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I believe it was discussed here a few days ago---and isn't it correct that the content of the July 1 report reflected only the 9 month interim results and nothing new since then?
I wish there were more current EVAPORATE information, but hoping that is on the way for August sometime. Or did I read recently that it would be December when Evaporate 18 month results are released?
This is old news.
But what about the U.S> Supreme Court case in Bancorp. Mtg in 1994? Is there a way to distinguish Bancorp?
U.S. Bancorp Mortg. Co. v. Bonner Mall Partnership, 513 U.S. 18 (1994) Rule:
Vacatur will not be ordered where the appellant is responsible for causing mootness. U.S. Bancorp Mortgage Corp. v. Bonner Mall Partnership, 513 U.S. at 24-25 (the principal equitable factor to which the Court has looked is whether the party seeking vacatur caused the mootness by voluntary action. Where mootness results from settlement or other strategic decision of the appealing party, the losing party has voluntarily forfeited his legal remedy by the ordinary processes of appeal or certiorari, thereby surrendering his claim to the extraordinary equitable remedy of vacatur).)
Bancorp emphasizes the need for consideration of equity and the public interest for vacatur determination
“Equitable principles have always been implicit in this Court's exercise of the vacatur power…” U.S. Bancorp Mortg. Co. v. Bonner Mall Partnership, 513 U.S. 18 (1994) “[I]t is the losing party who has the burden of demonstrating equitable entitlement to vacatur.” (Id.)
“ As always when federal courts contemplate equitable relief, our holding must also take account of the public interest. “Judicial precedents are presumptively correct and valuable to the legal community as a whole. They are not merely the property of private litigants and should stand unless a court concludes that the public interest would be served by a vacatur.” Izumi Seimitsu Kogyo Kabushiki Kaisha v. U.S. Philips Corp., 510 U.S. 27, 40, 114 S.Ct. 425, 428, 126 L.Ed.2d 396 (1993) (STEVENS, J., dissenting).
Congress has prescribed a primary route, by appeal as of right and certiorari, through which parties may seek relief from the legal consequences of judicial judgments. To allow a party who steps off the statutory path to employ the secondary remedy of vacatur as a refined form of collateral attack on the judgment would—quite apart from any considerations of fairness to the parties—disturb the orderly operation of the federal judicial system. Munsingwear establishes that the public interest is best served by granting relief when the demands of “orderly procedure,” 340 U.S. at 41, cannot be honored; we think conversely that the public interest requires those demands to be honored when they can.” U.S. Bancorp Mortg. Co. v. Bonner Mall Partnership, 513 U.S. at 26.
May God bless you for all of your efforts HinduKush.
Watch for Dr. Bhatt's late-breaking presentation tomorrow in the ADA virtual symposium.
https://www.adameetingnews.org/live-updates/session-coverage/expert-panel-to-provide-update-on-lipid-lowering-drugs/
I'm looking forward to Dr. Bhatt's presentations this weekend at the virtual ADA symposium, including his "late-breaking" presentation on Saturday the 13th.
Truly excellent conclusion BB.
Dr. Bhatt delivering a "late-breaking"presentation
on Saturday the 13th at 10 a.m. The symposium at which he'll speak will begin on Sunday.
https://www.adameetingnews.org/live-updates/session-coverage/expert-panel-to-provide-update-on-lipid-lowering-drugs/
Request for Judicial Notice filed with an Amicus Brief (and the Reply Brief) is it can be characterized as an unassailable/definite/noncontroversial scientific fact/doctrine/concept
Singer's Reply Brief will set forth all of the great arguments in a completely concise fashion (as well as refute the dog-shit arguments expected from the generics). It likely will be a shorter brief (hopefully) and bullet-point the strongest reasons why Du's decision cannot stand.
If done correctly, as I expect it will be, it will make it perfectly clear that the decision on obviousness was completely incorrect, whether a justice favors the prima facie analysis OR totality----since the prior art and science cannot logically or rationally be seen to support obviousness of what Amarin accomplished!
I view this as the most important point in our appeal. It should be black and white and not subject to which manner of review philosophy the individual justices proscribe---(totality v. prima facie)
Thank you ggwpq.
Do you recall if Singer's brief captured and expressed all of these?
In his reply, it would be great to have a second of bullet points lay out these (in one place)---just as you've done in your post!
I've read both amicus briefs. Both are favorable to AMARIN---Alliance directly so, while the other one is "neutral" bu argues against the approach DU took "the prima facie" approach.
I agree with you 100% Eightisenough! Exactly as you expressed.
supposed to be random selection---but who ever really knows what presiding justices or those on the intake process really do...
Bill B, how does the release of information on studies usually work? I saw somewhere the final report on Evaporate may be due on or about August 15, 2020. Is it the usual occurrence that preliminary results or guidance on what's expected to come is released early (at the point of the study's end of obtaining information and data)? Or possibly at some point in between? Does Amarin have a history of releasing info earlier than the projected final report?
Thanks
BB---you're absolutely correct. National airwaves and lots of positive articles.
Thank you BB!
Agree 100%
In my opinion, the issue before the Federal Circuit is less likely to be controlled by the political bent of the Justices on the panel than many cases. This case is far less a war on generics vs. bug pharma than it is doing the right thing under existing precedent. Du got both procedural and substantive issues wrong, including illogical and incorrect bases upon which she based her finding of obviousness.
I feel very good about our arguments and the way Singer and Fish &Richardson briefed them.
Don't get m wrong--I still would wish to have at least 2 pro-patent Justices on the panel, but this appeal is one that any remotely competent Fed. Cir. justice should reverse based on the law, medicine and raw logic.
The nice thing about Reply Briefs is that, not only does the Appellant get to refute all that is argued in the Appellee's brief, it also gets to provide the last word on the case---often a concise bullet-pointed summary of the list of grounds on which the reversal may be based.
Looking forward to reviewing Amarin's Opening Brief. Should provide for substantial discussion when it hits PACER.
Question for those with experience in awaiting reports of this nature--if any generalities can be drawn.
I believe I recently read or heard that the EVAPORATE STUDY is to be completed by May 15, 2020 and that the final report is expected out by August 15, 2020. Do these types of reports ever come earlier or significantly earlier?
Thanks for whatever input can be provided.
No matter how one feels about pursuing the Federal Circuit appeal to conclusion (my view is that Amarin has no practical choice and must see it to conclusion), I believe that the filing of its Opening Brief next week will give us all a boost of confidence. If the legal arguments are well presented, we may see a reasonable increase in current SP and there should be patent attorneys, both in the financial press and on this board, weighing in on the merits as presented.
I understand that often appeals are determined by the composition of justices drawn for the panel, but there are times when a decision (LIKE DU's) is so destructive or out of line with the recognized legal standards and analysis, that justices on both sides of the aisle as of the view that it must be reversed. This may be one of those times. And, please recall, that later in the process (after the generics' brief(s) are filed, we likely will see significant amicus curiae briefs from the industry.
CBB---well conceived!
I'm expecting (praying) that many of us here will feel more confident once we see Amarin's Opening Brief on Appeal (on or before May 12th whether the appeal is formally expedited by the Fed Circuit or Singer merely files as soon as possible after completing it).
Some of the patent attorneys on this board have done amazingly excellent analyses on the issues and many if not all will be reflected in an organized and concise format that highlights the strongest issues favorable to Amarin, including direct citation to precedent that will be argued to compel reversal. Also, we'll see the benefit of having it be Singer and his crew that is creating the brief---there should be abundant policy reasons set forth in the brief that show why the patent system, policies for innovation, and the practical aspects how despicable decisions like Du's harm everyone all require that the decision be reversed and Amarin's patents be restored. He understands the Hatch/Waxman big picture and can articulate why it doesn't mean that the generics should win every time.
The filing should generate patent expert commentators opinions and analyses, but also set the bar and focus for what the defendants/appellees will have to successfully respond.
Good luck to us all
If the Fed. Circuit reverses and remands, the opportunity for settlement is heightened dramatically----Du's decision is vacated, so settlement with H & R can take place without the ability of other generics to fl ANDAs etc---because the Marine patent will not have been invalidated----until the remand occurs and if, unless and until DU once again goes the communist route, there will be no invalidation order
Before then, I don't believe Amarin has any choice but to take this appeal to conclusion in the Fed. Cir.
I may be incorrect, but isn't the ability to settle the patent case truly impossible, as the District Court invalidation of Marine patents won't come off the books and every other generic can file ANDAs and eventually jump into the US generic market and, with the help of pharmacists and insurers "cheat" their way into use in the REDUCE-IT marketplace? Isn't that what Amarin has been saying all along in CC and court filings that settlement discussions are not useful?
Does this reality make it "no choice" but to pursue the Federal Circuit and win (or lose and commence a strategy to make US as profitable as possible for Amarin (even if reduced).
Any thoughts why AMRN is 8.68 AH at this moment?
It may be difference in perception. Personally, I do not consider pre-trial "settlement conferences" as "mediations." The PTC may be substantive or it may last 5 minutes---long enough to indicate to the judge or magistrate that the parties are too far apart for a longer conference/attempt to settle to be a fruitful use of everyones' time or it can be substantive, with a exchange of position papers and a multi-hour attempt at settlement. Meditations, on the other hand, are usually paid for settlement conferences, with a mediator who is outside the court system (retired judges or other attorneys expert in settlement techniques and strategies) where all parties undertake serious attempts at settlement during a day-long or multi-day effort.
AWEOME ANALYSIS SouthPacificIslander! Thank you for your focus and experience in this arena.
I believe that Amarin is absolutely working on research on Covid-19 applications for Vascepa. There is no way JT would have mentioned it early in his April 13, 2020 presentation if work/analysis on it had not already begun.
I believe Amarin is exploring actions on many different fronts. If and when it announces its work on Covid-19, it will be a more meaningful and impactful announcement than these other companies announcing trials. It may be in conjunction with an overture/activity by BP. As much as I too would like to know every step explored and taken on anything this important, until the news has real meaning and is ripe, it would only fuel speculation and market disruption by shorts etc. if it is not ready...
Obviously, a huge amount of patience is required for this company after the Du debacle.... not easy, but required
JMHO
Please add me to the list of those who couldn't agree any more than I do.
"I think that is a humongous error of law on her part, misapplication of the burden of proof... Even if obviousness in this case was a "close call," that does not get it done for the generics because that does not meet the 'clear and convincing' burden of proof. I expect Singer to hammer on this point."
be great if the generics are required to conduct a "four year life of product test"....
Thank you for posting---very important decision and doctrine!
AWESOME POST SouthPacificIslander. Spot on and very appreciated.
Myocardial injury with ST-segment elevation has been observed in patients with coronavirus disease 2019 (Covid-19). Here, we describe our experience in the initial month of the Covid-19 outbreak in New York City.
Patients with confirmed Covid-19 who had ST-segment elevation on electrocardiography were included in the study from six New York hospitals. Patients with Covid-19 who had nonobstructive disease on coronary angiography or had normal wall motion on echocardiography in the absence of angiography were presumed to have noncoronary myocardial injury.
Table 1.
Characteristics of 18 Patients with Covid-19 with ST-Segment Elevation on Electrocardiography.
We identified 18 patients with Covid-19 who had ST-segment elevation indicating potential acute myocardial infarction (Fig. S1 in the Supplementary Appendix, available with the full text of this letter at NEJM.org). The median age of the patients was 63 years, 83% were men, and 33% had chest pain around the time of ST-segment elevation (Table 1). A total of 10 patients (56%) had ST-segment elevation at the time of presentation, and the other 8 patients had development of ST-segment elevation during hospitalization (median, 6 days) (Fig. S2A).
Of 14 patients (78%) with focal ST-segment elevation, 5 (36%) had a normal left ventricular ejection fraction, of whom 1 (20%) had a regional wall-motion abnormality; 8 patients (57%) had a reduced left ventricular ejection fraction, of whom 5 (62%) had regional wall-motion abnormalities. (One patient did not have an echocardiogram.) Of the 4 patients (22% of the overall population) with diffuse ST-segment elevation, 3 (75%) had a normal left ventricular ejection fraction and normal wall motion; 1 patient had a left ventricular ejection fraction of 10% with global hypokinesis.
A total of 9 patients (50%) underwent coronary angiography; 6 of these patients (67%) had obstructive disease, and 5 (56%) underwent percutaneous coronary intervention (1 after the administration of fibrinolytic agents) (Fig. S3). The relationship among electrocardiographic, echocardiographic, and angiographic findings are summarized in Figure S4. The 8 patients (44%) who received a clinical diagnosis of myocardial infarction had higher median peak troponin and d-dimer levels than the 10 patients (56%) with noncoronary myocardial injury (Fig. S2B and S2C). A total of 13 patients (72%) died in the hospital (4 patients with myocardial infarction and 9 with noncoronary myocardial injury).
In this series of patients with Covid-19 who had ST-segment elevation, there was variability in presentation, a high prevalence of nonobstructive disease, and a poor prognosis. Half the patients underwent coronary angiography, of whom two thirds had obstructive disease. Of note, all 18 patients had elevated d-dimer levels. In contrast, in a previous study involving patients who presented with ST-segment elevation myocardial infarction, 64% had normal d-dimer levels.1 Myocardial injury in patients with Covid-19 could be due to plaque rupture, cytokine storm, hypoxic injury, coronary spasm, microthrombi, or direct endothelial or vascular injury.2 Myocardial interstitial edema has been shown on magnetic resonance imaging in such patients.3