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Sounds like a buying opportunity.
BB,
Not exactly. The judge’s summary judgment ruling signaled very clearly that she wanted to hear the expert testimony on at least the infringement issue, and that is not unexpected in this kind of case involving an issue like indirect patent infringement. Once she hears the competing experts, she can make a decision who she decides is more persuasive. That decision will be very, very hard to challenge on appeal, whichever way it goes. She is setting this up to limit the chances she could be reversed on appeal. That is what smart judges do, just ask one. That is what federal judges care about more than anything else. If no settlement, the best we can hope for is a decision based on her decision that is based mostly on her acceptance of our team’s expert opinions. That would be largely unassailable on appeal.
Hamoa—
Agree with your analysis and would add that trials are on a subconscious level about the decision maker deciding who are the good guys vs. the bad guys. The primary reason Amarin has the advantage in this case is that they occupy the moral high ground. That does not always prevail in this country as is evidenced by, for example, the intense litigation in the 1850s over the fugitive slave act that resulted in the abhorrent Dred Scott decision. But in this case, in my view, it will carry the day. Let’s hope you and I are right.
Bouf
Litigation experts are always subject to some question as to bias because they get paid by the party that hires them to testify about their opinions. Past payments for speaking etc. are one thing, and will be used to try to undermine him, but this is not that strong a point because he obviously does a lot of paid speaking for numerous players in the biz. He can get paid for his time testifying, but he can’t have a financial interest that would become more valuable if he testifies one way v. another. That would kill his credibility. I have to believe Covington has this covered, but the trial lawyer in me can’t help but worry about this kind of thing, as that’s what we do.
JL—yeah, but the question now is whether the other side respects him as a witness on infringement, and if it goes to trial, whether he can be knowledgeable, articulate and objective, without making the mistake of arrogance that highly credentialed professionals sometimes make in court, resulting in the court discounting what they have to say.
Thanks Ortakoy. Budhoff better not be a shareholder or have some other financial interest that can be brought out to show bias. I’m assuming counsel tied this down, and I don’t think his depo is available in the non-sealed record. Absent this kind of trial problem, he should be one of the stars of the trial.
Jonathan Sheinberg is actually the clinical expert for the generics that will testify on inducement. I was wrong in thinking Heinecke was the guy, he is actually the generics invalidity expert.
Sheinberg is a practicing cardiologist and lipidologist only with no research or academic credentials like Budhoff. He is board certified in cardiology but that’s it. Budhoff seems to blow him away on credentials, but that is only part of the story. A lot will turn on the ability to testify clearly and cogently, and I would expect Budhoff’s extensive experience in public presentation will help him. There’s too much redaction of expert testimony in the briefing to be able to assess their testimony, unfortunately.
Orkatoy—great post, thanks. On the inducement point I think it will be a battle of the experts based on the SJ ruling. Do you agree?
I noticed that their lead expert appears to be an academic with not much practice experience, which seems to me to undercut the weight of any testimony he may give about what the generic label will induce practicing physicians to do or not.
Dr. Budhoff is also an academic but his background seems more focused on cardio treatment v. research.
Interested on your thoughts regarding how the experts match up, as that is going to be they key in my view.
Which is why now is not a bad time to buy if you have dry powder.
I don’t agree with any of their conclusions, nor does the court.
Amarin also occupies the high ground on the non-legal, moral plane of right v. wrong, which can be just as important as the legal merits in any trial scenario. It’s clear who the good guys are here, and it is not the generics. Most federal judges know the difference between right and wrong, unlike some in other branches of the fed. gov. I’m putting my money on this judge.
Amarin Trial Brief
I have read Amarin’s Trial Brief filed yesterday and it is an outstanding piece of work. It does a terrific job of making the arguments on both levels of thinking that the judge will undertake at the trial: the first being the technical legal level, the second being the more human level of right v. wrong. All trials (jury or bench trial to the judge as here) are on one level about the decider figuring out who are the good guys v. the bad guys. Amarin’s bold investment in a novel use of 4 g of EPA to reduce trigs w/o increasing LDL was brilliant, and the judge will see this clearly from the evidence. The generics are clearly just trying to steal the benefit of this brilliant idea from its owner, and using every technical argument they can make to do it. BUT THEY HAVE NOTHING THAT GIVES THEM ANY FOOTING IN THE ALL IMPORTANT MORAL SPHERE OF RIGHT V. WRONG. Judges are human beings that are moved to do the right thing when the law permits them to do so. There’s a clear legal pathway drawn in Amarin’s trial brief for the judge to follow. Bravo for their fine work. I have no doubt Amarin and their fine counsel will prevail, if the case does not settle.
Amarin put one out but I’m referring to the one put out in Canada by CNW,
You can find it on Yahoo Finance
CNW PRESS RELEASE ON CAN. Approval
Did anyone else notice that this press release today described Amarin as a specialty pharmacy company focused on the “central nervous system” and cardiovascular markets.
I have not seen the “central nervous system” piece before. What does this refer to?
Marzan:
While I sense your point comes more from an emotional perspective, it also has some validity from the perspective of a litigator that has watched how judges make decisions for 30+ years. They are human beings, not machines. They read and they invest. They make many decisions based on what seems right in their heart of hearts. The good ones can fit the law to support the result they think is the right one. This all helps Amarin here because the company has done the hard and expensive work to get this product to market, and the judge will hear that loud and clear from Amarin’s top shelf counsel, who will be making all the right technical points while weaving in the moral superiority of Amarin’s position at every opportunity. Trials are really about convincing a jury or (in this case) a judge who are the good guys v. the bad guys. Amarin will win this fight if this has to go to trial for primarily this reason.
Patience has paid off every time. No reason to change course now folks.
KC: my sense is that the timing (recent FDA approval of R-IT label) will make the generics more inclined to play hardball right up to trial as they know AMRN needs to clear this litigation for a variety of reasons. But I think they will settle by time of the trial.
True, but your message was read by me and others I’m sure to mean doctors generally. Hence my message, which is more of a reminder to all (including myself) to think more before putting our thoughts out in writing in this world in which doing so is so (Maybe too) easy.
Might try thinking before you type and send.
Any great product sells itself to a great extent. We have many reasons to expect the world will view this as a great product.
I don’t know that much about promotion of a drug like this with a big new indication, but most of the comments I’ve seen from docs on the ground suggest AMRN would struggle going alone, but this is hard to evaluate with a new best in class offering. Kind of comes down to whether you believe VS will sell itself to a large extent due to its proven CV and other benefits, and largely benign side effects, or whether you think high promotion costs are inevitable. Thoughts on this Q appreciated, as its out of my ballpark.
I agree, peak price requires peak sales and a small biotech cannot ramp and sell like a big dog. If it tries it will keep the SP down for who knows how long as the costs weigh. If we had other revenue to support this it would be one thing, but with a one trick pony, the ramp up costs will hold it back for who knows how long.
JUDGES ARE HUMAN BEINGS LIKE THE REST OF US, OR AS THE JUDGE FOR WHOM I CLERKED SAID, “WE PUT OUR PANTS ON ONE LEG AT A TIME TOO.”
FEDERAL JUDGES ARE GENERALISTS WHO HAVE TO DEAL WITH A WIDE VARIETY OF CASES FROM CRIMINAL DRUGS TO SOCIAL SECURITY TO PATENTS. SO THEY HAVE TO RELY HEAVILY ON COUNSEL, AND IF YOU ARE REALLY GOOD LIKE THIS GUY, IT MAKES A BIG DIFFERENCE.
THIS ALL BODES WELL FOR AMARIN.
Kiwi—it’s also a good thing this will be a bench trial to the court, not a jury trial. The judge will be more focused on the higher standard of proof for proving obviousness, whereas a jury might overlook this important nuance.
Appreciate your kinds words.
Bouf
The generics have to prove obviousness by “clear and convincing evidence,” a higher standard of proof than required in other civil cases. That’s a big advantage for Amarin.
Report on pre-trial conf just added to docket. All standard stuff RE trial prep. Trial dates set for 1/13-17, 1/21, and 1/27-31. Court will try to resolve motions in limine (to exclude certain evidence before trial) by 12/27. Most courts don’t decide these motions until trial, absent very clear grounds to exclude before trial.
One important point to remember here is that it is a high burden for a generic to challenge the validity of an issued patent. The standard of proof for this is clear and convincing, higher than the normal “preponderance of evidence” standard in civil cases, but lower than the “beyond a reasonable doubt standard” in criminal cases. These generics are challenging the patents on obviousness grounds, but given the science, it seems like a real big stretch that the generics could show by clear and convincing evidence that this drug invention was so obvious that the multiple Amarin held patents should not have issued. While I’m no patent lawyer, just an experienced commercial litigator, it’s clear the generics have a tall hill to climb to invalidate ant patents.
If all patent challenges fail, then the main question is whether Amarin can prove infringement by the generics’ sale of their products. That is also a question above my pay grade, but it is true that Amarin only has to prove its infringement claims by the lower “preponderance of evidence” standard. Also, to avoid infringing, the generics have to differentiate their products from Vascepa, but we all know that the whole reason they want to make a generic version is to grab sales from Vascepa. In other words, they have an inherent conflict between their legal position and their business objective. A very tough needle to thread in my experience.
All of this leads me to think that there will be a settlement, with Amarin pushing these guys to the wall to give up as little as possible of their patent protection, to avoid the modest but inescapable risk of any litigation. But in the end, there does not appear to be real peril in going to trial, as patent validity is solid. If the court finds no infringement, the patents are still good, and they only get to sell in a way that does not take away Amarin sales.
Everybody hates lawyers until they need a really good one.
It’s called the “AMERICAN Rule” on attorneys fees. Each side pays their own fees absent egregious abuse. Contrast the rule in the UK where the loser usually pays.
The bad guys will play hardball until just before trial or during trial and then cut the best deal they can, as they will not want to risk losing by court ruling, which is worst case scenario. Hard to predict timing but would not be surprised by start of trial. Would be surprised if it goes all the way to court decision.
No damages in a case like this, and no legal fees either. Maybe you should stick to watching the legal shows on TV and not prognosticate about what you don’t know anything about.
Even if they don’t settle today, odds are high for a deal in the following days. My guess is that Amarin has one team dedicated to the settlement negotiation, and a separate team working only on getting ready for trial. If settlement does not happen before trial, they will be ready, but even then settlement often happens during trial.
Yeah but that is not what gets you to the Supreme Court on cert, unfortunately. You could argue it should, but that is not how it works.
On the one hand you could look at this as a waste of money given the very long odds on any cert. petition; on the other hand it sends the right message to the opposing parties and the FDA. Have to give the benefit of the doubt to company counsel who know much better how this fits into the bigger legal strategy for the company.
Almost all petitions for cert are denied. No news here.
Seems clear that the main if not only reason for the AdCom is to justify a broad label. Pretty hard to imagine a better scenario going into this for longs.
Goodrx.com can show you a comparison of current retail prices, all in the $300s. Don’t confuse this with the discounted price with a coupon. Not sure about your coverage; mine is an HDHP, everything is out of pocket until you hit the high deductible, so it’s retail price for now.
Here’s some reading for you.
https://www.bloomberg.com/quicktake/drug-prices
All I can say is that message board anonymity leads to really strange behavior sometimes, such as your claiming to have debunked numbers that came from your own post#180047, in which you put forward the $144/script revenue number for Q4 2018.
Who knows what the “wholesale price” numbers you quote may be. They are not Amarin’s revenue per script though .
Last post on this for me, got better things to do like walk the dog.
The Q4 script numbers and quarterly revenue numbers are straight from the Amarin Q4 report. There’s probably some misc. revenue in the “all in” revenue number, but you can’t dispute that the company’s revenue comes almost entirely from V sales. The Q4 2018 report says that “net product revenue” was $77.1 million.
Do you deny these numbers are the ones reported by the company?
C’mon Man!
What we know is that AMRN sold Vascepa at an approx. price of $144/script in Q4 2018(539K scripts x $144 = $77 MM).
Retailers like CVS and Walmart are selling the same product for $300-350. (Can’t figure out how to cut and paste an iPhone photo into IHUB, but you can call CVS yourself if you really think I’m lying.)
So there is at least 100% markup from wholesale to retail prices.
I AM NOT SAYING THIS IS INHERENTLY EVIL, despite your characterization of my argument.
I repeat, the point is that drug pricing affects everyone, from the consumer of V to those that pay private insurance premiums and taxes supporting public coverage like Medicare. We all have an interest in this issue, and I applaud the Trump administration for attempting to do something to reign in the growth in these costs. For the same reason that utility costs are regulated (this product is essential to public health and safety), drugs costs have to be controlled reasonably.
Have a good day.