[ramfan60]

I saw that as well Rosem......... I filed it under crap as soon as I read the Omega 3 fish oil

[rosemountbomber]

Makes my blood boil when I read sheet like this. And this is a cardiologist. Doesn't he read up on the latest medical data?

"Heart disease is the leading cause of death. A cardiologist takes 3 supplements to lower his risk."
https://www.businessinsider.com/supplements-cardiologist-takes-for-heart-health-omega-3-magnesium-2025-7

Dr. Dmitry Yaranov, the director of the advanced heart failure program at Baptist Memorial Hospital in Memphis, Tennessee, told Business Insider that being a cardiologist makes him extra aware of cardiovascular disease, the leading cause of death in the US.

"I'm always very conscious about my diet," Yaranov said, and that includes supplements to support his heart health. At the same time, he said the list of supplements he takes is "not long," as he tries to focus on supplements that have more research behind them. Supplements "support a healthy lifestyle, but they don't replace a healthy lifestyle," Yaranov said, emphasizing the importance of practicing heart-healthy habits such as regular exercise and a balanced diet. "I think that a lot of times, my patients forget about that." Of all the supplements he takes, Yaranov said omega-3 has the most research backing its heart health benefits.

Found in foods such as salmon, anchovies, soybeans, and walnuts, omega-3 helps support healthy blood cells, reducing the risk of blood clots. It also helps to lower triglyceride levels, a type of fat that can cause plaque buildup in the arteries and eventually lead to a stroke, heart attack, or heart disease.

"I know that for sure, I'm not getting enough fresh, fatty fish in my diet," Yaranov said, which is why he's been taking omega-3 supplements for years.

[JRoon71]

BBI, do NOT listen to Zacks. Those articles are Ai generated, and often contain errors, omissions, etc. There is NO qualitative review on those.

Plus, think about what a "42.5% growth rate" in earnings means for a company with negative earnings. It means Amarin loses ~$45M instead of $82M. This isn't exactly earth-shattering. But the algorithm Zacks uses finds companies with strong "growth rates".

[Birdbrain Ideas]

So the Zacks story says: "Amarin Corporation is expected to have an earnings growth rate of 42.5% for the current year." Aside from getting back CVS, how is that possible? Amarin has had shrinking revenues for the last five years. How is the company suddenly projected to have enormous growth? And who is projecting that. If that were so, wouldn't the analyst who made such a projection raised the company to a strong buy?

[rosemountbomber]

Sleven, I am not sure that at the time the bill was passed, that they appreciated how that balance could be upset.  Their goal was strictly to help facilitate the approval of generics drugs for indications for which branded drugs no longer had valid patents for.  1984 is 41 years ago.  

[Tatsumaki]

Regulatory Capture is a real thing. It's clear the (primarily foreign) Generic Industry spends big to get their allies into key FDA positions to push their agenda. Don't think for a minute the Courts are immune to this. All under the sales pitch of "cheaper drugs for Americans" to make it politically digestible for the voters.

[Number sleven]

RMB, I'm going to ask you directly, what is the balance that Hatch Waxman claims to achieve? A skinny label takes the entire market. That isn't balance. FDA wants to protect ANDA labels from litigation. That pushes the scale even further away from balance. This could be what the Supreme Court wants to address.
Sleven,

[DMC8]

https://finance.yahoo.com/news/3-strong-buy-breakout-stocks-190000945.html

[rosemountbomber]

You are not wrong, but I am just commenting on the stance the FDA is proposing in their FY25 proposals.

This is an aside comment, but I still think one of our best shots was the Marjac/North case, but for some reason Amarin did not join the effort and by doing so, basically doomed the case.

[Denisk]

Yes but Hikma didn't just infringe on the skinny label, they also lied and withdrew pertinent information to the case from Judge Du in their court filing, etc. Am I wrong or what? Your comments are appreciated.

[rosemountbomber]

Well, so much for this Admin being pro-patent, pro-innovators.

[Tatsumaki]

https://www.fda.gov/media/176924/download
Here's the FY25 proposals. They're pushing for a lot of pro-generic changes to law...

It clearly shows you what "side" the FDA is on. It's certainly not on Brand manufacturers.

[Tatsumaki]

https://www.fda.gov/media/166049/download
Page 3.

Just the FDA proposing congress pass law to make skinny labeling a safe harbor from infringement...

FDA is proposing that the provisions the Hatch-Waxman Amendments and the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) added to section 271 of title 35 of the U.S. Code be amended to create a safe harbor from patent infringement liability for human and animal generic drug applicants and 505(b)(2) applicants who market a drug with “skinny labeling,” by excluding such labeling from the evidence that can be used to support a claim of patent infringement, and by clarifying that statements regarding therapeutic equivalence cannot be used as evidence to support an infringement claim.

[Number sleven]

Denisk, That is the issue at hand.
Sleven,

[Number sleven]

JRoon, That's close. Hikma could file a motion to stay. Amarin would then file a motion in opposition. The motion to stay can be granted by the judge that issued the order or a higher court. Amarin does not file an injunction. Injunctions are issued by the court. Judgement of a jury and district court is considered final until a higher court rules otherwise. While Amarin and Hikma fight over the motion to stay, Hikma isn't allowed to sell it's generic product.
Sleven,

[Denisk]

So, my question is: if a patent cannot be enforced & protected from infringing use, what is the incentive for a brand company to develop, research & develop new indications for a drug, and spending millions of $$$ in the process?

[JRoon71]

Yes. If we win, and there is an appeal, Hikma could file a motion to stay the enforcement of the judgment. Amarin could file an injunction to enforce the judgment during the appeal. Hikma could file a motion to stay their injunction, etc.

Basically, this could get all wrapped up in motions. But ultimately, we would need the court to grant the injunction and enforce the judgement in our favor during any appeal, because the appeal could take years.

[Number sleven]

JRoon, Yes you can. Do you understand what an injunction is? At what point in time it occurs in civil legal procedure? How it's different from a preliminary injunction? I'm not trying to be a smart ass. The questions are honest.
Sleven,

[JRoon71]

You can appeal an injunction

[Number sleven]

JRoon, There is no such thing as an injunction hearing.
Sleven,

[JRoon71]

OK..."injunction".

And then I'm sure Hikma would drag out the hearing for the "preliminary" injunction after the SC hearing. And then they would drag out an injunction hearing if they lose the case and request an appeal.

It's exhausting thinking about how long this thing can drag out for. But becomes very clear why lawyers like to drag this shit out.

That's why the GSK v. Teva case will not die.

But ultimately, as long as we can re-capture the U.S. market in a reasonable amount of time, they can drag it out forever if they would like.

[Number sleven]

North,
https://irlaw.umkc.edu/cgi/viewcontent.cgi?article=1226&context=faculty_works
Sleven,

[Number sleven]

JRoon, I think we are having a terminology problem. A "preliminary injunction" is an order filled by a judge before final adjudication of a case. An "injunction" would be part of the final judgement. If Amarin is going to request preliminary injunctive relief, it would most likely happen after resolution of the Supreme Court appeal. Amarin would need to show that winning the suit was probable. I think Amarin would have a shot at this kind of relief. Hikma made the mistake of advertising directly for our patent protected CV indication.
Sleven,

[Number sleven]

RMB, Got it. If the Supreme Court thinks that section 8 is being interpreted in a way that creates a legal catch 22, they might want to clarify the issue. This could be good for us. Hatch Waxman makes it difficult to enforce method of use patents. If the court agrees with Hikma, they would in essence be invalidating that class of patents. At least for the pharmaceutical industry. We established an overt act or active steps. Hikma told doctors that they should use the generic product for our CV label. That is the requirement for induced infringement. Would the court want to eliminate the legal concept of inducement? I doubt the court would want to go in that direction. That would create more problems.
So I ask the question, Why would the court consider hearing this case?
Sleven,

[JRoon71]

Sleven, that's exactly what I was saying. And you said that could only happen during a trial. Now I'm confused.

[Number sleven]

JRoon, At the end of the short jury trial, assuming that the jury finds for Amarin, the judge would most likely issue an injunction against Hikma. That injunction would bar them from any further infringing action.
Sleven,

[Number sleven]

North, Yes. When I used the term, "districts" I wasn't referring to district court. I was referring to the different circuits. How would this case qualify as a Hatch Waxman litigation?
Sleven,

[Birdbrain Ideas]

Your analysis of the potential for the Supreme Court to take up the case is the most informed I've seen yet. It would truly be a diversion from usual practices to take up a case like this at such an early stage when all the claims made by Amarin are supposed to be accepted as true.

[north40000]

The Supreme Court doesn't review "districts"; it does review conflicts between Circuit Courts of Appeals. The CAFC has been in existence since 1982, and has had exclusive jurisdiction to review district court decisions in patent matters since then. Perhaps the Supreme Court sees a discrepancy between panels of the CAFC in how to determine active inducement of infringement issues arising under 35 U.S.C. 271? Perhaps the Supreme Court wants to review the panel's observation that the present case is not really a Hatch-Waxman case?

[Monk4444]

I’m at CVS right now
Guess what’s in stock?
GV

[marzan]

When is the ER date? Has it been announced or scheduled already?? TIA.

[marzan]

Very well articulated! Thanks!! The HW Act has been consistently abused by the generics; wish SC takes up the case and draw a line.

[rosemountbomber]

Agreed Sleven, I poorly worded that.  I meant why hope for the SC taking it up. 

[JRoon71]

Sleven, thanks. I also believe you can file a PI after judgment, but while the appeal is in process (prior to the appeal judgment).

Obviously they could file a PI during the initial trial, but I would assume the hurdle is a bit higher to have that granted.

[Number sleven]

RMB, It isn't a chance we are taking. It's a decision for the court. Amarin has presented a good argument against the court hearing the appeal. My question is academic. If the Supreme Court decides to hear this case, what would be the motivation?
Sleven,

[rosemountbomber]

Don't know whether it would be better for the SC to take the case or not, but I can say that the worst thing would be for them to take it and we lose.  So why take the chance?

[Number sleven]

JRoon, A preliminary injunction isn't a legal action that occurs after a ruling.
https://www.law.cornell.edu/wex/preliminary_injunction
Sleven,

[JRoon71]

Sleven, I get what you're saying. And I don't REALLY know whether it would be good or bad for us.

[JRoon71]

Michael, I don't disagree with you. But...lawyers can be creative with their defenses, and you never know how juries will respond.

I guess my only point is we can't just assume this is an open and shut case, despite how strong our position appears.

Just look at GSK v. Teva. They're 11 years in, still going, and I'm not sure GSK will ever see any award money from that, due to appeals and lack of an enforceable judgement. And none of the generics ever stopped selling the generic medications (the patents expired during trial, so we'll never know what would have happened).

So, I am sort of torn about how I would like to see things go...a couple hundred million in 5 years isn't going to do much for us. I would like to see the trial go fast and the judgement have teeth (not just monetary damages)...and possibly a PI in the interim (post-judgment, while appeals are being filed, etc.). I think the prelim injunction is the only way we see relief in a timely manner. This may also force the hand of the other 7 generics. Otherwise, we might as well just be waiting until the new formulation is commercialized in order to start marketing again, and get the U.S. market back. Remember - until we start marketing again, there's a pretty low revenue ceiling, even if we have the entire market.

[DMC8]

https://www.tipranks.com/news/company-announcements/recordati-updates-on-share-buyback-program-execution-14

[Number sleven]

Captain, I think the ruling does more than threaten section 8 of Hatch Waxman. Section 8 has been used, by generic companies, to nullify valid patents. I don't think that was the intention of the act. This is a vague notion and not really a legal argument. Since 1984 Hatch Waxman has been used to prevent enforcement of "method of use" patents. The intention was to prevent the practice of evergreening.. In order to move past the pleading stage, it is a requirement to show an "overt action" that promotes inducement. I think Amarin has done that. Do you agree? I think the real question before the court remains unspoken. Does the Hatch Waxman act give generic companies the legal authority to supply their product for all indications of a branded drug? That has been the practice.
Sleven,

[DMC8]

Icosapent ethyl modulates circulating vascular regenerative cell conte... https://t.co/Mw2PhToxfF

— Subodh Verma (@SubodhVermaMD) July 10, 2025

[DMC8]

https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2025.1631841/pdf

[CaptBeer]

Hikma argues that CAFC's ruling threatens the Section VIII Carveout provision of the HWA and needs to be settled sooner than later. Personally, I don't see the urgency and I don't believe the SC sees it either. 

[Number sleven]

TCI1, Can you give a reason why the Supreme Court might take the case? I think that's what I'm interested in.
Sleven,

[Number sleven]

TCI1, I can't argue with that. I'm wondering if I have missed a legal discrepancy between districts that would warrant Supreme Court involvement.
Sleven,

[ramfan60]

Keep up the good work SDL!

[SanDiegoLiving]

DEFINITIVE PROOF OF THE CVS CAREMARK WIN/RETURN TO BRANDED VASCEPA

https://stocktwits.com/SanDiegoLiving/message/621243547

[TCI1]

I just can’t see any chance the SC takes this case as it’s at such an early stage (motion to dismiss), the merits or otherwise have not been argued in court or appealed.

The issue at this stage before the SC is regarding the correct application of pleadings at the motion to dismiss stage. The case reaching the SC is not about infringement or section VIII carve outs under Hatch Waxman. Asking the solicitor general for a response is par for the course and not at all indicative of willingness to grant certiorari.

[Chromosome]

Sorry looks like Sleven had already posted…