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KIWI...
I did not want to post my hedge because I thought it might spook some of the Amarin holders...
The truth is I am trying to cut the chord with Amarin...It is still my biggest position, but I want to head in a different direction..I can not deal with this legal nonsense.
I felt right at home with the medical issues and the science. I was confident with my decisions even in the cases where most other people were betting the other way...I did get burned by Du's decision...My idea of reasoning did not mesh with the what happened in the trial..It has left me bewildered and shaken..with a feeling the trial was straight out of Alice in Wonderland...
I am selling more of my Amarin and buying TAAS, and 5G stocks...
":>) JL
HinduKush...
Quote: Legal question: does not de facto inducement to infringe on legal R-IT Patents ( acknowledged by J Du and therefore able to be considered by AC) without real legal recourse to relief not form a genuine basis for urgent appeal consideration- aside all the factual and procedural errors we have found on this board...?
Not qualified to answer that question.
":>) JL
Ex...
Sounds like you are a real optimist..You only left out the part when the Asteroid hits..Sell and mosey on down the yellow brick road..Not molten last time I looked.
Probably safer to call this a coin flip..Du made a few errors..messed up the facts... did not follow correct procedure... and neglected important secondary consideration which will weigh in...Total statistics for appeals include trials where the appeal was not accepted for appeal by the Appellate court..That is an important fact..I think Amarin has been accepted and that gives us over a 50% chance of prevailing...
":>) JL
raf...
Thanks..Not sure I can get through the entire information..I don't know how much of Du's statements regarding infringement come into this situation..
It seems it is much more complicated than I thought..
Thanks anyway..the first three paragraphs gave me a splitting headache...
":>) JL
marzan...
Nice post....
Quote: "In the meantime, Judge Du will be sanctioned, imo, for her horrendous act,".
Yes...Even though criminal charges would be more appropriate...
":>) JL
Hamoa...
As a layman I believe both sides will stipulate Judge D. made a factual error in asserting that there was a statistically-significant difference BETWEEN the change in Apo B levels for the EPA and control groups.
What I have learned from your posts and others who know the law..That making a factual error is not enough to result in reversal of the district court's opinion...But will be weighed against the entire body of evidence..
My theory is that Judge D's verdict will be overturned because it leads inevitably to the infringement of Amarin's valid R-I patents..
In the real world..FDA allows (encourages) doctors to use drugs "off label"..Vascepa has two separate indications..One is the MARINE indication which is for very high triglycerides 500-1500mg/dl which is a risk factor for pancreatitis...The second indication is to lower event risk for CVD events in patients with risk factors for CVD events including those with Type 2 diabetes..Judge D's verdict is narrow because she is only considering the first indication (MARINE)...She stipulates that using Vascepa for the R-I CVD event risk would infringe on Amarin's patents..
There is a serious flaw in her decision because she does not offer Amarin any protection against the inevitable conversion of the MARINE Vascepa scripts into R-I scripts..She does not understand that this conversion does not even require the participation of the generics..It will occur as certain as snow in January...
The judge did not think about this unintended consequence ..Her intent was to give the generics the MARINE indication based her opinion that Amarin's MARINE patents are invalid because they are "obvious"..but in the real world she has given the generics the R-I indication also; and she has provided absolutely no rationale for that and in fact during the proceedings she specifically stated that if the generics encourage physicians to write scripts for the R-I indication that would be indirect infringement by inducement of Amarin's patents..
I am a layman...But I can not see how this decision can be be correct.
":>) JL
Jas...
Quote: .JL you have any to add?,,,,
Sure...DES, Herpes simplex, cold sores and genital* cervical cancer.... Accelerates wound healing after injury or surgery..cardiovascular disease including stroke. Clincal Depression...Possibly/probably Alzheimers..Recovery after exercise..Recovery after head trauma. Canker sores..T2 DM...
.Slows all degenerative processes related to aging...and probably other conditions not considered ....Good stuff...
":>)JL..
concapk...
Grow up...You are full of it...
1) I started posting on the Yahoo board in Nov 2010...Ask Kiwi...I switched over to Amarin Ihub because the Yahoo board was out of control when I moved to Ihub there were only about five posters..A lot of yahoo posters followed me over here.
2)My losses are not from my initial investments in Amarin...My losses are against what my investment was worth before the judges decision...and what is was after...I am still ahead on my Amarin investment..
3) I attended the AHA annual scientific meeting where the R-I results were presented..I was sitting in the second row behind Dr. Bhatt and before his presentation I ask him if I could take his picture and he graciously allowed me to do that...He also asked me before his presentation what I thought the results would be and I told him the I thought the results would be great. Please checkout the picture I took at the meeting
4) I have talked to Elisabeth (the company) many times and sent her info that I thought was helpful..Sorry I did not run it through you..
You are not my boss and and I am not responsible to you..You are calling me a liar and you have not a shread of evidence to back it up..Any more comments or posts like this one and I will report you to Ihub and have the the Admin ban you..You are a creep who doesn't understand no one on the board has to answer to you..
":>) JL
marjac...
Same feelings here..A nasty crooked biatch...A disgrace to the legal profession..The FBI hates her too...
":>) JL
HK...
Seems all the Marine patents were invalidated by Judge Du..So I'm not sure where they fit into this story...I do not know if patents are needed for an ANDA. Don't think so..The judge did not invalidate the R-I patents. Amarin might want to embark on generic marine drug..Particularly if Amarin can produce and sell generic EPA for less than the generics can.
That's one strategy,,,dissenters might argue generics have other drugs they could draw revenues from if a price war broke out...That could be possible but it may go along way of taking the juice out of the Vascepa fruit..and might influence the generics to decide to settle..
IMO Judge Du will be reversed by the appellate court because her decision will induce indirect infringement by inducement of Amarin's legit R-I patents..That to my non legal mind seems obvious and will not change as the appellate can not introduce new evidence and Du has conventionally...laid out the road map of how generics, physicians and drug plans will infringe indirectly by inducing infringement on Amarin's R-I patents..
":>) JL
Nick..
All excellent points....The corker here will be the indirect infringement by inducement to the the doctors and the drug plans.
Fact is she underlined this issue in her comments and decision..But it turns out she will be the biggest inducer of all..How can the court decide that it is OK to infringe on Amarin's patents that have not been invalidated..
And no the court can not come back and decide the R-I patents are also invalid..because the appellate can only base its decisions on material considered in the district court..And Judge Du made a huge blunder by agreeing on the indirect infringement by inducement was a real thing..
Too bad she did not deny infringement along with obviousness..That would have really screwed Amarin...But she did such a half assed job all around.
She also blew that one..
":>) JL.
alm2....
I'm going to say it..The bet is the Appellate court is going to reverse Du and this is an asymmetric bet going the right direction unlike the district decision which was an asymmetrical bet going the wrong direction. There is no point in hedging here...the PPS will not go under $4 and will recover to a higher level than it is right now..Even on the remote chance Du will not be reversed.
IMO..The Appellate will reverse Du's judgement not because she made errors of fact. Not for secondary conditions which were ignored.and not because she used incorrect procedure.
She will be reversed for the stone cold fact her decision can not hold up because it induces infringement on Amarin's patents..She will be hung by her own reasoning...By agreeing generics using Vascepa for over twelve weeks would constitute indirect infringement by inducement. The thread here is generics can not legally use Vascpa for the R-I indication but only legally for the Marine indication....and then she does not understand that her decision leads inevitably to the same place...
Generics don't really care about the MARINE label...It is small and vague..The generics are after the the Dec 2019 post R-I label...Which could turn out to be the biggest drug in the world..The fact is the generics can get this simply by "Off labeling"..for the post R-I label. But there is a catch here and that is Judge Du has already said that if the Generics use Vascepa for the R-I indication, then they are indirectly infringing on Amarin's patents by inducement..So by her own reasoning her decision can not stand as the court would be inducing infringement on Amarin's valid R-I patents.
":>) JL
Kiwi...
jessellivermore Member Level Tuesday, 02/11/20 03:27:06 PM
Re: slimhere post# 183 0
Post #
184
of 225
Hi slim...
The INSG ihub board is such a relief from the Amarin board...Like a gentle breeze through the maples on a warm fall day in Vermont...Amarin is like a blast of arctic Air coming off the ChukChi...Dark and dangerous...
I am becoming very stressed as the never ending tale of Amarin creeps like some tardy gaited mutant, so slowly across the landscape..
I bought more INSG today...No FDA...no Generics...no buyouts..heaven on earth and bring on 5G in all its forms..
":>) JL
Kiwi...
jessellivermore Member Level Tuesday, 02/11/20 03:27:06 PM
Re: slimhere post# 183 0
Post #
184
of 225
Hi slim...
The INSG ihub board is such a relief from the Amarin board...Like a gentle breeze through the maples on a warm fall day in Vermont...Amarin is like a blast of arctic Air coming off the ChukChi...Dark and dangerous...
I am becoming very stressed as the never ending tale of Amarin creeps like some tardy gaited mutant, so slowly across the landscape..
I bought more INSG today...No FDA...no Generics...no buyouts..heaven on earth and bring on 5G in all its forms..
":>) JL
Kiwi sorry I did not post but this is not the first time I have hedged..Last time I bought puts and did not use them...If you doubt I sold and bought INSG Check out "Slim Here"...
":>) JL
KIWI...Its not all about cheerleaders. (edited view)..
If you can not understand why what this judge and perhaps the appellate court is doing is fundamentally wrong then you have no moral compass..
There is only one name for it and that name is THEFT...The REDUCE-IT trial did not fall out of a tree...And I feel certain the FDA when it gave Amarin instructions on what they wanted the company to prove...Did not do so with the idea someone else other than Amarin would get the payoff for running the trial...
All these psuedo lawyers who think they are so smart and the rest of us are so dumb and SA**** with all he pretension...I get it, The way this works is not very difficult to understand..What this genius does not understand is that is if this Judge's decision survives the appellate court and they agree with her in total...Then this is the crime of the century...
The H-W legislation almost guarantees this will not happen but there is a hole in the legislation that generics can subvert the exclusion periods by invalidating the patents..I'm not sure how many times this has happened and would like some of you legal beagles if you could estimate how many times this has happened..
Amarin's lawyers should point out the Generics are pulling a ruse here..They can have little interest in splitting the MARINE indication with their brothers.The value is not there...the defendants are using a trick to gain the much more valuable CVD R-I indication. the ruse utilizes the fact that doctors and drug plans can prescribe off label and since they know Vascepa is safe and effective for treating CVD events and lowers event risk. The generics true imtent is to use an end run around Amarin's R-I patents, by off labeling for the REDUCE-IT indication which the the judge has already determined prescribing Vascepa for the R-I indication will be infringe on Amarin's R-I patents...This should be one of Amarin's strongest arguments against granting Judge Du's decision..If the courts can not protect Amarin's legitimate patents and the court's decision infringes on Amarin's R-I patents..How could Du's decision possibly be legal.
":>) JL
KIWI...Its not all about cheerleaders.
If you can not understand why what this judge and perhaps the appellate court is doing is fundamentally wrong then you have no moral compass..
There is only one name for it and that name is THEFT...The REDUCE-IT trial did not fall out of a tree...And I feel certain the FDA when it gave Amarin instructions on what they wanted the company to prove...Did not do so with the idea someone else other than Amarin would get the payoff for running the trial...
All these psuedo lawyers who think they are so smart and the rest of us are so dumb and SA**** with all he pretension...I get it, The way this works is not very difficult to understand..What this genius does not understand is that is if this Judge's decision survives the appellate court and they agree with her in total...Then this is the crime of the century...
The H-W legislation almost guarentees this will not happen but there is a hole in the legislation that generics can subvert the exclusion periods by invalidating the patents..I'm not sure how many times this has happened and would like some of you legal beagles if you could estimate how many times this has happened..
What the appellate court should consider is the Generics are pulling a ruse here..They can have little interest in splitting the MARINE indication with their brothers...But are using a trick to gain the much more valuable CVD R-I indication by utilizing the fact that doctors and drug plans can prescribe off label and since they know Vascepa is safe and effective for treating CVD events and lowers event risk. The generics are planning an end run around Amarin's R-I patents which they definitely will be infringing on..This should be one of Amarin's strongest arguments of unintended consequences of granting Judge Du's decision..If the courts can not protect Amarin's legitimate patents and the court's decision infringes on Amarin's R-I patents..How could Du's decision possibly be legal.
":>) JL
ilove...
quote..."she recognized the value of Reduce-it, but didn't consider it relative. because it came after the period under litigation"
... OMG this is the stuff that just burns my butt..That line just sums up what's wrong with the law... We are living in the period after the period under litigation...We burned up ten years confirming the value of the R-I indication..The generics are stealing the sale of Vascepa after the period under litigation..The teeth of the decision are biting us today..And so is her litigation judgement...We can not change the past..Her trial is about the future..not the period of litigation..
":>) JL
dukess...
Save your words.. the guy's a DB..You see his message to me..
":>) JL
ilove..
Nicely put.
":>) JL
raf...
"Has a single poster argued the opposite (that it GENERALLY is easy to overturn a case)? " LOL.
Well it must be the case according to SA6174 or one of the numbers.We are all a bunch of Dummies and I am the dumbest..
Why make outrageous statements...example "No on on this board was neutral on the district decision". Guess he never bothered asking me (I understand..you don't need the idiot's opinion)..Or the opinion of several of the lawyers here who did caution posters that the the decision could be for the generics..But why kill a good headline with the facts...
I actually dumped 40K shares prior to the decision..Not enough to save me from a major loss...But KIWI will verify that historically I have not done a lot of hedging...In this case I should have done a lot more.
For what its worth I invested the proceeds in Insego (INSG)..Which is doing very well...So I am still driving the NSX,,
":>) JL
AMRN invest...
The point here is that regardless of Judge Du making a factual error..It may or may not figure heavily into the Appellate Court decision..They will consider the entire RENO trial in its full scope and weigh all the factors including the fact Du misread the APOb results... But that is just one factor..The fact is there is no formula here, but it is up to the three judges to weigh factors such as procedural factors, Importance of the discovery, secondary considerations, such as effects on the future of cardio vascular disease. (Generics will do no research and Amarin will probably be forced to end its research projects..Effect on the pharmaceutic al industry..and more...
So trying to handicap this appeal...is close to impossible
":>) JL
LBL...
I don't think anyone on this board thinks the appeal is a slam dunk..We learned a bitter lesson from the Du trial..And that is despite what Aristotle said about the law being reason free of passion.. Reason can be thrown under the bus if the judges are not impartial..
Even an idiot like me can understand that..Of course we all thought the Reno trial was a slam dunk because we knew the facts including patent situations..What we did not know and what would have changed our estimates on the Reno trial was that a biased judge can minimize the evidence on one side of the argument if does not support her preconceived notions and enhance or even lie about the evidence that supports her notion..The trial can be rigged..
Same thing can happen at the appellate court...The rules are convoluted and don't follow any definite formula. They are "subjective" and vary from judge to judge..Pick your precedent.
Well that is just beautiful (sarcasm)..And yes even morons like me can understand that. Not different than robbers divying up the loot.
":>) JL
Venus...
Quote: The tragedy of the law is not so much Judge Du's ruling invalidating the marine patents but the law NOT taking into account that this ruling "effectively" allows the generics to infringe on the Reduce-It label.
Oh but SA8717 or (whatever number) thinks that is fine and dandy..But what do I know..I'm just an idiot and he is genius..
Hard to believe that most of us who thought the trial was a slam dunk..We were stupid enough to think the decision would be just and equitable.And not just a biased judge's opinion and bunch of false statement to back up that opinion. But I am just an idiot..
":>) JL
Logical...What is logical about Du having the right to to base her decision on a factual errors..You do not need to lower yourself ...There were plenty of people on the board that were neutral Its just Du wasn't neutral..Copying and pasting the defendants arguments on her comments..When people make errors that always in the same direction makes me wonder about impartiality..
It was me just not agreeing with you. I was not calling you stupid..or making other derogatory comments...My comment is in general for the whole court process..If you actually think Du's decision was the correct one then you are twisted..What have the Generics done deserve to steal Amarin' property that has been gained over a decade of hard work and millions of dollars and was sanctified by the both the patent office and the FDA..
You are pathetic..like I really care what your opinion is all about..You calling me an idiot just proves how stupid you really are,,Get over it
":>) JL
SA6175
Quote:
"But in my opinion, as between the generics and AMRN, I would rather be in the generics shoes. At the time of the trial too many here keep reading trial updates from people who were NOT neutral. For the life of me, I could not find ANY trail updates that were from NEUTRAL sources or from sources favorable to the generics."..
There is more than one way of interpreting this information..Your take on it is that this is largely confirmation bias...But equally possible (and IMO more likely)...The opinion Amarin would prevail was due to factual information...ie there was not any good reason Amarin should not have prevailed...The wild card here, as I have posted earlier, was the crazy judge who violated the first principle which is to be impartial..But lucky for her...Principles of fairness and decency are not adhered to in the legal system.
As a lay person it is very difficult to swallow the proposition that these learned judges in their robes..think like four year olds..and follow precedence blindly even if they are not germane to the situation..Or support ignorance and false conclusions simply because the judge before them made mistakes..That type of reasoning is an anathema in medicine and will get you sued and lose your licence.
Shame on you..Wonder why so many people hate lawyers
":>) JL
zip....Well put...
How could we have been so stupid as to think the US PTO was the final authority when it came to patents...And the FDA's opinions were just pure trash.. Judge Miranda was who we needed all along...And now we find out it doesn't even matter very much that she misread the situation or got her facts screwed up...She's a federal judge and the fact she is (OBVIOUSLY) a moron is irrelevant...
If this is America...a country that my father and mother died for and I spent a year of my life in Vietnam for...Then I am disappointed and ashamed of being an American. If this Amarin situation passes for justice..This is more like Russia under Stalin where truth has long flown the coop..
Nobody who is a federal judge can be this stupid. This has to raise a suspicion that someone got paid off. And we should call for a federal investigation into this judges obviously flawed decision..
":>) JL
Quote;...
Successful gambling requires the bettor to understand what he is betting.
on..
Example...The odds of losing the first patent trial were not related to the strength of our argument...vs the strength of the generics argument..The outcome of the bet was determined by getting a judge who was careless; not impartial: and favored the generics..And under those condition our arguments were irrelevant...
As gamblers we are betting if we get an appeal. The judges in the appeal trial will consider the secondary issues such as future benefits from continued medical research on the drug by the Brand company. Something the generic are not equipped to do...and other considerations along with the procedural and factual errors framing Judge Du's verdict will be enough to reverse her...Ans I believe that will be more likely to be the case than the first trial was to be a victory...
If the Appellate Court does not reverse her...Then woe to live in America because the law is an ass.
":>) JL
Sabre....
Most calls do not pay off even in companies that are wildly successful..That's why selling covered calls..Is such a successful strategy so much of the time...
":>) JL
metsfan...
Excellent post...I am not a lawyer and don't think like a lawyer..
Quote from metsfan's post) "5) **My assumption** Amarin is in the process of ramping up R&D of icosapent ethyl by investigating other uses (pointing out the BRAVE study for Alzheimer's Disease, any COVID-19 studies, and other potential indications such as DES). This decision will cause Amarin to drastically cut R&D in the US, with a potential "significant negative impact on public welfare" by affecting these other patient groups."
Could this issue be considered a secondary consideration. Ie. unexpected consequences .The generics are not designed to do continuing research on possible new breakthrough indications for Vascepa...And with the loss of USA revenues (due not only to the loss of the high trig indication but the loss of the R-I indication by off labeling). Will put Amarin in a position where it will lack the resources and the motivation to continue to developing new and very important life saving indications such as Alzheimer's...And the court would be doing a terrible thing to the people of the world in preventing this research to continue. Particularly considering judge Du's verdict is rife with factual errors.
I would compare a vote at the appellate court to sustain Judge Du's verdict as no different than Cyril's decision to burn the great Library at Alexandria...
":>) JL
Jas...
Quote: "How could Leland Gershell know in advance what would happen - which he did' - 7$ - and 'Sell' - when every other Analyst were at target 35 - 55$"
------------------------
Ans: He didn't...This guy is no genius..He also put a $7 target on Acasti..And how did that work out..Gershell is a moron. Unfortunately so is Judge Du...Either that or she is a criminal...I think the company should spend some of its multi millions on investigating her.."Guilty feet aint got no rhythm."..
":>) JL
new...
Excellent thinking...I was there and nothing was obvious..nothing was even close to obvious..94% of cardiologist polled at the 2018 AHA annual scientific meeting..Did not believe that Vascepa who seriously impact CVD event risk in a positive way...They were completely surprised by the R-I trial results..and these are people who should know the most about whether EPA was obvious or not...
Why do these effing lawyers get to make these ridiculous conclusions..
Du is a moron..a disgrace...
":>) JL
My day in Federal Court...
In 1999 I was the lead plaintiff in a shareholder action against Tower Semiconductor...The firm bringing the suit was the famous and later infamous Lawfirm Milberg Weiss...Which was the biggest lawfirm and the most famous firm specializing in Shareholder lawsuits..Without going into detail T-Semi manufactured chips and HP was their biggest account..Amounting to roughly 80% of their revenues...In a case eerily similar to Michael Crichton's novel "Disclosure." Though they advertised that they were the foremost chip manufactures in the world...They were having trouble making the HP chips..
The problem was they did not let the shareholders in on that little secret. Meanwhile some of the exects and the CEO were unloading their positions..
Then one afternoon after 4PM they came with the announcement HP had cancelled their contract..The stock dropped from the twenties down to below $10 and kept going down..
I will skip the mad adventures I had in Manahattan while dealing with the mad existence of Milberg Weiss lawyer..That was dinners at LeCirque, or Lettece...including up to 20 lawyers in a "meeting" the check being paid for out of the lawsuit funds.for legal expenses.
But anyway..to the important stuff the trial and the Federal judge..The trial took place in New Jersey in a huge room which was much bigger than any courtroom I have ever seen.The judge exhibited no sensitivity and did not beat around the bush..He told both parties that he expected them to settle. And not waste his precious time drawing things out...and if one side opposed the settlement then he was not going to be very happy about it.And they would be doing it at their own risk. They settled for 85% of the Shareholder lawsuit insurance that all big Corps carry...
I think it is possible this could be the case in the appeals trial and the judges may be encouraging and facilitating a settlement...
":>) JL
Judge Du
Also ignored the fact that Vascepa's effects were not consistent with the Friedewald equation...And this is much more significant than any of the findings regarding Mori or Kuru. This is a total example of why Vascepa's effects were not obvious..
The Friedewald equation is a way to obtain an accurate determine LDL-C without a direct measure...It is widely accepted and in one study done at The Brigham measured over 29,000 observations and compared them to direct measurement which proved its accuracy .
The Fiedewald equations does have some limitations, at very high trigs the denominator under trigs, must be adjusted from 5..
The Friedewald equation* LDL = TC (Total Cholesterol) - HDL -trigs/5
* measurement is in MG/DL
This simple algebraic equation is an accurate determiner of LDL levels..Of note is the fact because the trigs are a negative factor opposite the LDL positive...If the rest of the factors on the right side of the equation remain constant and only the trigs are decreased then the LDL must increase..And that indeed was what happened in all other cases of drugs which lowered trigs...But did not happen when Vascepa (EPA lowered the trigs) This was very far from obvious and caused the patent office to grant the patent. The exact way that EPA does this is not completely understood today..But suggests EPA may reduce Total cholesterol..Unfortunarely Judge Du did not include this in her decision...
":>) JL
Kiwi...
Could you provide me with the 2012 article you authored on SA..regarding the Amarin 889 patent...Would it be possible for you to post it on the Amarin board.
tia...":>)JL
dreamer....
Don't get discouraged because this board is not Amarin..Lack of traffic just means you are early to the party. You are an early bird and you know what the early bird gets..
Check out the price action action...Strong as horseradish...you can tell the posters, when there are hundreds. that you bought the stock under ten dollars when they are paying fifty a share..Channel your Henry the fifth. We few.."We band of brothers."
":>) JL
MS..Sorry to butt in...
I am not a judge or a lawyer...and I don't like having to go back and digging through the Amarin Ihub posts...I believe I have heard from this site and others that the Appeals process might not place too much emphasis on Judge Du's factual errors and they (the appellate judges) may place more attention on unintended consequences..And other factors we lay people just don't understand..
I am trying to come with a solution that will allow Amarin to keep the R-I indication and not have to depend on the court reversing Judge Du..
But all I get is flack that I am rewriting the law..Which is not the case. And I do not get anyone offering a better solution..Which I would welcome..It is very difficult to imagine that our current situation is much better than it was at the time of the Du trial..IMO Amarin seemed to have presented the better case..But the judge ruled against Amarin and this does not make me extremely confident that Amarin will prevail in the appeal...
So please if any of you have a better idea than mine which is allow Amarin to keep its Vascepa patents. This allows Amarin to keep its patents for the SNDA (the REDUCE -IT indication) which the court agreed were valid...And Amarin would give the Generics the net profits from the Marine High trig indication which the judge opined the patents were invalid and the generics were free to pursue.. Judges Du's judgement was the generics would be allowed sell Vascepa for the MARINE indication because the MARINE patents were invalid..She made no such claim regarding the R-I patents..
The single greatest problem with the judge Du's decision to allow the Generics to sell the Marine indication..Is that in the real world of drugs..You can not by any measure prevent doctors from prescribing off label (including for the sNDA patent protected indication) nor is there an obvious way to stop drug plans from substituting the cheaper drug of the two ( Brand Vascepa vs Gen Vascepa)..So Judge Du's decision actually does much more than grant the generics the Marine indication, it also gives the generics the R-I indication via off labeling...And this violates Amarins R-I patents..
Please understand I am looking for the best solution for this very important problem..And posting that I am ignoring the law is not a better solution..I'm not breaking the law..I am not a judge..I am asking the Appellate Court to vacate Judge Du's decision to give the generics the Marine label because if the generics get it. Amarin is going to be very unlikely to survive..And that is their reward for doing all the work for developing the drug..Wasting hundreds of millions of dollars and ten years of their lives...
If anyone has a better idea..I would love to hear it because I want Amarin to survive and I am a shareholder..What I don't want are flip statements trying to be cute. or sound educated..It doesn't help anyone
":>) JL
I guess it was not the judge but the companies claim that continuing Vascepa past 12 weeks would be infringement..
PACER: Highlights from Amarin
Warning...format is horrible when copied to ihub, but the content should be enough to get the message across.
BB
Quote:
XI. DEFENDANTS INDUCE INFRINGEMENT OF ALL TEN ASSERTED CLAIMS ........ 78
A. Infringement Legal Standard ............................................................................................ 80
B. Defendants’ Labels Will Induce Clinicians to Administer Defendants’ ANDA Products to
Severely Hypertriglyceridemic Patients for at Least 12 Weeks ...
":>) JL
Irish...
Quote..s it possible that because no statin was trialed that the label could carry a very clear warning and state that "not to be taken with a statin if Tgs of 500 or over".
It is possible, but there is no reason to exclude statins based on the fact they were not used in this trial..Very high trigs are the residue of very high systemic inflammation...There is some anecdotal suggestion statins also have some anti inflammatory effects.
":>) JL
Sorry...I meant 12 wks not twelve days..
Thanx for the correction...
":>) JL