Kudos to HDG for tracking down the relevant patent claim citation to counter Heinecke’s erroneous characterization of all Amarin Apo B claims as not requiring comparison to a control group.
Below is a summary of the issue, incorporating HDG’s finding:
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From Doc. 234 at 201, where Defendants’ witness, Dr. Heinecke, in his response to Amarin expert witness Dr. Toth’s comments on Kurabayashi, states the following:
201. Dr. Toth notes that the difference between the EPA group and the estriol-only control group was not itself statistically significant. (Toth Rebuttal Rept. ¶ 433.) Again, however, none of the asserted claims as construed requires an actual comparison to a second patient in a control group. (Supra ¶ 197.) At most, some asserted claims require a statistically significant reduction in Apo B levels, which is exactly what Kurabayashi reported for patients taking purified EPA. (Kurabayashi at 523, 525, Table 3.)
But note the Amarin claim below from the ‘677 patent:
Claim 8 of the ’677 patent
“The method of claim 1, comprising administering to the subject about 4 g of the pharmaceutical composition daily for the period of at least about 12 weeks to effect a reduction in apolipoprotein B compared to placebo control.”
As Heinecke's opinions were central to Judge Du's Kurabayashi findings, the above opinion of Heinecke, which appears to be incorrect, is potentially significant on appeal. His view is that the Amarin patent claims, "as construed", do not require "an actual comparison to a second patient in a control group" when considering reduction in Apo B levels. But Claim 8 of the ‘677 patent indicates otherwise.
The above statement by Heinecke is also significant in that it represents an acknowledgment by the Defendants’ own expert witness that Kurabayashi did NOT show, as Judge Du erroneously stated in her decision, that there was a statistically-significant difference BETWEEN the change in Apo B levels for the EPA and control groups.
In Defendants' Post-Trial Proposed Findings of Fact, they did not pursue Heinecke’s above argument, but instead asserted the following:
282. In light of the statistically-significant differential effects reported between the EPA and control groups, a person of ordinary skill in the art would have attributed the reduction in Apo B to EPA. Id. at 737:24-738:8 (Heinecke).
Judge Du copied the latter assertion directly into her decision, where it was central to her invalidation of the patents.
AI
