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Monday, June 29, 2020 10:53:58 AM
Dear Mr. Singer Esq.,
I am New York attorney who once worked for Kenyon & Kenyon in patent law. I am a current shareholder in Amarin and appreciate your hard work on our behalf, especially your brilliant brief in which you intertwined the history of vascepa with the idea that it was not obvious.
I would like to make one suggestion. Would it be possible in your Reply brief to emphasize to the court in particular and in detail the incorrect statements /arguments that Judge Du made in regard to (1) our premise that patients with TG levels above 500 mg/dL respond differently to TG-lowering therapy than patients with TG levels below 500 mg/dL. and (2) Dr. Toth's testimony, which goes to the prima facie of obviousness.
MISTAKE #1
"Many of Plaintiffs’ arguments depend on the premise that POS As as of March 2008 would not have expected that using a composition of purified EPA would not increase LCL-C levels. But this premise is not supported by the evidence. To explain, Plaintiffs primarily point to testimony from Dr. Toth to support this premise.
But there are at least three issues with Dr. Toth’s testimony. First, he agreed under questioning that, as of “March 2008 the prior art reflect[ed] that all these treatments increased LDL-C in patients with very high triglycerides.” But that cannot be correct, because Mori taught that EPA did not increase LDL-C levels like DHA did." p. 59
*** this last sentence makes no sense, b/c Mori/EPA was not a study with "very high triglycerides". Hence, cannot make a connection between the two.
MISTAKE #2 (WORSE FALSITY)
"Moreover, Plaintiffs’ arguments also depend on another factual premise that lacks evidentiary support that patients with TG levels above 500 mg/dL respond differently to TG-lowering therapy than patients with TG levels below 500 mg/dL." p. 60
***. Amarin wrote extensively how all pre-vascepa drugs worked different on over 500 trigs population-as they increased the LDL significantly, while on populations below 500 they didn't increase LDL significantly. Amarin explained the mechanism of lowering trigs resulted in an increase of LDL.
MISTAKE #3
"But even if Mori and other studies on patients with lower TGs did not provide “conclusive proof” of EPA’s effects, they were enough to form “a reasonable expectation of success." p.60
*** what is her basis for that? Again , Amarin provided that all pre-vascepa drugs worked very different in high trig pop.?
MISTAKE #4 (2ND WORSE FALSITY)
"Indeed, Dr. Toth conceded that POSAs could rely on data in patients with triglycerides below 500 mg/dL to make reasonable predictions about how patients above that threshold would respond. As he
admitted, “a skilled artisan would know that a drug that reduces triglycerides in a patient at 400, is very likely to also reduce triglycerides in a patient at 600.” Thus, the Court finds that a POSA “would have reasonably expected purified EPA to reduce triglyceride levels above 500,” even without data confirming that result." p. 60
***the last sentence is false and "fudging" what Dr. Toth said. Dr. Toth was discussing predicting whether a drug that lowers trigs at 400 would do so also at 600--he wasn't discussing the subject matter of raising LDL. He didn't say that a drug that doesn't raise LDL in 400 range or lower will also not raise LDL in a 600 trig population.
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