Friday, March 05, 2021 9:40:49 PM
In the SCOTUS Petition, they are saying that it is contrary to law to shift the burden of persuasion to the patent holder once the challenger establishes prima facie obviousness.
In the Rule 60 Motion, we will be saying that factually in this specific case, the generics cannot and did not establish prima facie obviousness due to the statistical mistakes in applying Mori and Kurabayashi to support the Court's finding of prima facie obviousness.
We will be relying upon two Harvard professors (Curfman, Bhatt), the Director of Biostatistics at Duke (Pencina), and our own expert, a Professor of Pharmacology at Cambridge, to establish these points.
It is powerful stuff. Putting aside the shenanigans with the Cropped Table, and the legal wrangling at the highest levels over balancing tests, the fact remains that the decision invalidating Amarin's patents was based upon a lie.
A statistical and scientific lie. Mori and Kurbayashi do not say what the Court, the generics, and their expert, Dr. Heinecke, all think those studies say. The entire decision was a big tragic mistake, compelling relief under Rule 60(b)(1), which is the core of our position.
The statistical eradication of Mori and Kurabayashi likewise eradicates the purported 'clear and convincing' evidence of prima facie obviousness.
In the Rule 60 filing we don't care about balancing or secondary factors. We say that the generics do not even reach the prima facie obviousness threshold, so balancing/secondary factors do not come into play, as the case should have ended in Amarin's favor before balancing/secondary factors were even reached.
My 'drop dead' date for filing is St. Patrick's Day.
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