If allowed oral argument, maybe chance to re-characterize
... in tone if not substance. One strategy is to more align with Patent Examiner who also found prima facie obviousness based on prior art considerations, but then viewed secondary considerations as tipping the balance in favor of granting the patents.
Your honor, thank you for this opportunity. We believe that the Court has made mistake in its understanding and weighting of both Mori and Kurabayashi. As pointed out by the Curfman paper, written by disinterested scientists, and by our statistical expert, the Court used statistical mischaracterizations, abetted by the defense team’s grossly negligent or deliberate misrepresentations, to arrive at a verdict that is not supported by the two major pieces of prior art that the Court used in conjunction with the Lovaza PDR to reach a determination of obviousness.
You have read our motion, and thus understand the issues of significant versus nonsignificant results and within-group versus between group comparisons. We believe the statistical mischaracterizations made inappropriately affected both the analyses of the obviousness associated with the prior art and the secondary considerations of obviousness.
In support of our thesis, we look to the court’s own words. The judgment indicated that the Court credits Mori over von Schacky because "von Schacky incorrectly summarized Mori, and is therefore not credible." The court implicitly admits weighting Mori heavily in detracting from von Schacky because it incorrectly summarized Mori. It should be evident in our motion, that not only did von Schacky do this but Mori also incorrectly summarized Mori. Mori himself stated, without proper foundation, that DHA and EPA had differential effects on lipids and glucose metabolism. And as the Curfman paper clearly indicates, that is not true. If the Court was willing to disregard von Schacky because of its mischaracterization of Mori, the Court should similarly be willing to disregard Mori because of Mori's mischaracterization of its own findings.
The Court’s mistake in the two pieces of prior art on which it relied heavily are very much evident in the language of its judgement. “Mori found that EPA did not raise LDL-C levels, and Kurabayashi suggested that EPA reduced Apo B levels.” The Court badly misconstrues Mori. LDL-C levels were in fact raised in Mori, but the rise was not statistically significant. And while there may have been the “suggestion” that EPA reduced Apo B levels when combined with estriol, this was a within group analyses, and does not provide anywhere near the clear and convincing evidence needed for the Court’s determination.
Further, the Court uses Kurabayashi to undermine the Patent Examiner’s reliance on secondary considerations to grant valid patents to Amarin. The Court states that while the Patent Office found that a decrease in Apo B was an unexpected benefit constituting a valid secondary consideration, the Patent Office's examiner did not consider Kurabayashi. The Court goes on to indicate that because the PTO did not consider Kurabayashi, it did not have all the material facts before it and its judgment loses “significant force.” So in considering Kurabayashi material in both its determination of prima facie obviousness and in its consideration of secondary factors, the court doubles the mistake associated with Kurabayahsi which merely showed that when EPA is combined with estriol it yielded significant within group differences over time but no significant between group differences. We feel that the legend that was inappropriately removed from Table 3 would have highlighted for the Court that Kurabayashi should not have been given any undue weight in either the prima facie obviousness determination or in the Court's analysis of secondary considerations.
In summary your honor, given the weight that the Court mistakenly put on the mischaracterizations of Mori and Kurabayishi in its judgement, we believe that the prima facie case of obviousness was never made. In the alternative, if the Court still believes the prima facie case was made, the Court should agree that given what the Court now knows what Mori and Kurabayashi really say and don’t say, that prima facie case is a much closer call now. And like the PTO, even if the Court finds a close prima facie case for obviousness, then the secondary considerations of ‘long-felt need’ and ‘unexpected benefit,’ now not being diminished by the presence of a less weighty Kurabayashi, should tip the balance for patent validation.
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Summary: de-emphasis of fraud; allowance of court to use logic of PTO in finding patents valid.
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