I agree that a reversal on appeal is most likely to be based on Judge Du's procedural errors with respect to secondary considerations, as it was her "weighing the secondary considerations" that got her to her obviousness finding. However, I do think the Kurabayashi issues are real, as they potentially include errors of fact on Judge Du's part that were very consequential. I believe that if you take Kurabayashi out of the secondary consideration equation, the court would have to add "unexpected benefits" to "long-felt unmet need" and "commercial success" as secondary considerations, and that, I think, easily puts Amarin over the top for a reversal. Add the major procedural errors to that, and the appeals case starts to look very strong.
And just for fun, take another look below at Judge Du's "Weighing These Secondary Considerations" section. From a legal procedure perspective, it's probably a 9 on the 1-10 scale of judicial errors. She actually gave the section a title that explicitly describes exactly what the Federal Courts have painstakingly instructed judges to NOT do. And not only that, she made it the very core of her reasoning for her decision. The key words here are "weighing", "weighed", "outweighed", and "favored". The appeals court is likely to find that the whole concept of "weighing" is a gross misinterpretation of how secondary considerations are to be factored into an obviousness decision. A secondary consideration either supports a finding of obviousness, or it has no value. It should never have a negative value. And a secondary consideration should therefore never "favor" a Defendant. Finally, the court simply cannot cancel out a supportive secondary consideration by offsetting it with a non-supportive secondary consideration, which in this case reduced supportive secondary considerations to "weak evidence of the existence of secondary considerations ("However, these secondary considerations are outweighed by the fact that the Court found Plaintiffs’ other proffered secondary considerations favor Defendants. Thus, at best, Plaintiffs have presented weak evidence of the existence of secondary considerations, which do not overcome the Court’s finding that all Asserted Claims are prima facie obvious.)
And all of this is before even getting into the improper shifting of the obviousness burden to the Plaintiffs. The whole things is really pretty incredible from a legal perspective.
vii. Weighing These Secondary Considerations
The Court thus finds that the satisfaction of long-felt need and commercial success secondary considerations weigh in Plaintiffs’ favor, and the remaining secondary considerations weigh in Defendants’ favor. More specifically, the Court finds that Vascepa is a commercial success even though it has not yet turned a profit, and that there was long felt need for a single pill that reduced TG levels without increasing LDL-C levels. However, these secondary considerations are outweighed by the fact that the Court found Plaintiffs’ other proffered secondary considerations favor Defendants. Thus, at best, Plaintiffs have presented weak evidence of the existence of secondary considerations, which do not overcome the Court’s finding that all Asserted Claims are prima facie obvious. See, e.g., ZUP, 896 F.3d at 1373 (holding that “a strong showing of obviousness may stand even in the face of considerable evidence of secondary considerations”).For the reasons discussed above, in view of all four Graham factors (including alleged secondary considerations), Defendants have proven by clear and convincing evidence that all Asserted Claims are invalid as obvious under 35 U.S.C. § 103.
