Amarin Corp Plc (AMRN)

[mc1988]

Explanation for why Dr. Heinecke conflated comparison against baseline with comparison against placebo group

In ECF Document 234 Exhibit #10 (Excerpts from the Reply Expert Report of Jay W. Heinecke, M.D. Dated June 7, 2019), copy here https://www.courtlistener.com/recap/gov.uscourts.nvd.118340/gov.uscourts.nvd.118340.234.12.pdf

On Page 16, Dr. Heinecke states:

197. Dr. Toth notes that the reduction in non-HDL-C levels reported in Mori 2000 (and thus the expected approximate reduction in Apo B levels) was 0.58% from baseline. (Id. ¶¶ 426- 27.) Dr. Toth states that there was no reduction relative to placebo, and opines that the reduction from baseline was “so slight as to be effectively neutral.” (Id.) None of the asserted claims, however, requires any comparison to a patient taking a placebo. While some claims state that lipid effects are “compared to” a second patient who is not taking purified EPA, I understand that the Court construed this language as “not a claim limitation,” and that “the claimed effect can be compared to ‘the expectation if the subject did not receive purified ethyl-EPA.’” (August 10, 2018 Claim Construction Order, D.I. 135 at 12; Heinecke Opening Rept. ¶ 32(e).) Nor do any of the asserted claims require any particular degree of reduction in Apo B levels—they cover any reduction in Apo B levels, no matter how “slight.” (Toth Rebuttal Rept. ¶ 427.) Moreover, some of the asserted claims with limitations regarding Apo B merely require the lack of any increase in Apo B levels. ('715 pat. claims 13, 15, and 18.) Thus, it remains my opinion that Mori 2000 disclosed a reduction or lack of increase in Apo B levels within the scope of the asserted claims.

Notice that Dr. Heinecke explicitly states that his conflation of "comparison against baseline" and "comparison against placebo group" is because:

"I understand that the Court construed this language as "not a claim limitation", and that "the claimed effect can be compared to 'the expectation if the subject did not receive purified ethyl-EPA"

and he references Judge Du's Claim Construction Order.

But it appears that Dr. Heinecke is wrong about the conclusions of the Claim Construction Order. The Claim Construction Order does NOT allow Dr. Heinecke to equate "comparison against placebo group" with "comparison against the expectation if the subject did not receive purified ethyl-EPA". That is an incorrect reading of Judge Du's conclusions.

If I'm right that Dr. Heinecke has a false reliance on the conclusion of Judge Du's Claim Construction Order, possibly because he has been misled by the Defendants' lawyers, it should mean that the entirety of Dr. Heinecke's testimony as it relates to Kurabayashi during the bench trial is possibly invalid because he responded to cross-examination with a mistaken interpretation of the meaning of "compared to".

(Please see my previous post examining the Claim Construction Order here https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158468379)