Amarin Corporation PLC (AMRN)

DAR, excellent reminder. A lot of people seem to forget that Judge Andrews’ original dismissal was not the type of ruling that slammed every door shut forever and a death sentence. It was ‘Without Prejudice’. The alleged deficiencies were in the pleadings, and Amarin was effectively given an opportunity to come back with a stronger factual record if one existed.

What stands out to me is that during Supreme Court oral argument, Amarin’s counsel specifically asked that, at a minimum, the case be remanded so the company could pursue that path. The Supreme Court reversed the Federal Circuit’s legal theory, but it did not simply terminate the litigation and walk away. It sent the case back to the lower court. That matters.

Now Amarin has the benefit of years of additional information, discovery efforts, market data, and evidence that did not exist when the original complaint was filed. None of us knows exactly what Amarin will do next, but if management and counsel believe they have stronger inducement evidence, repleading seems like the logical next step. The silence since the decision may simply reflect careful legal planning rather than surrender.

Thanks for bringing the history back into the discussion. The 9-0 remand keeps the door open, and until Amarin announces its next move, I wouldn’t assume Hikma is completely out of the woods.

Deleted

Inconsequential but Judge Andrews is a he. 

marzan, if everyone would remember the original suit that landed in Judge Andrew's District Court, she dismissed the suit against Hikma. However she did that "without prejudice" to allow Amarin to stregthen their case and replead. Judge Andrews gave Amarin an out.

District Court (January 2022): Judge Andrews granted Hikma's motion to dismiss, finding that neither Hikma's "skinny label" nor its generic marketing statements constituted active steps to encourage infringement. Under federal procedure, a dismissal for failure to state a claim upon which relief can be granted is typically without prejudice, allowing the plaintiff the opportunity to amend their complaint to cure the defects if they can.

As Huston requested at oral arguments to the SC, he asked for at a inimum to be remanded back to the lower courts. Hopefully she will be open to listening to the facts uncovered through discovery.
I am not suggesting this is an end all choice for Amarin, but I personnally would like this to proceed at the DC.

SN5….do you happen to know if any of the targets in your examples were one product companies….if i was the buyer, it would make a difference….thanks

It is anything but dead with the new formulation weeks away some are still loading up the boat. I know of one guy gobbling up shares.

Monk, thanks for speaking up. It takes some courage to challenge the same small group that seems to patrol the AMRN board around the clock.

They often present themselves as guardians of retail investors, but somehow the message is almost always the same: doubt, pessimism, and reasons why nothing can work. Healthy skepticism is one thing; constant negativity is another.

The Supreme Court remanded the case, Amarin’s counsel specifically sought the opportunity to replead with additional evidence, and the story is clearly not over. I appreciate posters who are willing to look at all sides of the situation rather than simply declaring defeat at every turn.

10-4, Monk.

marz
10-4

What I find interesting is that some of the loudest voices declaring Amarin "dead" seem to spend an extraordinary amount of time discussing it every single day.

If the company truly has no future, the lawsuit is over, the pipeline is worthless, management has no plan, and shareholders are doomed, then why the constant attention? Most investors move on when they conclude an investment has no value. They don't spend months or years dissecting every filing, conference call, patent application, board change, and court docket.

The reality is that Amarin still has over $300 million in cash, global partnerships, a next-generation formulation under development, and a controlling shareholder in Sarissa that continues to reshape the company. You can disagree on where that leads, but calling the company "dead" while following it 24/7 suggests even the critics know there is still a story unfolding here.

Are you still the moderator? Just asking.

RMB, I can't disagree. I have not spent that much time following the patent approval process, because it mostly happens "behind closed doors". But Capt's explanation is absolutely valid. I just don't know where that would leave us.

My assumption is, if we had to abandon the patent, they could still partner with someone in the US market to sell and market Vascepa.

But I have to assume Amarin has already contemplated this issue when applying for the patent. Interestingly, they have applied for the patent in Japan. My only assumption is that with Amarin and Mochida's history together, that they have worked together on this to some extent. Maybe Amarin has improved on Mochida's original work (JELIS), and now Amarin is going to share that with Mochida, allowing Mochida to use their new work in Japan.

Originally, all of the work on IPE was developed by Mochida. And they shared that with Amarin for ex-Japan markets. And they had a long-standing collaboration to "share" their research. One can only hope this continues.

They do note on their 2025 Annual Report that they are still paying Mochida under their Agreement.

JRoon, good point highlighting something that we sometimes forget or neglect to think about. Namely, that Denner first got into Amarin after the Generics had already gotten in. Of course, so far, he hasn't been able to figure out how to monetize this investment. What I am not so aware of, is where the thought, idea, process of the new formulation was when Denner came aboard? Capt Beer's post this morning offered a sobering thought. Whether the USPTO will consider that the specific ratio's of ingredients are unique and that they have shown unexpected results. I am in a holding pattern until, hopefully by the end of the year, we hear whether the patent has been granted and if so what Amarin's plans for it are.

I agree that the case is essentially dead. And even if they can resurrect it somehow, it will be many more years of this. So I really don't think there is any "value" in the legal case going forward.

Having said that, I don't agree that the company is dead. The trial outcome could have been some icing on the cake for us, but I find it highly improbable that Sarissa was banking their entire investment on the outcome of a shaky trial - one which still could have legally left 7 other generic manufacturers in the market. And it's not as if they lost the patent after Sarissa invested. They knew going into it that the patent was gone.

I also don't believe that Sarissa thought that (1) losing the patent, then (2) firing the entire sales & marketing department, and having the company go virtually dark from a marketing perspective, was going to bolster their investment. So it leaves you to look much deeper at what Sarissa has been trying to do. And since they don't say a damn thing about anything, all you can do is watch their actions.

So, what have they done? They have outsourced sales & marketing for the entire world, ex-US. Will the U.S. market be next? Are they morphing into a cashflow/royalty machine?

Look at their Balance Sheet. Look at Retained Earnings. Then look at Innoviva's P&L. They are absolutely smoking it right now. Trailing 12 months they have a $95M Income Tax accrual. Innoviva is a cashflow/royalty machine. And their Balance Sheet is loaded with biotech startup investments. Look at some of their "Strategic Investments"...Armata, ImaginAb, Syndeio, Beacon, etc. All have Sarissa board members or executive committee members. Innoviva's CEO (Pavel Raifeld) is a former Sarissa employee. Mark Dipaolo (our former board member), is now chairman of the board of Syndeio. Innoviva's board has multiple members that are on other Sarissa holding boards, or have been in the past. Innoviva is continuing to host and fund those investments (this goes well beyond the ISP Fund). It has become Sarissa's investment incubator.

Go to Innoviva's website. Read their "Strategy" tab. Read the "Our Business" tab. It's not a pharmaceutical company. It's an investment company with a cashflow/growth engine. It takes a page out of Warren Buffet's BH playbook (using insurance company cashflows to fund his investments). And Innoviva is 100% owned by institutional investors. Wall Street absolutely LOVES them. Amarin? Beyond Sarissa's investment, we are 15%.

Innoviva went to like 8 healthcare investor conferences in 2025. Amarin? Zero. We used to go to most of them as well. Why wouldn't Amarin/Sarissa be attending those if Sarissa has now "cleared the decks to sell the company", as so many have stated, after the lawsuit failed?

I don't think Sarissa is interested in just selling to a 3rd party like Pfizer or Recordati. I think they have larger aspirations. And I do think it starts with the new formulation. My feeling is that there is still a very bright future for Amarin, but it is likely going to be a slow grind upwards for a while.

There would be a lot of hurdles to cross to combine the companies. But Innoviva is absolutely killing it right now. And adding Amarin's potential future cashflow from their Vascepa 2.0 royalties would be a huge addition to that. This is not some "pie in the sky" concept that requires ChatGPT to write out a novel with fancy icons, trying to find the connection. Sarissa is literally doing this in front of our faces.

This patent is #1 right now. We will soon get a feel for how the examiner sees Mochida’s patent as rejection of claims. I’m optimistic that we (Amarin) can show unique evidence. 

Monk, No darkness intended. I wish the best of luck to all who remain invested here. There is always a chance of a good outcome. I just don't see it.
Seriously, good luck.
Sleven,

Capt, you have done a ton of research on this investment over the years. What do you see as the Bull thesis for AMRN now?

You correctly point out that several acquisitions have been made prior to FOA's of key patents. However, the risk in this patent is particularly troubling to me because of the closeness of composition claims in this patent to those in Mochida's Self-Emulsifying Patent (USPTO 11,207,286). This will definitely be a challenge for Amarin to convince the Examiner that specific ratio's of ingredients are unique and that they have shown unexpected results.

Glad to see the infringement “investors” have moved on. That part of the con is almost over. I have faith in judge Andrew’s dismantling Sarissa’s game as they horde API and pretend the drug has no clinical utility. Keep reading and definitely keep contacting IR and don’t swallow the narrative sideways. We sent a strong message voting down all of the idiotic Sarissa and Torok proposals and they still don’t do share buy backs. Berg hates answering questions around returning money to shareholders and if he can keep the PBM contracts. Activism is next but first let’s talk about patents. 
Do We Need a First Office Action Before the Company Can Be Sold?
A common belief on this board is that Amarin cannot be sold until the LR-EtEPA patent receives a First Office Action (FOA). This is not accurate.
In biotech and pharmaceutical M&A, it is very common for companies to be acquired while key patents are still pending or early in prosecution — often well before a First Office Action is issued.
Here are several real-world examples of large biotech acquisitions where key patents were still maturing at the time of the deal:
•  Kite Pharma / Gilead (2017) — $11.9 billion

Several foundational CAR-T patents were still in active prosecution or had only recently entered examination when the deal was announced.
•  AveXis / Novartis (2018) — $8.7 billion

Core AAV9 vector and manufacturing patents were still relatively early in prosecution when Novartis acquired the company.
•  Forty Seven / Gilead (2020) — $4.9 billion

Key composition and method-of-use patents for magrolimab were still in prosecution at the time of the acquisition.
•  Juno Therapeutics / Celgene (2018) — $9 billion

Multiple important CAR-T related patents were still pending or early in the examination process.
These deals show that sophisticated buyers do not require patents to be granted — or even to have received a First Office Action — before moving forward with an acquisition. Buyers perform detailed due diligence on pending applications and underwrite the risk accordingly.
What about the Mochida prior art risk?
Mochida is the most relevant prior art the examiner is expected to cite when examining the elected composition claims. Mochida has marketed self-emulsifying EPA formulations in Japan that use similar components (EPA combined with phospholipids and emulsifiers).
Amarin is actively prosecuting around this prior art. The company narrowed its claims to a specific phospholipid-to-EPA weight ratio (approximately 1:1 to 1:5), defined lecithin specifications, and a limited set of emulsifiers. This is a standard design-around strategy. The First Office Action is the stage where the examiner will likely issue obviousness rejections based on Mochida, and Amarin will have the opportunity to respond with arguments and amendments.
Sophisticated buyers routinely diligence exactly this type of prior art risk. They assess the strength of the elected claims, the applicant’s ability to overcome rejections, and the commercial value of the resulting patent scope. Many large deals have closed with similar or greater patent uncertainty than what currently exists with LR-EtEPA.
Bottom line
The idea that Amarin must wait for a First Office Action — or a full patent grant — before a sale can happen is not supported by how these transactions actually occur in the industry. The LR-EtEPA application is still early in substantive prosecution, but that status alone does not prevent a transaction. What matters more to a potential buyer is the defensibility of the composition claims and the overall clinical and commercial story supporting the asset.

NS
Seriously? You sell all your AMRN yet you come back here with this dark shit? "no pathway forward" ? I hope you're not a mod anymore.
Good luck to you but please just go away and be dark somewhere else.

AP271, The Supreme Court ruling, effectively ends AMRN as an investment. There is no reasonable pathway forward. Not that I can see. Unless you believe Novartis bought this company, connect all the dots.
Sleven,

" We therefore reverse the judgment of the Federal
Circuit and remand the case for further proceedings con
sistent with this opinion."

Consistent with this opinion. Done.
District court judge dismisses the case.
3 judge panel circuit court says wait a minute maybe there's something here, let's look a little more deeply.
Supreme court says nope first guy was right, buh bye.
First guy celibrating that his decision backed up by the supreme court and no way he changes his mind.
JMHO and still invested hoping for bigger and better things.

I like the remand point but then what are we reversing
So i reverse the circuit judge and disagree with him on the passive inducement méritos
Then the case is remanded to a Judge that has already dismissed
Then do you think we can automatically reopen a trial that was dismissed? Or do we file an amended suit? 

That is not necessarily how U.S. federal litigation works. A 9-0 unanimous remand does not automatically erase every deposition, document, or discovery item gathered previously. Judge Richard G. Andrews still has procedural discretion on how the case proceeds from here.

Also, remember: Amarin’s counsel specifically argued they had additional evidence and sought the opportunity to replead. If the court allows an amended complaint, prior discovery can still influence the case directly or indirectly, and the judge can also reopen or restart discovery if needed. The SCOTUS ruling clarified the pleading standard for induced infringement under 271(b); it did not say all evidence collected becomes legally radioactive or unusable forever.

Most importantly, the case was remanded, not terminated. That distinction matters.

Would love to agree but if the Circuit Judge gets reversed then it means first decision was right (to dismiss)
Im from Europe but in our law system you cannot use evidence gathered out of a procedure so probably all the info gathered is useless
I would love to be mistaken so more than happy to hear your arguments

100% like Jron said this would have been the icing on the cake but the new formulation was always going to be the game changer that will move the stock to 200 overnight. Its a matter of when not if now. Jron is loading up the boat who else is?

Thanks North for stepping in to offer your expert view. Agree with you and In fact 9-0 is all 9 SC judges agreed to REMAND back to the lower court..

Everyone is obsessing over the “9-0 reversal” headline while missing the equally important fact: it was also a unanimous 9-0 remand back to the lower court. If the Supreme Court truly believed Amarin had zero path forward, they could have shut the door completely. Instead, all nine Justices agreed the case goes back to Judge Andrews for the next phase.

That matters. A remand keeps procedural options alive, including Amarin’s ability to seek repleading with stronger inducement evidence that counsel already referenced. The legal standard was clarified, but the litigation itself was not buried. In my opinion, the market is now waiting to see whether Amarin comes back more aggressively rather than quietly walking away.

rmb- some people here cannot be wrong on this trivial (as it relates to the value of the company) matter and need a narrative to get through their day. A 9-0 reversal is not what our council was looking for when mentioning a remand back to the lower court. I actually believe that some people on this board need to be right much more than financially rewarded for their investment. I believe getting the hell out of the US legal system ASAP is by far the best path to a sale of the company.

“ended”?  Not true yet, rmb. This particular case will be ended if, and when, the judge refuses 1) to allow Amarin further discovery, 2) to amend its complaint asserting active inducement of infringement with that further evidence discovered. The judge might/should look at the evidence Amarin has already discovered from Hikma on the issue of active inducement of infringement before signing any renewed motion by Hikma to dismiss this case with prejudice. Most judges would permit Amarin to exhaust discovery from witnesses on that issue before signing such an order.

Although some describe the SC decision as "remand" it was actually "Reversed and Remand". This has for all intents and purposes ended.

How much more time would be required for the judge to reconsider and deliver a verdict?

Even though it is hard to read - it is in fact a rather precise description of facts regarding the late SC ruling.

Hikma people - surely had champagne in London !
----------------------------------

https://finance.yahoo.com/sectors/healthcare/articles/generic-drugmakers-gain-key-victory-115131688.html

Turns out many of you pretended to listen to the hot wash post SCOTUS with the Goodwin law firm who successfully tried the GSK/Teva infringement case. If you actually listened and read the slides you would have learned that Amarin caused the problems by going to the FDA with a method of use patent not Judge Du. You would have learned what the 505b2 path is, you would have heard their predictions that Amarin would lose 9-0 and you would finally learn how infringement works at the state level. Good thing Sarissa didn’t hire Goodwin law and instead hired Perkins Coie, a political law firm (Russiagate) because now Judge Andrew’s who dismissed the case in 2020, sat through the recent court case and now has Amarin back in his court with a 9-0 beat down from SCOTUS gets to finally rub it in Amarin’s nose. Anyways, keep reading and see the photo. Because we move on to activism next. Sarissa and Torok are jokers in this con. 
How State Pharmacy Laws (Not the FDA) Drive Generic Substitution
Fellow shareholders,
Many people are confused about how skinny-label generics have captured volume in the REDUCE-IT population. The answer lies in state law, not federal law or the FDA.
Here is the simple reality:
•  When a generic is rated AB (therapeutically equivalent) in the FDA’s Orange Book, state pharmacy laws generally require or permit pharmacists to substitute it for the brand-name drug.
•  This substitution happens at the pharmacy counter.
•  Substitution is not limited to the indications listed on the generic’s label.
This means:
•  A doctor can write a prescription intending the branded product for a patient in the 150–499 mg/dL cardiovascular risk reduction population (the carved-out indication).
•  The pharmacist sees an AB-rated generic available and substitutes it anyway.
•  This occurs even if the generic’s label only lists severe hypertriglyceridemia (≥500 mg/dL) and properly carves out the patented cardiovascular use.
State laws do not require the pharmacist to verify whether the prescription is for the carved-out patented indication. They substitute based on the AB rating, not the label language.
This is why skinny-label launches have been so effective at eroding branded volume. The legal protection the generic gains from using a skinny label does not prevent real-world substitution at the pharmacy level.
Prescribers can block substitution by writing “Dispense as Written” (DAW) or “Do Not Substitute,” but this requires active intervention by the physician and does not happen automatically in most cases.
This mechanism is controlled by state pharmacy statutes, which vary somewhat by state but follow the same general pattern across the country. It is a structural issue that the current Vascepa formulation cannot escape without a new, non-AB-rated formulation.
Civil discussion welcome.
Thank you for your attention to this matter.

The silence from Amarin Corporation after the SCOTUS remand may actually be constructive, not bearish. The Supreme Court of the United States did NOT terminate the case outright or dismiss it with prejudice. Instead, it sent the case back to Judge Richard G. Andrews, leaving the door open for further proceedings. Amarin’s counsel already told SCOTUS they obtained stronger new evidence and should be allowed to replead. This is no longer the same thin pleading record from years ago.

What many overlook is that substantial discovery already occurred after the Federal Circuit revived the case. Depositions, executive testimony, marketing evidence, and other discovery groundwork do not simply vanish. Judge Andrews could allow a focused amended complaint and targeted continuation of discovery rather than forcing a complete restart. If Amarin now repleads with a stronger inducement record tailored to the SCOTUS guidance under 271(b), Hikma Pharmaceuticals could suddenly face much greater litigation risk than bears currently assume.

There are ways this could be addressed, but I don't think the industry has any interest in fixing it. And it's a huge problem.
Big industry players fix the issue by focusing their R&D on new drugs with full NCE plus one NME while exclusivity is intact and generally dont chase new indications on older drugs coming off patent or exclusivity. That's their solution to the HW skinny label risk.

JR,I’m not sure who is obsessed more you or him. Most just ignore so we don’t have to deal with him but your constant responses keep him alive. 
Noel

Yeah, I don't disagree. But again, it's a significant weakness in the structure of the industry. There is literally nobody policing it. Every pharma company has to police their own drugs, and use the courts as remedy.

Yeah, the Supreme Court, like the states, insurance companies, doctors and pharmacists, all kneel at the altar of the vulture foreign generic companies. It was like a slow-motion version of when the Federal Circuit dismissed the appeal of Judge Du's decision with a pithy one-page rejection the next day, not even giving it the dignity of an analysis of the arguments.

I don't think your message is a response to what I wrote since I wasn't talking about corruption. But I do think you make some very solid points. We operate in very strange, if not scary, times. The world that affects Amarin and every other pharmaceutical I own is upside down and I think everybody is running for cover until some normalcy returns. Hopefully we see light at the end of this dark tunnel soon.

BBI, what you mention about the comments made by that judge made me think of a program that used to be back in the 90's I believe. Called The Fleecing of America it would highlight similar ridiculous stuff. By the end of every program I watched I would scream: "But nobody does anything about it!!!"

considering how much money is at stake with FDA approvals it would be niave there is no bias or corruption on how or if drugs are approved or not etc.or that there is no corruption in the FDA or no corruption with the SEC. or there is no corruption a the Trump administration. the corruption is in your face. how can you say there is no corruption. Trump doesn't even know what corruption since everyone is doing it must be okay and nothing wrong with it. is it really a "serious crime" is everybody is doing it. it's like speeding ticket..nobody cares. since everybody does it.
the FDA head want to deny and drug approvals for mRNA and he was fired due to drug lobby. what does that tell you.?

and they(wall street) wanted to fire Federal Reserve jim powell or anyone who doesn't lower rates.
you have political interference and used to be illegal. Trump is openly intefering with agencies and now people think it is normal thing to do .

what you have is the regulated companies tell the gov't regulators how they should be regulated. its like theives advising the gov't how crime bills should be made.

https://economictimes.indiatimes.com/news/international/global-trends/fda-drug-center-head-expected-to-leave-after-commissioners-exit-sources-say/articleshow/131142051.cms

I don't remember exactly what the Delaware judge said during those oral arguments a few years ago, but I remember him acknowledging that the generics had taken over a lot of the market for Vascapa and it has to be somebody's fault. It was a moment where it almost seemed that he could rule in Amarin's favor before he did not.

I think I paid $60 for a one-month supply of Vascepa. The generic would have been $10. But I'll definitely look for a coupon because I think I'm supposed to get a three-month supply next time. I wasn't too concerned because I paid it with my flexible spending account.

It's not an issue of being overworked. It's a fundamental flaw in the structure of the entire pharmaceutical industry. It's not the responsibility of the pharmacy to know which indication you are being prescribed for. They just need to follow the doctor's script.

Let's just say for example that all of the generics were labeling and marketing exactly how they are supposed to. Yet, generic IPE is still being dispensed for the CVD. Who do you you finger that on? Doctors aren't responsible for knowing every patent on the planet. They just need to know the drug that helps someone. Pharmacies just dispense what is written. Insurers and PBM's just set their formulary and pricing. Patients have no idea.

There are ways this could be addressed, but I don't think the industry has any interest in fixing it. And it's a huge problem.
every pharmacy is overwhelmed and their employees are overworked and its impossible to keep track of everything, especially the lesser known drugs like Vascepa.

SCOTUS did not shut the courthouse door on Amarin. The case was REMANDED back to Delaware, exactly where Amarin’s counsel said they wanted to return with stronger evidence and an amended complaint. That matters.

Hutson openly told the Supreme Court Amarin obtained new evidence supporting inducement and should be allowed to replead. If there was no path forward, SCOTUS could have ended it outright. Instead, the litigation continues before Judge Andrews.

The silence from Amarin right now may simply mean legal strategy discussions are already underway behind the scenes before announcing next steps. Today’s price action reflects that waiting game, with investors looking for Amarin proceeds with an amended complaint and renewed inducement allegations.

Hikma may have escaped for now, but the fight is clearly not over yet.

Yeah they tried to charge me $650 but the coupon does the trick. Mine is based in North Arlington.

Oh great. I'll try that. I go to a pharmacy in Hoboken.

That all makes sense. I'm sure every pharmacy is overwhelmed and their employees are overworked and its impossible to keep track of everything, especially the lesser known drugs like Vascepa. Hard to believe that we're now only three years short of when generics were going to be let into the market even if Judge Du had ruled the other way.

Dar, here is one explanation. As I mentioned once before on this board, I came to the realization that if I or my spouse croak we would get screwed because of some of the very, very high cost basis shares we own in Amarin. Reason of course is upon death cost basis resets to stock price at time of death (that is usually a good thing but in our case takes away potential losses that could be used to offset gains). So a few weeks back I collected my highest basis Amarin shares (185 in total) and put in an order to sell them at 16.44. Never hit and stock price slumped lower. Late last week I changed the order to $15.22 and sure enough someone ran up and grabbed them this morning. Of course we all still want Amarin's sp to rise, but I can sleep a little better knowing that if one of us does not wake up, the other won't get screwed as bad.

Me too getting 3 months supply of brand V (imprinted IPE now) for $9 for the past several refills.

delete.

2013 - sorry !

Its been said many times before. The experts at USPTO - use 10 years analyzing and finally approving the 6 patents on VACEPA - Amarin is/were built on.

A random Judge - with no expert knowledge 'what so ever' opens the gates for generic volves - hardly one year after 2019 hard fought new label - and to this day company hasn't recovered from the injustice.