Meowza
“Claiming a patent is invalid, as a matter of law, places burden on generics to show by clear and convincing evidence.”
Yes, but that doesn’t mean that every fact the generics rely on has to be shown by clear and convincing evidence.
“All known hypertrig therapies also raised LDL, even the FDA understood this was the case” … “Mori fails to address this scenario.”
Other known hypertriglyceride therapies are part of the prior art and need to be weighed, along with Mori. They don’t make Mori disappear. One could reasonably think that Mori is more pertinent, since Mori deals with EPA, the subject matter of the claims. Mori did not need to address other prior art for Mori to be relied on by the district court.
“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.”
Good points that were made at the trial level. The district court made the factual finding that they were not enough to overcome Mori’s explicit teachings. Maybe the Federal Circuit will hold that finding to be clearly erroneous. It can happen.