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Kurabayashi, et al., Eicosapentaenoic Acid Effect on Hyperlipidemia

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JDUR   Sunday, 04/05/20 04:02:06 AM
Re: Laurent Maldague post# 262297
Post # of 361960 
Kurabayashi, et al., Eicosapentaenoic Acid Effect on Hyperlipidemia in Menopausal
Japanese Women. Obstet. Gynecol. 96:521-8 (2000) (“Kurabayashi”) was published in
2000 and is prior art to the patents-in-suit.
Kurabayashi investigated the effects of administering purified EPA (96.5% EPA) at
a dose of 1.8 g/day in combination with estriol (the “EPA group”) as compared to estriol
therapy alone (the “control group”) for forty-eight weeks to hyperlipidemic, menopausal
women. (Ex. 1534 at 1.) Estriol is a form of estrogen that is commonly used in menopausal
women to alleviate the symptoms of menopause. (ECF No. 367 at 735:2-20.) As an
estrogen, estriol is known to elevate triglyceride levels. (Id.)
Despite coadministration with estriol, Kurabayashi reports a statistically significant
27% reduction in triglyceride levels in the EPA group. (Ex. 1534 at 3.) As compared to the control group, the EPA group experienced a statistically significant reduction in triglyceride
levels at the 12, 24, and 48-week checkpoints:
(Id. at 4.) Kurabayashi further reports that “[l]ow-density lipoprotein cholesterol levels in
both groups were significantly lower.” (Id. at 3.)
Kurabayashi further reports a statistically significant reduction in Apo B levels in the
EPA group of 6.9%. (Id. at 4-5.) With a p-value of < .001, EPA’s effects on Apo B were
highly significant. (Id.; see also ECF No. 367 at 737:1-23.) In contrast, Kurabayashi reports
a non-statistically significant 1.5% reduction in Apo B levels in the control group:
(Ex. 1534 at 5; see also ECF No. 367 at 737:1-23.)
The results reported in Kurabayashi do not suggest any interaction or synergy
between EPA and estriol. (ECF No. 367 at 735:21-736:9.) Instead, synergy is usually only
seen between drugs that have similar effects, such as two drugs that reduce blood
pressure. (Id.)
In light of the statistically-significant differential effects reported between the EPA
and control groups, a POSA would have attributed the reduction in Apo B to EPA. (Id. at
737:24-738:8.)

and

As explained above as to Defendants’ prima facie obviousness case, Mori found
that EPA did not raise LDL-C levels, and Kurabayashi suggested that EPA reduced Apo
B levels. (ECF No. 373 at 76-80, 246-47.) Further, while the Patent Office found that a
decrease in Apo B was an unexpected benefit constituting a valid secondary
consideration, the Patent Office’s examiner did not consider Kurabayashi. (Id. at 246-47.)
Where “the PTO did not have all material facts before it, its considered judgment may lose
significant force[.]” See i4i, 564 U.S. at 95. Thus, the Court finds that the unexpected
benefits secondary consideration does not weigh in favor of finding the Asserted Claims
nonobvious.


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