Had Judge Du considered the secondary considerations in a procedurally correct way, she would have looked at the prior art and the secondary considerations as one combined matter before making any judgement of prima facie obviousness. Using the “clear and convincing” standard, it would be very, very difficult to reach the conclusion that, in light of the acknowledged long-unmet need and significant commercial success of Vascepa, the patents were clearly and convincing obvious. The weakness of any other secondary considerations would not be relevant if even one secondary consideration is strong enough to suggest non-obviousness and muddy any “clear and convincing” conclusion.
On appeal, I think it likely that the panel will look at Mori and, at best (for Amarin), say, “This study, given its small size, low trig level population, different baseline trig levels between the EPA and DHA arms, etc, does not clearly render the Amarin patents obvious. This, COMBINED WITH several strong secondary considerations, causes us to find that there is no clear and convincing evidence of obviousness. We therefore reverse the district court’s finding of obviousness and we judge the plaintiffs’s patents to be valid.”
Using this correct procedure, the appellate court, like Judge Du, could still also find Mori to be clear and convincing evidence of obviousness, but when considering the prior art TOGETHER with the secondary considerations, would likely still find that there is not clear and convincing evidence of obviousness.
My sense of what really happened with this decision is that Judge Du mistakenly followed the model of the USPTO decision (i.e. first judge prima facie obviousness based mostly on Mori, then consider secondary considerations separately) to construct her decision, and that led her down a procedurally erroneous path. She should have considered the prior art and secondary considerations as one issue. To compound her error, she then weighed the secondary considerations against each other, effectively canceling out the significance of long-unmet need and commercial success with what she perceived to be the weakness of the other secondary considerations. And she based that erroneous methodology on no legal precedent for such a methodology. So from an appeals standpoint, her decision is really a mess, and very vulnerable to reversal.
