Zip—you are spot on my friend. “Clear and compelling” is going to play a big role in the appeals court decision. It is a middle standard of proof between “preponderance of the evidence,” and “beyond a reasonable doubt.” To meet the preponderance standard, you only need to be able to make some down weight on a scales of justice to win, e.g., more probable than not. To meet a beyond a reasonable doubt standard, you have to be able to eliminate any reasonable doubt as to the ultimate question. Clear and compelling means you have to show your position is highly probable.
Appeals courts play very close at attention to the standard of proof at trial. There is some evidence in the record to support every finding made by Judge Du. Probably enough to meet a preponderance of evidence standard. The question is whether that evidence shows in a clear and convincing way that a POSA would have had a reason to be confident that 4g of pure EPA would reduce TGs without raising DHA in the severely high trig population. AMRNs appellate counsel has done an excellent job of explaining why the evidence available to a POSA was at best uncertain as to whether any TRIG lowering drug could do that job without raising LDL.
The generics did a very good job of showing there was some reason to study if pure EPA might reduce trigs without raising LDL, but they did not show that a POSA would have thought it was “highly probable” that this would be the effect of 4g of EPA in this population.
This will be the CTA rationale for reversing in my judgment.
JMO.
B
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