Replies to post #295355 on Amarin Corp Plc (AMRN)

[cmm3rd]

I revised the post to clarify a few things. Here is the revised version. Note, to fully understand this post, one would need to have read my post # 7232 on Investor Village AMRN mb. I don't recall whether I posted that analysis here.

A few thoughts about oral argument, Jefferies' consultant's opinions and next steps

The Jefferies report re its legal consultant's opinions has a number of good observations. A few with which I disagree/agree are briefly discussed.

Jefferies says that 33% of the active CAFC judges would be generally favorable to Amarin. As discussed in post 7232, I know of only 3, so I believe a larger majority (more than 2/3) would favor the generics on the main issue presented. This is relevant for reasons discussed below.

I disagree that all three assigned panel judges are not in the "generally favorable" bucket. Judge Reyna would have to be in the generally favorable bucket, given his being on record as supportive of the traditional Graham v. John Deere ("Graham") approach and disapproval of the "prima facie -- rebuttal" framework, all as discussed in post 7232. See also discussion of Reyna's dissent in Intercontinental Great Brands, criticising the "prima facie -- rebuttal" approach, here: https://www.dlapiper.com/en/us/insights/publications/2018/12/federal-circuit-judges-disagree/

I agree that Dyk and Hughes would be expected to be adverse to Amarin because of their past rulings favoring the prima facie -- rebuttal approach v. the Graham approach, with one possible qualification, discussed below.

I further disagree that "Judge Reyna didn't seem to think anything was wrong in the initial case." Before listening to the replay of the argument, I would have said such must be a baseless claim, as judges hardly ever say anything in oral argument that goes that far in revealing their views of a case. After listening to Judge Reyna's questions (and knowing his past stance on the relevant legal issue), I am confident in my disagreement. We don't know what he is thinking overall; but his question addressed directly Hikma's (apparent) argument that the district court had not used the procedural framework that Amarin claims was used (the traditional Graham approach and also the weighing (or balancing) of the secondary considerations factors amongst themselves) and was erroneous. Attorney Singer addressed that question (and the followup question) well, in my opinion.

It is quite common for judges to use questions to facilitate one side's addressing the other side's contention, and I infer that is what Judge Reyna was likely doing here. I thus draw no inference adverse to Amarin from Reyna's questions.

I would have to add, also, that when I read the judgment months ago when writing post 7232, I thought it fairly clear from the wording of the judgment that the trial court did use the prima facie -- rebuttal framework as Amarin claims and which Amarin claims to be error. So, it's a bit surprising to me that whether that framework had been used is an issue. It appeared evident to me then that Judge Du had used that framework; however, apparently there is sufficient ambiguity in the wording of the judgment that Hikma is claiming that the traditional Graham approach had been scrupulously followed, so clearly that issue is in the case. The more pertinent (but equally problematic) issue is whether the trial court's having used the prima facie - rebuttal framework, if it did so, was improper.

Judges Dyk and Hughes, as noted, are on record as accepting the prima facie -- rebuttal framework and not requiring the traditional Graham framework. So, on that narrow point, at least, I would expect them to favor Hikma.

While I have not done full research, I am aware of no case supporting the "balancing" test that Judge Du used (or that Amarin argues -- and I agree -- she used) regarding the secondary considerations. My quick review of Novo is that it, Novo, does not. http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/11-1223.Opinion.6-14-2013.1.PDF

Judge Dyk, by the way, was on the panel that decided Novo, and joined in the majority opinion. It is therefore no surprise that he pushed Singer on why Novo should not be distinguished and should control the outcome here.

I am not familiar with the entire record and thus can't evaluate the strength and weaknesses of the arguments re Mori prior art.

What follows should be read with this in mind. I am not predicting any particular result here.

Just based on what I do know, while anything is possible, I will be surprised if there is a 3-0 decision against Amarin. Yes, such is possible, but I would be surprised if all three judges agree (with Hikma) that the trial court used the Graham framework, and if at least Reyna decides Judge Du did use the prima facie -- rebuttal framework, I would be surprised if Reyna changes his previous stance regarding the impropriety of such. Of course, a 2-1 decision against Amarin would still be a loss, so why is this relevant?

It would be relevant here because of Jefferies' consultant's saying there is a 50% chance of a Rule 36 ruling (Affirmance without opinion), which, if it is used, would come in a matter of days. I will be surprised if that happens. I just don't believe the case is so clear as to meet the criteria for a Rule 36 judgment. See Fed. Cir. Rule 36, http://www.cafc.uscourts.gov/sites/default/files/rules-of-practice/FederalCircuitRulesofPractice-July2020.pdf

A 2-1 decision against Amarin would also be relevant because it would cast a different light on what comes after any such opinion, Amarin's petition for rehearing and for rehearing en banc. Given the stakes, I will be surprised if the losing party does not avail itself of this tool, even though the chances of overturning the panel opinion would be extremely low, statistically speaking.

Without going into all the many details, if Amarin loses (2-1 or 3-0), I expect they will file such a (combined) petition. See IOP ##12, 13 and 14. http://www.cafc.uscourts.gov/sites/default/files/rules-of-practice/IOPs/IOPsMaster2.pdf

The active judges on the CAFC would decide (by majority vote) whether to grant any petition for rehearing en banc, and thus for them to rehear the case. If they do rehear it, it would be decided by a majority.

Given my impression that a majority of CAFC judges favor the prima facie -- rebuttal approach and only a minority (including Newman, Reyna and O'Malley, that I know of) would require the traditional Graham framework, my guess would be that Amarin would be unlikely to succeed with the en banc court were it to have failed with the panel, at least on that issue.

There are two significant unknowns in my analysis. First, the weighing/balancing of the secondary considerations, if CAFC reads Judge Du's judgment to have incorporated such, is, I believe, new and not in keeping with the intent underlying the Graham case precedent (SCOTUS). Thus, even those CAFC judges who would give Judge Du a pass on her having used the prima facie -- rebuttal framework (such as Dyk and Hughes) might have misgivings about extending that departure to the point of incorporating a balancing of the secondary considerations. There just is no case law on it that I am aware of, and there is a good (imo) argument (that Amarin makes) that such results in burden shifting. Burden shifting is one of the criticisms made by the few who disapprove of the prima facie -- rebuttal approach, so I would think they might also disapprove of this balancing element. Again, however, this is a nuanced, deep-in-the-weeds argument that CAFC may find unpersuasive.

Second, as noted, I am not conversant with the Mori prior art evidence and issues. I have no idea what any of the judges might be thinking about that point of error.

My bottom line on the legal result is not quite as pessimistic as might be inferred from reading the Jefferies report (and it is not fully informed, either), but I do agree that Amarin is in a deep hole and still has an uphill climb trying to get the trial court's judgment reversed.

[Jasbg]

Louie@ You know more than how to feed your cats. Very impressive input - of which i understand about half - aimed at law people I understand :)

I would have liked to see you give Ammarin a bit higher odds in winning - but 'at least there is grounds for hope' as I read your summary.

Jasbg

[circuitcity]

Great post snd dd, like it.

[johnking29]

louieblouie - Question for you:
In the Novo case in the Closing Summary, it noted that had their been Evidence submitted that was intentionally altered (in effect - see the quote below) the case would qualify as a "but/for" case meaning it would open the door for a review of the BAD evidence in question if that evidence was used to sway the Trial Judges opinion.

That to me is exactly what Singer is doing... He is forcing the Judges hands to reconsider the evidence.

How will the Appeals Judges respond to evidence used that was altered and clearly incorrect that was a major piece used to decide the case?

I've been saying that the misuse of the SCs opened the door requiring the Judges to review the (bad) evidence - Singer is tying one to the other (bleed over I believe is the term he used.) It appears that they do have to comment on it at this point.

Do you agree?

Quote from Summary of Novo:

"Dr. Sturis was accused of failing to notify the PTO that the original test plan did not include his data calculations at 120 minutes. The Federal Circuit found it to be a nonmaterial omission because it did not qualify as “but-for” material. The Court explained that this was not a case in which adverse results were hidden in favor of more positive data, nor did the omission undermine the opinion stated in the declaration."