Praise Plaintiffs also argue that praise for Vascepa weighs in favor of finding the Asserted Claims nonobvious. (ECF No. 377 at 269-271.) However, the Court finds that the evidence Plaintiffs proffer to show praise is more qualified and equivocal than Plaintiffs represent in their briefing.Thus, the Court finds Plaintiffs’ proffered evidence of praise does not weigh in favor of finding the Asserted Claims nonobvious. Plaintiffs’ expert Dr. Toth cited several articles as purported evidence of such praise at Trial, but none of them support his opinion. (ECF Nos. 370 at 1722:15-5, 371 at 1848:11-20.) First, Dr. Toth cited the O’Riordan article, which quoted several doctors on the results of MARINE. (Ex. 1581.) Specifically, Dr. Toth cited a statement by Dr. McGuire that “if you can have favorable cardiovascular effects without raising LDL cholesterol, that’s going to be an advantage,” and a statement by Dr. Nissen that this “gives you all the benefit without the downside.” (Id. at 1-2; see also ECF No. 370 at 1606:24-1612:24.) But as the article reveals, neither doctor gave unmitigated praise; both expressed caveats about those statements. Dr. McGuire “was cautious in interpreting the results” of MARINE, “insert[ed] a dose of caution,” and made clear that his focus was on “cardiovascular effects,” not just triglyceride reduction. (Ex. 1581 at 1.) If anything, Dr. McGuire saved his praise for “trials such as Japan EPA Lipid Intervention Study ([“]JELIS[”]),” which actually “showed a favorable signal of reduced cardiovascular events.” (Id.) Similarly, Dr. Nissen “expressed the same caveats” about MARINE, and noted that he “would like to eventually see a head-to-head comparison between Lovaza” and Vascepa, which to date has never been done. (Id. at 2.) Even apart from these caveats, Dr. Toth ignored the statement by Dr. Blumenthal, which O’Riordan also reported. As discussed above, Dr. Blumenthal did not praise Vascepa or MARINE, but instead dismissed MARINE’s significance because typical increases in LDL-C with Lovaza were “‘modest’ and ‘not that big an issue,’” especially since Lovaza “works well with statins.” (Id. at 2.) Given these conflicting statements, O’Riordan as a whole does not suggest that Vascepa’s ability to avoid increases in LDL-C has been praised by the industry. Second, Dr. Toth relied on articles by Fialkow (Ex. 852) and Castaldo (Ex. 866). (ECF No. 370 at 1612:25-1615:13.) But those articles merely state the fact that Vascepa does not increase LDL-C—they do not praise Vascepa for that reason (or indeed, for any reason). The statement that Dr. Toth quoted from Fialkow states that “treatment with the EPA-only product, icosapent ethyl [i.e., Vascepa] has no LDL-C monitoring requirement.” (Ex. 852 at 5.) Similarly, the statement that Dr. Toth quoted from Castaldo states that Vascepa “does not increase LDL-C levels, as supported by clinical studies and the icosapent ethyl product label.” (Ex. 866 at 6.) These matter-of-fact observations, which merely repeat information from the Vascepa product label and the MARINE trial, do not praise Vascepa or the claimed invention. As the Federal Circuit has made clear, such “journal citations that reference the findings stated in [the patentee’s] published efficacy studies . . . fall well short of demonstrating true industry praise.” Bayer Healthcare Pharm., Inc. v. Watson Pharm., Inc., 713 F.3d 1369, 1377 (Fed. Cir. 2013). Third, Dr. Toth relied on an Amarin-sponsored article in which Dr. Bays said that MARINE’s results were “surprising.” (ECF No. 371 at 1848:11-20 (referring to Ex. 833 at 6).) The Federal Circuit has made clear, however, that such “self-referential commendation [also] fall[s] well short of demonstrating true industry praise.” Bayer, 713 F.3d at 1377; see also In re Cree, Inc., 818 F.3d 694, 702 (Fed. Cir. 2016) (rejecting patentee’s reliance on “self-serving statements from researchers about their own work” as alleged evidence of praise). In sum, Plaintiffs have not produced evidence that the industry “praised” the claimed invention for avoiding an increase in LDL-C. Thus, the Court finds as a factual matter that Plaintiffs’ proffered evidence of praise does not support its nonobviousness arguments discussed in more detail in the Court’s conclusions of law below.
Here is a set of POSA's unconnected with Bays or Amarin full of praise for the benefits of Icosapent Ethyl and the LDL effects shown while potently lowering severely elevated TG's in the MARINE trial:
Conclusion Icosapent ethyl is emerging as a promising alternative to the many available TG-lowering agents such as niacins, fibrates, and other omega-3 agents containing both EPA and DHA. Overall, icosapent ethyl is a high-purity form of EPA that reduces TG levels in patients with HTG who possess TG levels $500 mg/dL, as well as an adjunct therapy in patients with residual TG elevations after statin treatment. A remarkable feature of this TG-lowering effect is that it does not come at the expense of increasing LDL-C significantly. Both the MARINE28 and ANCHOR7 trials support the efficacy of EPA in lowering TG levels, and they also illustrate that EPA does not increase LDL-C as much as the EPA and DHA combinations or placebo. Ongoing studies will need to determine whether TG lowering with omega-3 confers additional CVD benefit beyond that attained via LDL-C reduction, as well as the relative clinical impact of the lipid differences between the EPA/DHA combination and EPA alone.
Ther Clin Risk Manag. 2014; 10: 485–492. Published online 2014 Jun 24. doi: 10.2147/TCRM.S36983 PMCID: PMC4077874 PMID: 25028554 Icosapent ethyl for the treatment of severe hypertriglyceridemia Hassan Fares,1 Carl J Lavie,2,3 James J DiNicolantonio,4 James H O’Keefe,5 and Richard V Milani2
