Amarin Corporation PLC (AMRN) News

I know only the facts I reported re NVS from a PR alert I read. Entry of the MSN generic into the market may occur because the Delaware District Court judge did opine that the MSN product does NOT infringe the claims of the NVS patent. That early entry is not risk-free. E.g.,  I'ts possible NVS could obtain a reversal of the D.Ct. judgment/decision from CAFC prior to Entresto patent expiration in November 2026. 

Solicitor General Sauer is also aware of the facts in the Hikma et al fraud on the Nevada District Court. So are FDA Commissioner Makary and FTC Charman Ferguson. I see the potential for the Solicitor General to present U.S. Government opinion on 2 issues to the Supreme Court, with the suggestion that the Hatch-Waxman issue and other pending antitrust actions involving Amarin, Hikma and Dr. Reddy could be moot if the fraud issue is decided by an affirmative vote (in Amarin's favor). Only a determination of remedies, including damages resulting from the fraud, would remain. Note how the Solicitor General's brief urging reversal was followed by the Supreme Court in Hazel-Atlas, 322 U.S  238(1944). There will have been time for deposition testimony from appropriate persons responsible for that fraud to have occurred,  prior to scheduled filing of Solicitor General's brief.

north40000, I am certainly not an attorney and have no knowledge of the NVS case, but how could they lose their case and the generic be allowed entry into the market prior to the expiration of the patent?
TIA for your knowledgeable response.

One known: NVS, an AMRN collaborator in Europe, lost a generic's challenge to remaining patent coverage of its blockbuster heart failure drug Entresto( $7.8 Billion sales 2024)  today in a non-infringement (by MSN Pharmaceutical ) decision in the District Court in Delaware, advancing potential generic entry before the patent expiration date in November 2026. NVS indicated it will appeal to Fed. Cir. 

Pediatric patent Extension also expired. IRA price cap/control of Entresto is scheduled. NVS is looking at its options. 

Has there been a halt? It's 2:42pm and I'm seeing 17.00/17.08 but Interactive Brokers is showing "C17.32" as the last price as if it is not trading. Disregard.. traded again at 2:58pm.

Lizzy, The purpose of the lawsuit isn't money.
Sleven,

Dancing in the dark, Thank you for understanding. I shouldn't have implied that you were tricked. I personally felt mislead by the AI response.
I do enjoy a few drinks in the evening.
Sleven,

no need to apologize, i am not beyond criticism.
your suggestion i was "tricked" and "wanted to believe something that was inaccurate" was unwarranted.
we are strangers on a message board. you don't know me, or how i think.

a better reaction on your part might have been, "what does gemini think about the impact of a different person in the role of SG?"
to which you would have received the below confirmation of what you have already stated. i.e.,

Slow thinking.
A change in leadership at the Office of the Solicitor General has direct implications for the Amarin v. Hikma case.

The previous expectation for the government's position was based on the stance taken in the Teva v. GSK case under former Solicitor General Elizabeth B. Prelogar. However, with the confirmation of the new 49th Solicitor General, D. John Sauer, the government's recommendation in the pending Supreme Court matter is now uncertain.

Solicitor General Sauer is not bound by the position taken by his predecessor. He and his office will conduct a new review to determine the government's official stance. This means the forthcoming CVSG brief could either:
o Maintain the previous position for institutional consistency and recommend the Supreme Court hear the case.
o Reverse the previous position based on a different legal or policy analysis and recommend the Court deny the petition.

Regarding the second possibility, some reasonable speculation on why the new Solicitor General might recommend the Court deny the petition includes:

o A Different Statutory Interpretation: The new Solicitor General could argue that a strict textualist reading of the Hatch-Waxman Act does not create an explicit "safe harbor" for skinny labels. Under this view, if Congress did not expressly forbid a skinny label from being used as evidence of infringement, then it is permissible for a jury to consider it as part of the "totality of the circumstances" when determining intent.

o A Policy Shift Favoring Patent Holders: A new administration could prioritize strong patent protection as the primary driver of pharmaceutical innovation. The analysis would be that the Federal Circuit's standard correctly protects the value of a brand's patent from being undermined by generics who use skinny labels to indirectly target the patented use. This view would favor the innovator's rights over accelerating generic competition.

o A View of Judicial Prudence: Solicitor General Sauer could conclude that these induced infringement cases are too "fact-bound" to create a clean, universal legal rule. Because each case turns on the specific wording of press releases, marketing materials, and label nuances, the office might argue that the Federal Circuit's flexible, case-by-case standard is more appropriate than a rigid, one-size-fits-all rule from the Supreme Court.

Sleven, the only people who make out in these cases are the lawyers. Personnally speaking I don't have 20 yrs to wait for the companies and courts to settle the Hikma infringement suit. Teva still hasn't paid the $235mill to GSK and probably never will.

Zip, yes, anything is possible. 
The on thing I keep going back to is, Amarin has clearly turned all attention back to the U.S. market. They would not make any massive, long-term decisions that hinge on the outcome of a trial - settle, win, lose, etc.
AND they have now licensed out every market outside the U.S. This leads me to believe that they have something else in their back pocket that they are very confident with.
The new formulation is the only thing I can think of. UNLESS they feel that they have a buying partner waiting to buy the company.
Too many unknowns.😩

Dancing in the dark, Once again I apologize. I was not properly clear about the Gemini assumption that I had an issue with. Gemini assumes that when the Solicitor General files his brief, it would be in support of Hikma. Everything that followed was based on that. I don't know who the government will back in this suit.
Beyond that I don't actually have an opinion.
Sleven,

Zip I agree with you but it is hard to know (at least for me) the timeline with the new formulation. Unless I am wrong we still haven't gotten final PTO decision and then not sure what the FDA would require. I almost think the court case v Hikma decision would happen before that. Of course appeals and whatnot not included in that timeline.

Lizzy, I tend to agree with Sleven in terms of a settlement with Hikma may not do much to stop the other Generics UNLESS there is something within that settlement (and it is well publicized) that would cause the other Generics to fold up their tents.

JR...Once Lr-Et-EPA comes to market, the court case against Hickma for infringing on Amarin's CVD patent on Vascepa becomes far less important to Amarin ...and Amarin might then be inclined to accept a decent monetary settlement of the case from Hikma as compensation for their severe loss of income.

Lizzy, Do you think that Teva is still selling the generic version of the GSK product?
Sleven,

JRoon, if the outcome is a win for AMRN, it will take years, with the continued countersuits. Use GSK as an example. AMRN would be much better off settling and moving on.

Sleven, yes, I agree. However, we also don't know what Sarissa knows. They MAY be willing to settle sooner rather than later, if they believe they can take back the market through other means (ie. a new formulation).

They also may weigh the option of waiting until early 2027 for a ruling, plus a few years for an appeals process, vs. getting something done with Hikma now, and moving forward.

BUT...the new formulation will ALSO likely take a few years, so if they are waiting for that, they might as well continue pursuing the case with Hikma to the end.

These are all the scenarios I have been bantering around in my head.

But I agree, all things being equal, a ruling in our favor is far better than a settlement.

Denisk, No, I actually don't necessarily WANT them to settle. I was really just thinking through what both sides might be thinking and what might happen if Hikma DOES want/try to settle.

I actually think a ruling in our favor is FAR better than a settlement. Of course, I suppose the settlement could have some big teeth. But even a big cash settlement is not really a huge win for us, as we don't have as much use for cash at this point (as far as I know, unless Sarissa has other ideas).

The bigger issue is winning back the US Market. And I'm not sure a settlement accomplishes that.

@JRoon71, I understand that in your opinion, it would be best for AMRN to settle the HIKMA case as soon as possible, just as many others here think the same way.

https://www.linkedin.com/feed/update/urn:li:activity:7348975408949690368/

Dancing in the dark, My apologies. I didn't intend to suggest that my opinion had any particular validity. I just wanted to point out that Gemini was making an assumption. It was telling us that the opinion of the government would be unchanged. After that assumption it gave details about the legal argument. My point was that this Solicitor General might have a different view on the "careful balance" created by Hatch Waxman.
I don't trust my opinions. I certainly don't trust opinions generated by an AI.
Sleven,

Rather presumptuous for you to prematurely believe you are correct. You may very well be correct; but let's see what the CVSG has to say.

Dancing in the dark, This is my point with AI. It tricked you. You wanted to believe something that was inaccurate. AI told you something. You accepted it. No question. Be careful.
Sleven,

Dancing in the dark, Do you think the former administration had the same agenda as the current administration? Gemini only looked at the logic of the office representing the government. It didn't consider a change in governorship. Does this Solicitor General believe that all drugs should be controlled by generic companie?. Does this Solicitor General believe in the importance of patents and the importance of innovation?
Sleven,

Are you implying a belief that the argument will change when the arguer is a different person? I wonder is there a stronger argument to be made?

JRoon, I can't think of a single reason why Amarin would settle this case. They need all of the generic companies out of the market. That would require the generic label being invalidated by the court.
Sleven,

Dancing in the dark, It doesn't sound like Gemini understands something important. The office of Solicitor General is no longer occupied by the same person.
Sleven,

Zip, I'm not sure I understand your point.
Sleven,

The U.S. Supreme Court is aware that the "skinny label in dispute, emerged as a result of a fraud on the court and the justice system by Hikma, which used a cropped study to show that the Amarin high triglyceride patent should be adjudicated as invalid by the ninth circuit court!

continuing the thread with gemini.

argue both sides, why would the Court choose to take, or not to take, the case?


Show thinking
Of course. The Supreme Court's decision on whether to take the Amarin v. Hikma case involves weighing significant competing arguments. Here is a breakdown of why the Court would, and would not, agree to hear the case.

Arguments FOR Taking the Case (Granting Certiorari)
The arguments for taking the case center on the need for legal clarity on an issue of major national importance.

1. To Resolve Pervasive Industry Uncertainty.
The Federal Circuit's standard in Teva v. GSK has created significant risk and unpredictability for the generic drug industry. Generic manufacturers who follow the congressionally designed "skinny label" pathway to the letter can still face multi-million dollar lawsuits based on how their labels and marketing materials are later interpreted by a jury. This uncertainty chills pro-competitive behavior and makes it difficult for companies to plan product launches, ultimately harming the market. The Court could take the case to provide a clear, definitive rule that all parties can rely on.

2. The Issue Has Not Gone Away.
The strongest argument in favor of review is the existence of the Amarin case itself. When the Court denied certiorari in Teva, it may have hoped the issue would resolve itself. Instead, the Amarin lawsuit demonstrates that the Teva precedent is now the established playbook for brand-name companies to challenge skinny-label generics. Taking this case would be an acknowledgement that the problem has festered and requires intervention.

3. The Executive Branch's Likely Recommendation.
The Court has asked for the U.S. government's opinion via a CVSG. The Solicitor General, representing the FDA and the administration's policy interests, argued emphatically that the Court should hear the Teva case to protect the skinny label system and consumers. It is almost certain the government will repeat this recommendation. Such a strong recommendation from the executive branch on an issue concerning a major federal regulatory scheme carries significant weight with the justices.

4. To Correct a Flawed Legal Standard.
Proponents would argue that the Federal Circuit's standard is legally unsound. It allows a jury to infer an intent to infringe from the very actions a generic company takes to avoid infringement. This paradoxical logic undermines the purpose of the law. The Supreme Court may feel the need to step in and clarify that compliance with a regulatory safe harbor cannot, by itself, be used as evidence of wrongful intent.

Arguments AGAINST Taking the Case (Denying Certiorari)
The arguments against taking the case focus on judicial restraint and the nature of the legal question itself.

1. The Court Just Declined to Hear This Exact Issue.
The most compelling reason to deny review is that the Court denied the petition in Teva v. GSK just two years ago, in 2023. The legal question is identical. For the Court to reverse course so quickly might suggest inconsistency. The justices may conclude that nothing has fundamentally changed since their last decision and that there is no pressing need to intervene now.

2. The Dispute is "Fact-Bound".
The Supreme Court prefers to decide clean questions of law, not to second-guess lower court decisions that are heavily dependent on specific facts. A court could argue that determining a company's "intent" is an inherently factual inquiry. Whether Hikma's press releases, website content, and label changes showed an intent to induce infringement is a question for a jury to decide based on the evidence presented. The Court may see this as a poor vehicle for setting a broad legal precedent, as any ruling would be tied to the specific marketing materials in this one case.

3. There is No "Circuit Split".
Typically, the Supreme Court steps in to resolve disagreements between different federal appellate courts (a "circuit split") to ensure federal law is applied uniformly across the country. However, the U.S. Court of Appeals for the Federal Circuit has exclusive nationwide jurisdiction over patent appeals. Therefore, no split can arise on this issue. While critics argue the Federal Circuit's standard conflicts with the intent of Congress, the absence of a true judicial split makes it easier for the Supreme Court to decline review.

4. The Legal Standard is Not Unworkable.
A justice could reason that the Federal Circuit's "totality of the circumstances" test is a common and appropriate legal standard for determining subjective intent. The ruling does not outlaw skinny labels; it simply clarifies that a skinny label is not an absolute shield against liability if there is other evidence of inducement. From this perspective, the system is working as intended by allowing a jury to weigh all the evidence

credit to gemini.

how do you expect the CVSG would differ from the amicus curiae?



Show thinking
Excellent question. While the forthcoming CVSG brief from the Solicitor General in Amarin v. Hikma is expected to be very similar to the amicus brief filed in Teva v. GSK, there will be critical differences in context and emphasis.

In short, the legal foundation will be identical, but the argument will be sharper and carry a new sense of urgency based on what has happened since the Court declined to hear the Teva case.

Expected Similarities: The Core Argument
The fundamental legal reasoning and the ultimate recommendation will almost certainly be the same.

The Solicitor General's Office values consistency and its position on the core issue—that the Federal Circuit's ruling undermines the Hatch-Waxman Act—has not changed. Expect the CVSG brief to reassert that:
o The "Skinny Label" Pathway is at Risk: The government will reiterate that allowing a carved-out label to be used as evidence of infringement intent creates a chilling effect that jeopardizes a key mechanism for generic competition.
o Congressional Intent is Thwarted: The brief will argue that the Federal Circuit's "totality of the circumstances" test subverts the balance Congress struck between rewarding innovation and ensuring access to affordable medicine.
o Consumer Harm: The government will again point to the significant harm to consumers from delayed access to lower-cost generic drugs.

Recommendation to Grant Certiorari: The brief will conclude, as it did in Teva, by recommending that the Supreme Court take the case to provide a clear, nationwide rule.

Expected Differences: Sharper Focus and New Evidence
The key differences will be tactical and contextual, leveraging the history that has unfolded since the Teva denial.
o The Amarin Case as "Exhibit A": The biggest difference is that the Solicitor General can now point to the Amarin case itself as direct proof of the harm it previously warned about. The Teva brief spoke of potential future harm and uncertainty. The Amarin brief can state that this harm is no longer hypothetical; the Teva precedent is actively being used to block generics, just as predicted. The brief will be tailored to the specific facts of Amarin, citing Hikma's press releases and label changes as the type of "label-plus" evidence that is now routinely being used to allege infringement.

o Argument of Increased Urgency: The tone will likely be more pointed. The underlying message will be that the Supreme Court's denial of certiorari in Teva did not resolve the issue—it entrenched a problematic legal standard. The CVSG can argue that the problem has festered and that the "very permissive" standard established by the Federal Circuit is now the law of the land, creating precisely the instability the government sought to avoid. This makes Supreme Court intervention more, not less, necessary.

o A Chance to Refine the Argument: While the core points will remain, the Solicitor General's office may refine its arguments slightly. It might more forcefully distinguish between marketing a generic equivalent (which is legal and expected) and actively promoting a patented use (which constitutes inducement). It can use the specific facts in Amarin to draw that line more clearly and explain why, in its view, Hikma's actions fell on the permissible side of simply marketing a generic version of Vascepa®.

In summary, think of the Teva amicus brief as the original warning. The forthcoming CVSG brief in Amarin will be the follow-up report confirming that the predicted negative consequences have come to pass, making the call for Supreme Court intervention even more compelling.

I believe also that it was a last ditch effort before they come to the conclusion that they don't want this to go to trial........I also feel that if the Supreme's don't take it up, then Hikma will try to settle....... I think AMRN could accept a settlement but I would want it public and financially painful such that other generics decide it's not worth being in this market.

BBI,
https://www.supremecourt.gov/DocketPDF/22/22-37/260207/20230329144852194_22-37%20Teva%20CVSG%20-%20final.pdf
After the Solicitor General advised the court to grant the writ, how many Justices wanted to take the case?
Sleven,

If I was in the Hikma camp, I would be very happy that the Supremes are asking advice from the Solicitor General. That means they could seriously consider taking up the case. And if they do, it could be bad for Amarin. So I don't think anybody on Amarin's legal team is doing high-fives right now or thinking they have Hikma over a barrel and can get a settlement. Quite the opposite.

@JRoon71, I understand that in your opinion, it would be best for AMRN to settle the HIKMA case as soon as possible, just as many others here think the same way. However the real question is : is it in best interest of Amarin to settle quickly or for them to go to trial? Personally, I am not certain that's the direction they prefer to go after all the costs they incurred , as well as the huge losses they suffered because of this infringement.
Comments from everyone are appreciated & welcome.

Thanks Caddie, I wonder if certiorari request was their last-ditch effort. It's still possible for them to settle before trial.

And I agree, I decision in our favor is certainly more advantageous to us than a settlement. But if Hikma offers a settlement, I wonder if Amarin would accept.

The Hikma hacks are asking the Supreme Court to get involved. They’re not settling. This case needs a precedent set and monetary damages awarded, as well, for the other generics to slither away and close up their anemic business.

In thinking through the Amarin v. Hikma case, am I correct in thinking that it might be in Hikma's best interest to settle with Amarin, rather than risk losing at trial and establishing another Hatch-Waxman precedent? (monetary damages aside)

I don't think IPE can be all that profitable for them, and seems that it could get much worse (with potential tariffs, and the loss of some insurance coverage). So it seems that settling would be in their best interest, especially if they could get Amarin to agree at the right moment.

If they are truly concerned about the fate of skinny labels, it seems that a negative judgment here could impact them beyond just their IPE product.

Does that line of thinking make sense?

And if so, would it make sense for Amarin to agree to a settlement? And if so, how would that impact the other generics?

Zip, I am guessing but not sure and defer to anyone with more knowledge on this, but would Edding have to seek 1) first approval for new formulation;2) and then secondly the national healthcare reimbursement decision?

Zip, agreed. I would expect that the new formulation would be available worldwide.
China is obviously another big wildcard. If we get reimbursement approval there for 2026, this could mean very nice royalties and milestones, like EU.

JR...Although prescription Vascepa has already been approved for private paying patients in China, Amarin is still awaiting the Chinese national health plan approval of payments for Vascepa for its large population in need of reducing incidence of CVD (hopefully in the near future)...I would think that the Amarin agreement with Eddingpharm to market Vascepa in China will soon be altered to also include Eddingpharm's marketing of Lr-Et-EPA in China.

Golf, I think $500+ ($10B) is within the realm of possibility, but most likely only if we roll out Lr-EtEPA. Obviously, we would need to take back the entire U.S. market. But with the current formulation, I don't think that would get us there. We need the NEW formulation. Possibly even a new name and marketing strategy.

This is counter-intuitive, but I actually think licensing away Europe was a positive sign for us. If Sarissa did not have a very strong belief in the strength of re-capturing the U.S. market, I don't believe they would have handed off Europe (at least not yet). There are SO MANY unknowns right now, but I really believe that turning all of their focus back to the U.S. market is a massive positive sign. And I think there is a LOT that Sarissa knows, that we don't yet know.

As far as the stock price, whether the current stock price is $15 or $17 or $20 or $25 is sort of meaningless in the grand scheme (unless you are flipping shares). We're not just going to "float" up to $200 day by day. I think we will get a massive announcement one day, and the stock explodes. But in the short term, I honestly am hoping that they start buying back shares, and would prefer the SP to stay as low as possible for now. This would then make that target stock price much easier to hit.

As a side-note, Europe can still be very lucrative down the road. High-teens royalties are essentially cost-free cashflow, and not much different than the profit margins we would eventually be running over there. And if we DO roll out the new formulation, they could roll it out to our Europe partner as well, and see revenue spike even more.

Well not predicting more asking what people here think will happen. Marzan is on the books saying $520 plus is coming, birdbrain thinks between $100-$200. Lots of variables but if we get US market back with a new formulation skies the limit in my view. We shall see.

AI is rapidly becoming a crutch for people that don't want to do their own research. Some people are using this tool in order to avoid thinking. If you are an investor you need to gather all the information, so you can come to your own conclusion. You shouldn't trust analysts, AI, or other people's options. There is no shortcut to avoid basic research and critical analysis.
That includes TA squiggles.
Sleven,

Hey bullrunner, since you're up so much, can I grab some of that profit to offset my losses? Thanks in advance!

Didn't 

You did hear nay-saying from me. I only wish I had the dry powder to follow your recipe. 

Up almost 6 figures here and soon 7 figures. Where are all the idiots laughing about my buys .36 to .55.

Monk, the AI response was based on the current valuation, not future estimates.

What would make sense is Amarin buying and retiring as much of the $50m at current prices as possible. Buyback limited to 20% of daily volume?

Been tough on AMRN longs but a new 52 week high is always welcome. That's ~140% up from our 52 week low. Here's hoping for higher highs and higher lows.