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It’s not a question of whether it is new evidence. The Q is whether this argument was ever presented to the trial court, and if not, the general rule is it cannot be raised for the first time on appeal. Why was it not presented to the trial court? That is what the CTA will ask. They have to come up with a good response.
Covington blew this one bad.
P. 14 of the Amarin brief concedes that the increase in LDL in the DHA arm of the Mori study was statistically significant, while the the increase in the EPA arm was not. This must have been the state of the evidence presented to the trial court.
It seems pretty clear to me that Amarin did not raise this argument of no statistically significant difference between the EPA and DHA arms of the Mori study to the court.
Not good news.
Having said that, the evidence showed that the increases in LDL in the two arms were not that different, 3.5% for EPA and 8% for DHA. So there is an issue imbedded in the case about whether this study showed by “clear and convincing” evidence that EPA would not increase LDL in the severe HGL patient population. The CTA judges will be focused on this because the trial judge relied so heavily on Mori.
Singer in my view is savvy enough to get the question of statistical significant difference into the Reply Brief so he can argue it to the court. I don’t have a feel for how well known is the principal of statistics relied on by Bhatt & co. The more well know, the easier it is to argue it should have been known to the trial judge, even though it was not argued to her directly. No matter what, they have to figure out a way to get this before the CTA, as it shows just how much the Mori study is of so little value on obviousness in this case.
That’s an argument a doctor would make who does not know the law.
Maybe, need to double check
Almost seems from reading the trial submissions that Amarin’s trial counsel thought so little of Mori that they did not attack it on the statistical basis Bhatt et al. have raised.
Amarin’s Proposed finding #506 argues that the increase found by Mori in LDL from pure EPA was only 3.5%, not statistically significant. There’s not a direct argument that the differences between the EPA and DHA arms in that study were not statistically significant (this is the argument from the Bhatt piece), but to me this seems close enough to open the door. But still not sure why this was not raised in the primary appeal brief.
B
I do not see any challenge to the statistical validity of the Mori conclusion in the post trial brief. Checking the proposed findings next, but not likely there if not in the brief.
The basic problem is the rule that you can’t bring up on appeal for the first time an argument that was not raised before the trial court.
B
The good news is that the generics will have to rely heavily on Mori in their brief, so this will open this up for argument by Amarin in reply, provided there is someplace in the trial record where the statistical issue with the Mori study was raised at trial.
Trial counsel must have raised the statistical issue at trial, no? I’m going to go back and check the post -trial briefs.
This analysis is hugely encouraging . But the skeptic in me asks two questions:
1. Why was this not pointed out at trial by Amarin, and if it was, in what document or testimony?
2. Why was this not raised in Amarin’s primary brief, where I did not see it. If it is there, can someone please give me the page.
Bouf
This is the primary Q that Amarin’s appellate counsel must pose to the CTA: if no one had previously studied the impact of using pure EPA in ester form to treat severe HTG (500+), and it was known in relevant medical/academic space that patients in this population were susceptible to spikes in LDL from all known treatments for severe HTG, why would a POSA expect that pure EPA would be able to reduce TG without pushing up LDL?
You have to be a bit more thoughtful as to what is the fact in Q. Sky is blue sometimes, sky is red other times, and other colors at other times like all the shades of grey, many very beautiful where I live. The key facts at issue in the generics trial were what did the prior art teach to a POSA.
ZMAN—the lawyers do not make the final decision where to file a case, the client does. Lawyers give advice and make recommendations, clients make the final decision. Kennedy must have supported the Nevada venue, so he bears a lot of responsibility for the final decision.
In any event, shareholders could not sue derivatively for the company unless the company had a good claim and refused to sue. The recommendation to sue in NV was not malpractice unless you use the same hindsight bias Judge Du used in her decision. See how easy it is to make that slip?
ZIP—yes the problem with some judges that suffer from what I call black robe disease is that they allow themselves to accept legally specious arguments in order to favor the party that is aligned with their own personal biases.
It’s unfortunate it happens but this case is a poster child for the phenomenon.
ILT—there is an edge to the Du decision, such as the repeated citation to Toth’s testimony for her findings, etc. It is not uncommon for a Trial judge (or a jury) to react badly to one side or the other on a personal level, with this form of personal bias ending up reflected in the decision. Judges are human beings and don’t always keep their personal biases away from their decisions, despite the promise of impartiality. I would not be surprised if she got turned off by arrogance from the Covington people. The good news is that appeals courts exist to be a check on bad decisions infected by this kind of defect.
I have personally handled two appeals to a state Supreme Court in the last 5 years where the trial judge reacted badly to our client and hammered them both in decisions that could not stand up to scrutiny. Both were reversed. So this gives us some reason to expect that the CTA judges here will pick up on the subtle bias reflected in the decision and not be shy to reverse if they conclude Du was not acting impartially.
JL—why is the market not factoring in EU? If it is a gimme it should be reflected in the share price. What is the bogey?
Bouf
Everyone hates lawyers until they need a good one.
Clearly erroneous means there is not enough evidence tending to establish a fact that a reasonable fact finder could conclude it is true. So in an intersection car crash case, if all the witnesses say the light was red, but the court finds the light was green, the finding is clearly erroneous. However, if there are some witnesses who say the light was red, and some say the light was green, and the finder of fact (judge or jury) decides the witnesses saying green are more credible and believable, a finding that the light was green is not clearly erroneous, even if the appellate judges think the other set of witnesses are more believable. It is the sole province of the trier of fact to weigh conflicting evidence and choose which competing version of facts is true.
Sorry, I have to defer to others on the valuation Q.
The court’s findings on obviousness are based on a foundation of various subsidiary facts she found to be true, such as what the various elements of prior art would teach a POSA. Here, the foundation had to be much stronger than usual because it was the burden of the generics to show obviousness by clear and convincing proof. The foundation has to be taken apart and knocked down piece by piece until there is not enough left that a reasonable trier of fact could say the remaining evidence shows obviousness to a clear and convincing standard.
So as you read the generics brief, think about this question: why is the evidence they will cite to support the trial courts findings on obviousness not sufficient, when measured against the clearly erroneous standard.
No worries. Trying to avoid the confirmation bias our brains are trained to follow, and which the board tends to encourage.
The standard of review for factual issues is clearly erroneous, meaning that there is no evidence that a reasonable finder of fact could say supports the finding. So here, the CTA will have to conclude there is nothing in the evidence that supports the courts findings as to the teaching from the prior art, and what a POSA would find obvious.
I want to see the other sides brief first. But I will say that the standard of review in any appeal favors the winning party at trial because of the deference the appeals court must give the trial court on truly factual questions. But we have some solid arguments.
Whatever it is , it is her decision and it will be given deference unless it is a pure legal ruling.
Appeals courts do not make decisions on what the facts are, they only decide if there is enough evidence in the record to support a finding by a trial judge.
A judge that is happy with this result will fall back on the rule that the trier of fact gets to decide which expert to believe. I’m pointing out that this is a very real risk in the appeal. Singer & Co have done a good job of attacking the scientific logic behind the decision, but they are stuck with Toth’s testimony, which the trial judge very cleverly cited as the basis for her findings.
TT—I get it. What I am saying is that the generics will rely heavily on the first rule of appellate law that it is up to the trier of fact to decide which witness to believe. AMRN will be left to argue in reply that neither expert, nor the evidence, supports the findings or conclusions made.
Suggest you read the decision and the AMRN brief again carefully
They can always try but all appeals to SCOTUS are discretionary and they only take something like 1 % of cases that apply for review
TT—I’m telling you what to expect from the generics brief. Their main point will be that it was up to the trial judge to decide which expert was more credible, because the trial judge heard the testimony. Appellate courts are not in the business of deciding based on a paper transcript which expert is more credible. That said, factual findings have to support a legal conclusion, and that is where AMRN has room to run here.
Right, the facts as found by the trial court can only be disregarded if the finding is clearly erroneous, meaning no reasonable person could find the fact to be true based on the evidence.
One problem in the appeal is that the trial judge was able to cite testimony of Amarin’s expert Dr. Toth, for several of the findings on which the obviousness ruling was based. She relied on his testimony for a reason. I did not see any clear explanation in the AMRN brief why this testimony did not support her findings.
TT—no it is not de novo review on fact questions, such as which expert the trier of fact chooses to believe.
De novo review is only for legal conclusions.
B
TT—It will be that the judge heard the testimony of the experts and found the defendants’ experts more credible. Trial judges can’t be overruled on this basis. It is up to them alone (or a jury when one is in place) to decide which part of conflicting evidence to accept or reject. This is not a retrial.
B
JL—agree with all your points, but the appeals court is stuck with H-W as is. What AMRN has going for it is a high standard of proof that the CTA could just say was not met by the generics, given the conflicting evidence on what the prior art showed about trig reduction from using pure EPA w/o raising LDL in the severe 500+ cohort. To me some of the best evidence for AMRN is that no one else thought of this for a bunch of years after the prior art cited by Du, even though there was a clear unmet need. Let’s hope we get some appeals judges with some common sense and backbone.
Because they benefit by precedent favoring patent holders over generics.
Yes, they are an important part of the process, but they don’t make the decisions. The panel will conference the case after the argument and will make an initial vote. One of the judges in the majority will be assigned to write the majority opinion. A draft majority opinion will be circulated. The law clerks will have an important role in drafting and shaping the opinions, but their work will be directed at advancing the position of their boss on how the case should come out.
B
That is why courts of appeal exist
Yes it is a negotiation of sorts. It is majority rules. They will caucus after the argument and make preliminary votes on reverse or affirm. The majority will control who gets assigned to draft the opinion explaining the majority opinion. A draft will be circulated. It will be debated. Revisions made. Sometimes the outcome gets changed in this process, but not often. Process has to end and decision gets issued. Only if case raises major issues in dispute within the Circuit will it get reviewed en banc by the entire court. Not likely here In my view.
Bottom line is majority rules. Democracy in action!
The brief actually did a good job outlining the science behind the “logjam problem” with severe high triglycerides patients. The judges will do their own side reading on the science if they are not satisfied by the record, but I doubt it.
The what if’s are interesting to think about, but this will not be the case for crazy splits. It’s either obvious or it is not. A remand is possible after the court sets things straight on the required analytic framework, but more likely the appeals court will make the call here in my view.
RTC—Look, the other side has very good lawyers too, and they are smart enough to see the weaknesses in the trial court’s decision. So they must have expected a strong brief from the Fish/Singer team. They got one. So I don’t see this brief as upping the settlement ante much, as it was largely expected, maybe a bit.
Settlement is always better because it allows parties to control their own destiny and possibly do things in settlement the court cannot do. All the court can do is affirm or reverse the trial court, very narrow outcomes.
I feel settlement chances go down as time passes from here. They could very well be working parallel litigation and negotiation paths, as often happens. But they have had time to assess and talk settlement, and nothing yet, so that tells us a deal is uncertain at best.
But I feel very good about the appeal.
B