There appears to be much confusion and debate regarding the following statement from the Curfman, Bhatt and Pencina paper:
Furthermore, our detection of an error in the prior art does not constitute new evidence in the case that could not be considered by the Court of Appeals for the Federal Circuit. Rather, our observation constitutes a re-interpretation of evidence that was already cited multiple times in the judge’s opinion.
The “error in the prior art” is Du’s deduction that Mori’s study would have provoked a POSA to ask if DHA or EPA (if not both) was responsible for the increase in LDL cholesterol. The paper indicates that this question would have been inconceivable by a POSA because Mori did not address the question of differential effects of DHA and EPA on LDL cholesterol levels and if they had, the difference would have been determined to be statistically insignificant. Therefore, Du’s extrapolation of the Mori results conflict with the basic principles of statistical analysis. Mori should not be faulted for not performing this analysis because the purpose of the small study was to “generate hypothesis” and not to provide definitive results. The “error” is solely Du’s and was only brought to light in her post-trial decision. Since this error appears to be a primary driver or her opinion on obviousness and was not available prior to her decision, it is directly relevant and should be allowed in the appeal.
I would also expect that the Curfman, Bhatt and Pencina paper was well planned, coordinated and reviewed by the Singer legal team to maximize the impact on the appeal. Neither the above excerpt nor the timing of the paper’s release was an accident. Singer focused on the procedural errors in his brief and is now tapping into the scientific experts to demonstrate that Du’s deduction is not supported by sound statistical analysis.
