA, DHA or placebo, respectively. Thus, Mori 2000 is one of the few studies that examined the differences between individual administration of EPA versus DHA. On the one hand, the study showed lower increase of bad cholesterol with DHA versus EPA, namely, 8% for DHA and 3.5% for EPA. (The decrease of 3.5% for EPA was not considered statistically significant.) Given this, the generics argue that it was obvious that DHA, rather than EPA, was responsible for increasing LDL-C levels for Lovasa®, and thus, it would have been obvious to a person of skill that administering pure EPA would not increase LDL-C levels.
Now take a look for yourself at the results table from Mori et al:
Does this look like a result to you that "DHA was responsible for increased LDL-C levels, rather than EPA"? LDL-C goes up on the EPA arm! Not as much, but it goes up. The claim is that EPA not increasing LDL-C levels was obvious. Does it look obvious from this?
We're not even considering now that we're looking at tiny groups of Japanese subjects who don't have trigs > 500...
“The trick is in what one emphasizes. We either make ourselves miserable, or we make ourselves happy. The amount of work is the same.” Carlos Castaneda
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