Yep, and Amarin's lawyers seemed to decisively put Mori in its place as set forth below:
15 Second, Defendants’ references say nothing about the expected effect of EPA on LDL-C
16 in patients with severe hypertriglyceridemia. While Defendants principally rely on Mori to assert
17 that there was a reasonable expectation of success, the POSA would have understood that Mori
18 addressed the mildly hypertriglyceridemic population (with only slightly elevated TGs), rather than
19 the severely hypertriglyceridemic population (with TGs > 500 mg/dL). PPF ¶ 683. Indeed, the
20 population studied in Mori was most like the mixed dyslipidemic population in the Tricor label—
21 which experienced a decrease in LDL-C. PPF ¶¶ 509–10, 550. That Defendants principally rely
22 on Mori, even though it studied the wrong population and touted the benefits of DHA rather than
23 EPA, is telling: as Dr. Heinecke admitted, “I don’t think there’s any evidence in the prior literature
24 about what the impact of EPA would be on LDL cholesterol in [the severely
25 hypertriglyceridemic].” PPF ¶ 508. Of course, plenty of literature and decades of experience does
26 bear on the question, but all of it taught that LDL-C would dramatically increase in severely
27 hypertriglyceridemic patients. Defendants ignore that consistent teaching and cite to inapposite
Case 2:16-cv-02525-MMD-NJK Document 379 Filed 02/28/20 Page 24 of 40
1 references—including not only Mori, but also Hayashi (mean of 300) and Kurabayashi (mean of
2 136)—which reported on administration of EPA in patients with TG levels far below 500. PPF
3 ¶¶ 549–82. These references have nothing to say about patients with severe hypertriglyceridemia,
4 and would not have provided the POSA with any reason to expect that EPA would avoid the large
5 LDL-C increases observed with all approved severe hypertriglyceridemia treatments. PPF ¶¶ 549– 6 82, 704–18, 837–49.
7 Third, even in patients with TGs below 500 mg/dL, the prior art taught that EPA raised
8 LDL-C. While Mori reported that the LDL-C increase with EPA was not statistically significant
9 in that small study (in the wrong population), it was but one of many articles studying the lipid
10 effects of omega-3-fatty acids. When that prior art is considered as a whole, it is clear that it did
11 not distinguish between DHA and EPA based on their effects on LDL-C. PPF ¶¶ 684–91. And
12 when a review article—by von Schacky—surveyed and synthesized that literature, it found that
13 both DHA and EPA raised LDL-C, and to a similar degree. PPF ¶¶ 688–691. Indeed, that the prior
14 art did not teach the benefits of EPA alone for severe hypertriglyceridemia is confirmed by real-
15 world evidence: more than a decade after purified EPA was available in Japan, GlaxoSmithKline
16 and Reliant developed the Lovaza mixture, not EPA, for treatment of severe hypertriglyceridemia
17 and, even then, no one suggested removing the DHA to achieve a better outcome. PPF ¶ 503.
18 Faced with this compelling evidence, Defendants rely on a mischaracterization of the law
19 of obviousness—contending that they are not required to show a reasonable expectation of success
20 because the Asserted Patents do not themselves present clinical data showing that LDL-C did not
21 substantially rise when the claimed method is practiced. DPF ¶¶ 727–39. But the cases they rely
22 upon—Merck & Co. v. Teva Pharmaceuticals USA, 395 F.3d 1364 (Fed. Cir. 2005), Alcon
23 Research, Ltd. v. Apotex Inc., 687 F.3d 1362 (Fed. Cir. 2012), Hoffmann-La Roche Inc. v. Apotex
24 Inc., 748 F.3d 1326 (Fed. Cir. 2014), and In re Copaxone Consolidated Cases, No. CV 14-1171-
25 GMS, 2017 WL 401943 (D. Del. Jan. 30, 2017)—do not purport to overrule the long-standing
26 requirement that obviousness may be found only where a reasonable expectation of success has
27 been shown (PPF ¶¶ 512, 756) and are inapposite for other reasons as well. See generally PPF
Case 2:16-cv-02525-MMD-NJK Document 379 Filed 02/28/20 Page 25 of 40
1 ¶¶ 755–61.
2 In these cases, the patent holder attempted to denigrate prior art suggesting the claimed
3 invention by pointing to a lack of proof also absent from the patent itself. Here, by contrast, nothing
4 in the prior art suggested using purified EPA to treat severe hypertriglyceridemia—only the patents
5 teach the clinical benefits of doing so. PPF ¶¶ 508, 758–59. Thus, in this case, unlike those relied
6 upon by Defendants, the patents dramatically add to what was disclosed in the prior art—
7 specifically teaching a new way of treating severe hypertriglyceridemia and describing its clinical
8 benefits, and then confirming those benefits during the prosecution by submission of the MARINE
9 results. PPF ¶¶ 759–60. None of Defendants’ cases suggest that because the MARINE results were
10 submitted to the Patent Office during prosecution rather than as part of the patent specifications,
11 the Court should dispense with the mandated reasonable expectation of success inquiry. PPF ¶¶
12 756–61. To the contrary, the Patent Office has instructed, and the Federal Circuit has confirmed,
13 that clinical study results need not be included in a patent application, and can properly be
14 submitted during prosecution. Amarin Reply in Support of Motion for Partial SJ at 2–3, ECF No.
15 264. And the Federal Circuit has repeatedly made clear that an obviousness challenge must
16 overcome all unexpected benefits of the invention, regardless of when they become known. See,
17 e.g., Sanofi–Aventis Deutschland GmbH v. Glenmark Pharm. Inc., U.S.A., 748 F.3d 1354, 1360
18 (Fed. Cir. 2014) (“Glenmark also argues that later-discovered benefits cannot be considered in an
19 obviousness analysis, here referring to the improved kidney and blood vessel function that were
20 observed after the patent application was filed. That is incorrect; patentability may consider all of
21 the characteristics possessed by the claimed invention, whenever those characteristics become
22 manifest.”). Thus, while it is unsurprising that Defendants seek to avoid having to prove that the
23 POSA would somehow have expected EPA to defy the outcome seen in every prior-art TG-
24 lowering product approved for severe hypertriglyceridemia by avoiding LDL-C increases, the law
25 does not allow the invalidation of an issued patent so readily.
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