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RAF—if it was just a pure math mistake RE: Mori, rather than a point of statistical interpretation, it would be in the principal brief, one would think. Interpretation of the results of a scientific lipid study is not within the ken of the general public. Hence it would ordinarily be presented by an expert in the discipline.
That is where I am getting hung up. Any insight on this appreciated.
B
HD—what day was this testimony and who is the witness?
Is your point that this testimony was not presented vis a vis Mori?
Best
B
HK—
As to your point #1, the problem we have is that AMRN did not present an expert who testified as to the proper statistical interpretation of the Mori and Kur studies. I believe this would be treated as a matter of interpretation based on recognized principles of statistical science. That was a HUGE mistake. That is why AMRN could not and did not make arguments on the key statistical interpretation point that has been made on this board in the lead appeal brief. It is simply not in the appeal record. So we have to rely on the appellate wizardry of Singer & Co to get this argument into the minds of the panel, but it will have to be done indirectly and subtly. Not impossible, but also hard to accomplish, like boxing with one arm. I am eagerly anticipating the Reply brief to see how they approach it. We may also have to wait until the oral argument.
HK, amazing work. This just makes me more angry that Amarin and it’s trial team did not have a good expert lined up to present the limitations of what teaching could be validly be drawn from the studies relied on by generics. My greatest fear is that the CTA will accept the notion that this should be viewed as a battle of the experts that AMRN lost.
But this may help Singer in the effort to show that the trial court’s conclusions about obviousness are not supported by the evidence. I think this is the best shot at reversal: showing weaknesses and flaws in the interpretation of prior art so that the CTA can conclude that the generics did not show by clear and convincing evidence that the invention is obvious.
B
Anything is possible in this world, and there is no way to rule out the unexpected turns that only the universe can drive, but realistically this board is not going to make the difference in whether this appeal is won or lost. That is not to say I do not appreciate the effort by all.
B
This is praiseworthy activity but realistically I hope you understand none of this will impact the appeal outcome. The CTA will decide the case based on the appeal record and the law, period. That is the way it works, whether you think it is fair or not. What could make a difference is the oral argument, but most cases turn on the strength or weaknesses of the briefs. As Justice Ginsburg once said, you can’t win an appeal based on oral argument, but you can lose one.
I am staying long through the appeal ( I have been long for almost 10 years) but it is fantasy land to think that this board is going to impact the appeal outcome, despite all your best efforts. Sorry to be Debbie downer, but that is the way it is folks.
B
MAR—
In my view you are getting way ahead of yourself in suggesting malpractice and the idea of disclosure of pre-trial settlement negotiations to get at these legal malpractice questions. This thing is still being litigated and there are likely some level of ongoing negotiations. Let’s keep our eye on the ball people!!! Winning on appeal or settling on acceptable terms is the goal. You might get a few mil out of a legal malpractice case against Covington, but that is a very long and tough fight for sure. The prospects there are tiny in comparison the what a good resolution of the ANDA litigation can bring.
B
K—yeah but with this snake bitten stock one has to ask what is lying in the weeds? Again, is EU approval for RI type indication a lock , or not? Appreciate any responses from similarly situated folk.
B
So is the consensus that there is zero risk with regard to EU approval for a R-I like indication?
If so, why is that not reflected in the stock price?
B
Thanks, but I’m hoping to get some deeper insight on timing and risks on approval.
B
EUROPE?
Who has the scoop on likely timing of approval and the risks that exist for same. Seems like most of the commentary assumes EU approval, but it cannot be risk free?
B
Time to move on
We have all (including me) done way too much Monday morning quarterbacking about the trial, time to move on.
B
Enough woulda coulda shoulda already!!! What matters now is what can be done in the appeal or in the marketplace. Time to move on all....
B
None
You clearly have had no experience in appeals court decision making. Every court is different, and the judges will always say they make all the decisions, and the clerks will agree, but the reality is that the clerks have an influence, and if they understand this decision is based on a poor understanding of the science, that can only help. Again, AMRN has to attack from all angles now, and I’m glad to see they are.
TTE—It’s more than that. The law clerks at this court are top notch people and they read, despite the technical rule that the appeal record is all that matters. As Pink Floyd would say, another brick in the wall.
B
This article is all about creating public controversy about the decision, outside the formal appeal process. Nice move by AMRN. Don’t expect it to be a direct influence on the appeal, but we all know that life happens on more than direct vectors.
B
In hindsight very hard to understand why this was not done, but we are on the outside and can only see a limited part of the iceberg.
Woulda coulda shoulda is not going to help us now
RAF—my best guess for what it’s worth is the the Covington people felt Mori was not enough of a problem to justify the level of scrutiny it has now received. I cannot think of any other reason they would not have hired the best statisticians on the planet to take it apart piece by piece. Can you?
B
Yes, what is still unclear is why AMRN did not raise this argument at trial in the face of heavy reliance by the opposition on Mori.
Any thoughts on why would be useful. To me, I do not understand this decision, but I also know that there are many tactical decisions made in a trial based on how the evidence comes in and how the arguments unfold. Very hard to understand in hindsight even if one were to read all the transcripts.
Good news is that everybody reads in the online world, even CTA judges and (more importantly) their law clerks, some of the most talented law grads in the country. They will read up on Vascepa and it’s history for sure. This new statistical analysis will not go unnoticed, even if it is not technically part of the appeal record.
B
B
One—yes that is one of the grounds for appeal. I personally care more about winning the appeal than any sanctions. Let’s keep our eye on the ball here.
B
Meow—you can hope because you have money in this stock that the rules will not apply here as usual because it does not seem right to you. But I can guarantee you the rules will not change because you hope they will. Your opinions will not alter the rules either.
B
Yes I agree. But this is not the ball game or a knock out, at best it is a helpful part of a broader case that needs to be made why Mori is at best weak evidence to support obviousness, far short of clear and convincing.
RAF—
An appeal is NOT a RE-trial. It is a review of the decision made by the trial court (in a bench trial case) based strictly on the record before the trial court. This may seem unfair, but there are very good reasons related to the functioning of the court system for these rules. The CTA in this case is going to follow these rules. Period.
Would you hire a lawyer to handle your cancer treatment or a doctor to handle your divorce?
RAF—they did a very nice job with the piece from a scientific perspective as docs, but they are obviously not qualified to say how their work might fit into this litigation, given that their analyses was not presented to the trial court. Would you let a lawyer handle the scalpel in you cancer surgery?
B
Markman is right on the procedural obstacles to getting the new paper formally before the court. These rules are strict. Otherwise appeals would be a s.... show. That said, Singer will find some way to add this into the mix of reasons why the trial court’s heavy reliance on Mori to find obviousness is flawed.
Yes yes and yes
If it had been pointed out at trial, the judge would have had to deal with it and could not just disregard it. This could have been brought out as point # 1 in the trial brief, instead of in a post trial science paper. Would be a much stronger position on appeal.
Because if the government wanted to own the market for the product, it would tell the court what to do.
ILT—broadcasts more of a failure by AMRN’s trial counsel than the courts generally. Trial courts do not decide what evidence gets presented, lawyers and their clients do. They also have to decide cases based on the evidence presented and the law as it exists, not how others think it should be. It’s not a perfect system, hence we have appeals courts to fix the errors that do occur. Not defending this judge in particular, but you have to appreciate how the system works before you can indict it.
It’s the best court system in the world. Talk to your congressman if you think the courts are not up to the task of weeding out bad patents. Good thing AMRN is not trying to protect these patents in the Chinese courts.
B
RAF—
Plus there must have been some signals along the way that the judge was buying into Mori as important prior art, giving AMRN plenty of reason to tear it to shreds at every opportunity. I too am baffled they did not have an expert shred the damn thing based on its now clear flaws.
Very bad lawyering at a minimum.
B
ILT—
Agreed. All we need is for the CTA (2 of 3) to be persuaded that Mori is not definitive enough on the ability of EPA to reduce TG without raising DHA that it would be obvious to try pure EPA to do this job. We do not care how they get there, although it’s fun to think about it.
B
ILT—
I like the point, but I think it is slightly off. This is not just a math issue like a calculation based on a common formula or equation. At issue is a statistically based interpretation of the meaning of a scientific study. The generics offered their interpretation at trial, and the trial judge bought it. Amarin did not offer the counter interpretation that has now been published, and one has to wonder why if it was such a basic statistical point bearing on the meaning of the Mori study.
The argument being made now is that the district court accepted a statistically flawed interpretation of Mori. Amarin has to show it was clear error for the court to adopt its interpretation. The interpretation of Mori in the new paper will get before the CTA somehow, even though it will take some good lawyering. It will become one of several building blocks supporting the conclusion that the Mori study, by itself or combined with the Lovaza patent, does not show obviousness by clear and convincing evidence. This is a matter of undercutting the district court’s reliance on Mori in as many ways as possible. This paper gives Amarin a strong new reason to ask the CTA to reject the DCT’s conclusion on obviousness, but it is not definitive in and of itself, particularly given AMRN’s failure to raise it at trial.
B
It may be more of a question whether the new information from the JAMAICA article is an opinion or new scientific fact. If the former it will be much harder to get the CTA to accept a new opinion as to the limits of the Mori analysis, but if the latter, the CTA will be more open to receiving new scientific facts that were not known at the time of trial.
I don’t know enough about statistics to tell the difference here, but would love to hear other thoughts as I study up.
All this drama just gets in the way of clear headed thinking about this.
Inconceivable AMRN would not point this out at trial.
If they can’t come up with something better, that’s the other option.
Still, the CTA will be bothered about why this was not pointed out to the trial court. They do not like deciding cases based on something the parties did not raise themselves at trial.
This could be a reason for a remand.