HK....Re: Silbersher...
Quote..."Yet, the problem that Amarin now faces is that it is no longer trying the case to a fact-finder. Rather, the case is on appeal. Amarin’s contention that scientists did not expect pure EPA to be LDL-C neutral in severe patients is not the issue. The issue, rather, is whether Judge Du’s finding that it was expected was clear error."
I don't see where this is a problem..Facts were and still are the Friedewald equation predicted that trig lowering by any method (including
EPA) should increase the LDL-C..And though the Friedwald equation is normally considered accurate for Trigs under 500Mg/DL..A real POSA would know that any error in the Friedwald equation related to trigs over 500 can be corrected by altering the constant 5) under the trigs/5 factor.
The Friedewald Equation has been proven accurate in studies involving more than 25 thousand individual measurements and like the speed of light, is not subject to opinion..At the time of the Amarin patents the Friedewald Equation was widely used and known to be accurate. And the Friedwald indicated any drug which lowered Trigs must increase LDL-C
The Friedewald Equation...LDL-C = Total cholesterol - HDL-C -trigs/5 the friedwald equation is accurate over a wide range of triglycerides with the proviso that at very high trig the denominator of the trigs/5 estimate must be changed to accommodate the higher trig levels. The Friedewald Equation was introduced into medicine in 1970s was in widespread use during the Amarin patents. The Friedewald equation clearly indicates that any drug that lowers Triglycerides must increase LDL-C if the drug does not substantially increase total cholesterol.or decrease HDL-C. Which neither DHA nor EPA did....So arguing that EPA was expected by anyone at the time of Amarin's patents to be able to lower trigs and not raise LDL or thought it was obvious is dead wrong..There was no expectation that EPA had a statin like ability to lower Total cholesterol.And to this very day it is difficult to understand how EPA actually does manage to lower trigs without raising the LDL-C fraction..And that was why the patent office granted the patents..
Hope this helps...
":) JL
N.B...At the time of Amarin's patents circa 2008-2015. All framed opinions about the effects of drugs on blood lipids would have taken the Friedewald Formula..(equation) into consideration and that is like the Speed of Light.."Not subject to opinions"..No POSA would have predicted EPA's special attribute..And no POSA would have considered Amarin's patents as obvious..
