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Generic launch - this is all a game of chicken - the Teva case changed the equation.... generics want to make a safe sure fire profit -legal costs are a chicken feed gamble (continuing the theme) but now it’s all about assessing risk and profit for the generics
We can all pontificate about where the infringement law was / and now is .... but if you were cock sure(again continuing the theme) about making a killing profit on GV before the Teva case you are currently seriously recalculating now if you are a generic
Why risk ? For what reward ? Amarin don’t have to PR to tell the generics what they will do ... they are working it out for themselves ....
This is now a watching game ... wait see what happens ... en banc ? Further legal action to get decision changed ?? launch ..??. injunction ???... infringement/damages??
But each day as time passes by the damage shrinks just a little /and potential for Amarin to make profit in USA grows and Europe approval nears ... a slow recovery in SP over time ... hopefully ???
Alm
I
Maybe Singer will get another chance - en banc or SCOTUS to make sure he knows and explains the law correctly and why the D.C. and FC got it wrong !!
Alm
Marjac - noted
Whom can bring such an action ? Amarin of course .. but a body of shareholders if needs be independent of Amarin ? Can you do it farting for such a group and funded by them ? Are we certain Amarin will bring such an action ?... I do not perceive any immediate time limit would apply to such an action ??
However going back to the immediate issue ... it still seems to me that the Mori flaw has to find its way into the current litigation ....in this sense that whilst Mori flaw may be rejected (because the court can not (so it seems)take this into account on a procedural basis(new evidence) (am I correct) the court will despite this be more influenced by its knowledge of it - even though rejecting it
Are they more likely to reject en banc. Knowing - although not admitting in procedure -that another fatal flaw exists in this case upon which du unwittingly relied -which played huge part in reaching the wrong decision???
Is this not similar to the concept that judges are (sadly )influenced by other persuasions eg their politics)
All sorts of things influence their judgement
A fair judge would I feel reach the conclusion They are going to make good the wrong - They would consider there are several wrongs here - they can legally take into account the K wrong and Having knowledge of another wrong - Mori -be damned sure to rely upon it
We need be certain the FC judges are aware of Mori flaw -even though they on the face of it can not take it into account
So I say find another way to get it to be required to be considered as whether it is or is not admissible evidence - even though they then say they can not on the face of it consider it because inadmissible - it is then nonetheless-within their knowledge and actually impossible to ignore !!!!
How often is it that the question a lawyer asks -even though objection is raised and sustained -is THE most important question that goes on to play in the mind of a court ??
Ask the question .... !!!!!
I do it all the time !!!
Alm
Marjac - I understood completely your logic and reasoning for Mori to not be in your wonderful amicus -and I mean the team when I refer to “your”... it is frustrating to think that the wrong that is Mori can not be placed before the court ... is there some other mechanism by which this could be still done ? Even as lawyers we must think outside the box here .... the amicus is brilliant -not necessarily because it will create the en banc -(I really hope it does) but because it opens up new dimensions as to the conduct of Hikma/their lawyers/ their expert - if it is considered that there is fraud / a perversion of the course of justice - then the du decision can be righted by other means (you and I others have referred to the same - even if en banc does not materialise
Mori is a different kettle of fish - no assertion of impropriety is associated with this - but for a court to unwittingly found in part at least its monumental decision on a study which has fundamentally flawed statistical analysis is an injustice which has to be righted
How ? By what mechanism can this be done ? And how succinctly - in one page can this be stated - HinduKush ??
The double effect of K (fraud) and Mori (statistically flawed ) is what must be negated
Marjac and team .... think this through ... how ??
The answer provides salvation
And Marjac I too will be delighted to reciprocate ... on anything that crosses the pond ...
Alm
8 maybe correct as to CAFC procedure as to response to the court - but forgive me these are allegations/assertions that Hikma/ it’s lawyers it’s expert perpetrated a fraud on the court / misled the court / deliberately altered the face of a document (cropped table )
Hikma / their lawyers/ their expert may wish in the public domain to respond to such ..whether formally as requested by the court or not
You are a lawyer ... if such allegations were made against you how would you respond ? You might wait until invited by the court to do so .. if not so invited would you just ignore ??
And as to professional investigation/ disciplinary action - seriously are they not valid considerations here ... ??the amicus says fraud - in effect by Hikma it’s lawyers it’s expert
If there is traction in this amicus there would have to be such
If deliberate conspiracy by Hikma it’s lawyers it’s expert to pervert a courts decision - one with billions of dollar consequence as to loss -you bet it would be a criminal investigation
Alm
Marjac-I stayed away from reading the board for a month -so I have missed the party -sorry this not to have contributed financially if nothing else -awesome job you and the team-getting it in quick was absolutely right approach-he who hesitates...we discussed time back that litigating the f...out of the generics is the way..delay delay delay...the amicus serves purpose-both to support and add dimension to the singer en blanc but also sends shot across the bows to generics that this litigation has way to go and yet in different directions of travel.. the TEVA case was the gift from heaven as to decision and timing - from one lawyer to another -admiration -Hikma and their expert are now stuck between a rock and a hard place ....how do they answer to the Amicus assertion of fraudulently / deliberately misleading the court -evidence on oath -was it truthful?-was it deliberately misleading the court - both expert and the Hikma lawyers have a duty to the court...was the cropping of K tables deliberate and thus fraudulent ... was it intentional but this the court was nonetheless misled
Hard to see that Hikma and expert can ignore these assertions
Silence - an acceptance of the facts and an exercise of right to not self incriminate ??
Or respond - denying what exactly ? ...
they have to respond - the court can not simply ignore these assertions without asking Hikma / expert to reply to these assertions
That is not the same issue as to whether the FC allows / denies the en banc ...
The FC has no choice in the face of such grave allegations but to invite and consider Hikma/ expert response before deciding en banc
It may be that in the light of the response the FC will refer the assertions for investigation by the professional bodies of both the Hikma lawyers and expert /professional body and even further to criminal investigative authority if perjury and perverting the course of justice are considered in issue
Indeed further it would be entirely appropriate for Amarin shareholders to report Hikma lawyers and expert to their professional bodies and criminal investigative authority
(As you know I am UK lawyer so not au fait with names of the professional bodies concerned)
Nothing worse for lawyers and experts to have professional disciplinary investigation / criminal investigation
Huge can of worms unlocked here -
Mori - is it not possible ?? Time permitting and from another Shareholder group ? For a further Amicus to be lodged - is it not right that the FC is formally made aware that the statistical basis behind the Mori conclusion was fatally flawed and the D.C. should actually of its own volition in the light of same have reviewed its own decision Du failure to do so a matter which should be highlighted in such secondary Amicus
Alm
North Marjac - welcome your views on the fish article and prospects of injunctive relief on generics selling into the reduce it market and infringement of such
A potentially mighty weapon in this battle ??
Alm
Dancing - or indeed gather the evidence that the drug has been sold in such quantities by the generics that they know that it can only have been sold via infringement
The trick here may be for Amarin to make it clear before the generics even start that this is exactly what they will do go on boys set your business up to sell gV but by golly if you sell so that reduce it patents are infringed then we will seek injunction and triple damages on lost profits
Big risk to generics ???? We all know and the market has reacted this way reflected in share price that the generics want the reduce it market by the back door ... but can they get it ???
Played well this could give Amarin the opportunity to stop them dead when they have spent huge amounts setting up to sell GV
Alm
Correct - and Amarin seeks injunction to prevent infringement - and if they obtain such generics are toast
Alm
Marjac
Injunctive relief for infringement of reduce it patents ?? See fish article ... viability of obtaining an injunction - needs very careful consideration in my view
Alm
Excellent analysis- from earlier posts - see Fish and Richardson article-there appears opportunity to seek injunction to prevent infringement of the reduce it label patents which are not affected by the D.C./FC decision
If granted the generics would have to cease selling
Amarin would lose nothing in attempting to obtain such an injunction save the legal fees involved - the gain would be immense - such goes without saying
Evidence could be carefully collected from various sources as to how generic sales infringe on the reduce it patents
The generics will of course be aware of this risk to them and it may colour their enthusiasm
Alm
HinduKush
Can you consider this ?
Alm
Cards see this post
Card and G
Agree with this as a valid line of attack
But see also re the Vascepa 2.0 impact of that could be very significant
Alm
Kiwi / J
Now that would be A very I interesting prospect ....
There may be many ways to skin generic cats ...
Alm
Send to singer ....
given he is at Fish he should have read it ... but you never know
?? Marjac./ North ... what do you think
? My view ... they should hit generics with every bit of litigation they can whenever they can
Generics play a very dirty game
Amarin needs to give it back to them in spades ...
Delay / prevent .... any way you can
Alm
Marjac - quite clear that the OA was a complete sham .... the decision had already been made - Dyk volunteered to be the mouth piece of the panel - other two happy to let him
I actually doubt they have any detailed reading to the briefs or the underlying case evidence
This was a skim read at best knowing they could get away with an “affirm “ which did not require a detailed opinion
The appeal process was in its entirety a sham
Losing at DC was everything
Amarin failed to throw every resource in its possession at that trial when winning was everything to the life of the company
We need now collect the shreds of meat from the bones and get whatever value we can from whats left
I can’t see that Amarin will work with generics over entry timings - too many separate interests in play
- so they should try delay by any legal means to give breathing space to re group
Sure singer who is a bright lawyer will be advising as to how they can best do this
Gaining time before generics launch is vital
Alm
Kiwi
I agree that if Amarin is to succeed globally they in effect need to stack it high and sell it cheap
- I see Hamoas point - there will be 4 generics fighting over what is yet in USA a small established market - whether this delays entry is a big question .. Amarin would be profitable if lots of costs were stripped away - continuing to throw big bucks at market development without profit and for a short time is pretty pointless - it worked if they had long patent protection in USA - that’s gone
So things must change
Effectively Amarin could - if it can sell it cheaply enough now become the generic in USA-and make it economically unattractive thus for other generics to compete
This would also enable them to sell it cheaply in Europe and row
Making as much profit as it can out of any particular market place
It is now -if Amarin an independent company -all about how they operate financially
They could be acquired of course by another drug company who for example has established sales and management in Europe /row and who could still operate effectively as a generic seller in USA
Questions of timing and low cost market delivery
I suspect for a small company such as Amarin / with no organisation outside USA - and limited one at that in USA- where it is designed currently to operate on a different model -this is all too big an ask
Question is also whether any pharma out there want to take this challenge on - and to have to pay to BO a Amarin for the privilege of taking this task on
Alternatively Amarin could just operate on a Canada basis country by country across Europe and row letting local partners do the leg work and simply become a royalty company in effect - whilst this was not likely in the past whilst they had USA behind them with patent protection it may be a direction they have to travel now
All very big questions and decisions ahead and very careful financial management required
Staying independent poses huge long term issues of running and developing the company business ahead
I can see that if anyone would buy JT and board would jump at it
Alm
None of these options are easy
Could
I agree the desire financially for JT Personally is likely now on A sale ASAP - post Europe grant
I agree that he will have a long very hard slog running company on a Europe / row basis
I agree he would be seen still as successful if he arranges sale on a reasonable sp basis
Suspect he want to retire from the job enjoy his money rather than die on the job consequent to the momentous challenges ahead
Just a question of finding a buyer !!!
Alm
Kiwi
I agree that when generics launch Amarin either should or would have to stop the costs of funding a build of USA market
The question is whether they stop it right now or not ... saving costs inevitably important ... but so are sales
If sales could be maintained - prior to generic launch at current levels or even increase without advertising / big sales force this may yield good profit to the company - cash in the bank
The assessment of whether they would get a return via increasing sales from further promotion - and for how long ? Is a difficult question to assess
Careful business trading management is absolutely necessary in this balancing time
I am not sure the TEVA early launch / 6 mths exclusivity as a generic is worth that much in an underdeveloped market - only for other generics to come in and split the market even further
Hamoa has made the very valid point that generics usually capitalise on generic drug price undercutting in a well developed market
Why launch if you lose money ?
They will need to be very sure of their profit line here ...
The longer launch is delayed the stronger Amarin should aim to get financially
Another thought ... a developed european /row market would entail diverting supply away from USA ? A higher price could be paid by the selling company ?
Some time ago there was much debate about whether there was enough world wide to create sufficient supply - I recollect 5 billion in sales was the sort of level as being discussed as to total world supply potential
Europe /row should be able to pay a higher price for the drug from supplier to selling company than generics would want to pay for a cheap generic USA supply
Alm
Kiwi
Amarin can spend to build but can still make a profit as they do so ... I presume
So for example getting the market big and fat through Amarin’s efforts - and Amarin make money whilst on the way enables generics to enter at a profitable point for them
The generics will know how much they need to sell to turn a profit - if market and share of market not big enough - no profit
Alm
Hamoa’s point is that it is uneconomic for a generic - the first generic - to launch - followed 6 months later by two other generics -and maybe more ?? Amarin selling V as cheap as generics can - for if generic can profit from a generic version so to may Amarin ?
Is there any profit to be had by launching now ?- even though you may be the first to launch (only a six month gain) - that is the question for Teva. And then if Teva don’t launch do Hikma and Dr R - ?
Or do they all wait until Amarin has developed a big fat market for them to try carve up ?
It’s an interesting question ...
another year or two of USA market without completion will help Amarin as to Europe/ Row
Generics want to make money not loose it ... so they have much to consider perhaps
Alm
Many have had sleepless nights- two in a row for me -with thoughts reflecting yours
The strongest feeling I have is why with a one drug company - everything riding upon it they did not take the right steps - for example choice of district court and right response s - for example tearing each of the studies relied upon to pieces - eg Mori - the best schooled experts and so forth
They should have thrown everything at it and more so not to lose in DC
Madness .....
What you say about now and hereafter as to the future I agree and share as the only option available to a long large shareholder
If it takes 2/3/4 years or more I will have to wait ... 10 - 12 -15 dollars would be a wildest dream come true
Good luck to us both and all others in the same boat
Alm
hi Marjac
You will be as disappointed as I am at the travesty of these two judicial decisions- D.C. and FC
Amarin need to work the problem create every remaining legal difficulty open to them to delay and frustrate generics ... throw as much as they can at them - whether it’s a realistic option or not frustrate the hell out of them !!
The second appeal ... not consolidated - why should they not run it ? En blanc S.C. ... other patents being infringed if they launch ? Injunction? ...
where could they go with all of this .... I???
Alm
hi Marjac
You will be as disappointed as I am at the travesty of these two judicial decisions- D.C. and FC
Amarin need to work the problem create every remaining legal difficulty open to them to delay and frustrate generics ... throw as much as they can at them - whether it’s a realistic option or not frustrate the hell out of them !!
The second appeal ... not consolidated - why should they not run it ? En blanc S.C. ... other patents being infringed if they launch ? Injunction? ...
where could they go with all of this .... I???
Alm
Ok ... it’s done the appeal is lost ... the roller coaster continues
Amarin will have had two plans .... one based on a win one based on a loss
The plan now it is lost may have many elements
Let’s think through what they will be ...
- settle with genetics - personally can’t see how that would work ??but ...
Find further ways to litigate - to protect patents - delay delay delay and frustrate generics
- they may have agreed a sale with two values - a higher win value. A lower lose value
- they may now actively seek to sell if they had not lined up a deal prior to
- they will conserve cash -
- keep sales in USA going for as long as they can but keeping tight control on costs
-partner
- GIA Europe
Just some brief thoughts
Let’s get our thinking caps on
There is value in this company ... longs want to see i the share price go up from here - so how will value in the company be driven forward
Ok so board changes may be a focus - heads to roll ? But I would rather see our efforts as a board focus on what can / could lie ahead
Thoughts ?????
Alm
Lemmi
We haven’t lost USA - not today
We may win it back but if we don’t what you say is true
Keep the faith
Alm
Irish
Correct beautifully and calmly expressed
You and your family be well also
Alm
I have not read all posts yet following OA
But ...
There were 3 judges on the panel
Hughes I gather said nothing - so tell me how do you read his position from OA ?
Reyna did not say a great deal but from what I gather was not condemning of Amarins position on appeal - he sought certain clarifications - how do you read his position from OA
Clearly one of the 3 did not come over as supportive - gave Singer a hard time - but are you sure you know which way he will rule?
Now reflect on the fact that these 3 judges have Considered / will yet consider in detail the briefs - the bedrock of an appeal
Anyone / the market / who says they know the appeal outcome on the OA is a fool
I don’t know we have won
I don’t know we have lost
Do you think the Judge - Who was so noisy in the OA spoke for all 3 judges - ? the judge who incidentally has just been overturned by the FC - maybe he was a bit pissed and wanted to make a show
I will know whether we have won or lost when I here the outcome
I am a lawyer
I have lost cases I thought I had won in front of a tribunal and I have won cases I thought I had lost
The legal arguments remain strong ... they are reflected in the briefs in a compelling manner
Await the outcome - before you either rejoice .. or jump off a ledge
Alm
8 -one lawyer to another - we don’t quit when we are committed to a client - no matter how unpalatable they sometimes can be ...
so you ain’t quitting- the board needs good lawyer input - which you give - same as we lawyers need the other intelligent and helpful work of others on this board
So — your back !!!
We need you
Alm
Simply put there are two separate appeals - the first to be heard as to oral arguments on 2nd September
The parties in effect recognise -as does the court -that the finding on the first appeal after oral arguments - will in reality determine the outcome of the second appeal -there is thus no need to consolidate the two cases -
So the first appeal outcome is what counts
It’s essentially a procedural way of resolving the two appeals as one rather than consolidating them
Trying to keep this simple -But USA lawyers on the board will correct me as needs be ...
Alm
One wonders whether the Covington team took much cognisance of DU’s past patent decision record in the way in which they failed to pursue their Amarin litigation with a cover all leave no stone unturned approach
Given what rested on the Du decision (and certainly with hindsight -forgive the expression) so much more could and should have been done
Alm
Send to singer
Brilliant and concise
Alm
8 - now that would be pointless ... a contribution .....but Singer could not consider it ?
What I do consider is that some of the technical contributions made here (and I would be a fool of a lawyer to try and write one) have been breathtaking in their detail and depth and I am damned certain I would have wanted to consider them if I was Singer !!
It is moot but nonetheless the case that had some of the depth of work that has since the DC trial been conducted been undertaken earlier by the trial lawyers expert team (as demonstrated since by a number of posters - for example the genius that is HK ) we might not be facing an appeal at all !!
I don’t think you need protect J Singer
Alm
8 - I suspect he is busy - but I suspect also other eyes and minds are working with him -my experience - as a lawyer - sometimes things come to you unexpected and last minute that you would regret not having ...
Alm
M -agree - let’s keep nudging- Alm
Amarin inevitably want the appeal and eu to coincide - win appeal and combined strength of these two markets makes delivery to both these markets /patients -through amarin - or more likely through the buy out of amarin - an incredible business proposition -for the company -or the big pharma that acquires the company
That is their hope and first choice as to the way forward
Loose appeal and it gets complicated - but let us not dwell on such now
It should never have been so
Everything I have read ... and there has been a great deal to read and digest -leads to the inevitable conclusion that the appeal will be won - I sincerely hope and pray - as a lawyer - that justice is served and the appalling travesty of Du’s Judgement will be consigned to history
Let her conscience for all the damage she has caused lead her to the conclusion that she should resign her position as a District Judge - such is the correct course for her to follow - her intellectual and legal judgement was wrong on so many levels that she should never allow herself to be trusted with such responsibility again
Alm
Send to singer ....
alm
Not to late— send to singer
Alm
Send to singer
Alm