[Number sleven]

JRoon, First. FDA is the organization that ultimately decides what is and is not on the label. Every generic company has a discussion with FDA, but FDA position remains constant. If you want to read any of the generic labels they are easy to find with Google. Second. No. We needed an overt act of inducement in order to get past the pleading stage. Hikma was cooperative. If the court decides that the label is a "partial label" it would immediately apply to the other generic companies.
Sleven,

[JRoon71]

Sleven, I'm not familiar with the labels of all of the other generics.

And to expand that one step further, if every other generic company has the same label as Hikma, would Amarin then need to sue each generic company to find any relief?

[Number sleven]

JRoon, I ask this question because it relates to prior conversations. All generic labels are essentially identical. If the court comes to the same conclusion as this author, every generic company will have a "partial label" not a "skinny label".
Do a Google search on the difference between the two.
Sleven,

[JRoon71]

Yes. That is why I said I think he agrees with Amarin.

[Number sleven]

https://news.bloomberglaw.com/business-and-practice/skinny-label-legislation-is-a-solution-in-search-of-a-problem
Sleven,

[Number sleven]

JRoon,
"when a generic label closely aligns with an infringing use"
Does that sound like the author thinks this is not a proper skinny label?
Sleven,

[Whalatane]

N7. thx for linking
Kiwi

[JRoon71]

RMB, in reading it, I took his comments to mean that he generally sides with Amarin. Yes, his argument was not overwhelming. But it seemed pretty clear to me that he believed that there was more than enough to at least allow the case to proceed, as the Federal Circuit decided in their reversal.

Here:

This scenario exemplifies the “label-plus” theory of inducement, wherein a generic drug’s label alone, even if it suggests infringing use, cannot constitute infringement because it falls within a congressionally authorized regulatory scheme. However, when a generic label closely aligns with an infringing use and is combined with additional active steps, inducement liability may arise. In my view, the label itself is not part of the active step, but instead creates the underlying fragile conditions that make it easy to induce infringement. In Hikma’s case, Federal Circuit concluded these active steps involved explicitly highlighting parallels to the branded drug Vascepa—such as marketing it as a “generic version” and emphasizing sales data strongly associated with the patented cardiovascular use—while omitting any explicit mention of the label’s carve-out. Note here that this was all at the motion-to-dismiss stage of the case; Amarin has not yet proven infringement but has alleged enough to allow the case to proceed into discovery.

And here:

In a typical patent inducement situation, minor promotional statements or commercial equivalence claims would ordinarily not be enough to constitute active inducement. Here though, we have a quite different setup given the major economic incentives and prescription patterns inherent in our pharmaceutical markets. For me, the issues fall back on the traditional elements of inducement:

Knowledge of the patent and awareness that the encouraged acts infringe;
Affirmative steps—beyond mere passive knowledge—that actively encourage, promote, or instruct infringement; and
Actual direct infringement resulting from those affirmative actions.
In the present scenario, Hikma clearly had knowledge of Amarin’s patents covering the CV indication. Its statements and marketing strategy involved active steps that arguably encouraged the infringement; and we have actual underlying infringement. I think the weakest evidence from the complaint is that that the infringement was a direct result of the Hikma’s actions beyond just selling the product with the label, but that is not the issue before the Supreme Court.

[Number sleven]

RMB, This article isn't about what the Supreme Court might do. It's more about how the issue of induced infringement should be framed. The author is telling us that the label on its own is not inducing infringement however; it is setting the stage for it. He outlined the fact that regulatory speech should not be ignored. Because of the label, it wouldn't take a significant active step to encourage infringement. His conclusion is summarized in the last paragraph.
Sleven,

[rosemountbomber]

Thanks for posting Sleven.  I have only had a quick skip but if I read it correctly it didn't seem to me that the author had a feeling one way or the other how the SG would come down on this. You?

[Number sleven]

https://patentlyo.com/patent/2025/06/infringement-tinderbox-inducement.html
Sleven,

[north40000]

Continued observations of patients in Brave trial were promised earlier this year. Investigators have a phone number at a U. Wisconsin Radiation Center. Cynthia Carlsson was chief investigator. Phone numbers are listed at www.clinicaltrial,gov./Brave or some link like that

[ziploc_1]

JR....Spinal taps and cat scans are more cumbersome and more expensive than blood tests in the diagnosis of AD.....I expect new studies, checking the progress or lack of progress of Tau in the blood, will be done, using these new blood tests....especially on family members of those already diagnosed as having AD.

[JRoon71]

Zip, are there any trials getting started on ALZ research? Obviously BRAVE had little outcome (though I'm not sure it was designed well to produce a positive outcome), but I'm not aware of any other research on EPA and ALZ.

Lr-Et-EPA will replace generic EPA's in the treatment of CVD and Alzheimers Disease

[north40000]

I was seeing share price at $17, now $16.99 pre-market.

[CaptBeer]

Putting things into perspective, I'd say we're doing nicely!

[ziploc_1]

Tatsumaki..."Big Pharma doesnt spend hundreds of millions on the *mab development and approval plus the supporting blood test development and approval to shuffle people over to an existing public domain molecule."

Lr-Et-EPA will replace generic EPA's in the treatment of CVD and Alzheimers Disease...as well as other conditions, which have an inflammatory component.

EPA will become known for what it is...i.e. (an anti-inflammatory molecule, which is safer than a steroid med.

[DMC8]

https://www.linkedin.com/posts/jonathan-provoost-5b02343_advancing-amarin-activity-7345978017531277313-upUq?utm_source=share&utm_medium=member_ios&rcm=ACoAAAappXEBEo5xWglK2bmEx478x0aaRWW4o7I

[ProLiberty]

HLS gained reimbursement in Novia Scotia. Incremental add to revs.

Amarin’s Canadian partner HLS gained reimbursement in Nova Scotia (1m+ population) $AMRN pic.twitter.com/lLQYhcl2IP

— OD Green (@OliveDrabGreen) July 2, 2025

[Number sleven]

North, You are correct, Centene is the parent company of Health Net. Not United Healthcare.thank you for correcting me.
Sleven,

[north40000]

Did Centene (as a parent company) ever have that account?  Centene reduced its guidance for the remainder of 2025 yesterday.

[Number sleven]

Hayward,
https://www.uhc.com/medicare/alphadog/AAUT25HM0255400_000
The parent company of Health Net is United healthcare. I haven't seen icosapent ethyl covered by UHC since the settlement. I can't prove that UHC excluding the generic was part of the settlement. I do have an opinion.
Sleven,

[DAR53]

RMB, The three largest are the UHC, Aetna and Cigna which is over 59%

[DAR53]

Lizzy, yes I agree and it can't happen soon enough. PBM's may have originally served some urpose, but now they make more profits than the drug companies. And, PbM 's are tied to the largest insurance companies with the three largest representing over 59% of the market.

[lizzy241]

RMB, oh the webs they weave. You are correct. But the conflict lies between the pharmaceutical co. and the PBM's which is what the govt is looking into, it's a greedy money grab, and the customers who buy from these pharmacies are clueless about how they're getting scammed. Bring back the local corner drug stores!!

pharmacy benefit managers (PBMs) are not solely owned by pharmaceutical companies. In fact, the biggest PBMs are typically owned by large healthcare conglomerates that also operate health insurers and pharmacy chains, creating vertically integrated giants.

[north40000]

Rmb, if/when FDA acts in the manner I postulate, there would be no Hikma nor Dr Reddy company marketing/selling a prescription icosapent ethyl capsule in the United States. Their respective ANDAs and product labels earlier approved by FDA would no longer be approved by FDA. 

[Tatsumaki]

All the Lilly marketing will be Dr Office->Blood Test->Lilly's drug. It's all the general public and Dr's will ever see. Big Pharma doesnt spend hundreds of millions on the *mab development and approval plus the supporting blood test development and approval to shuffle people over to an existing public domain molecule. It's to sell their drug first. If some generic molecule is at risk of undercutting a newly patented and approved drug system worth billions, the big guys use their leverage in the FDA and media to strangle it.

[hayward]

north4000

I was referring to the health net settlement that was never made public. Sorry for the confusion

Michael

[north40000]

Hayward, where do you see news about Amarin having settled any lawsuit against any generic competitor this year? SEC filing?

[ziploc_1]

Amyloid in the brain can now be diagnosed early in Alzheimers disease by a Lilly p tau test....AD is due to inflammatory changes affecting the brain....now we need a study to show that EPA can delay accumulation of amyloid in the brain and therefore symptoms from AD.

When this condition is treated early with EPA, it can be delayed.

AD is as horrible as it is common.

[rosemountbomber]

Lizzy isn't it mostly insurance cos that own the PBMs?

[Tatsumaki]

It's a catheter-based procedure

Way too invasive for the masses to get the procedure. Test needs to be fast, cheap and easy and minimally invasive like Arterial Elasticity or CT Imaging and do-able early in the process to get people on board early. You're not going on the table for a catheter unless you're deep into CVD already and it's just a matter of "how bad is it". By then there have been other indicators that should have gotten you on the drug much earlier.

Want to see how a real drug co markets a new drug? Look at what Lilly is doing with their new Alz drug. They got the drug approved. Now they're working with Roche to get approval for the blood test for the biomarker (pTau217) that'll tell Dr's the patient should be on the drug. Just another test kit added in the clinical lab. Does the drug reduce pTau217? Irrelevant... the test shows you've got a biomarker for Alz, so get on the drug ASAP. They know Dr's and patients need a measurable reason to use the drug they're delivering that very thing that will help trigger sales.

[lizzy241]

RMB, this week should continue to be slow cause of the 4th wkend. But the chart looks like it may have another leg higher going into the cc which should be fairly upbeat.
Ha, on another note on CNBC is having a discussion about pricing by PBM's e.g. CVS Caremark is dropping lly's GLP-1 and picking up Novo's GLP-1 drug. Double edge sword with these PBM's, I'm sure that's how amarin got the exclusive with V. They undercut the GV's. Eventually, the govt will force pharmaceutical companies to divest from the PBM's.

[rosemountbomber]

You with Amarin there is always a good chance it takes a dump but I am kinda liking this slow and steady rise.  If we can keep rising into higher and higher double digits, I could see where some big move by the company could shoot up the stock price to 100 and maybe beyond that.  Won't happen overnight but maybe 6-18 months down tge road.  Good luck to us all.  

[Johnniegalan]

Tal….you are correct i’m an old timer…made a lot of money in the stock all from the long side…bought institutional size in the last couple of years principally based on valuation (less than cash on balance sheet)…i’m a bull from here…Sarissa knows this molecule and has an open mind..i’m hopeful for the success of new formulation……you sounded like you understand the Patent process and why its taking so long..it seems to me the recent activity shown on the USPTO website at least shows the patent has not been denied…your response suggests you had something to add…now your saying not the case?

[TalShu]

Johnniegelan,

I should like to clarify that whatever SUVI/SDL will post will not be in reply to your post.

You are alias born on 02/13/2013 with a total of 172 posts.

A few were posted in your youth years, then one in the period 2015-2016, and trickles thereafter.

You didn’t express any positive welcome when top line results were published on 9/23/2018; or deception when Du struck the patents; or any welcome for the FDA grant approval. In fact, you had consistently raised doubts and questions and continue to do so to this date.

And now you don’t reveal how you discovered the names of the lawyers and law firm, or enlighten us – for once - with your analysis of this event.

I wonder if you’re a strayed foot soldier in the one-man-basher army animating this board.

[ziploc_1]

The most interesting and most impressive press release from Amarin, detailing the CVS new policy for only marketing Vascepa and excluding generics, will come in the discussion of the Amarin sales and profits figures for Vascepa, which will be released in the Q3 report for 2025.

[CaptBeer]

I think my dog ate it.

[hayward]

CapBeer

Where is the Pr from Amarin ???????

Michael

[SanDiegoLiving]

I'll get a chance to review this in the next couple days. Thank you for your efforts, this is incredible.

[rosemountbomber]

Capt, appreciate all you do and this another example of your great efforts. I only wish that it was Amarin putting this out.

[Number sleven]

It looks like Mr. Wiggam doesn't understand that the price of Vascepa/icosapent ethyl is based on the cost of the API. If you can generate Bioequivalancy with half of the API, the wholesale price of the new product could be substantialy less. The profit margin would be substantialy higher. I think providers would be swayed by this. That's Ralphy.
Sleven,

[CaptBeer]

VASCEPA: Backed by Science. Now backed by CVS. It starts tomorrow!

[rosemountbomber]

North, if this was mandated by tge FDA, would we see that with every PBM?

[hayward]

north4000

Love to see that ! IMO Amrian agreeing to settle these lawsuits without public knowledge to me is criminal ! Make them state that they infringed !

Michael

[north40000]

How about an FDA PR that explains why/how AMRN is back on CVS formulary as exclusive/preferred? That would include information 1) regarding FDA/OCI investigation of at least 2 generics' fraud on the Nevada District Court, 2) finding/confirming from subpoenaed deposition testimony that fraud on that Court does exist, and 3) concluding that FDA withdrawal of its previous approval of the generics' respective ANDAs and labels is warranted/appropriate. 

I reference again a) all sections of FDA Compliance Guide ( CPG) 120.100 Fraud, Untrue Statements of Material Facts, b) Hazel-Atlas Glass Co.  v. Hartford Empire Co., 322 U.S. 238(1944) and 18  U.S.C. 1001.

Such an event tomorrow or in the near future seems just as probable as watching a soccer game played by 2 teams of robots on a soccer field. See NBC-TV tonight, 7 pm news, ~ 7:25 for an early sample of such a game, replete with robots falling to the ground and standing up again to kick a goal.

[alwayswatching1]

One can hope! Should be lots of goods news to finish out the year IMO

[hayward]

CVS Pr tomorrow ?

Michael

[ralphey]

LR-EtEPA A Lot to do About Nothing

While LR-EtEPA may offer marginal improvements over standard EPA formulations, the investment case hinges on a critical bottleneck: payer adoption and insurance coverage. In the current healthcare landscape, even patented or slightly more efficacious products struggle to gain traction if payers perceive a lack of clear cost-benefit superiority.

Generic icosapent ethyl (EPA), the active ingredient in Vascepa®, is now widely available and costs under $100 per month. In contrast, branded EPA products—including any novel formulations like LR-EtEPA—can exceed $350–$400 per month without payer support. Health insurers and pharmacy benefit managers (PBMs) are increasingly applying step therapy protocols and generic-first mandates, regardless of clinical nuance. I am certain PBM's and insurers will NOT pay an extra $150 per month simply for once a day convenience.

Importantly, LR-EtEPA would need to demonstrate substantial, not marginal, clinical advantages—ideally with new cardiovascular outcomes data—to justify any meaningful premium pricing or preferred formulary placement. Absent that, its market access will be severely constrained. Historical precedent suggests that without reimbursement, providers will default to prescribing the cheaper, covered alternative.

Conclusion for Investors: The core value proposition of LR-EtEPA is fundamentally undermined by payer dynamics. The barrier is not clinical—it's economic. Unless the drug can redefine the treatment standard or secure exceptional reimbursement agreements, the commercial opportunity is minimal. This is a classic case where scientific promise is eclipsed by market pragmatism or as Ralphey advised all of you a long long time ago The Science doesn't matter the insurance company does and yet the believers will continue, it is so entertaining and a great study in investor behavior

What Ralphey Says ; Continued Hopes about AMRN being saved by a magical new compound is nothing short of delusional. If you haven't yet learned that PBM'S and INsurers run the show there is little hope for you as an investor

[north40000]

I mis-construed what you intended by use of term "patent heavyweight" in your previous post. The Perkins law firm has previously represented Amarin in its appeal to CAFC from judgment of Judge Andrews in Delaware. The Perkins firm won that appeal in 2024.  Appointment of that firm to represent Amarin in Supreme Court would be expected. Appointment of that firm via a Power of Attorney to prosecute proceedings in an Amarin patent application pending in the PTO is not unexpected. Sticking with an excellent firm with a winning record that is familiar with Amarin technology and legal/management personnel makes sense.