Amarin Corp Plc (AMRN)

[HinduKush]

SINGER states it categorically in the Appeals brief Case: 20-1723 Document: 30 Page: 53 Filed: 05/12/2020:

As to VASCEPA®’s unexpected lowering of Apo-B, the district court erred in
brushing this aside based on Kurabayashi. While we address below in Section B the
district court’s error in relying on Kurabayashi as part of its prima facie case, the
district court’s only other basis for rejecting this unexpected result was its statement
that the examiner, who cited Apo-B lowering as an unexpected result in allowing the
claims, was not aware of Kurabayashi. (Appx62.) This is wrong, as Kurabayashi was
before the examiner during prosecution and listed on the face of the patents-in-suit.
(Appx79.)

Here is the refutation of Kurabayshi analysis [Case: 20-1723 Document: 30 Page: 28 Filed: 05/12/2020]:

Kurabayashi is even further afield. Kurabayashi is a year 2000 study comparing
the effects of estrogen and estrogen plus 2g of EPA in 141 menopausal women.
(Appx88400.) Both groups had normal average triglycerides, around 135 mg/dL.
(Appx88403; Appx 1429 (Heinecke); Appx1495–1496 (Heinecke); Appx2415–2416
(Toth); Appx2432 (Toth).) Table 2 of Kurabayashi reports that triglycerides declined
significantly in the EPA plus estrogen group, and went up non-significantly in the
estrogen-only group, while LDL-C went down significantly in both groups.
(Appx88403.) In addition, Table 3 shows that Apo-B went down significantly in the
EPA plus estrogen group, but this finding was not significantly different from the estrogen only group, where Apo-B declined only numerically.4 (Appx88404.)
Notably, Kurabayashi excludes any patients with triglycerides above 400 mg/dL.
(Appx88401.)

There is more [Case: 20-1723 Document: 30 Page: 64 Filed: 05/12/2020]:

For the same reason, the court’s finding that
Kurabayashi taught that EPA reduced Apo-B levels (Appx58; Appx66) is flawed
because Kurabayashi was in the wrong population of patients—patients with normal average triglycerides (around 135 mg/dL)—not patients with severe
hypertriglyceridemia[/b]. (Appx88401–88403.)

And here is the coup de grace:a selection of truths admitted by Heineke the Generics expert witness:

So here is the only conclusion logic dictates [Case: 20-1723 Document: 30 Page: 64 Filed: 05/12/2020]:

Second, the district court erred in concluding that the EPA-only references
Mori, Hayashi, and Kurabayashi filled this gap, when it was undisputed that none of
these references were directed to the relevant patient population, i.e., severe
hypertriglyceridemia. (Appx24–30; Appx57–60.) On Mori, Dr. Heinecke admitted
that the patients tested did not have “even high triglycerides, let alone very high
triglycerides[.]” (Appx1495.) On Kurabayashi, he (Heineke) admitted that the “upper limit on
triglycerides” was 400 mg/dL, and that the patients did not have severe
hypertriglyceridemia. (Appx1495–1497.) And on Hayashi, Dr. Heinecke admitted
that, even if there may have been 1 or 2 patients with levels above 500, “they were not
measuring LDL-C values for patients over 500” and “Hayashi is not telling us
anything about the effect of EPA on LDL-C values in severely hypertriglyceridemic
patients[.]” (Appx1492–1494.) The district court’s finding that “Mori, Hayashi, and
Kurabaysahi disclosed that EPA did not increase LDL-C” (Appx58) is, at best,
incomplete, in light of these admissions...