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Deleted - Already Posted...
So now that we have US clarity, it opens the door for Offers and maybe a possible Buy-out... That and Europe are the only silver linings on the horizon less the Patent Infringement Case which will go on for a year or two...
Could be OLD news yet Posted on Yahoo Finance yesterday by SV - well summarized:
GREAT NEWS: UHC creates path for Amarin to RECAPTURE UHC'S ENTIRE USA MARKET, Stockvadar-reports: As Amarin will sue other insurers, they too will be forced to follow UHC
UHC removed all generic & Vascepa from ONLY hyper-triglycerides (Marine study) and has maintained coverage of Vasecpa for Reduce-IT ONLY SCRIPTS. This is great news. Why?
1. UHC easily avoids Amarin suing them for infringement because doctors (script writers) and pharmacies (suppliers) may substitute generic.
2. While Amarin APPEARS TO LOSE (actually they won't) the much smaller hyper-triglycerides market, the BIGGER ISSUE IS UHC has CUT OFF THE GENERICS.
3. Because now UHC will only cover scripts for REDUCE-IT FDA use, it makes it impossible for a generic substitute otherwise it would be clear infringement. By not covering hyper-triglycerides, UHC has also stopped the pharmacy from substituting a generic and expecting UHC to pay, which they won't. So the script holder (patient) will only be allowed Vascepa
4. But here's why Amarin virtually recovers ENTIRE USA MARKET (at least to start with UHC). Doctors can use REDUCE-IT as a heart related umbrella to continue treating hyper-triglycerides assuming they can tick off the check list of heart-related issues, so actually, Amarin recaptures the ENTIRE MARKET WITH UHC.
Look for Amarin to use UHC with other insurers.
Exactly! Love to hear if Amarin is seeking that and if not why!?!
Good question... I do not recall yet the simple fact that we are seeing ZERO growth cannot be blamed on Covid... It's just disheartening to see all of our Profits going to Form 4's and a staff that is just keeping the lights on here in the US UNLESS...
Amarin is taking the tact we all spoke of and that is to NOT build up the US sales so to not enable the Generics until we exhaust all litigation options THEN decide how to or not to build the US!
Thero said he was still going to move ahead and build the US yet that obviously is not the case if sales are holding at 80k!?!
Which do you believe: Covid or a US Pull Back!?!
I say the latter...
Thanks Capt!
I've been invested since 2012. I only have ONE question that keeps popping into my head over and over:
How can we have 600 paid Sales Reps yet never see an increase in Scripts past the locked-in-Mid-80,000's???
Just unfathomable! I can only hope they are 100% Commission-based!
And one of the two Approved include the Boston Bombers appealing their Verdicts! Hopefully that means we stand a chance! Eyeyeye...
CERTIORARI GRANTED
20-443 UNITED STATES V. TSARNAEV, DZHOKHAR A.
The petition for a writ of certiorari is granted.
Louie - (FYI) - The All-in-One link does not work... I deleted mine seeing this one up yet when I click yours, I get an error telling me it was deleted...
Thank you for the follow-up! As you've heard many times already: THANK YOU VERY MUCH FOR ALL OF YOUR EFFORT! If it ended here, I will remember it and always be grateful the rest of my life on this earth! Thank you!
That's the way that page was posted by on Facebook where I grabbed them to create the single PDF...
Marjac: At what point do you get to argue the specific "doctored" and "clinically insignificant" documents used towards Amarins Patent losses? Does The Rule 60 case first have to be "accepted" or will you automatically get the opportunity to argue the noted points in front of a Judge?
I just posted a link 10 minutes ago to a single PDF using your Facebook files...
RULE 60 SINGLE PDF FILE LINK:
https://drive.google.com/file/d/1X7y3QObzCQgCQzFwPFPcWCGN--zHHFas/view?usp=sharing
I can knock it out right now...
Louie... I can take all Word pages, "Print" each as a single PDF page, then with a full version of Adobe, print them as a single PDF document. If you want to Email me all pages, I can do it... johnking29@comcast.net
You can take all Word pages, "Print" each as a single PDF page, then with a full version of Adobe, print them as a single PDF document. If someone wants to Email me all pages, I can do it... johnking29@comcast.net
And how to do you justify a Team holding Sales at 80 - 90k for a year now!?! Absolutely sickening!
IMPORTANT: From "SV" on Yahoo Finance:
United Health creates pathway for Amarin, Stockvadar-reports, to recapture 100% USA MARKET!
THIS IS HUGE PEOPLE, TRULY HUGE!
Breaking Monday, United Health, to avoid abusing the skinny label has decided to:'
Narrow scripts to
=> 150 trig + CVD
This means-- https://www.uhcprovider.com/content/dam/provider/docs/public/prior-auth/drugs-pharmacy/commercial/h-p/COMM-PA-Med-Nec-Vascepa.pdf
Hikma generic just got its can kicked down the road. Any script via UH via Hikma would be a direct violation.
The beauty of this is the parallel to Europe. The EU is going to adopt the same. UH WILL BECOME A USA PRECEDENT that Amarin can press other insurers to do the same otherwise get sued.
No - It is a pre-planned Stock Bonus... He paid nothing for it... Just frustrating as we watch these guys keep taking huge sums from the company while we sit back and hope our paltry share total starts climbing...
Form 4s out: JT grabs almost 500,000 shares x 6.50 = 3,250,000.00 +/- Bonus!
INTERESTING ARTICLE (sorry if this was already uploaded here) - I read that this was posted on Investor Village yesterday:
Justices Urged To Fix Fed. Circ. 'Paradox' In Heart Drug Case
Law360 (February 24, 2021, 7:44 PM EST) -- Inventor group U.S. Inventor is asking the U.S. Supreme Court to take up Amarin Pharma's appeal of the Federal Circuit's decision to strike down six patents on its heart drug Vascepa, saying the appeals court has created a "jurisprudential paradox" in how it analyzes obviousness.
The group filed an amicus brief Tuesday supporting the pharmaceutical company, which argued in a Feb. 11 certiorari petition that the Federal Circuit didn't properly take into account some secondary evidence of non-obviousness when it invalidated six of Amarin's patents covering Vascepa, which is used to treat high levels of triglycerides in the blood.
U.S. Inventor said the appeals court has "consistently overlooked" such evidence — including whether a product satisfied a long-felt need — even though it found that an ordinarily skilled person would have been motivated to modify prior art to get the claimed invention. To the group, this was a "jurisprudential paradox" that could not be squared with the law.
"The Federal Circuit created this preposterous and unstable legal landscape," the group wrote. "The paradox materializes as a one-way ratchet that only operates against patent owners."
Counsel for the parties did not immediately return requests for comment Wednesday.
Since Vascepa is Amarin's only marketed drug, it accounts for all of the company's revenue, according to the company. Amarin reported in regulatory filings that Vascepa had $427.4 million in sales in 2019, predominantly in the U.S. The patents were set to expire in 2030 before the invalidity decision cleared a path for potential generic competition.
The case began when Amarin sued Hikma Pharmaceuticals plc and Dr. Reddy's Laboratories Inc. over their planned generic versions of Vascepa. U.S. District Judge Miranda M. Du, however, ruled in March 2020 that the drug's patents were obvious in light of earlier treatments.
Judge Du said her finding of obviousness was not outweighed by Amarin's argument that there was a long-standing need for a treatment that, unlike earlier ones, didn't cause a dangerous surge in bad cholesterol, and that the industry was skeptical of Amarin's approach.
The Federal Circuit in September summarily affirmed that decision, leading Amarin to lodge a petition for rehearing that urged the court to prevent certain evidence of non-obviousness from being treated as "second-class citizens."
The full Federal Circuit in November denied Amarin's rehearing petition.
Hikma said after the appeals court's ruling that it had received approval from the U.S. Food and Drug Administration for its generic version of Vascepa and was working toward launching it. On Tuesday, the company waived its right to respond to Amarin's certiorari petition, filings show.
The patents-in-suit are U.S. Patent Nos. 8,293,728; 8,318,715; 8,357,677; 8,367,652; 8,431,560; and 8,518,929.
Amarin is represented by Mark C. Fleming, Amy R. Pearlman, Jonathan E. Singer, Seth P. Waxman and Claire H. Chung of WilmerHale.
Hikma is represented by Charles Klein of Winston & Strawn LLP.
US Inventor is represented by Robert Greenspoon of Flachsbart & Greenspoon LLC.
The case is Amarin Pharma Inc. et al. v. Hikma Pharmaceuticals USA Inc. et al., case number 20-1119, before the U.S. Supreme Court.
GSK vs Teva - Having listened to the whole Hearing:
My take on this: Yesterday was just an opportunity for the Judges to clarify the difference between "a clean cut Skinny Label" that is handled exactly as Hatch/Waxman intended for it to be vs. how a Generic can have a "Skinny Label" yet still "Infringe on a Patent" for all of the World to hear and understand. The Judges seemed to want to make sure everyone understands Skinny Labels are alive + well and will always be protected by Hatch/Waxman!
This seemed to be a bit of a Clown Court where anyone listening to it could hear that there was NO new evidence by Teva to say they did not Infringe.
The Judges clearly explained the two interpretations (a properly utilized Skinny Label vs Infringement) and gave the Teva Attorney several unsuccessful chances to show that they did not Infringe. How many times did the one Judge say: "Do you understand why I am asking you these questions?" which was code for: "Give me some reason to be able to overturn the Jury's decision..."
They couldn't...
It felt good to be on what hopefully appears to be an Affirmation of the original Jury's decision...
I did not hear anything yesterday that went in favor of Teva's argument(s)...
The GSK Attorney basically hit a Home-Run in my opinion!
How much would a decent study cost? Count me in if you post a GoFundMe page! I bet you'd get enough to cover one!
Bhatt: Follow here:
https://stocktwits.com/Sggibson86
Du: And keep in mind - Du already said she expects the Generics to Infringe on Vascepa/Reduce-It and she wasn't referring the Marine Patents...
Table Cropping - Just a guess on publically pushing the 'Cropped Table' issue: It boarderlines on Slander and Liable knowing it wasn't proven as intentional or 'intentionally malicious' with the intent to deceive for personal gain... You go down that path and get sued for liable, your in big trouble for economic losses on the Business side... And will it honestly change the outcome? We'll never know! Amarin apparently doesn't believe so nor do their Attorney's.
YES... Per the GSK suit, Hikma will be liable for ALL combined losses from ALL generics sales that Amarin sustains which seems strange YET I suspect the premis is all Drs can read Hikma’s Ads and then pic a 3rd generic. This leads back to Hikma finding them liable for Amarins lost profit...
For whatever it's worth: Short interest is at an All-Time-Low:
10/15/2020 24,611,710
PRESS RELEASE: VASCEPA® (Icosapent Ethyl) Found to Significantly Reduce Cardiovascular Events in Patients with Compromised Renal Function at Baseline in Prespecified and Post Hoc Subgroup...
https://investor.amarincorp.com/news-releases/news-release-details/vascepar-icosapent-ethyl-found-significantly-reduce
Excellent feedback...
Excellent Video: Watch "Vascepa the "Super Fish Oil" - Is it for you?" on YouTube
That's probably the cleanest explanation of the problem that I've read... I call it "say it in 2nd grade English!" Much appreciated!
Excellent Proposal!
I could be wrong yet I read their conclusion/summary to say (in my words) when they found the Patent to be so profoundly obvious, the Judge didn't need to consider Secondary Considerations and the Secondary Considerations would not have changed the outcome no matter how strong they were.
The part of their Conclusion that still haunts me today is where the say if there was "But/For" evidence (their words) the Case would possibly have been reconsidered. They were referring to a claim by Novo where the Generics "accidentally" left out evidence or something to that effect that would have bolstered Novo's case.
The Judges determined that it would not have changed the Obviousness determination meaningthey agreed that they intentionally did it yet it was weak or non-material.
"But/For" in our case (relative to their Summary) meant:
"But For the fact that the Generics cropped the Kubashi study that helped bolster their case, we find in favor or the Plaintiffs!"
AND:
"But For the fact that Judge Du misinterpreted Mori which helped bolster the Defendants case, we are overturning this case!"
The Kubashi example is spot on to the language used in the Closing Summary of Novo.
What they were saying again was had the Novo Claim included bad evidence or an intentional omission of evidence by the Generics that seriously worked against Novo, they would have taken that "But/For" evidence into consideration.
In the Novo case they did not feel the omission of something by the Generics (Novo's claim in the Appeal) would have changed the Obviousness decision!
The cropped Kubashi absolutely would have in ours. It would have taken on less weight which in turn would have made our Secondary Considerations that much stronger!
That's why Singer kept saying the evidence was wrong YET the Judges didn't understand him...
When they asked how "whatever" Singer was saying applied to Novo, had Singer said:
"I am referring to your written comments in your conclusion in Novo that you would have considered "But/For" evidence..."
...I believe that would have opened up a whole new door for Kubashi and possibly Mori to be explained YET Singer missed that chance in both the Appeal and the En Banc submission.
That is why our Amicus is so strong. I just wish it included the Novo reference to "But/For" evidence meaning I wish we used the Novo Appeals Judge's own words against them knowing they wanted some reference back to Novo. I believe they feel Novo is the latest Precedent Setting Case relative to how Secondary Considerations are considered...
If they really feel strongly about having the wool pulled over their eyes, they WILL consider our Amicus Brief!
Kind of like they do here in his NJ Office as well! Bahahahahaha!