Positive Refresher: HAMOA Post (Read in Full)...
The reply brief from the generics was as expected. They went to great lengths to promote a narrative that relies on the impression that Amarin's case is weak on multiple points. However, for the generics there is no getting around the fact that central to the district court's finding of obviousness is a major procedural error that the appeals court will have no choice but to address. Setting aside the reply brief for a moment, it's illuminating to revisit the actual language of Judge Du's opinion as it relates to the law.
Here it is, in all its glory:
vii. Weighing These Secondary Considerations
The Court thus finds that the satisfaction of long-felt need and commercial success secondary considerations weigh in Plaintiffs’ favor, and the remaining secondary considerations weigh in Defendants’ favor. More specifically, the Court finds that Vascepa is a commercial success even though it has not yet turned a profit, and that there was long felt need for a single pill that reduced TG levels without increasing LDL-C levels. However, these secondary considerations are outweighed by the fact that the Court found Plaintiffs’ other proffered secondary considerations favor Defendants. Thus, at best, Plaintiffs have presented weak evidence of the existence of secondary considerations, which do not overcome the Court’s finding that all Asserted Claims are prima facie obvious. See, e.g., ZUP, 896 F.3d at 1373 (holding that “a strong showing of obviousness may stand even in the face of considerable evidence of secondary considerations”).
For the reasons discussed above, in view of all four Graham factors (including alleged secondary considerations), Defendants have proven by clear and convincing evidence that all Asserted Claims are invalid as obvious under 35 U.S.C. § 103.
The generics can say what they will, but the appellate panel will look long and hard at the above conclusory paragraph from the decision, as it represents not just major judicial error (as there is no basis in law for the "weighing" methodology), but error that very likely yielded a different finding (obviousness) than would have been reached had the error not been committed. The district court, notwithstanding the generic's desperate attempt to deny as much, clearly and erroneously assigned negative values to the "unproven" objective indicia in its calculation that yielded a finding of "weak evidence of the existence of secondary considerations". In effect, the evidence of secondary considerations was only rendered weak by the courts erroneous discounting of their value based on the flawed "weighing" methodology. If the erroneous "weighing" made them weak, what were they before? When the district court writes, ". . . these secondary considerations are outweighed by the fact that the Court found Plaintiff's other proffered secondary considerations favor Defendants. Thus, at best, Plaintiffs have presented weak evidence of the existence of secondary considerations, which do not overcome the Court’s finding that all Asserted Claims are prima facie obvious", the court is explaining exactly, in no uncertain terms, how it got to its obviousness conclusion, and that explanation provides the appeals court with a blueprint for the district court's error. This is not the inconsequential error that the generic's are attempting to pass it off as. It's a monumental error that was at the heart of the district court's obviousness finding.
Another interesting point from the district court's decision, related to Mori:
In the district court's language below, you can see that the finding of prima facie obviousness was based largely on the court's dismissal of Dr. Toth's testimony in support of non-obviousness. The court based that dismissal on three grounds that , we now know, can all be pretty easily refuted. First, the court claims that, based on Mori, Toth was wrong when he stated about the prior art that "all these treatments increased LDL-C in patients with very high triglycerides". Mori, as we now know per Bhatt's recent paper, showed exactly what Toth stated, that there was no statistically significant differential effect on LDL between the DHA and EPA groups. And the court's second dismissal of Toth's testimony, related to Von Schacky's interpretation of Mori, was also factually incorrect, as it turns out that Von Schacky was right in concluding that Mori showed no difference in LDL-C effects between EPA and DHA. And the third dismissal of Toth testimony is based on the very weak argument that anything from 1977 would, by definition, not be considered relevant to a POSA in 2008. Now, the issue of admissibility of the new Mori information to the appeals case takes on even more significance, as the statistically correct interpretation of Mori largely undercuts the district court's critical finding of prima facie obviousness. Add to that the fact that the district court, had it followed proper procedure for applying the four Graham factors, would likely have not reached a conclusion of prima facie obviousness, even given the dismissal of Toth's testimony, and you have the makings of a real dismantling of the district court's decision. But obviously, the big question here is if/how the correct Mori analysis gets into the appeal.
The Court therefore finds that Defendants established by clear and convincing evidence at Trial that all Asserted Claims are prima facie obvious. Plaintiffs arguments to the contrary are unavailing. Many of Plaintiffs’ arguments depend on the premise that POSAs as of March 2008 would not have expected that using a composition of purified EPA would not increase LCL-C levels. (ECF No. 379 at 22-23.) 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.” (ECF No. 370 at 1574:1-1575:1.) But that cannot be correct, because Mori taught that EPA did not increase LDL-C levels like DHA did. (Ex. 1538 at 3.) Second, Dr. Toth testified that von Schacky contributed to his view that all TG-lowering therapies increase LDL-C levels. (ECF No. 370 at 1697:9-1703:7.) But as Defendants point out (ECF No. 378 at 26), von Schacky did not correctly summarize Mori. Specifically, von Schacky, citing Mori, wrote, “In more recent comparative studies, no effects of either EPA or DHA were seen on total cholesterol, HDL, or LDL levels.” (Ex. 1605 at 5.) But even Dr. Toth agreed on cross- examination that is not what Mori said. (ECF No. 371 at 1847:8-17.) Mori actually found that LDL-C increased with DHA, but not EPA. (Ex. 1538 at 3.) Third, part of Dr. Toth’s opinion, and Plaintiffs’ argument, is based on the Carlson reference from 1977. (ECF No. 377 at 43-44 (citing ECF No. 370 at 1577:22-25 and Ex. 1026.).) The Court is unpersuaded that an article from 1977 reflects the knowledge of a POSA in 2008. Thus, Plaintiffs’ argument, in part based on Dr. Toth’s testimony—that a POSA would have thought that both DHA and EPA would cause an increase in LDL-C in March 2008—lacks evidentiary support. The Court accordingly rejects this argument.
Lastly, as others have noted, the attempt by generics to claim that the district court, in its decision, was not stating that the court believed that the PTO was unaware of Kurabayashi when issuing the patents in suit, is ridiculous in light of the actual language below from the decision:
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.
So it's possible "unexpected benefit" could make its way into the appeals court's consideration of the district court's obviousness finding.
As for the issues of prima facie/rebuttal methodology and the related burden shifting, it will be interesting to see how Singer takes on the Novo v. Cyclobenzaprine citation showdown. The generics obviously are leaning heavily on convincing the court to look at this case through a Novo lens, and Amarin is banking on a Cyclobenzaprine perspective. I think it's fair to say that the generics mischaracterized Cyclobenzaprine in several key ways in their brief in order to encourage a Novo view, so I think Singer, who was winning counsel on Cyclobenzaprine, and who obviously knows this stuff better than anyone in the world, will have a strong response.
