Claiming a patent is invalid, as a matter of law, places burden on generics to show by clear and convincing evidence.
Singer's appeal brief strongly refuted obviousness. Even though Amarin didn't bear burden of proof. All known hypertrig therapies also raised LDL, even the FDA understood this was the case, as hypertrig was widely understood to have a genetic component. Mori fails to address this scenario. He cites ample evidence showing contemporaneous doubt of Amarin's eventual invention, even among most Amarin colleagues. Like other therapies, EPA was originally thought to raise LDL where trigs >500. Amarin's proprietary research was the first to overcome this general understanding.